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Student Textbook

ISO/TS 16949:2009 Certified Lead Auditor


Training

By: AQS Management Systems, Inc. and Quality WBT Center for Education

Note: The student textbook contains the text content of the class without
interactive exercises, activities, notes, glossary links, images, examples, key
points, tips, tests, handouts or summaries. The student textbook can be used for
off-line refresher and future reference after the class. The student textbook
should not be used in place of the web-based training program.

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Table of Contents
LESSON A01: TERMINOLOGY AND DEFINITIONS...................................................................................... 4
NOTABLE ORGANIZATION CONCEPTS .................................................................................................................. 4
NOTABLE TERMS RELATED TO CONFORMITY....................................................................................................... 5
NOTABLE TERMS RELATED TO MANAGEMENT ...................................................................................................... 6
NOTABLE TERMS RELATED TO DOCUMENTATION ................................................................................................. 6
LESSON B02: BACKGROUND, HISTORY AND RATIONALE OF QUALITY MANAGEMENT................. 8
A. HISTORY OF ASSURING QUALITY.................................................................................................................... 8
B. LACK OF CONSISTENCY ................................................................................................................................ 11
C. NEED FOR A COMMON APPROACH ................................................................................................................ 12
D. INTERNATIONAL ORGANIZATION FOR STANDARDIZATION ............................................................................. 12
E. CREATION OF ISO 9001................................................................................................................................ 12
F. REGISTRATION AUDIT DRIVES QUALITY IMPROVEMENT ................................................................................ 13
G. IMPACT OF CONFORMANCE .......................................................................................................................... 14
LESSON C03: INTRODUCTION TO ISO 900116
A. QUALITY MANAGEMENT PRINCIPLES ............................................................................................................ 16
B. PURPOSE OF ISO 9001.................................................................................................................................. 21
C. ISO 9001 DESIGN/ STRUCTURE .................................................................................................................... 21
D. ISO 9000 FAMILY ....................................................................................................................................... 22
E. FUTURE ....................................................................................................................................................... 22
LESSON D04: THE CONTENTS OF ISO 9001 - INTRODUCTION ............................................................. 23
0.1 GENERAL ................................................................................................................................................... 23
0.2 PROCESS APPROACH ................................................................................................................................... 24
0.3 RELATIONSHIP TO ISO 9004........................................................................................................................ 25
0.3.1 IATF GUIDANCE TO ISO/TS 16949.......................................................................................................... 25
0.4 COMPATIBILITY WITH OTHER MANAGEMENT SYSTEMS ................................................................................. 26
LESSON D05: SCOPE/ EXCLUDING CLAUSES/ DEFINITIONS ............................................................... 27
1.2 APPLICATION .............................................................................................................................................. 28
2. NORMATIVE REFERENCE ............................................................................................................................... 29
3. TERMS AND DEFINITIONS .............................................................................................................................. 29
LESSON D06: GENERAL SYSTEM/DOCUMENTATION REQUIREMENTS............................................. 31
4.1 GENERAL REQUIREMENTS ........................................................................................................................... 31
4.2 DOCUMENTATION REQUIREMENTS .............................................................................................................. 32
4.2.2 QUALITY MANUAL .................................................................................................................................. 33
4.2.3 CONTROL OF DOCUMENTS ........................................................................................................................ 33
4.2.4 CONTROL OF RECORDS............................................................................................................................. 34
LESSON D07: MANAGEMENT COMMITMENT/CUSTOMER FOCUS/QUALITY POLICY AND
PLANNING REQUIREMENTS......................................................................................................................... 36
5.1 MANAGEMENT COMMITMENT ..................................................................................................................... 36
5.2 CUSTOMER FOCUS ...................................................................................................................................... 37
5.3 QUALITY POLICY ........................................................................................................................................ 37
5.4 PLANNING .................................................................................................................................................. 37
5.4.2 QUALITY PLANNING................................................................................................................................. 38
LESSON D08: MANAGEMENT RESPONSIBILITY/REVIEW (5.5 - 5.6)..................................................... 40
5.5.1 RESPONSIBILITY AND AUTHORITY ............................................................................................................ 40
5.5.2 MANAGEMENT REPRESENTATIVE ............................................................................................................. 40
5.5.3 INTERNAL COMMUNICATIONS .................................................................................................................. 41

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5.6 MANAGEMENT REVIEW .............................................................................................................................. 41


LESSON D09: RESOURCE MANAGEMENT (6)........................................................................................... 45
6.1 GENERAL ................................................................................................................................................... 45
6.2 HUMAN RESOURCES ................................................................................................................................... 45
6.2.1 ASSIGNMENT OF PERSONNEL .................................................................................................................... 45
6.2.2 COMPETENCE, AWARENESS, AND TRAINING ............................................................................................. 46
6.2.2.1 PRODUCT DESIGN SKILLS: ...................................................................................................................... 47
6.3 INFRASTRUCTURE ....................................................................................................................................... 48
6.4 WORK ENVIRONMENT ................................................................................................................................. 50
LESSON D10: PRODUCT REALIZATION (7.1 - 7.4).................................................................................... 52
7.1 PLANNING OF REALIZATION PROCESSES ...................................................................................................... 52
7.2 CUSTOMER-RELATED PROCESSES ................................................................................................................ 53
7.3 DESIGN AND DEVELOPMENT ....................................................................................................................... 55
7.4. PURCHASING ............................................................................................................................................. 60
LESSON D11: PRODUCT AND SERVICE OPERATIONS (7.5-7.6) ........................................................... 66
7.5.1 PRODUCTION AND SERVICE PROVISION CONTROL ..................................................................................... 66
7.5.2 VALIDATION PROCESS ............................................................................................................................. 70
7.5.3 IDENTIFICATION AND TRACEABILITY ........................................................................................................ 72
7.5.4 CUSTOMER PROPERTY.............................................................................................................................. 73
7.5.5 PRESERVATION OF PRODUCT .................................................................................................................... 73
7.6 CONTROL OF MEASURING AND MONITORING DEVICES ................................................................................. 74
LESSON D12: MEASUREMENT, ANALYSIS, AND IMPROVEMENT (8.1-8.5)......................................... 79
8.1 GENERAL ................................................................................................................................................... 79
8.2.1 CUSTOMER SATISFACTION ........................................................................................................................ 80
8.2.2 INTERNAL AUDIT ..................................................................................................................................... 81
8.2.3 MONITORING AND MEASUREMENT OF PROCESSES ..................................................................................... 82
8.2.4 MONITORING AND MEASUREMENT OF PRODUCT ....................................................................................... 84
8.3 CONTROL OF NONCONFORMING PRODUCT ................................................................................................... 85
8.4 ANALYSIS OF DATA .................................................................................................................................... 87
8.5 IMPROVEMENT ............................................................................................................................................ 88
LESSON D13: PROCESS APPROACH EXPLAINED .................................................................................. 93
END ................................................................................................................................................................. 95

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Lesson A01: Terminology and Definitions


Objective of Part A
To familiarize students with the terms that are associated with:
• the proper administration of the quality management systems
• the proper auditing of quality management systems

Discussion:
The ANSI/ISO/ASQ Q9000-2005 Quality management systems – Fundamentals and
vocabulary (ISO 9000) standard defines selected terms and provides background
information about quality fundamentals. When dictionary definitions are not sufficient to
support the quality management (9000 series) and technical standards (10000 series),
definitions are provided in ISO 9000.

Take out the ISO 9000 standard now and look through it.
Turn to the table of contents and see how the standard is organized.
Turn to clause 3, Terms and Definitions and read the first clause on how definitions can
be nested and when special meanings apply. Notice that the terms are not in
alphabetical order.

Turn to Annex A to see how terms are grouped by concept diagrams.


Turn to the alphabetical index; this is where you go to look up a word.

You will need to reference the proper definition of some terms from time to time to fully
understand the ISO 9001requirements and their intent. You will find that your
knowledge of the definitions will be very useful in determining conformance or
nonconformance to a requirement. The concept diagrams in Annex A are like a family
tree. The diagrams link terms that are related to a particular concept or topic.

ISO 9000 Terms and Definitions


We do not have the time to discuss every word definition, so we have picked some that
we think are especially important or have some aspect that you need to be aware of.

Notable Organization Concepts


The word organization is used to indicate the user of the standard. The organization can
be a manufacturer or service company, private or public, regulated or non-regulated,
and small or large. The organization implements the management system and is
audited by a registrar.

In the United States, the term "stakeholder" has been used over the last two decades to
reference individuals or groups that have a stake (something to lose or gain) in the
outcome of a process or activity. Worldwide, the term 'stakeholder' does not translate
well so the ISO 9001 standard uses the term interested party to refer to those interested
in the performance or success of the organization. Normally a competitor is not
considered an interested party since they seek the elimination of the organization.

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The term infrastructure is defined and used as the title of ISO 9001, clause 6.3. The
word "infrastructure" may be used when referencing an organization's facilities, utilities,
and equipment.

Notable Terms Related to Conformity


The definition of the term nonconformity is non-fulfillment of a requirement.
Nonconformities result in other actions (see diagram a01concept1). The term correction
refers to responses to nonconformities that only alleviate the specified nonconformity.
Other popular terms for correcting are containment action or remedial action.
Correcting must not be confused with corrective action or preventive action.

Important: Please note there are two kinds of prevention. Corrective action requires an
organization to prevent "recurrence" (reactive) and preventive action requires an
organization to prevent "occurrence" (proactive).

Notable Terms Related to Process and Product


A product is the result of a process. Therefore, a product can either be a service like
housekeeping or something tangible like a paint can or a lawn mower. There are four
product categories supported by the standard.

The categories are:


• Hardware: The value added item for the customer is an item that has physical
form, you can see it and touch it; it is produced with machines or assembled
[nuts & bolts, automobiles, I beams, refrigerators, computers, etc.].
• Processed materials: The value added item for the customer is an item that
normally undergoes a treatment, change of state or chemical reaction when
produced [ chemicals, rubber, plastics, gasoline, pharmaceuticals, food]
• Software: The value added item for the customer is a code which gives
instructions to hardware or other software.
• Service : The value added item for the customer is the execution of a process
such as: retail sales, renting, personal service, and collective bank or insurance
services.
Product is produced by a process. The technical definition for a process is that it is a set
of interrelated or interacting activities which transforms inputs into outputs. Simply, a
process is associated with some type of action or transformation such as stamping,
rolling, designing or other actions that create value.

Notable Terms Related to Auditing


As standards evolve, such as the auditing and environmental standards, so does our
need to understand the terminology used by the audit experts. The term quality audit is
not in the ISO 9000 vocabulary standard and has been replaced with the generic term,

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audit . There is little difference between the "quality audit," “environmental audit,” and
"audit" definition.

The audit definition simply requires that audits determine the extent to which the audit
criteria are fulfilled. The audit criteria may be determined on an audit-by-audit basis.

There is an audit client, who is the person who has authority to request the audit. Audit
evidence is collected and then evaluated objectively. An auditor collects audit evidence
to determine audit findings. The term audit findings refer to the conformity or
nonconformity to the audit criteria as well as any opportunities for improvement. The
output of the audit process is the audit conclusion. Based on the findings, an auditor
may recommend or not recommend registration.

Notable terms related to Quality


The definition of quality is short but somewhat technical in nature and not as simple as
we would like for everyday use. In this group of quality-related terms, there is a
definition for customer satisfaction. Since customer satisfaction is one of the primary
aims of the standard, it is important to define this term. The definition for requirement
(ISO 9000, 3.1.2) is very interesting because it goes beyond stated needs and
expectations.

Notable Terms related to management


Probably one of the most prominent and challenging of audit terms in the standard is
effectiveness. Effectiveness shows up 14 times in the ISO 9001 standard. One of the
most recurring phrases is to continually improve the effectiveness of the quality
management system. Other clauses in the standard require effective application,
implementation, processes, planning, operation, control, arrangements and
communication. Auditors will need to verify that effectiveness requirements are being
met.

The term system is in this same group of terms. A system is a collection of processes.
There are some alternate definitions in the glossary to provide more background, but for
conformity audits, only the ISO 9000 definitions apply. There is a quality management
system that includes quality control, assurance, planning and improvement processes.
It is important to know how quality control and quality assurance are related. The
concept of quality planning and issuing quality plans should be well understood.
The term for senior management, executives or high level management is top
management. Top management is universally acceptable worldwide.

Notable Terms related to documentation

A document is information (meaningful data) and its supporting medium (paper,


electronic, film, and so on). A document can be a record, specification, procedure,
drawing, report or a standard. Set or collection of records or specifications can be called

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‘documentation.’ A procedure is a particular type of document that states a way to carry


out an activity or process (determines how it will be done). A record is another type of
document that states results or evidence of activities performed (determines what was
done).

Comments
Studying word definitions (lexicology) can be very insightful. The ISO 9000 definitions
are somewhat technical but will prove useful during an audit. Knowing the words will
result in a sharper focus and better understanding when determining conformance to
requirements. Using the correct words will improve communications between you and
the organization representatives.
Sector specific terms are normally included in clause 3 of the requirements standard.
Clause 3 word definitions will be discussed in order as we discuss each clause in a
step-by-step fashion.
In the next lesson we will discuss the basis and evolution of quality management.
Knowing the history will help you understand how the standard has evolved to what it is
today.

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Lesson B02: Background, History and Rationale of Quality


Management

Objectives for Part B (Lesson PartB02):


Students will be able to:
• Compare traditional with new QMS philosophy
• Explain benefits for adopting a QMS
• Review cautions that apply to the misapplication of QMS
• Identify forces that encourage QMS adoption

Knowing the history of standards and how we got to where we are today will help you
be a better auditor. An understanding of history will put quality and the auditing
profession into perspective. When you understand history you will understand why we
do what we do and how we got to where we are with regard to our quality practices.

You will also be able to explain the benefits of adopting a quality management system
(QMS) to others. You also need this perspective to learn about misapplications of
standards. History is only a small part - but a valuable part of this class.

A. History of Assuring Quality


The quest for quality is not new. Going back 2000 years or more, there were master
craftsmen and apprentices. In the very early years, products produced were used in the
local community. They tended to be focused on survival and were often associated with
farm tools and hunting equipment. As society progressed, products and the demands
for products moved beyond providing the basics for survival. Many products such as
silverware or furniture were produced upon demand by tradesmen such as a silversmith
or cabinet maker. Products were produced in a small workshop environment where
people were responsible for the business as well as quality. Craftsmen took pride in
their work. One of the hallmarks of this era, was that products tended to be unique. It
was the norm that no two products looked exactly alike, even when produced by the
same craftsman.

As customer demand increased, those producing products responded by producing


higher volume products with higher quality. As we become more sophisticated at
producing quality products we adapted many techniques to achieve results. With mass
production came engineers and product standards. Products were produced to an
increasingly well defined standard or specification. Companies were formed and
products were produced in large shops or factories. To produce products in volume and
at low cost, it became important for processes to be repeatable. Repeatability in
processes and product drove down costs and drove up quality. The first product
produced in the morning was the same as the last product produced in the afternoon.

As organizations grew, it became necessary to hire people to supervise people and to


assure the end result. As the demand for quality and increasingly complex products

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continued to grow, it became nearly impossible for supervisors or shop foremen to


assure results. Customers such as the military wanted to make changes and they
wanted products to function as designed. Defective mortar fuses reduced military
effectiveness and caused friendly fire casualties. Placing all of these responsibilities on
the shoulders of one person no longer achieved the results demanded by increasingly
sophisticated customers. Inspection departments were formed to check products to
make sure they met specifications.

The major event in the evolution that drove quality to a more reliable and more
systematic endeavor was World War II. The United States had a very small military and
was simply unprepared to fight a major conflict. The key component to overcoming
these problems and winning the war was the unprecedented “ramp up” of production for
war purposes. More people would be involved in producing more products and more
sophisticated products than ever before in history. A way needed to be found to
achieve the desired quality, productivity and reliability results demanded by a nation
entering a major world conflict.

The United States Navy undertook the problem with a systematic approach that
changed the way organizations approach nearly everything they do. The Navy actually
went out and studied those organizations that were already producing product and were
doing it well. The question that the Navy wanted to answer was “what techniques are
these organizations using that make them so successful?”

The results of this study generated a “Best Practices” list that was eventually shared
throughout all branches of the service and with our allies in the war. It contained those
things that were associated with high levels of quality and productivity results. This list
of Best Practices became the first written attempt at a generic quality standard and
should be considered the grandfather of what eventually became ISO Quality
Standards. This was the first formal attempt to study quality from a systems
perspective.

As countries and businesses responded to increasing global trade after World War II,
generic standards started to appear. There were inspection standards (Mil I 45208),
quality program standards (Mil Q 9858A) that required production control, quality
assurance control, nonconformance controls and specialists in planning and metrology.

As the world moved into even more global trade, it became evident that nations and
industries needed to agree on the definition of quality. The lack of a clear definition
resulted in disagreements and barriers to the free movement of goods and services
across international borders. Standards began evolving from a list of rules for QMS into
a philosophy backed by principles and quality management goals that were clearly
documented. The first successes in this effort were clearly defined product standards.
Product standards evolved for two reasons:
• Product standards brought consistency to issues impacting health, safety and the
environment, such as safety standards for electrical components.

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• Product standards brought uniformity that enabled products to be exchanged and


used across international borders, such as photographic film.

Quality systems standards evolved so that purchasing organizations could have an


increased level of trust in the vendor organizations they use.

Today we live in a world where quality management systems standards are accepted
world wide. They help everyone follow a common model that is proven to represent
best practices. They provide confidence to purchasers throughout the world and they
help organizations demonstrate to themselves, their customers and other stakeholders
that they are meeting the requirements that are considered necessary to do business in
today’s competitive marketplace.

History of Assuring Quality


Critical components of
achievement
Time Significant characteristic/ Trends Quality System Pride Product System
uniformity uniformity
Pre- Craftsmen Guilds X
1850
1850- Mass production Initial use of X
1900 standards
1900- Increased product complexity and Inspect in quality X
1950 consumer demand
1950- Increasing global trade First use of X X
1970 generic standards
1970- Focus on quality Use of various X X
1987 generic and
product standard
increases
1987- World trade ISO 9000 and X X
Today harmonization
product standards
Future World quality focus World class TQM X X X

Summary:
On the chart above we watched the evolution from quality assurance to quality
management. Pride and ownership was the primary assurance of quality in the early
years. As organizations and their products became more sophisticated, we developed
other means to assure product consistency. While this did not necessarily mean that
pride and ownership were missing, it does mean that these attributes were not the
central focus of achieving customer satisfaction and performance results.

As we developed means to produce consistent products it became apparent that we


needed systems to manage how people worked together to achieve desired results.
This is what we today call Quality Management Systems. Quality Management
Systems allow organizations to focus on product consistency through a defined system.

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The challenge for organizations today is that they will need to rely increasingly on their
people to achieve necessary quality and performance results. Most experts agree this
will only happen when people have personal ownership in the achievement of product
and systems results. As we move to the future of quality, the challenge will be to
increase pride and ownership on the part of every employee.

B. Lack of Consistency
Prior to the introduction of ISO 9000 quality management series standards, people/
groups/ nations/ industries around the world all addressed quality in different ways.
Many factors could influence how countries and industries addressed quality.

Also the maturity of quality control and quality assurance varied from country to country
and industry to industry. Some quality programs had evolved and others had stayed
stagnant. And even given the same set of rules, there could be inconsistencies in
methods of deployment and implementation.

Formal standards for product quality are written. Informal standards are not. Nations
and even industries differ in when, how and where these requirements are used. ISO
9001 is a formal standard. Other formal standards would include the use of electronic
circuit breakers on electronic equipment.

Regulated requirements are driven by the force of law or regulation. Different industries
and different cultures demand different levels of control in the way that some product or
system quality activities are performed. For example Medical devices are built under a
well defined regulation outlining quality management systems requirements. Light bulbs
have clear product definition regarding the power consumed in watts.

Specific standards are standards that drive product specifications. Generic standards
don’t drive the product; they drive the way the product is produced. ISO 9001 could be
called a generic standard – it is not product specific

This lack of agreement often led to trade barriers by nations, industries and special
interest groups. For example: what types of ingredients can be put in the food we eat,
and what types of control needs to be placed on the design of a product that may
impact public safety. The artificial trade barriers created by these disagreements were
not in the best interests of world economy. The trade barriers tended to benefit a select
few and protected from outside competition. . Nearly every industrialized country on
earth practices some level of protectionism that is enforced by building in requirements
to product quality or quality management systems requirements. Something needed to
be done. There was a need for a common approach to quality to resolve this issue.

As early as the 1950's, the lack of uniform standards was recognized by political leaders
and world economists as a barrier to growing international trade. The 1957 Treaty of
Rome (signed by France, Germany, Italy, Belgium, the Netherlands and Luxembourg)
established the European Economic Community. Evolution of the European

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Community in the 1970’s began to focus attention on the lack of uniform standards in
quality.

C. Need for a Common Approach


Something needed to be done to bring harmony to international trade. In the quality
field many countries and industries had their own quality standards. To ship a product
from France to Germany or US to Japan became a daunting task. There needed to be
a set of standards that are universally accepted across international borders. Such a
set of standards would enhance free movement of goods in Europe and around the
world. The time had come to overcome international differences to seek common
ground.

D. International Organization for Standardization


ISO was originally derived from the Greek root word ISOS meaning equal. In some
technical fields iso is used as a prefix meaning the same or “level”. Almost daily,
meteorologists show isobars (lines that show the areas with the same barometric
pressure) during the weather forecast. In the standards world ISO stands for the
International Organization for Standardization. ISO is not an abbreviation of the
organization’s name but is used as the logo to represent the organization.

ISO is an international standards writing organization consisting of technical committees


supported by a world-wide federation of national standards bodies. The U.S. is a
member body (American National Standards Institute [ANSI] is the U.S. representative).
ISO maintains thousands of different standards, such as those for photography,
pressure vessels, quality management systems, environmental management systems,
toys, screw threads and so on.

E. Creation of ISO 9001


The ISO 9001 standard was created from several standards. The roots of ISO 9001 can
go back as far as World War II. Another important root document was created in 1963
when the US military issued Mil I 45208A (Inspection System Requirements) and MIL Q
9858A (Quality Program Requirements). MIL I 45208 was used when a contract
required final inspection and testing and MIL Q 9858A was used when a comprehensive
quality assurance program was required. In the 1970s there were efforts by several
countries to issue national standards for quality inspection and quality programs. The
British considered inputs from several standards to publish BS 5750 in 1979. The
introduction of BS 5750 in the United Kingdom included a national third party
certification scheme. Eventually, in 1987, the BS 5750 (with modifications from US and
other standards) became the first issue of the ISO 9000 series of standards.

The technical committee, TC 176, was formed in 1985. The ISO committees have a
basic methodology for creating consensus standards. Standards are proposed and
then there is a series of reviews by member nations until the final consensus standard is
ready for publication. The review process can take several years. There is a vote at

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each step to determine if the standard needs more work at that stage, or if it can be
moved to the next stage or the work on the standard is discontinued.

The ISO Technical Committees (TCs) create the standards with input from sector-
specific interests. When the creation process is complete, member nations vote to
accept the standards. International Standards exist to serve many diverse industry
needs. Its goal was to create a generic standard for Quality Assurance Systems. The
first revision of ISO 9000 series standards was in 1987 with a second revision published
in 1994. Revisions are scheduled approximately every five year.

The technical committee (TC 176) created goals for the ISO 9000 series documents.
The document goals are:
• Outline commonly accepted requirements for quality assurance (established
practices)
• Document a common sense approach (practical, not theoretical)
• Not industry specific (be generic, applicable to all organizations)
• Not intrusive (not too prescriptive in nature – can apply to nearly any
organization)
• Organization-wide impact (affect nearly all functions)
• Provided tools for, cost reduction, continual improvement and effective
management control (establish baseline for maturing the QMS)

F. Registration Audit Drives Quality Improvement


ISO 9000 does not require or imply registration (sometimes called certification),
however this is what most organizations do. Auditors and other quality practitioners
should understand that ISO 9001 is good business whether the organization chooses to
become registered or not.

The combination of requirement standards and third party audits (registration audits)
form the basis for the conformity assessment process. Registration/Certification audits
verify conformity to requirements. Beside the obvious benefits of auditing, other
benefits are derived from the audit process. The following are some advantages of
being registered by a third party organization.

Benefit of registration Explained


Provides discipline Knowing actions will be checked instills a
discipline for an ongoing program
Establishes a baseline measurement Audit data are input into the measurement
process that can be used to assess
progress
Causes an ongoing, organization-wide Because of the scope of the standard and
quality system analysis analytical requirements, there is better
management oversight
Targets areas for corrective action Findings may point to processes that need

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fixing
Provides feedback to management and Findings provide input to management
demands management attention review and help provide a basis for factual
decisions by management review.
Causes continual improvement Provides the basis for continually
improving the quality management system

G. Impact of Conformance
There are many proven advantages of conforming to ISO 9001 requirements. Benefits
of conformance to ISO 9001 are:
Benefit of conformance Explained
Accepted internationally Reduces communication issues
Verification of the QMS on a regular basis Ensures functions stay focused on QMS
by the internal audit process objectives
Documents practices Improves management control and
consistency
Provides a benchmark for evaluating on- Enables the assessment of progress in a
going QMS effectiveness factual manner
Provides evidence of a documented QMS Tells customers you are organized and
to show to customers committed to quality
Enhances employee involvement within a Makes employees aware of quality and
clearly defined system how they can contribute
Better trained workforce Documented practices provide basis for a
better training program.
A “preventive” attitude is instilled within the Helps foster a mind-set of gauging the
organization impact of actions on quality
Customers are more receptive to forming Customer know you have achieved some
customer/supplier relationships level of QMS maturity and have higher
levels of confidence in ISO 9001 suppliers

That finishes the history of the standard. A story not normally told is that the ISO
standards process has continually improved. Standard writers are more sensitive to
user needs and processes have been established to seek, collect and analyze user
feedback. The end result is an ongoing process of better and more effective standards.

One common question that is often answered by this part of the class has to do with the
vague language that is found throughout the ISO 9001 requirements. The answer to
this question should now be clear. ISO 9001 was created to work for nearly any
organization of any size producing any product anywhere in the world. To make it work
in this broad context, it was necessary to leave the specifics of “how” to the organization
that will be using the standard.

You are encouraged to get involved and volunteer your time to developing and
modifying standards. To find out more about US efforts go to:

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http://standardsgroup.asq.org. For international information go to:


http://www.bsi.org.uk/iso-tc176-sc2 or http://www.iso.ch.

Another source of involvement is to join an ISO discussion list. To join the ISO 9000
internet discussion list e-mail (listserv@listserv.nodak.edu) and enter ‘subscribe iso9000
your name.’

In the next lesson we are ready to start learning about the ISO 9000 family of standards
and how they are to be used.

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Lesson C03: Introduction to ISO 9001


ISO 9001 is part of a family of documents that work together to provide support for
quality management systems. All 9000 numbered documents relate to quality
management systems. All 10000 numbered documents relate to technical topics
needed to support management systems. This lesson is about this family of
documents. This material is presented so that you will know where to get additional
guidance or direct others who need help.

A. Quality Management Principles


A "Management Principle" is a comprehensive and fundamental rule or belief for leading
and operating an organization. Quality management principles are aimed at quality and
improving performance over the long term by focusing on customers.

"The principles were the basis for developing ISO 9001. Each
principle has a place within ISO 9001 requirements, but the
extent of application to ISO 9001 is quite limited compared to
its application in the new ISO 9004." Jack West, Quality Progress, October
1999, page 78.

The quality management principles are fundamental to all quality initiatives and ISO
9001 is no exception. ISO 9001 is the baseline management system that can be
leveraged to move advanced management systems such as ISO 9004 or a national
quality award criterion such as the Baldrige Award.

It is important to note that the Quality Management Principles do not contain auditable
requirements. Understanding the principles is important for determining if the intent of
the principles is addressed in the design, deployment, maintenance and improvement of
the QMS.

Principle 1 - Customer-Focused Organization: Organizations depend on their customers


and therefore should understand current and future customer needs, meet customer
requirements, and strive to exceed customer expectations.

Discussion
This principle must be paramount within the QMS for
organizations to rise above an internal focus. Quality level
targets, specifications and standards are minimum
requirements and may have little to do with what the
customer actually needs and wants. As the QMS model
depicts, the process starts and ends with the customer.
First, the organization must understand and define
customer requirements. In the end, the organization must
be measured on its ability to satisfy the customer, not their

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audit score or quality levels.

Benefits:
⇒ The organization stays focused on what is important
(on the market and changes in the market or
customer needs).
⇒ Customer loyalty and goodwill increases in value.
(an intangible asset that may affect the market price
of the stock or value of the organization).
⇒ The organization remains competitive with current
customer offerings (the right product, service and
features).
⇒ The organization experiences increased market
share and revenue when customers switch from
competitors.

Principle 2 - Leadership: Leaders establish unity of purpose and direction for the
organization. They should create and maintain the internal environment in which people
can become fully involved in achieving the organization's objectives.

Discussion
An organization cannot achieve an effective Quality Management
System unless management takes an active role in its
implementation, maintenance and improvement.
Good leaders provide clear direction and enable others. They
provide direction through a quality policy and quality objectives
for functions within the organization. They can enable others by
sharing responsibility and showering people with praise when
praise is due. Leaders incorporate the eight Quality
Management Principles into everyday decisions for a proactive
style of management.

Benefits:
⇒ Employees sense they are trusted and will take risks to
benefit the organization.
⇒ Employees will be more productive when knowing what is
expected and working in a positive environment.
⇒ Employees will be more willing to share and work in teams
for the common good of the organization.
____________________________________________________

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Principle 3 - Involvement of People: People at all levels are the essence of an


organization and their full involvement enables their abilities to be used for the
organization's benefit.

Discussion
People, not machines, create quality. When people are involved
they are more likely to contribute to the process and its ongoing
improvement. Employees must be educated in the quality
management principles and the quality management system.
Employees must know what is expected of them and their ongoing
role in the QMS. Quality cannot be achieved by a single
individual, people must work together within processes and across
process boundaries.

Benefits:
⇒ People put aside their differences to come up with
remarkable ideas.
⇒ A better informed and motivated workforce is more likely to
ward off competition and attacks on the organization’s well
being.
⇒ Involving people will increased employee loyalty to reduce
turnover.
_____________________________________________________

Principle 4 - Process Approach: A desired result is achieved more efficiently when


related resources and activities are managed as a process.

Discussion
The process approach is powerful because it is how we normally
perform an activity. Businesses can be more effective when
activities are managed as processes instead of individual tasks.
Process outputs must meet requirements and contribute to
customer satisfaction to provide maximum value to the
organization. Measurement of process outputs allows for
adjusting processes for on-going improvement.

Benefits:
⇒ Keeps processes streamlined for optimal efficiency.
⇒ Keeps the focus on organizational goals for achieving
customer satisfaction and profitability.
⇒ Promotes team accomplishments.

_____________________________________________________

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Principle 5 - System Approach to Management: Identifying, understanding, and


managing a system of interrelated processes for a given objective improves the
organization’s effectiveness and efficiency.

Discussion
A collection of interrelated processes must be managed as a
system for the overall good of the organization. The system
allows for processes to be aligned and prioritized to achieve the
organizational objectives. The system is managed by providing
direction, training, planning, feedback, resources, and incentives.

Benefits:
⇒ Individuals and process owners can see how they
contribute to the overall goals.
⇒ The organization stays focused and avoids surprises that
could be a risk to the system.
⇒ Instills confidence to interested parties external to the
organization.
_____________________________________________________

Principle 6 - Continual Improvement: Continual improvement should be a permanent


objective of the organization.

Discussion
Continual improvement is a business philosophy that imbeds that
attitude that there is nearly always a better way: never settle for
the status quo. Continual improvement requires that the quality
principles be constantly reinforced through ongoing
communication and exchange of ideas throughout the
organization. Continual improvement is accomplished through
continuing education, feedback from assessments and
management reviews, a preventive style of management (what
can go wrong), and integration of all the principles throughout the
organization.

Benefits:
⇒ The organization will stay ahead of competition by reducing
costs, better quality products and services tailored for the
customer/ market.
⇒ Establishes a reputation of being a leader and innovator.
⇒ Gain customer loyalty through improved responsiveness
and follow-through.
_____________________________________________________

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Principle 7 - Factual Approach to Decision Making: Effective decisions are based on


analysis data and information.

Discussion
Things happen for a reason. The cornerstone of a successful
QMS are when decisions are based on reliable and accurate data.
Quality management principles must be advanced by comparing
performance against measurable goals and objectives. People
understand measures and can react and make informed decisions
based on them.

Benefits:
⇒ The organization can determine if there is improvement.
⇒ Informed decisions result in better management of
organizational resources
⇒ The organization can solve problems faster with a mature
information data base.
_____________________________________________________

Principle 8 - Mutually Beneficial Supplier Relationships: An organization and its


suppliers are interdependent and, a mutually beneficial relationship enhances the ability
of both to create value.

Discussion
Supplier performance has never been more important than it is in
today’s world of out-sourcing. Supplier partnerships are critical for
an organization to achieve the highest possible level of product or
service quality. Suppliers should share a common vision with their
customers to achieve mutual prosperity.

Benefits:
⇒ Supplier partnerships will result in more flexibility in the
market place.
⇒ Working together with suppliers will help ensure the
organization’s products and services are competitive.
⇒ Organizations will have another source for benchmarking
and learning from others.
_____________________________________________________

When organizations adopt the eight Quality Management principles, it will benefit the
organization, their employees, customers, suppliers, the local community and our
society.

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B. Purpose of ISO 9001


Why ISO 9001? It is a tool to assist organizations in the establishment and
achievement of sound quality practices. ISO 9001 is a worldwide consensus standard
that contains fundamental and proven requirements. The standard provides a means
for organizations to achieve and demonstrate quality performance to customers and
other interested parties. Audits can be used to independently verify conformance to
requirements in the standard. The standard is structured in such a way as to be a
model for a management system that can be integrated with existing or future
management systems (such as safety or environmental systems). ISO 9001 already
shares management system principles with the ISO 14000 series of environmental
standards. The ISO 9001 and ISO 14000 management model will likely provide the
basis for future health and safety standards.

Just as houses are designed for certain purposes, so is the ISO 9001 standard. The
purpose of the ISO 9001 house include requirements for 1) establishing a basic system,
2) usability by registrars and customers, and 3) expandability. .

The standard was to be used to address industry sector-specific requirements. Industry


sectors such as automotive ISO/TS 16949, aerospace AS9100 and medical device ISO
13485 will have additional requirements that go beyond the basic ISO requirements.
These additional requirements may describe a very different approach to quality that
specifically relates to their industry.

C. ISO 9001 Design/ Structure


The standard is written in such a way that it applies to all types and sizes of
organizations. It was designed to be used by small and large organizations whether
producing pacemakers, pencils or selling insurance. It is written to be independent of
cultural, social or geographic conditions. The standard is generic and universal in
nature. The standard is structured so that it can be used by independent organizations
(third party) to assess and register an organization’s quality management system.
Customers or market conditions may require organizations to seek registration of their
quality management system. Although it is not intended to increase or change the legal
obligations of organizations, authorities (governments) may require compliance to ISO
9001 to operate. Also, it is not intended to create non-tariff trade barriers but authorities
may require it for safety or other purposes.

Design inputs to our ISO 9001 house (standard) includes requirements to ensure it is fit
for its intended purpose.

ISO 9001 does not:


• establish absolute requirements for quality performance. There may be
exceptions to the requirements depending on the nature of the organization, the
products or services they provide and the customers they serve.
• require or guarantee optimum quality outcomes. The standard establishes a
baseline quality management system that can be used by the organization to
meet customer requirements.

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• work without management commitment to an internally generated and


implemented quality policy. ISO 9001 is a management system that requires
management commitment for implementation and on-going maintenance.

D. ISO 9000 Family


ISO 9001 is just one standard in a family of quality management system standards and
technical support standards. All 9000 numbered standards (such as ISO 9001) are
related to quality management. All 10,000 and 19,000 numbered standards (such as
ISO 19011S) are technical standards to support management system standards. To
view a list of the family of ISO 9000 and supporting standards and documents, view the
handout.

There are three primary documents that you will be concerned with as part of the
application of the ISO 9000 Series. We have discussed two of them already. The first
one is the quality management system requirements standard number as ISO 9001.
The second one is the quality management system fundamentals and vocabulary
standard numbered as ISO 9000. The third one is quality management system
standard for improved performance.

E. Future
The ISO 9000 series of standards and associated documents will be revised over time.
• Future revisions of ISO 9001 and ISO 9004 are planned every 5 years to ensure
standards stay current.
• ISO 19011S quality and environmental system auditing standard has taken the
place of ISO 10011 quality system auditing standard to eliminate the need for
separate auditing standards.
• Standards will be modified as necessary to meet the needs for ongoing
compatibility between quality, environmental and other existing or future
standards. Alignment and compatibility needs may necessitate changes in
requirements and approaches.

Future revisions and additions to the ISO 9000 series of standards and associated
documents are needed to address changing user needs.
• There is increased use of standards by non-manufacturing organizations.
• The marketplace is demanding improved quality performance.
• there are market and competitive reasons to raise the “bar” (more sophisticated
systems) with quality standards

Quality auditors and ISO 9000 practitioners will need to keep themselves current with
quality issues and resulting changes. As standards change and improve, auditors will
need to stay current. It is important for auditors to stay up-to-date to act in the best
interests of their organization and the organization they are auditing.

The next lesson starts off with the actual ISO 9001 standard. It is the beginning of
learning about the specific requirements and their application.

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Lesson D04: The Contents of ISO 9001 - Introduction


The next series of lessons (grouped as part D) and activities are very important for
successful completion of this class. The material in the following lessons is
paraphrased for instructional purposes. Only the actual language of the standard is the
language that is to be used in a conformance audit. The ANSI/ISO/ASQ Q9001 Quality
management systems – Requirements standard is the source document and should be
referenced regarding the need for interpretation of requirements. During the class you
should follow along in your copy of the ANSI/ISO/ASQ Q9001 standard as we discuss
each clause. Open your standard and turn to the introduction to start this lesson.

0.0 Introduction

0.1 General
Discussion: 0.1 General
This is the big picture clause. It does not contain any baseline auditable requirements
but there is valuable information that will affect the quality management system (QMS).
Adoption of ISO 9001 should be a strategic decision of the organization. The word
strategic is used to represent the fact that top management will need to be involved in
the use of ISO 9001.
The design and implementation of the organization’s quality management system
(QMS) is influenced by:
• Organizational environment
• Needs
• Objectives
• Products provided
• Processes employed
• Size and structure of the organization

Requirements in this standard are complementary to requirements for


products/services. An effective QMS will result in product and service requirements
being met.

The standard is intended to be used internally and/or by organizations external to the


user organization, such as an auditing organization (registrar or customer). External
organizations can use it to assess the user organization's ability to meet customer and
regulatory requirements. Additionally, the quality management principles discussed in
the prior lesson were taken into account during the development of the ISO 9001
standard.

Baseline: [by-the-book requirements]


• No baseline requirements are contained in this clause. However it is important to
notice in the very first paragraph of the introduction that it is not the intent of the
standard to imply uniformity in the structure of the QMS or uniformity of

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documentation. This opens the door for more effective alternatives for structuring
and documenting the QMS. Organizations that choose to use ISO 9001 are able
to adjust the application to meet their own unique needs. Auditors of the ISO
9001 standard will need to be open to the many different approaches that
organizations take when implementing the requirements.
The purpose of the quality management system should be the creation of a system of
processes that produce internal and external results. The example below could be
considered a purpose statement for effective QMS’s.

The quality management system should define the system and the processes
contained within them to enable the systems and processes to be clearly
understood, managed and improved. Management should ensure effective
operation and control of processes and the measures and data used to
determine satisfactory performance.

0.2 Process Approach


Discussion: 0.2 Process Approach
The ISO 9001: standard is based upon the use of the process approach. The standard
promotes the adoption of a process approach when developing, implementing and
improving the QMS.
• To function effectively, an organization must determine and manage numerous
linked activities
• A process is an activity (using resources) that is managed to enable the transition
of inputs to outputs
• Outputs from one process often provide inputs to the next process
• Multiple processes create a system of processes

The aim of the process approach is to achieve customer satisfaction by fulfilling


customer requirements.

The systematic identification and management of processes employed and their


interactions are referred to as the process approach. The process approach strings
activities together that result in an output such as a product or service. The process
approach provides ongoing control over:
• Linkages between processes
• The system of processes
• The combination and interaction of processes

When used within the QMS, the process approach emphasizes:


• The understanding and fulfillment of requirements
• The need to consider processes in terms of added value
• Obtaining results of process performance and effectiveness
• Continual improvement of processes based on objective measurement

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Simply, an organization’s management system is more effective if structured using the


process approach as opposed to an element or department approach. A process
represents action. The processes are normally collected under a system (clause 4) or
subsystems to a bigger system.
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There are two types of processes: 1) product realization processes and 2)


administration processes. Clause 4 of the standard introduces the idea of the system
while clauses 5-8 are organized with the process approach in mind.
The quality management system (QMS) requirements start in clause 4 and continue on
to the end of the standard (clause 8).

Processes start with customer requirements and end with customer satisfaction. This is
an important clarification of the aim of the quality management system (QMS). First, the
need for the product or service must be established (customer requirements) before raw
materials are acquired. Once there is a need, raw materials and services are acquired
for the process to meet those needs.

Baseline Requirements: [by-the-book requirements]


• None

0.3 Relationship to ISO 9004


Discussion: 0.3 Relationship with ISO 9004
The same clause arrangement is used for both the ISO 9001 and ISO 9004 standards.
It is easy to reference a clause in 9001 and then cross-reference the same clause
number in 9004. This alignment is called creating a "consistent pair" of standards (9001
and 9004). In fact, the 9001 requirements are embedded in the 9004 standard. These
documents are designed to be used together, but can be used independently.
The design of our ISO 9004 house (standard) includes all the ISO 9001 requirements.
The ISO 9004 provides guidance beyond the baseline requirements in ISO 9001. The
ISO 9004 should be used by organizations that want to move to a higher level of
performance improvement and business excellence. It is not a guideline for
implementing ISO 9001 and is not intended for certification or contractual use.

Baseline: [by-the-book requirements]


• None

0.3.1 IATF Guidance to ISO/TS 16949


IATF Guidance to ISO/TS 16949 is a document containing recommended
automotive industry practices, examples, illustrations and explanations. It
provides assistance in the application to conform to the requirements of this
technical specification. The guidance document is not intended for certification.

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0.4 Compatibility with other management systems


Discussion: 0.4 Compatibility with other management systems
The 9001 standard has been aligned with other management system standards such as
ISO 14001 (environmental management system) for the benefit of users of both
standards. ISO 9001 does not include requirements specific to other management
systems, however, it allows an organization to align or integrate its system with related
management system requirements.

ISO/TS 16949: 0.5 Goal of this Technical Specification


• The goal of this technical specification is the development of a quality
management system that provides for continual improvement, emphasizing
defect prevention and the reduction of variation and waste in the supply
chain.
• This technical specification coupled with applicable customer specific
requirements, defines the fundamental quality management system
requirements for those subscribing to this document.
• This technical specification is intended to avoid multiple certifications
audits and provide a common approach to a quality management system
for automotive production, and relevant service part organizations.

In Lesson D05, we will look at the actual standard scope and how organizations may
customize the quality management system to fit their situations. Organizations are
allowed to exclude the clauses that do not apply to them.

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Lesson D05: Scope/ Excluding Clauses/ Definitions


The scope and tailoring of the standard for an organization QMS are important to both
auditors and users of the standard. For effective implementation users need to
determine the products and services to be provided under the QMS and any non-
applicable clauses. Auditors need to understand the rules for developing a scope to be
able to verify proper determination by users.

1 Scope
1.1 General

Principle Concept:
• Consistently provide products and services that satisfy the customer
• Continually improve the quality management system
Discussion: 1.1 General
This clause explains the scope of the standard in that it is a generic standard and may
be used by all size and types of organizations. The standard should be implemented
when an organization needs:
• to provide a product/service that consistently meets customer and and applicable
statutory and regulatory requirements,
• a system to enhance (achieve) customer satisfaction
• a system for continual improvement and prevention of nonconformities
A very important note in the standard states that the word "product" used in the
standard is ONLY the product intended for or required by the customer.
The emphasis of the standard is on customer satisfaction and improvement rather than
on implementation of the system alone.
It is important to note that it is the customer's perception that determines if
requirements have been met and is not an internal quality level calculation. The ISO
9001 organization will need to evaluate information relating to the customer's
perception to determine if customer requirements are being met.

Scope: ISO/TS 16949


This technical specification, in conjunction with ISO 9001, defines the quality
management system requirements for the design and development, production and,
when relevant, installation and service of automotive-related products.
This technical specification is applicable to sites of the organization where customer-
specified parts are manufactured, for production and/or service.
Supporting functions, whether on-site or remote (such as design centers, corporate
headquarters and distribution centers), form part of the site audit as they support the
site, but cannot obtain stand-alone certification to this technical specification.
This technical specification can be applied throughout the automotive supply chain.

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1.2 Application
Principle Concept:
The QMS can be tailored for the organization.
Discussion: 1.2 Application
Users of the ISO 9001 standard must identify clauses that don't apply or may be
excluded from their system. Only clause 7 (Product Realization) sub clauses can be
excluded from the QMS. Registrars need to pay particular attention to defining the
scope of the registration certificate issued to organizations registered to ISO 9001. For
an organization to maintain a valid registration of their quality management system, they
must address all the requirements that apply to their organization.
Registrars should investigate the validity of exclusions claimed by the organization.
Exclusions must be justified in the quality manual [ISO 9001, 4.2.2].
For those products that are included in the scope of the QMS, all requirements of ISO
9001 have to be met, unless it can be demonstrated that certain requirements of section
7 are not relevant to the particular situation of the organization.

ISO/TS 16949 Only


The only permanent exclusions to the ISO/TS 16949 technical specification will link to
7.3 where the organization is not responsible for product design and development.
Secondly, permanent exclusions do not include manufacturing process design.
Organizations registered to ISO/TS 16949 may ONLY exclude design, but 2nd and 3rd
tier automotive suppliers registered to ISO 9001 may exclude any part of clause 7, if
applicable.

First, determine the scope of the registered QMS. Determine the


products/services and locations covered by the QMS registration.
Test Criteria for Granting Exclusion:
Requirements can only be excluded if they do not affect the organization's ability or
responsibility to provide products /services that meet customer and applicable statutory
and regulatory requirements.
Note: An organization cannot claim an exclusion because a regulation doesn't require it.
For example: If an organization designs products, it cannot claim an exclusion because
the FAA (or other customer or regulatory body) granted them exclusion from design
control.
The following are some of the more likely sub clauses that may be considered for
exclusion to tailor the standard to the user needs.
7.3: Design and development
7.4: Purchasing
7.5.2 Validation of processes
7.5.4 Customer property
7.6: Control of measuring and monitoring devices (for service organizations)

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Important Note: Auditors need to be open to the idea that any part of clause 7 can be
excluded provided the exclusion can be substantiated.

Issues:
• Organizations must comply with requirements outside clause 7, even when
processes such as training (clause 6) or testing (clause 8) are outsourced. [ISO
9001, clause 4.1].

2. Normative Reference

Discussion:
This clause is used to point out the existence of the new fundamentals and vocabulary
standard, ISO 9000.

3. Terms and Definitions


Discussion:
A reminder that the ISO 9000 terms and definitions apply.

Clause 4 marks the start of the ISO 9001 QMS requirements. If you are not familiar
with standard writing styles you may want to take a couple of minutes to review the
information in the handout (Finding Requirements in Standards, D05verbs1). Most
standards conform to a style that makes them more professional and improves their
utility to the users (readers).

ISO/TS 16949 Clause 3 Terms and Definitions Discussion

Discussion: Where there are terms for which the wording in the definition differs in ISO
9000, the definitions given in the technical specification apply.
Instructor Note: This may include explanations in the ISO/TS 16949 text.
The terms will be linked to our glossary as you continue with the class as necessary.
We have provided a handout so that you can view the definitions. There are twelve
words in the definitions section. The definitions should be referenced when
implementing and evaluating the QMS. Some notable points follow.

ISO/TS 16949 has special characteristics while ISO 9000 defines characteristic and
quality characteristic. The ISO 9000 definitions of characteristic and quality
characteristic are more generic than the ISO/TS 16949 definition. A special
characteristic is any product characteristic or manufacturing process parameter which
can affect fit, function, performance, safety, regulator compliance or the subsequent
processing of product. This helps organizations focus on the important things to
manage and improve product and process effectiveness and efficiency.

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ISO/TS 16949 has control plans and ISO 9001 has quality plans. They are very similar
except ISO/TS 16949 control plans are more specific to the automotive sector. Annex A
of the ISO/TS 16949 standard provides an outline of what a control plan should contain.
Error-proofing is in ISO/TS 16949 but not in ISO 9000 definitions. Error-proofing is also
called mistake-proofing or Poka-yoke (Japanese term). Mistake/Error-proofing is a
prevention tool (methodology) to identify and eliminate potential product and process
errors from occurring during design and post design as an existing process. ISO/TS
16949 defines error-proofing as the use of product and manufacturing process design
and development features to prevent manufacture of non-conforming products.
Both ISO/TS 16949 and ISO 9001 use the out-sourcing term. For ISO/TS 16949 it is
linked to a process of acquiring product from outside the organization while ISO 9001
(clause 4.1) refers to out-sourcing processes.
The next lesson will show the overall system view and set the stage for the clause-by-
clause discussion.

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Lesson D06: General System/Documentation Requirements

Clause 4 marks the start of the ISO 9001 QMS auditable requirements.

4 Quality Management System


4.1 General Requirements
4.2 Documentation Requirements
Principle Concepts:
• Establish a system to meet requirements
• Manage processes to meet requirements
• Document important processes
• Establish a quality manual
• Control important documents (issuing, distribution and updating)
• Control quality records

4.1 General Requirements


Discussion:
The key points are that you must establish a system; then you must maintain it, and
improve it. Management review (clause 5.6) can be used to attest to the maintenance
and on-going improvement of the system.
Clause 4.1 contains a list of items that must be addressed as part of the quality
management system. The list of items includes:

a. identify needed processes (such as processes for management activities,


provision of resources, product realization and measurement, ISO 9001 note at
the end of clause 4.1)
b. determine order (sequence) and interaction of the processes identified
c. determine controls (criteria, procedures, methods) for effective operation
d. ensure data (information) and resources are available to operate and monitor
the processes
e. measure, monitor, where applicable, analyze processes
f. take action to achieve planned results and continual improvement

The key steps in the successful implementation (as well as auditing) of the new
standard are found in the first three items on the list (a, b, and c), which are: a)
identifying the processes (such as ordering, designing, providing, reviewing), b)
determining the sequence (how processes connect), and c) determining the criteria
(check against requirements) .

The list should be used both during implementation and management review (as a
means to identify shortcomings of the system) or used by an auditor for an overall check
of the QMS.

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In this clause there is an additional requirement for organizations to manage processes


in such a way that they meet the requirements of the standard. Rewording the
requirement using a Webster definition would be: "The organization shall handle or
direct with a degree of skill these processes in accordance with the requirements of the
standard." It is difficult to envision a nonconformity for this requirement unless there was
a breakdown of the system.
You need to have a very good understanding of this clause (4.1) in order for all of the
other clauses of your completed Quality Management System to come together and
work as a complete system.
In the past, there has been some confusion about the control of out-sourced or
subcontracted processes. This clause makes it clear that if conformity of product is
affected, the organization must control outsourced or subcontracted processes, and
such processes must be identified within the quality management system

4.2 Documentation Requirements


4.2.1 General
Discussion:
The standard provides two test criteria as guidance for determining if documents are
needed.
Documentation Criteria:
1. When the standard requires it.
• quality policy
• quality objective
• quality manual
• specified “documented procedures”
• specified records
2. When documents are needed to ensure effective planning, operation, and control
of processes.
The standard requires very few document procedures. The phrase for effective
planning, operation, and control will be very important in determining when documents
are needed. The word "control" is used throughout the new standard in reference to
either process control or document control.
If a document is required per the two above criteria, the documents must be controlled
under clause 4.2.3.
There are 6 references to "documented procedures" in the standard

The extent of the documentation required is dependent on the organization; the size,
type, complexity and interaction of processes; and the competence of personnel. One
would expect that smaller organizations and organizations with highly proficient
personnel would need fewer documents whereas high tech or complex operations and
those with a lack of proficiency would require more.

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Documents can be on any medium such as paper, magnetic, electronic, photographic,


master example.

Control of documents 4.2.3


Control of records 4.2.4
Internal audit 8.2.2
Nonconforming control 8.3
Corrective action 8.5.2
Preventive action 8.5.3

It is not up to auditors to specify the QMS structure (see clause 0.1) or the documents
needed to adequately control the system. Auditors will need to know the documents the
organization decided it needed to properly manage the QMS.

4.2.2 Quality Manual


There must be a controlled quality manual. However, there is broad flexibility on what it
contains, what it looks like, and what medium it is in. The manual is only required to
contain four things.
First, it must include the scope of the quality management system. The scope
clause (clause 1) should identify the QMS physical boundaries (facility).

Second, there must be justification for exclusion of any ISO 9001


requirement/clause (clause 1.2).

Third, the quality manual must include the documented procedures or


reference to them. Many registered organizations currently reference
documented procedures as they describe their QMS. The documented
procedures and other controlled documents may be compiled in a booklet
(Quality Manual) or available as separate documents.
Fourth, the quality manual must describe the interaction of processes. This is
very similar to the requirement in 4.1 to define the sequence and interaction
of processes. To comply with this requirement an organization may use
process flow diagrams (flow charting, process mapping techniques) to show
processes of the system, their sequence, and interaction. Think "process
approach" and the process model used in this course. The standard is not
looking for an organizational chart. Organizational charts do not show
interaction of processes that transform inputs into outputs.

4.2.3 Control of Documents


Control required documents (in any medium or type) in accordance with a documented
(in any medium) procedure. Except for the six required documented procedures, the
organization determines what documents are required to effectively manage the quality
management system (clause 4.2).

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The specific document control requirements are:


• Documents must be approved for adequacy prior to release or issue (Any
competent authority should be able to approve documents)
• Documents should be reviewed, updated and re-approved as necessary
• Document versions must be identified
• Documents must be available at points of use
• Documents must be legible and easily identified
• External documents used for the planning and operation of the Quality
Management System must be identified and their distribution controlled
• Identification or markings must be applied to prevent unintended use of obsolete
documents

ISO/TS 16949 discussion


ISO/TS 16949 4.2.3.1 Engineering specifications. Here it requires that the organization
have a process to assure the review, distribution and implementation of all customer
engineering standards / specifications and changes based on a customer-required
schedule. Timely review should be as soon as possible, but cannot exceed two working
weeks. If it is over two weeks, it is not timely. When a customer publishes a date, you
have to adhere to that date.
This clause requires a record of the dates that the changes are made (the date that the
change occurred). Why would the date of the change be important in the automobile
industry? What happens when a part does not function as intended? That’s right, you
were probably thinking, Recall!

This clause requires:

A review process for customer specifications


Reviews conducted within two weeks
A record of changes (including document updates) in production

4.2.4 Control of Records


Control required records (in any medium or type) in accordance with a documented (in
any medium) procedure. The organization must control records used as part of the
quality management system ("control" meaning a process checked, tested, or verified
by management).
A record can be defined as any medium, soft or hard, that contains data, which gives an
account of something that happened, and which is not normally subject to update.
When the standard requires a record, there must be a record. Records must be
identified, legible and retrievable. If records are not accessible or available to an auditor
to examine, there could be a nonconformity. If records are incomplete or data is
missing, there could be a nonconformity.

ISO/TS 16949 discussion:


ISO/TS 16949 4.2.4.1 Records retention. The control of records shall satisfy regulatory
and customer requirements. For the main clause, a note was added to explain that

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disposition includes disposal. A second note explains that records include customer-
specified records.

Baseline: [by-the-book requirements] with ISO/TS 16949 related requirements in blue]


• The requirement for clause 4.1 is to establish and manage a quality management
system in accordance with the standard requirements.
• There must be an established, documented, implemented, and maintained
procedure where the standard requires documented procedures.
• There must be documents to ensure effective planning, operation and control of
processes. Note: Documents may be needed where the standard calls for
planning, identifying, defining, arranging and establishing.
• The extent of the documentation must be consistent with the type of organization
(simple or complex).
• Outsourced QMS processes should be Identified and controlled.
• A quality manual must be established that contains the system scope,
justification for exclusions, the procedures or references to them, and a
description of the interaction of processes. The manual must be controlled.
• A documented procedure must be established to control documents (see
checklist for specifics).
• New and changed engineering specifications must be reviewed and implemented
changes recorded.
• A documented procedure must be established to control records for identification,
storage, protection, retrieval, retention time, and disposition.
• Records must be legible, readily identifiable, and retrievable.
• Records control must satisfy both regulatory and customer requirements

This lesson introduced the first "shall" requirement of the standard. As both a job-aid
and guidance for this class, an ISO 9001 checklist has been provided. For every ‘shall’
statement in the ISO 9001 standard, the checklist has a corresponding question.

Next, we will look at the management responsibilities and administration processes


needed for control of the ISO 9001 QMS.

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Lesson D07: Management Commitment/Customer


Focus/Quality Policy and Planning Requirements

5 Management Responsibility
5.1 Management Commitment
5.2 Customer Focus
5.3 Quality Policy
5.4 Planning

Principle Concepts:
• Top management must actively participate
• Top management must aim for enhancing customer satisfaction
• Top management must ensure there is a quality policy
• Quality objectives must be defined
• There must be a plan to achieve the quality objectives

5.1 Management Commitment


Discussion:
Top management must commit to the quality management system and show this
commitment. The ISO 9001 requires top management to provide evidence of
commitment by:
1. establishing a quality policy (clause 5.3) and ensuring there are quality related
objectives (clause 5.4) for the organization.
2. communicating the importance of meeting customer requirements and regulatory
and legal requirements. For example: Top management may distribute memos,
make presentations, conduct one-on-one talks, etc. to get out the message.
3. conducting management reviews to close the loop on accountability for the
quality system. For example: Top management may review poor customer
satisfaction ratings and identify areas of the system that need to be improved.
4. making resources available to ensure the success of the quality system. For
example: Customer satisfaction cannot be measured unless there is a budget
and resources allocated to collect and analyze the data.

The top management we are discussing here, is the top management of the
organization who implements and maintains the quality management system.

ISO TS 16949 discussion


ISO/TS 16949 5.1.1 Process efficiency. Clause 5.1.1 was added that requires top
management to review the product realization processes and the support processes to
assure their effectiveness and efficiency.
This expands the scope of management responsibilities. Management review does not
stop at the product realization processes because it includes support processes as well.

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A support process may be human resources, accounting, or maintenance. It is also


clear that the review includes efficiency as well as process effectiveness. Being efficient
is only contained in the ISO/TS 16949 requirements (not ISO 9001).

5.2 Customer Focus


Discussion:
Customer focus is a common thread throughout the standard. Meeting customer
requirements must be aimed at enhancing customer satisfaction. This is a major
difference in the ISO 9001 standard compared to most regulatory or compliance
standards. The customer focus provides the linkage to "higher level" QMS standards
such as ISO 9004 and quality award criteria.

5.3 Quality Policy


Discussion:
Clause 5.3 states that top management will ensure there is a quality policy. The
requirement standard states that the policy should contain a commitment to meeting
requirements and continual improvement . The policy should be appropriate for the
organization and linked to organization objectives.
The policy must be communicated and understood within the organization. The policy
must provide a framework for establishing and reviewing quality objectives. However,
there is no specific guidance for what the policy should contain how is should be worded
except that it should be relevant to the organization.
Sidebar: audit evidence:
If the wording of the policy is such that it is irrelevant, uncheckable, or that when
audited the evidence showed that it has not been effectively implemented, then there
will be a nonconformity against the requirements of clause 5.3.

5.4 Planning
5.4.1 Quality Objectives
5.4.1.1 Quality objectives: Supplemental

ISO TS 16949 discussion

ISO/TS 16949 5.4.1.1.1 Quality objectives is supplemented text from the ISO/TS 16949
requirements. The automotive standard requires that top management define the quality
objectives and measures. The objectives and measurements must be included in the
business plan and used to deploy the quality policy. There is a note that states: Quality
objectives should address customer expectations and be achievable within a defined
time period. This makes sense because organizations should not set objectives that
take several years to accomplish with no deadlines or milestones.

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Sidebar:
An auditor cannot cite a note as a basis for a nonconformity.
Even if an organization establishes measurable quality
objectives that will take several years to achieve, such that the
true intent of the requirement has been circumvented. An
auditor could determine the organization is not meeting the
intent of the requirements in clause 5.4.1.1. Also, an auditor
could seek another basis for a nonconformity such as found in
clause 5.6 regarding the review of QMS effectiveness and
performance or showing evidence of achievement of quality
objectives (5.6.1.1).

5.4.2 Quality Planning


Discussion: Quality Objectives
Attainment of a quality objective must be measurable and consistent with the quality
policy or mission statement. There must be quality objectives for all relevant
organization functions and levels. Relevant functions may be those functions that have
1) responsibilities for management of the quality management system, 2) responsibility
for attainment of requirements (customer and ISO 9001 standard requirements), and 3)
processes of the QMS (linkage to ISO 9001, 4.1). The organization must establish
quality objectives and they must include those directives needed to meet product/
service requirements (see clause 7.1).
Organizations may show auditors some type of business, operation or QMS plan.
Business plans should give consideration to quality management system needs.
Organizations should include how they plan to achieve their quality policy and how their
progress will be measured toward that goal. Inputs to quality planning may include
results of management reviews of the quality system.

Now that there is QMS (quality management system) planning, there needs to be
resources to implement the outputs of the planning process. Funds or people may be
needed for implementation. The planning outputs may identify the resources (clause
4.1) for executing the plan or plans.

The scope of the planning process should include all processes within the quality
management system.
Next, an almost overlooked requirement for the organization is to ensure change is
planned and implemented in such a manner that the integrity of the existing system is
maintained (clause 5.4.2b). This is also known as management change control. The
primary emphasis will be on identification of changes that can impact the finished
products or services which will affect the external customer. A process should only be
changed or modified with the full understanding of its potential impacts on quality,
safety, health, and environment.*

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If changes are not controlled, there is a nonconformity. Auditors may seek to determine
if interested parties were notified of pending changes (i.e. start-up meeting, sign off).
*Russell, Quality Management Benchmark Assessment (QMBA), 1995, Quality Press and Quality Resources, page 87.

Sidebar:
There is a difference between quality planning required by clause 5.4 and the
use of quality plans. Quality planning or QMS plans are the big picture view
that establishes the organization’s quality objectives. A quality plan is used as
a tool to improve control of a particular project, product or process. More
information about quality plans is available in ISO 10005.

Sidebar:
If process flow charts, process maps or process flow diagrams were used to
help satisfy clause 4.1, they may be considered quality plans for the
organization.

Baseline: [by-the- book requirements] with ISO/TS 16949 related requirements in blue]
• Top management must show commitment by participating in the quality
management system.
• Top management commitment includes review of realization and support process
effectiveness and efficiency.
• Top management must ensure the overall system of meeting requirements is
aimed at enhancing customer satisfaction.
• Top management must ensure the quality policy is: 1) appropriate, 2) shows
commitment to meeting requirements and continuous improvement, 3) can be
linked to objectives, 4) is communicated to all that need to know, and 5) is
reviewed for suitability.
• The organization must establish measurable quality objectives for all relevant
quality management system functions (departments, units, subsystems, areas,
etc.). Objectives for meeting the requirements of the product/service must be
included.
• Top management must define the quality objectives and measurements.
• QMS Planning must be performed to achieve quality objectives and requirements
in clause 4.1.
• Changes as a result of planning must be planned and implemented. This can be
as simple as following procedures and measuring outcomes such as the impact
of the change on the product, service, process, and customer.

The establishment of a quality policy leads to creating plans for achieving the quality
policy and objectives. Next, we continue with management responsibilities and
administrative processes such as communicating and reviewing.

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Lesson D08: Management Responsibility/Review (5.5 - 5.6)

5.5 Responsibility, Authority, Communication


5.5.1 Responsibility and Authority
5.5.2 Management Representative
5.5.3 Internal Communications
5.6 Management Review
Principle Concepts:
• Functions, responsibility, authority, and interactions are to be defined
• Responsibility and authority for the quality management system are to be
assigned
• Organizational members must communicate to each other
• Measures are to be reviewed and improved

5.5.1 Responsibility and Authority


Responsibility and authority may be in a document such as a manual, a procedure, or in
job description (the exact means of communicating and defining is not specified in the
standard).

ISO TS 16949 discussion:


ISO/TS 16949 5.5.1.1 Responsibility for quality. ISO/TS 16949 has added the text
5.5.1.1. It has to do with responsibility and authority specifically related to quality.
Managers with responsibility and authority for corrective action shall be properly
informed. This is related to product and processes whenever there is a problem.
Personnel responsible for product quality shall have the authority to stop production and
fix the problem. And all shifts have to have personnel who are in charge of, or delegated
responsibility for, ensuring product quality. You can't have that third shift just running the
machines.

5.5.2 Management Representative


Clause 5.5.2 requires that top management appoint a member of the organization who
has the responsibility and authority for the quality management system. This person
may be a VP, a quality manager, or any member of management. The appointed
representative has responsibility and authority for establishing, implementing, and
maintaining the quality processes. The representative is also responsible for reporting
quality system performance to top management. The report can be input for
management review meetings or any other means to report performance as long as the
information gets to top management.

There is a requirement for the representative to promote awareness of customer


requirements. This may mean promoting the quality policy, linking training to customer

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requirements, authoring organization newsletter articles, speaking at department


functions, and so on.

ISO TS 16949 discussion


ISO/TS 16949 5.5.2.1 Customer representative. ISO/TS16949 has additional
automotive requirements here. The organization must designate personnel with
responsibility and authority of ensuring that customer requirements are being dealt with.
These include selecting special characteristics for the product, setting quality objectives,
training, corrective and preventive actions, and product design and development.

5.5.3 Internal Communications


This clause is a broad overall system requirement to ensure that people at various
levels and functions communicate (talk to each other) about the quality system
processes and its effectiveness. This should not be a problem for most organizations.
Organizations need to take a serious look at how they disseminate quality system
information to all levels. Not reporting on effectiveness of the QMS processes is a
nonconformity. This is the third requirement where information about the QMS must be
communicated.
There is no requirement of how to communicate about the quality system and its
effectiveness. One method is to publish a newsletter (monthly or quarterly); another is
to use the internal telecommunications network (for example: bulletin boards, journals,
magazines, team briefings, internal company radio station) or use focused feedback
method where people could communicate directly to management or another
department or function.

5.6 Management Review


Discussion:
The standard uses the words improvement and Effectiveness throughout the document.
The meaning of the word "effectiveness" is not well understood or agreed upon, but the
vocabulary standard (ISO 9000) has defined it (recall the earlier lesson). Just following
the rules is not enough, there must be improvement and processes must be effective.

Top management (the individual or group who directs and controls an organization at
the highest level *) must review the system for continuing suitability, adequacy, and
effectiveness on a scheduled basis (planned intervals). Top management must
determine (evaluate) the need for changing (improving) the quality management system
(i.e., change of policy, objectives, and processes). Note: *Taken from ISO 9000 QMS -
Fundamentals and vocabulary

The following text from an illustration shows the inputs, the process, and resulting
outputs of the management review process. Reviews must be conducted at planned
intervals and records must be maintained.

Management review process

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Schedule review
Collect Inputs
audit results
customer feedback
process performance
product conformance
status of corrective actions
status of preventive actions
follow up prior actions
change control issues
recommendations
Review inputs
Verify continuing
auditability
adequacy
effectiveness
Evaluate need to improve
system and processes
policy or objectives
Keep record of reviews
Output actions
Improve the system
Improve the processes
Improve the product
Provide needed resources

Review outputs must result in decisions and actions for improving the process, product,
and providing resource needs. Management review is a significant indicator of
management's commitment to quality.

Note: The inputs of actual and potential field failures and impact on quality, safety and
environment was added in ISO/TS 16949 clause 5.6.1.1.

ISO TS 16949 discussion


ISO/TS 16949 5.6.1.1. There are additional automotive requirements in 5.6.1.1. They
require the automotive industry to look at performance trends, monitor quality objectives
and regularly report and evaluate the cost of poor quality (See 8.4.1 and 8.5.1).

The American Society for Quality has a book, Cost of Quality, that describes what you
need to look for. The cost of quality, in its simplest form, is no more complicated than
comparing the cost of how things should happen if done right the first time to how things
actually happened. The cost of poor quality is the difference. The idea is that once you
understand what poor quality actually costs, you will be driven to take corrective or
preventive action. Actions should be taken and recorded with the intent of achieving the
quality objectives and improving customer satisfaction with the product that's been

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supplied. These comprise the background and the inputs to the management review
process.

TS !6949 Transcript of live instructor discussion:


Well, a management review process isn't fully implemented and effective unless its
looking at specific inputs; and the inputs listed in clause 5.6.2 review input as the
minimum along with the supplemental from the automotive, the TS 16-949. These
inputs include:
1. Results of audits. These audits can be internal audits, external audits and
customer audits. Top management needs to pay attention to the results of these
audits.
2. Customer feedback. Customer feedback may be customer complaints. It may be
testimonials to customer satisfaction or other things. For example, the customer
may say, “You ship in boxes of ten. We would buy more if it were in boxes of
two.”
3. Process performance. How a process is working, product conformity. Are
products meeting the requirements?
4. Status of preventive and corrective actions. Is action being taken? Are we closing
these out? Is it within a defined time frame? Are there follow-ups from previous
management reviews? This is an issue that may be problematical. If you are only
doing a management review once a year, would you really want to wait an entire
year before you checked in on whether or not you are taking action from last
year? Or even from four months ago?
5. Are there changed plans that could have affected the quality management
system?
6. Are recommendations for improvement implemented?
7. How much are field failures costing us?

The output of the review process closes the loop. The output is the improvement of the
effectiveness of the quality management system, improvements to the product
(particularly those related to customer requirements and identification and provision of
resources) and resource needs. Clause 5 begins with management commitment and
ends with management review.

Baseline: [by-the-book requirements with ISO/TS 16949 related requirements in blue]


• Responsibilities and authorities for the quality management system must be
defined and communicated.
• Managers that are responsible for corrective action must be informed of
problems; those responsible for quality must be able to stop work, and there
must someone on every shift responsible for ensuring product quality.
• Top management must appoint a management representative. The
representative must have responsibility and authority for the establishment,
implementation, and maintenance of the quality management processes,
reporting ongoing performance, and promoting awareness of customer
requirements. The management representative, or other person designated by

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top management, must have responsibility and authority to ensure customer


requirements are addressed.
• The organization must ensure there are communication processes, and that
information about the quality management system effectiveness is
communicated. Some organizations may tend to overlook the requirement to
report effectiveness or not really know what that means.
• Management reviews must be scheduled for top management to evaluate
measures (clause 8) to determine the need for improvement.
• Records of management reviews which should include evaluated inputs and
determined outputs must be kept. Records must include achievement of quality
objectives and customer satisfaction with product provided.

In the next lesson, we will move on to resource management. The standard will
establish requirements for QMS resources in order to enhance customer satisfaction.

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Lesson D09: Resource Management (6)

6 Resource Management
6.1 Provision of Resources
6.2 Human Resources
6.3 Infrastructure
6.4 Work Environment

Principle Concepts:
• Resources shall be provided to improve the system and satisfy the customer(s).
• Personnel with quality system responsibilities must be competent.
• Competency needs must be determined and acted upon.
• Training and other actions must be evaluated for effectiveness.
• The organization must provide and maintain facilities to meet requirements.
• The organization must control the work environment to meet requirements.

Discussion
6.1 General
This clauses starts out with a broad overall system requirement for the organization to
determine (identify), and provide resources needed. The resources are those needed to
implement, maintain, and improve the quality management system (including bringing
about customer satisfaction).
The organization must determine (identify) resource requirements of areas affecting the
quality management system. For example: this could be done during the annual
budgeting process.
Resources to be provided can include people, equipment, supplies, facilities, etc. If
QMS controls are not being constantly applied due to lack of resources, auditors can
issue a nonconformity citing this clause.
An audit thread is to ask about customer feedback. If customers are not satisfied,
determine what was done. If resources were not provided to address customer
feedback issues, a nonconformity could be reported.

6.2 Human Resources

6.2.1 Assignment of Personnel


Personnel performing work affecting product requirements must be competent .
Competence denotes having acquired (and using) one's formal education, training,
skills, and experience. This is an overall system requirement to ensure the organization
takes responsibility for competency of people. When people are selected for a position,
consideration should be given to individual education, training, skills, and experience
necessary to carry out the duties of the position. Most organizations have position

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requirements or a position description that includes individual requirements (such as


years of formal education and prior work experience).

6.2.2 Competence, Training, and Awareness


There should be a comprehensive plan to meet competency needs for all positions
supporting the quality system. The plan may require training; if so, its effectiveness
must be evaluated. Other actions (other than training) may be necessary to meet
competency needs. The plan may call for an individual to seek formal education or
certain work or skill experience.

The method to identify competency needs may be input from managers or from annual
performance reviews. When considering training programs, management should give
thought to the type and extent of skills, experience, and education of the personnel
involved. The organization must keep records to verify that training or other actions
were conducted. Auditors may check for auditor training and/or determination of training
for all personnel performing work affecting product quality (6.2.1).

The organization must evaluate the effectiveness of the training provided. Certifying
associations such as IACET (International Association for Continuing Education and
Training) stipulate that training is effective if the learning objectives were achieved. The
organization must have evidence that training effectiveness is evaluated. The same is
true of other actions. Other actions may be a reorganization, changing roles, changing
the job, changing the technology, and so on. The effectiveness of these actions must be
evaluated.

Effectiveness can be evaluated by a pass mark in an examination at the end of a


course, satisfactory attendance of the course with a completed survey, a practical test
at the end, on-the-job training, acceptable workmanship over a number of hours on a
machine, or a combination of these.

Evidence can be in the form of certificates with authorized CEUs awarded, the
supervisor's signature, annual reports, and so on. The effectiveness of other actions
may be linked to performance data.

Every individual working in the QMS must be aware of the relevance and importance of
his/her job (activities) and how it supports (contributes) to the achievement of the quality
objectives.

This requirement could be a major challenge. It is not unusual for organizations to have
difficulty communicating the quality policy and now they must also link the job function
to what the organization is trying to achieve. An auditor may ask an individual how
his/her job contributes to the achievement of quality objectives.

ISO/TS 16949 Transcript of live instructor discussion:

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What's the difference between education and training? If you go to college are you
being educated or trained? What's the difference between training and experience?
What's the difference between skills and experience? The more experience you have,
do you have more skills? Not always.
Education is usually formal, usually focuses on the big picture and how the big chunks
fit together. Training has to do with the doing, the how, the mechanics. Sometimes we
need education before we can successfully do training. We sometimes need to know
the big picture. in order to understand that what we do needs to be done, and
sometimes not.

Skill is the easiest of the four to understand. Either you have it or you don't. Take the
example of shooting baskets. If you can shoot ten baskets in a row you have the skill. If
you can't, you don't. Skill is often closely associated with experience, although that's not
a universal truth.

There's an awfully strong linkage between experience and skill. Have you heard the
axiom “That person hasn't had 10 years of experience, he has had one year of
experience 10 times?" So the linkage between skill and experience is usually there, but
not always.

I'd like to define experience as those things that you see, touch, feel, experience and do
that allows you to make better decisions in the future. If you are not able to do things
better and make better decisions in the future, then it's not experience. It's just tenure
and time on the job. Would you want your brain surgeon to be experienced? To be able
to look at your brain and say, “You know what, it doesn't look right. Let me have another
look at that?" And you only get that with experience.

ISO TS 16949 Discussion


ISO/TS16949 has several additional external requirements associated with employee
competence and some of these contain some requirements that are rich in value.

6.2.2.1 Product design skills:


The whole idea of designing the product to customer requirements begins with the
process of having people who are competent to do the design which includes proper
use of tools (e.g. a CAD {computer aided design}) and techniques. Techniques used in
the design process may be accrued through the individual industry. And then these
applicable tools and techniques must be identified. The standard doesn't say listed. It
doesn't say recorded. It doesn't say documented, although that's a good way to do it
and it certainly makes this easier to audit. Identified can be marked, numbered, color-
coded, segregated, or can even be a memorized list or documented list.

ISO/TS 16949 6.2.2.2 Training:


This clause requires a documented procedure for identifying training needs. This
documented procedure is for identifying training needs and achieving competence of all

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personnel whose work affects product quality. And those personnel who perform
specific tasks must be qualified. This is open-ended, but generally if a specific, assigned
task requires some special knowledge or skill, the personnel assigned to these specific
tasks should be qualified. Examples could be: a visual inspection; operating a special
tool, machine or instrument; and application of digitized, mathematically-based data.
Qualification means that there are some criteria that personnel must meet before they
can perform the task. When a person has met the criteria, it may be recorded in
personnel records or he/she may be issued a certificate or license.

ISO/TS 16949 6.2.2.3 Training on the job:

On the job training must be conducted for any new or modified job that affects quality.
Notice from an auditor's perspective and from an organizational perspective, this
includes contract personnel (sometimes called "temp. personnel" or "agency
personnel"). These people doing jobs that affect quality, must be informed about the
consequences to the customer of any non-conformity that may come out of what they
are doing (for example the product does not meet product requirements resulting in the
customer operation shutting down, or consequences resulting in a recall, or
replacement costs and inefficiency).

ISO/TS 16949 6.2.2.4 Employee motivation and empowerment

The organization has to have in place a program for motivating employees to achieve
quality objectives, improve and be innovative. Many organizations do this very
successfully; but how do you audit, and how do you as an auditor determine this? The
organization says they have a program, but you're there to audit it and you're not sure
that it's motivating people. When you talk to them, they don't sound very motivated. So
some of this can be difficult to audit. As part of this process to motivate employees, the
organization must include promotion of quality and technological awareness. It really
needs to go throughout the whole organization and not just manufacturing. And finally,
the last sentence states that "The organization shall have a process to measure the
extent of which its personnel are aware of the relevance and importance of their
activities and how these activities contribute to the treatment of quality objectives." This
can be done as part of the internal audit process where you actually ask them and track
responses.

6.3 Infrastructure
There is an overall requirement to determine, provide, and maintain an infrastructure
needed to ensure conformity to product requirements. The facilities include: workspace,
equipment, hardware, software, and support services. Workspace may be buildings,
office space, work stations. Equipment may be just about anything needed to complete
a task. Hardware is equipment such as a computer and its attachments. Software is a
program on some type of hardware. People also need to be provided with support

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services as part of the infrastructure. Support services could be bug spray, electricity,
waste disposal, potable water, fire alarm testing, and security.

ISO TS 16949 discussion


Clause 6.3.1 regarding, plant, facility and equipment planning, asks that a multi-
disciplinary approach be used in developing all of this infrastructure, in particular the
plant facility and equipment planning. This means that representatives from
manufacturing, engineering, sales, and perhaps quality assurance (and whomever else
the organization feels is appropriate) need to sit down and review planning needs
together. This will bring a variety of ideas to the table and promote the consensus-
building process.

Plant layout in the second sentence shall optimize material travel. This usually means
the shortest travel, but not always. It may also mean the fastest or the safest, or the
warmest or the coldest (depending on the situation). Optimum may be the most
favorable result based on cost-quality-schedule. The layouts for the shop floor and use
of floor space must consider synchronous flow. Operations must be monitored.

Clause 6.3.2 includes a contingency plan. The auto industry suppliers can have
profound negative impacts on customers if they shut down or if there is a business
interruption. Suppliers need to prepare a contingency plan that enables customer
requirements to be satisfied in the event of an emergency (e.g., tornado, strike,
equipment failure, etc).

Transcript of live instructor discussion:


A couple of years ago, I had someone who had a small
ejection molding plant ask me, “Do we have to build another
plant because we could get hit by a tornado? And so do we
move five miles away and build another plant and be ready to
move into that in a moment's notice?”

I think the answer to that is “No;” but I think that all of this
needs to be coordinated, approved, or at least there needs to
be some communication with the customer. Organizations
need to take a look at the standard and their risk management
plan to look at the likelihood of something going wrong and the
consequences; using that to prioritize those things that are
highest on the list.

Highest on the list would be the greatest, negative impact on


the customer; and then begin putting in place at least some of
the steps. Highest on the list could be tooling or it could be the
working environment. This is the work environment for people
and for product, and it does not necessarily mean human
comfort. Although, in the last few years it has come to mean

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that.

6.4 Work Environment


There is a broad overall requirement to determine and manage the work environment to
achieve conformity to product requirements.

Work environment includes human and physical factors. Human factors are people’s
involvement, safety attitudes and habits (rules, use of equipment), meeting special
needs (exercise programs, stop smoking programs, etc.), and ergonomics .
Physical factors are noise, cleanliness, vibrations, air quality, light, temperature,
humidity, hygiene, and so on.

The standard is very vague regarding the extent the organization must identify and
manage the work environment. Most organizations do this (manage the work
environment) to some degree. Organizations may have employee programs for self-
improvement, programs to boost morale, and increase motivation, or they may accept
suggestions for improvement of the workplace, and so on.

ISO TS 16949 discussion


ISO/TS 16949 6.4.1 Personal safety to achieve product quality. This means to minimize
potential risks to employees, and planning must address those risks.

6.4.2 Cleanliness of premises. The organization shall maintain its premises in a state of
order, cleanliness and repair consistent with the product and manufacturing processes.
It means cleanliness, dust free, static free, vapor free, temperature not too high and not
too low, etc. Note that what is considered clean in a carbon black plant will be different
than in a company that makes LCDs.

Baseline: [by-the-book requirements with ISO/TS 16949 related requirements in blue]


• Provide resources for implementing, maintaining and improving the quality
management system. Note: Resource limitations may be identified during
management review (5.6).
• Individuals given responsibility for the quality management system must be
competent.
• Identify competency needs and provide training or other actions to satisfy these
needs. The training provided or other actions must be evaluated to determine
effectiveness.
• Keep records of competency (i.e., training, qualifications, education, and
experience).
• Provide and maintain the infrastructure and facilities needed to achieve
conformity of the product.

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• Provide the work environment (human and physical factors) needed to achieve
conformity of the product.
ISO/TS 16949 baseline requirements
Ensure design personnel are competent and design tools must be identified.
• Establish and maintain a documented procedure for meeting training and
competency needs.
• On-the-job training must be provided for new or modified jobs that affect quality.
• Establish a process to motivated employees, promote awareness, and method to
measure employee awareness.
• Use the multidisciplinary approach to develop and optimize facility plans and
layout. Develop methods to monitor the effectiveness of operations.
• Address employee safety and keep the premises clean and in good order.

This concludes clauses 4, 5 and 6 of ISO 9001, the administrative and support
requirements for the realization processes. In the next module, we will discuss the
requirements for the value-added processes for creating a product or providing a
service.

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Lesson D10: Product Realization (7.1 - 7.4)

7 Product Realization
7.1 Planning of Product Realization
7.2 Customer-Related Processes
7.3 Design and Development
7.4 Purchasing

Principle Concepts Planning and Customer-Relations:


• Plan the activities needed to provide a product or service
• Determine all the requirements for the product/service
• Ensure the organization can meet the requirements
• Keep customers informed
• Listen to the customer

7.1 Planning of Realization Processes


Discussion:
The standard uses the term Product Realization to describe the steps for producing (or
manufacturing) a product or going about providing a service. The term realization is
used to balance manufacturing and service organizations’ needs and does not create a
worldwide language problem.
There must be realization planning. The organization may document its plan in any form
or medium. Examples may be a flow chart, quality plan, outline, a procedure, a process
description, or any other means that shows the processes and sub-processes required
to achieve the product or service
There may be processes within processes and not all processes are equal in value or
risk. The processes in the plan for realization of the product/service should meet the
requirements of the customer and the management system.

Some of the things that must be considered when developing the realization plans are:
• quality objectives for the product/service (project, contract)
• the need to establish (create) processes, documentation
• the need for resources
• verification, and validation activities and the acceptance criteria for them
• records to determine conformity of processes and product/service
Organizations need to know the successful outcomes, they need to provide resources
for the processes for them to work, they need to test and try out the processes, and
finally, they need to determine what records must be maintained for management
control. It is still heard from time to time that the organization should keep records to
satisfy the auditor. Closer to the truth is that organizations keep records in order to

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manage their businesses. A business cannot operate on hearsay. It must be able to


verify important activities from time to time.

ISO TS16949 discussion:


Generally, ISO/TS 16949 emphasizes the need to incorporate customer requirements in
the supplier's realization processes as well as keeping the customer informed of any
changes in the realization processes.

ISO/TS16949 7.1.1 Planning of product realization: In this clause, the automotive


industry asks that customer requirements and references to technical specifications "be
included in the planning of product realization as a component of the quality plan.” For
clause 7.1.2, acceptance criteria must be defined and where required and approved by
the customer. For attribute sampling data (pass/fail, go/no-go), the acceptance level
must be zero defects. In clause 7.1.3, Confidentiality, customers want their stuff to be
confidential and the organization has to ensure confidentiality of customer contracted
product and projects.

7.2 Customer-related Processes


This clause is about identification of product/ service requirements. An agreement
exists between a organization and a customer. It may be called a contract, order, or
purchase order. Although most requirements are specified in the contract, some
requirements are implied or assumed. The organization must determine all product/
service requirements. Requirements come from customers and other sources.

Product/ Service Requirement Examples:


• product (color, size, weight, time, features, materials, options, etc.)
• delivery (time, condition, markings, damage free, etc.)
• post delivery (technical service, servicing, refills, etc.)
• not stated, but necessary (traceability, clean, damage free, etc.)
• regulatory or legal (safe, marked, notice, caution, etc.)
• other requirements determined by the organization [internal specifications,
methods or techniques,]

Before accepting the order or making an agreement, the organization must review all
requirements. There can be one review or several reviews depending on the purpose
of the review. The review can be a face-to-face meeting, exchanging e-mails, following
a checklist, or whatever fits the situation. There must be a record of the review and
actions taken as a result of the review.

For record keeping purposes, an organization may require that order entry personnel
initial and date the order as a record, another organization may require the completion
of a checklist and signature, another may require that a box on a computer screen is
checked to indicate the electronic record was verified, etc.

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It is important that there is a review process. The standard is more specific about what
is expected of the review process. The review(s) must ensure:
1. product/service requirements are defined
2. contract or order issues are resolved
3. the organization has the ability/capability to meet/provide the requirements
If the customer does not provide a documented statement (order, purchase order,
specification, etc.), the organization must confirm the customer requirements before
acceptance. This may an internal self confirmation, asking the customer to confirm a
statement about what the organization intends on providing and other similar actions.
When orders are changed or modified (different from previously agreed) all relevant
documents must be changed and all relevant people must be informed (made aware of
the change). Most of the time organizations follow a well thought-out process for the
initial order but handle changes informally. Businesses put a strong emphasis on getting
the order and closing the deal. Sometimes order changes are considered secondary
unless there have been customer complaints and there is a possibility of losing the next
order.
Most organizations have an order taking or a contracts department. Orders may come
in by telephone (verbal), by fax, teletype, post, e-mail, etc. Even when there is an order
department it is not unusual for occasional orders to be taken by field sales, marketing,
operations, and development.
Organizations must first determine their method of communication (the best channels) If
organizations don't keep their customers informed, then they may not receive what they
were expecting, which may result in customer dissatisfaction and complaints.
(8.2.1Customer feedback, including customer complaints, was added to the customer
communication clause where they should have been all along.

ISO TS 16949 discussion


ISO/TS 7.2.1.1. Customer-designated special characteristics:
These are the characteristics that the customer points out as being special where care
has to be taken. The organization has to demonstrate conformity to customer
requirements for designation-documentation-control of special characteristics.

There are two ISO/TS 16 949 requirements following 7.2.2.


Clause 7.2.2.1 states that waving the requirements in 7.2.2 for formal review requires
customer authorization. So if an organization is not going to go through the review
process, they must get customer approval. Clause 7.2.2.2. "The organization shall
investigate, confirm and document the manufacturing feasibility of the proposed
products during the contract review process, including a risk analysis." The organization
must document (in some fashion) that they determined the product is feasible along with
anything that may be considered risky.

7.2.3.1 Customer communication. When the customer wants the communication to go


back and forth in a certain format or using a certain method, the organization has to
have the ability to do that. This may be specified language, specialized format,

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computer language, electronic data exchange, and so on. Organizations must be able
to communicate necessary information in the required method.

7.3 Design and Development


Principle Concepts of Design:
• The design project shall be planned and controlled
• Design input shall be defined and documented
• Design output, including crucial product characteristics, shall be documented
• Design output shall be approved prior to release
• Designs shall be reviewed
• Designs shall be verified and validated for intended purpose
• Design changes shall be controlled

Discussion:
This clause may not apply to some organizations because they do not design and
develop products or services. Here are some examples when design should be included
in the organization's QMS.
1. If the customer requires (contract) design/development of a product, process or
service
2. If the organization designs the product or service that is provided to the customer
3. If the organization believes that design and development play a key role in the
quality management system
Note: permissible exclusions were discussed earlier.

The design and development clause is like a mini standard all on its own. It covers
everything from inputs to the design process to the design output. It even has its own
document change control requirements.

7.3.1 Design and Development Planning


The design and development clause is organized into a plan it, do it, check it and
improve it format. First, there must be a plan that determines: the design stages,
review-verification-validation activities; plan and update responsibilities and authorities.
Communication between groups must be managed to ensure it is effective. Once there
is a plan, there can be design inputs.

ISO TS 16949 discussion


ISO/TS 16949 has the additional requirements of a multidisciplinary approach in clause
7.3.1.1. This includes:
• development / finalization and monitoring of special characteristics
• development and review of FMEAs (including action to potential risks)
• development and review of control plans

Simply, the organization must use cross functional teams to prepare for product
realization and specifically for the development of special characteristics, FMEAs and
control plans.

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There is a note that says the multidisciplinary approach typically includes the
organization's design, manufacturing, engineering, quality, production, and other
appropriate personnel.

Typical functions for an OEM organization may include:


- Engineering / Technical
- Quality / Reliability
- Purchasing / Materials Mgt
- Cost Estimating
- Manufacturing / Production
- Product Service
- Tooling Engineering / Maintenance
- MIS / Data Processing
- Marketing and Sales
- Subcontractors

7.3.2 Design and Development Inputs


Design inputs include:
• Functional and performance requirements.
• Regulatory and legal requirements
• Essential information from similar (previous) designs.
The inputs must be reviewed for adequacy and any ambiguities or conflicts resolved
before design work starts. There must be evidence of this review.

The design and development group may get inputs from sales or marketing (new
product or service), order entry (special order) or operations (production requirements,
issues, and interfaces). Ideas for new projects may also come from within the design
group.

Very little is said about the actual 'do' part of design because that varies from
organization to organization. It is up to the design group to decide what documents will
be needed to complete the design. Typically there are established methods for design
of certain types of equipment or protocols for development methods.

You may evaluate the controls within design to see if they are working as intended. You
(as the auditor) may ask about the qualifications for designers and then check personal
records to verify educational and experience requirements.

Creating the design may be in the form of blue prints, models, specifications, drawings,
pictures or cad files.

ISO TS16949 discussion


There are several supplemental automotive requirements:

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ISO/TS 7.3.2.1 product design inputs. The organization shall identify, document and
review the product design inputs or requirements, including:

1. customer requirements (contract review) such as special characteristics (See


7.3.2.3), identification, traceability, and packaging
2. Information from previous designs, competitor analysis, supplier feedback,
internal inputs, field data, and other sources for current and future projects
3. targeting the product quality, life, reliability, durability, maintainability, timing and
cost

This is a very prescriptive list of things that must be addressed for the product design
input to implement or audit, develop a checklist, and work off the list. Next is the
process design list of requirements.

ISO/TS16949 7.3.2.2. Manufacturing process design input. This clause requires the
organization to identify, document, and review the manufacturing process design input
requirements including:

1. customer requirements
2. experience from previous developments
3. targets for productivity, process capability, and cost
4. product design output data

You should note that the two lists are very similar except that product design output
data was added to the process design input requirements. There is a note for
clarification that says, "Special characteristics are included in this requirement."

7.3.2.3. Special Characteristics says that the organization shall identify special
characteristics {see 7.3.3.d} and
• include all special characteristics in the control plan. (Note: there's a document
on control plans published by the auto industry action group (AIG) called Control
Plans, Control Planning)
• comply with customer specified definitions and symbols
• identify process control documents including FMEAs, control plans, and operator
instructions with the customer's special characteristics symbol (or the
organization's equivalent of that symbol or notation) to include those process
steps that affect characteristics. All of these are part of the input process.

Under TS 7.3.2.3 is the Note: "Special characteristics can include product


characteristics and process parameters."

The special characteristics are the critical things we need to focus on to ensure the
product performs as intended. For ball bearings it may be hardness, for a plastic cover it
may be tensile strength or for a washer it may be inside diameter.

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7.3.3 Design and Development Outputs


You will need to verify that controls are effectively implemented by checking project
files, notebooks, and various records called for in the design and development
procedures. Design outputs must be in a form that will allow comparing design outputs
with design input requirements. Design outputs must meet design input requirements.

Design outputs must include the following:


• acceptance criteria (included or referenced, performance parameters,
tolerances, attributes, etc.)
• requirements for safe and proper use of the product or service
Appropriate design information must be provided to purchasing, production, and service
operations (7.5). Many organizations already have some type of transition or hand-off
plan to the operations group. This is an important step to ensure successful project
startup.

ISO TS 16949 discussion


The ISO/TS 16949 portion of the standard has added two more lists regarding product
and process design outputs. When you need the list, refer to your checklist or the
standard. As with the input lists discussed earlier, the output lists are similar in nature
but customized for actions related to product design output and actions related to
process design.

The product and process design output shall be expressed in terms that can be verified
and validated against input requirements.

7.3.3.1 Product design outputs (list)

The product design output shall include:


design FME, reliability results
product special characteristics & specifications
product error-proofing as appropriately
product definition including drawings or mathematically-based data
product design reviews results
diagnostic guidelines where applicable

ISO/TS 16949 7.3.3.2 Manufacturing process design outputs (list)


The manufacturing process design output shall include:
specifications and drawings
manufacturing process flowchart / layout
manufacturing FMEAs
control plan (see 7.5.1.1)
work instructions
process approval acceptance criteria
data for quality, reliability, maintainability, and measurability
results of error-proofing activities, as appropriate

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When you implement or audit, check off the outputs against the prescriptive list.

7.3.4 Design and Development Review


For clarity, the standard writers have included what should take place during the
reviews. The review shall include:
• evaluation of ability to meet requirements
• identification of problems
• proposed necessary (follow-up) actions
The requirements listed above are what typically takes place during design review
meetings. Review must be performed systematically and according to planned
arrangements. Records of reviews and follow-up action must be maintained. An auditor
should examine the review records and verify appropriate attendance at the reviews.
ISO TS16949 discussion
ISO/TS 16949 7.3.4.1 Monitoring: Measurements must be taken at specified stages of
design development. The organization must define, analyze and report measurements.
A summary of the measurement results shall be input to management review. There is
an ISO/TS16949 note clarifying that measurements are expected to include quality
risks, costs, lead-times, critical paths, etc. This clause helps ensure that management is
involved and takes responsibility for design and development no matter how complex or
small the project.

7.3.5 Design and Development Verification


The standard requires that there is a record of verification of results and necessary
actions. There is no requirement for a documented procedure, but verification must be
performed according to planned arrangements.
Designs are verified by several means to include:
• Alternate calculations
• Comparing to similar proven designs
• Prototype testing and other tests
• Verification of the same calculations by an independent body
• Review of design documents prior to release

7.3.6 Design and Development Validation


Designs must also be validated. Validation deals with evaluating the performance of the
product to ensure it meets user needs and requirements. This may be a field test or a
performance test during use in the actual environment it was intended. Validation
results and necessary actions must be recorded. Validation is required (whenever
practical) prior to the delivery or implementation of the product/ service. Validation
activities must be performed according to planned arrangements.

ISO TS16949 discussion

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ISO/TS 16949 7.3.6.1 Design and development validation. Validation has to be


performed in accordance with customer requirements where these are provided.

7.3.6.2 Prototype program. When required by the customer, the organization shall have
a prototype program and a control plan. The suppliers, the tooling, the manufacturing
processes, the equipment, and the other things that you use to make a prototype -
wherever reasonable and wherever possible - should be the same ones you use for
actual production because there can be differences that are not readily apparent.

Simply, it reduces project risk. If you change equipment or if you change tooling, it may
not all work out the same. Also, these shall be monitored for timely completion and
conformity to requirements.

Sidebar:
"Timely" should be reasonable considering the project and
customer expectations. As an auditor, you will want to look at
the prototype timetable to see if testing is on schedule or if
there have been delays. Review the reasons for testing
delays. Are resources provided as needed?

If the organization outsources services, it is still responsible for those outsourced


services (including technical leadership).

7.3.6.3 Product approval process. The organization must conform to the product and
process approval procedure that the customer has recognized. This same procedure
shall also apply to suppliers.

The standard does not use the term "documented procedure," but organizations need to
be able to follow along certain steps or stages to ensure the product and/or process is
ready. There is a note here that product approval comes after process verification. This
only makes sense.

7.3.7 Design and Development Changes


The design changes must be identified, documented, and controlled. Auditors may
check drawings or specifications to ensure changes are properly communicated and
recorded. Design change control must include review of the effect of the change on the
design (function and performance), constituent parts, and product already delivered.
When appropriate, the design change must be verified and validated. Changes must be
approved before implementation. There must be a record of the design change reviews
and necessary actions.

7.4. Purchasing
7.4.1 Purchasing Process

ISO TS 16949 discussion

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Supplemental ISO TS 16949, Clause 7.4.1.1 Regulatory conformity states that all of the
products purchased have to meet regulatory requirements.

In 7.4.1.2, there is some interesting language. It requires supplier / quality management


system development, which means that the organization has to exercise supplier /
quality management systems and development activities with their suppliers. The goal
is that conformity with this technical specification and conformity with 9001 is the first
step. What the standard authors are really saying is, "You need to have as much
confidence in your suppliers as we have in you." It is preferable to think of it as
something positive rather than whipping people into shape and getting them to. in turn,
whip their suppliers into shape. It is all about confidence.

The Note under it states that 'Unless otherwise specified by the customer, suppliers to
the organization shall be third-party registered to ISO 9001 by an accredited third-party
certification body." Conforming to 9001 is the first step toward advancement of a
supplier's QMS. Outside the automotive sector there is disagreement as to whether a
requirements standard should require the suppliers to an organization register their
QMS too.

7.4.1.3 Customer-approved sources: When a customer contract specifies the use of a


particular product material service from an approved source, the organization needs to
do that and auditors need to confirm it during an assessment. This may seem to be
redundant because if you have a contract with a customer, you need to comply with the
terms of the contract. The clause goes on to state that when the organization uses
customer-designated sources (including tools and gauges), it is NOT relieved of the
responsibility of ensuring purchased product quality.

Purchasing product from customer-designated sources should be a good thing, but


there can be quality and competitive pricing issues that need to be worked out. This
clause was originally crafted by the Mil Q9858A authors in 1959 and later revised in
1963.

7.4.2 Purchasing Information

Principle Concepts for Purchasing:


• Purchases of important product/services shall be controlled
• Suppliers shall be evaluated and selected
• Requirements shall be clearly defined
• Incoming material shall be inspected or verified

Discussion:
The planning clause 7.1 applies to purchasing as well as all the other clause 7 sub-
clauses. There should be a plan for the purchasing process. The standard does not
require that there be a documented procedure, but the organization is required to
ensure the purchased product conforms to requirements. Since there are no required

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procedures, the auditor must investigate how the organization's purchasing process is
able to ensure purchased products and services conform to specified purchasing
requirements. The organization must determine the extent of the control necessary to
ensure conformity of the purchased product or service.

The organization must establish criteria and evaluate, select, and re-evaluate suppliers.
The standard does not require an approved supplier list, but most companies end up
with one in order to identify selected (approved, certified) suppliers. Next, the results of
evaluations and any necessary actions shall be recorded and maintained.

7.4.2 Purchasing Information


Purchasing documents (such as purchase orders) must contain QMS requirements and
approval and/or qualification requirements for the item or service being sought (when
appropriate). Approval and qualification requirements may be needed for: product,
procedures, processes, equipment, and personnel.
Before release of purchasing information (such as a purchase order) to a supplier, the
organization must ensure the information is adequate. The objective is to provide
sufficient information in the purchasing documents such that suppliers understand
exactly what they need to provide. There is no requirement for a record but the
organization must provide audit evidence that they ensure that the purchasing
information is adequate prior to communicating it to the supplier. Examples of audit
evidence could be a signature associated with a criteria, a completed check sheet, initial
and date on purchasing forms and so on.
7.4.3 Verification of Purchased Product
This is the only place in the standard that requires assurance (inspection or other
means) that purchased product meets purchase requirements. Many organizations
have receiving and inspection departments that formally check and verify incoming
parts and materials.
When products are verified at the supplier's premises (if source inspection controls are
appropriate for ensuring conformity of the purchased product), the organization must
specify the arrangements for verification and the basis for release of product in the
purchasing documents.

ISO TS 16949 discussion


ISO/TS 16949 adds two clauses to this section of the standard. Clause 7.4.3.1,
Incoming quality, states that the organization must have a process to assure the quality
of purchased product and it reinforces the verification of alternative methods the
organization can use. Verification methods allowed are:
1. receipt of, and evaluation of, the statistical data by the organization
2. receiving inspection or sampling based on performance
3. second- or third-party assessments or audits of supplier sites when coupled with
records of acceptable product delivery
4. part evaluation by a designated laboratory
5. another method agreed upon with the customer

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7.4.3.2 Supplier, performance monitoring is required. So we are going to watch the


indicators:

• delivered, product quality


• customer disruptions including field returns
• delivery schedule performance
• special, status or customer notifications related to quality or delivery issues

At the end of this clause is a sentence that requires organizations to promote supplier-
monitoring the performance of their processes. A supplier may be registered to ISO
9001, but ISO 9001 does not specifically require or exclude monitoring of manufacturing
processes. Where applicable, ISO 9001 requires monitoring QMS process, but ISO/TS
16949 is very specific about monitoring manufacturing processes (see clause 8.2.3.1).

Baseline: [by-the-book requirements ISO/TS 1694 requirements in blue


7.1]
• There must be a plan for realization of the product/service.
• The planning process must be consistent with QMS requirements. Some
examples are: 1) quality objectives, 2) the need for creating processes and
providing resources, 3) conducting verification and validation activities compared
to acceptance criteria, and 4) the need for records to assure conformance of
processes and the product/service.
• Product realization planning must include customer requirements, acceptance
criteria and provision made for confidentiality of customer information.
• There must be control of changes to product and the manufacturing process.
Changes must be assessed, verified, and validated before changes are
implemented.

7.2
• Customer (product/service) requirements must include: customer specified
requirements, availability, delivery, post delivery, support service, and those
specification/performance requirements not stated but known to the provider
organization.
• Requirements must be determined from obligations such as contracts,
regulations, and statutes.
• Special product characteristic requirements must be addressed.
• Reviews of customer and other requirements shall be conducted prior to
commitment to supply the product/service. Reviews shall ensure: requirements
are defined, requirements are documented or otherwise confirmed, differences
resolved, and that the organization has the ability to meet the requirements.

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• Records of review(s) and actions (follow-up) shall be kept.


• Manufacturing feasibility of proposed products will be determined as part of the
review process.
• When product/service requirements are changed, the organization must change
applicable documents and inform appropriate people.
• Communication channels for transmitting as well as receiving information from
the customer must be established. Communicate information related to: product
information, inquiries, contracts, order handling, amendments, product design
data, and customer feedback
7.3
• Design planning must include: 1) project (design and develop) stages, 2) review,
verification, validation points, and 3) responsibilities and authorities.
• Project plans must be updated as the design progresses.
• The organization must use multidisciplinary approach during the design process.
• Inputs to design must be determined, recorded, and reviewed for adequacy.
Inputs must be clear, unambiguous, and not in conflict with each other. (see list
of inputs above or clause 7.3.2).
• Product and manufacturing process design inputs must identified, documented
and reviewed.
• Design outputs must be in a form that can be compared against inputs
(requirements, parameters) and approved prior to release (see list of output
requirement above or clause 7.3.3).
• Design reviews must be conducted according to planned arrangements. There
must be a record of the review and subsequent necessary (follow-up) actions (as
a result of the review).
• Design review summaries must be submitted for management review.
• Design verifications must be conducted according to planned arrangements and
recorded.
• Design validation must be conducted and recorded according to planned
arrangements.
• Design changes must be defined. The effects of change must be evaluated,
verified, validated, and approved prior to implementation. Design change reviews
must be recorded. The effect of the changes on constituent parts and delivered
product must be evaluated (determined).

7.4
• Purchasing processes must be planned and developed to ensure product
conforms to purchase requirements.

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• Purchasing controls must be varied based on needs (effect on realization


processes and outputs).
• Suppliers must be evaluated and selected based on established criteria.
• Suppliers must conform to ISO 9001 requirements with a goal to conform to
ISO/TS 16949.
• Records of evaluations and necessary (follow-up) actions must be kept.
• The requirements for approval, qualification, and QMS on purchasing documents
must be described.
• The description on purchasing documents must be adequate. Check the
description before documents are released.
• Activities (a process) must be established and implemented to ensure purchased
product meets specified purchase requirements.

Now we are ready to review the requirements of the actual operation. This is the value-
added activity for the organization.

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Lesson D11: Product and Service Operations (7.5-7.6)

7.5 Product and Service Provision


7.5.1 Control of Product and Service Provision
7.5.2 Validation of Processes for Production and Service Provision
7.5.3 Identification and Traceability
7.5.4 Customer Property
7.5.5 Preservation of Product
7.6 Control of Monitoring and Measuring Devices

Principle Concepts:
• Control the processing (production) of the organization's products or
• Control the delivery (performance) of the organization's services
• Processes whose outputs cannot be verified by measuring and monitoring must
be validated
• Identify the product or service and know status
• Trace the product or service when required
• Identify and protect customer property from loss or damage
• Protect product from damage
• Ensure that accurate and reliable measuring equipment is used

7.5.1 Production and Service Provision Control


Discussion:
This clause addresses the activity of providing the product or service. Product is any
intended output, tangible or intangible. Hardware, software, and process companies
need to plan and develop processes for production and installation (reference 7.1).
The standard identifies six actions that must be considered for control of the product
realization process.

1) Management must provide information that includes the acceptance criteria


(characteristics of the product) for the process. For example: When is the job/process
done right? What are the product or service specifications? What is desired? What is a
success for that process? There are linkages from this clause to other clauses of the
standard such as clause 4.1c and 4.1d, which also discuss providing information.

2) The standard calls for documents (procedures, work instructions) when needed to
ensure effective planning, operation and control of its processes (4.2b). Auditors should
check to ensure work instructions/procedures are being followed. The need for work
instructions or other documents may depend on the organization’s size, type,
complexity, interactions, and competency of personnel (4.2b). When it is important for
an activity to be done a certain way every time to ensure quality, safety and other
objectives (such as economic) are met, the organization may decide to issue a work
instruction. Work instructions and other documents are management control tools.

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3) The equipment must be suitable for the intended purpose. Equipment must be
properly used and maintained (see clause 6.3). An auditor may determine if there are
instructions for the equipment, if operators know how to operate the equipment and if
there is a preventive maintenance schedule.

4) Using measuring equipment


5) Monitoring the processes
Equipment for measuring and monitoring can be about anything needed to gauge and
make adjustments to the process. They may be anything from gas chromatographs to
tire gauges. When the organization needs devices to control (pass-fail) the process,
they should have them, use them, and maintain them. Monitoring can include: process
control charts, measuring tolerances, testing samples, trend charts, conducting process
audits, etc.
Measuring equipment are used to test a product, resulting in a pass/fail decision.
Monitoring equipment are used to control a process and may result in an operate/don't
operate decision.
6) Implementing product release, delivery and post delivery processes
To complete the product/service realization process, the organization must include a
release process, delivery process, and when applicable, a post delivery process (such
as installing or maintaining). The wording (such as release or post delivery) may seem
strange to some, but most organizations already have these processes in place.
Normally there is some type of final release, such as: it is okay to send to the
warehouse or ship to the customer step (or both). In all cases for a product company,
arrangements have been made to get the product to the customer. And finally, many
organizations have some type of installation or technical service linked to the sale of the
product. For a service organization, the release may come before the service is
performed (i.e. a release that it is okay to perform the service). Or if a service (image
i752 repairing) is performed on customer equipment, there may be a release prior to
returning the equipment to the customer.
It is important to note that delivery and post delivery processes are mentioned as part of
the operations control clause. For a JIT (Just In Time) company, product may come off
the line and be put on a truck or train without any storage. When service is provided it is
normally being delivered, but there may be post delivery processes such as an annual
review of policies or equipment maintenance requirements.

ISO TS 16949 discussion


ISO/TS 16949 has added 8 supplemental clauses (with additional requirements) to
Clause 7.5.
7.5.1.1 Control plans (see Annex A): The clause states that the organization shall
develop control plans at all levels (system-subsystem-component-material) for product
supplied. The organization must also take into account design FMEA results for pre-

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launch and manufacturing process FMEAs for production. The control plan information
may be included in routing cards or travelers.
There is a prescriptive list of things that must be in the control plan. All these items are
also in the Annex A Control Plan, but since they are in the standard, the following four
must be addressed and will be audited against.

• list the controls used for the manufacturing process control,


• include methods for monitoring of control exercised over special
characteristics (see 7.3.2.3) defined by both the customer and the
organization,
• include the customer-required information, if any, and
• initiate the specified reaction plan (see 8.2.3.1) when the process
becomes unstable or is not statistically capable.

The end of this states that "control plans must be updated when product or process
changes occur. Control plans must be reviewed and updated when there are changes
(to product, process, measurement, logistics, supply or FMEA assumptions)." A FMEA
will not change unless there is a process or product change. In other words, control
plans must be updated when there are changes to the process, process input or
process outputs. In some cases, the customer may want to approve any control plan
changes. If auditing, you will need to know if any customers require their approval of
control plan changes.

Sidebar:
There are two specific places in the standard that require
customer approval. Customer approval is required for
customer requirements to be waved (7.2.2.1) or if alternate
analytical methods and acceptance criteria are used (7.6.1).
There are many other places in the standard that refer to
customer approval as "if applicable", "if appropriate" or "if
required." For example: customers may require approval of
control plans (7.5.1.1), acceptance criteria (7.1.2), and
reaction plans.

7.1.5.2 Work Instructions. Also supplemental in the automotive industry is this clause on
work instructions. Here it talks about documented work instructions for all employees
who have responsibility for the operation of processes that impact product quality. If
work is being performed that impacts product quality, there must be instructions. The
work instructions must be accessible for use at work stations or areas of work.
Organizations cannot keep a tidy manual of work instructions in the quality manager’s
office just to show auditors. Work instructions must also be available to those who use
them. Work instructions must come from the quality plan, the control plan, and the
product realization process. In other words, work instructions must reflect the work
taking place.

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7.5.1.3 Verification of job set-ups. This clause asks, “Are the set-ups right?” Set-ups are
often done on the initial production run in the machine and tool industry. They may be
required for each production run and usually every time there is change.
The requirements here are:
1. Job set-up must be verified (such as initial run, material change over or job change)
2. Verification must be done using statistical methods where applicable
3. The work instructions must be available to set-up persons

The key requirement is that set-up processes must be verified. The new machine set-up
must be verified that it is the right tool for the run and that the settings are correct.
Incorrect set-ups can result in schedule loss, delays, scrap, or worse (e,g., the customer
gets the wrong, but similar, part). The clause ends with a note that last-off part
comparisons are recommended. In other words, is the new part the same as the last
part of the previous run? Remember that notes are not requirements. They are included
as reminders or for clarification purposes.

In the process industry, there may be start-ups for continuous operations that may run
for months. Batch operations may have frequent start-ups of new batches or repeat
batches. For example: Today there will be three batches of white paint followed by one
batch of blue. Batch prep may be different when changing from white paint to blue
versus going from blue to white.

7.5.1.4 Preventive and predictive maintenance is required. The organization must


identify key process equipment; develop a total preventive maintenance system; and
provide the resources for maintenance. Then there is a prescriptive list of things that
must be included in the preventive maintenance system. They are:

• planned maintenance activities


• packaging and preservation of equipment, tooling and gauging
• availability of replacement parts for key manufacturing equipment
• documenting, evaluating and improving maintenance objectives

In general, you would expect some type of schedule and that equipment; tooling and
gauging (in use or storage) are protected. Replacement parts for key equipment should
be available instead of cannibalizing back-up or alternating equipment.

The auditor should look for evidence of improved maintenance objectives. The key in
any preventive maintenance program is to balance the cost of preventive maintenance
versus the cost of unscheduled downtime.

How do you do maintenance before it is needed and how do you know when things are
likely to go wrong ahead of time? Do predictive maintenance. The organization must
utilize predictive maintenance methods to improve the effectiveness and efficiency of
production equipment. For example: Normal wear and tear of equipment may be due to
fatigue caused by cycles or vibration. Equipment capability and reliability can be
increased if causes of failure are addressed.

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ISO/TS 16949 7.5.1.5 Management of production tooling. The organization shall


provide resources for tool and gauge design, fabrication and verification. The
organization must establish and implement production tooling management
system. There is a prescriptive list on things that must be included in the
production tooling management system. Since the list is self-explanatory, it will
not be reviewed here but should be reviewed when you audit or implement the
QMS. If any part of the production tooling management system is outsourced,
there must be a program to monitor outsourced activities. There is a note that
clarifies that this clause includes tools for vehicle service parts.

ISO/TS 16949 7.5.1.6 Production scheduling has to be done in a manner that ensures
customer requirements are met (such as just-in-time) and this includes all of the
supplemental components such as a management information system or an IP or
software of some kind. The information system must permit access to production
information at key stages of production. Product schedules must be order-driven. The
schedule must be order-driven as opposed to other criteria such as cost-driven. Cost is
a factor but should not be the primary driving force. Cost versus schedule decisions are
made every day. Do organizations hold up orders to save on set-up time or ship the
most economical means available?

ISO/TS16949 7.5.1.7 Feedback of information from service. A process has to be in


place so you can provide customer service feedback to manufacturing, engineering and
design. An auditor may ask the folks in engineering or manufacturing if they receive
information about problems encountered by the customer service department. There is
an explanatory note that states: The intent of the addition of “service concerns” to this
sub-clause is to ensure that the organization is aware of nonconformities that occur
external to its organization.

ISO/TS16949 7.5.1.8 Service agreement with customer. When there is a service


agreement with the customer, the organization shall verify the effectiveness of any
organization service centers, any special tools or equipment, and the training of
personnel. For example, an organization may have a contract to service equipment
provided or to transport or inventory parts or equipment.

7.5.2 Validation Process


Discussion:
In the past, processes that needed validation were called special processes. When a
process output (product) cannot be verified by subsequent measurement and
monitoring, the process must be validated.
In simpler terms, If you cannot check it before the customer receives it, you must
validate the process that produced it. Examples include cases where (a) the
characteristics of interest do not exist until further downstream in the process; (b) a

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method of measurement does not exist or is destructive; or (c) results within the process
cannot be measured in later inspections (prior to customer receipt).
Processes needing validation have been associated with medical treatments, flying
aircraft, metalworking, welding, nondestructive examination, and heat treating. These
processes require the process itself to be validated, equipment approved, and operators
qualified. The process that produces a finished welded product must be validated if the
purchase or use of expensive x-ray inspection devices is not practical. The weld
strength cannot be measured unless the weld is broken (product must be destroyed to
verify requirements).
If part of the service includes engaging the customer, such as training courses, then the
process must be validated.
There may be a considerable number of opinions concerning the identification of
processes that need to be validated. Some experts may say all services must be
validated. One must go back to the exact wording in ISO 9001 to determine what
processes must be validated.

"The organization shall validate any processes for production and service provision where
the resulting output cannot be verified by subsequent monitoring and measurement. This
includes any processes where deficiencies become apparent only after the product is in
use or the service has been delivered." ISO 9001, clause 7.5.2.

Subsequent measurement and monitoring comes after the operation (production) but
before customer receipt. For example one cannot argue that welding does not need to
be validated because we can go back 20 years later to see if the bridge is still standing,
or that ability to measure the safe arrival of the airplane precludes the need to validate
the air carrier process.
The validation process must verify that the process being validated can achieve planned
(specified) results (objectives). Validation is demonstrating (verifying) that the process
can achieve planned results. The organization must arrange for validation and must
include the following (as applicable) for validation:
• qualification, or registration of processes (demonstrate performance)
• qualification, or certification of equipment or people/operator license
• use of specified procedures or techniques or work practices
• determine record requirements
o determine re-validation requirements

This is the same type of validation discussed in 7.3.6, design and development control.
Design and development validation would be the first-time use product validation. After
the initial first time start-up validation, no other ongoing validation may be required by
the design group (for example: performance testing of a pump or stamping machine
after installation to validate the design). However, revalidation may be required from
time to time to verify capacity, through-put, or safety.

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ISO TS 16949 discussion


ISO/TS 16949 7.5.2.1 Validation of processes for production and service provision
supplemental

The requirement is that 7.5.2 applies to all processes for production and service
provision. This means all processes for production and service provision must be
validated. Processes are responsible for all change and should be validated and
revalidated when there are changes to them. Monitoring changes in product
characteristics is after-the-fact and in many cases does not reveal changes in its
intended use.

Sidebar:
My experience is that many field failures are a result of
seemingly minor or inconsequential process changes. This
requirement and manufacturing process design requirements
are probably the most value-added requirements beyond
existing ISO 9001 ones. This would be an example of
breakthrough improvement compared to ISO 9001 QMS
designs.

7.5.3 Identification and Traceability


Discussion:
Product identification, traceability and status are three separate processes but they
must be compatible. If it is important to differentiate between similar products (parts,
batches, lots, etc) or services (treatment, project, transaction, etc.), there must be some
type of identification process.
Once there is an identification process, traceability may be required by the customer or
a regulatory agency. One form of traceability is to be able to match the finished item
with the incoming parts and materials. This is very useful for failure analysis. It is called
backward traceability.
Traceability calls for identification of the finished product by stamp or serial number.
Those warranty cards you fill out when you purchase a new microwave ask for a serial
number. This allows the organization to trace the sale back to the factory and date of
production. In the food processing and pharmaceutical industries, the organization
needs to be able to trace the distribution of the product, in case of recall. This is called
forward traceability.
The 9001-quality system standard does not require any form of traceability. Those
requirements come from your customer or your regulator.
As an item or service progresses through the various steps of processing, an
organization may need to know if it is ready for the next operation. For many processes
it is important for organizations to know the status of a product or service. It helps
organizations make good decisions, and in many cases it keeps the customer informed
of production, performance, delivery progress.

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Knowing the status of a product during production is one of the earliest forms of quality
control. It allows fellow workers to know the quality of something before they work on it.
More importantly, it allows the customer to know the quality before he or she buys it.
Product identification, status, and traceability are concepts that have withstood the test
of time. They are 'good business practice.' No documented procedures are required by
ISO 9001 for this clause.

ISO TS 16949 discussion


ISO/TS 16949, 7.5.3 Identification and traceability.
16949 Note: There is a note to clarify that inspection and test status is not indicated by
the location of product in the production flow unless inherently obvious, such as material
in an automated production transfer process. Alternatives are permitted, if the status is
clearly identified, documented and achieves the designated purpose.

Then there is a separate clause 7.5.3.1 which states the ISO 9001 wording where
appropriate is not appropriate. If reworded, the requirement would be: The organization
shall identify the product by suitable means throughout product realization.

7.5.4 Customer Property


Discussion:
Customer Property is anything provided by the customer that is tangible (has physical
form) or intellectual property that the organization doesn't own.

The organization must exercise care in identifying, verifying, protecting and


safeguarding customer property (e.g. equipment) that has been received. If the
customer property is lost, unsuitable, damaged upon receipt, or in storage, the customer
must be notified. The organization must keep records of lost, unsuitable, or damaged
property. No documented procedures are required.

ISO TS 16949 discussion


ISO/TS 16949 Note: There is note that explains customer-owned property includes
customer-owned returnable packaging. Customer property is not just raw material
incorporated into the product or tool or mold used to create the product.
7.5.4.1 Customer-owned production tooling supplemental clause

The automotive supplement in 7.5.4.1 specifies some customer property must be


identified so the organization can keep track of the customer’s property and readily
identify the property owned by different customers. The customer-owned tools,
manufacturing, test, inspection tooling and equipment must be permanently marked so
that the ownership of each item is visible, and can be determined.

7.5.5 Preservation of Product


Discussion:
Management must preserve the conformity of the product to customer requirements

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during internal processing stages and subsequent delivery to the intended destination
(customer). This includes identification, handling, storage, packaging, and preservation.
Protection of constituent parts (component parts) is included in the scope of this
requirement.

This clause may be very difficult to audit using the requirements approach because
there are few requirements and the ones that exist are conceptual requirements. There
is no requirement for a documented procedure or specific requirement for management
control of this process. However, the general requirements in clause 7.1 apply to all
realization processes to include preservation of product. Auditors can audit the
preservation process defined by the organization, degree of implementation and
achievement of desirable outcomes.

ISO TS 16949 discussion:


ISO/TS 16949 7.5.5.1 Storage and inventory supplemental clause.
The condition of product in stock shall be assessed at appropriate planned intervals in
order to detect deterioration. There must be some type of schedule, such as a monthly
walk through the warehouse, yard, storage, or holding area. Some organizations
combine the assessment of the condition of stored product with a safety assessment.

The organization shall use an inventory management system to optimize inventory turns
over time and assure stock rotation, such as “first-in-first-out” (FIFO). Controlling the
rotation of inventory makes sense but some organizations don’t have a system.

Additionally, obsolete product must be controlled in a similar manner to nonconforming


product. Obsolete product is not specifically included in clause 8.3 for control of
nonconforming product, however, it may fit the description of product with suspect
status (see clause 8.3.1). In a similar manner, obsolete product is identified to prevent
its unintended use or delivery and there is a predetermined method to deal with the
obsolete product.

7.6 Control of Measuring and Monitoring Equipment


Discussion:
This clause if very prescriptive. It is commonly thought of as the calibration clause but
more importantly it deals with proper maintenance and control of measuring and
monitoring equipment (test equipment). The clause requires that the organization
determine (identify) the required product/service measurements. See clause 7.5.1a
(product characteristics, acceptance criteria) and 8.2.4 (product measurement).
Next, the organization must establish processes to use measuring and monitoring
equipment consistent with device requirements. Other familiar terms may be measuring
devices , test instrument, test gauge, tool, and so on.

In order to have confidence in the measurements taken to demonstrate control of


processes or conformance of product to specifications, management must plan and

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then control all aspects of measurement. There must be equipment to test for the
parameters and characteristics identified (acceptance criteria) in clause 7.5. The
equipment used to conduct the test must be capable of providing a test result within
specified ranges or tolerances.

The measuring and monitoring devices must be maintained in a proper environment.


Test and calibration equipment and standards should be properly stored to protect from
damage or deterioration. Some organizations have calibration laboratories and closely
monitor the environment.

The equipment must be calibrated and checked against national or international


standards when they exist. When there are no national or international standards, the
basis for calibration or verification must be recorded. For homemade tests, the
organization will need to develop their own methods to calibrate the equipment.

When measuring and monitoring devices are found not to conforming to requirements
appropriate action must be taken concerning the devices and product affected. There
must be a record of action taken.

The calibration status of equipment must be known to the user of the equipment. This
is normally a sticker with the next calibration due date indicated on the sticker. Other
methods of calibration status notification are acceptable as long as they work.

There is a note to refer to ISO 10012 for additional guidance

ISO TS 16949 discussion


ISO/TS 16949 7.6 Control of measuring and monitoring devices.

The ISO/TS16949 Note clarifies that a number or other identifier traceable to the device
calibration record meets the intent of requirement of c) of 7.6. This note reinforces the
fact that organizations are no longer required to have calibration stickers on calibrated
equipment. In some situations stickers are not practical or the sticker program upkeep
takes almost as much time as does the calibration checks. An auditor should record test
equipment identifiers throughout the audit and either check the sticker at the time or
check a record book that has the calibration status indicated.

ISO/TSTS 16949 7.6.1 Measurement system analysis [MSA]

Another supplemental clause the automotive industry adds is that 7.6.1 Measurement
system analysis requires statistical studies be conducted to analyze measurement
variation for each measuring and test equipment system referenced in the control plan.
In other words, if there is a test referenced in the control plan, then there should be a
statistical study that determines the variation in the test results. A test result is actually
only an estimate of the true value of the measured characteristic or parameter. Knowing
test uncertainty is important to ensure organizations meet customer requirements and
avoid over control of processes. For example if the total measurement error for the

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value 90 is 1 and the top range is 90, do you adjust the process if the test result is
90.25? Probably not since the next test result could be 89.25.

In general, repeatability is about instrument or device error and reproducibility is about


inspector or appraiser error.

The analytical methods and acceptance criteria must conform to those in customer
reference manuals or be approved by the customer. The methods and acceptance
criteria must agree with customer manuals. If the organization provides product for more
than one motor company, it may have different methods and acceptance criteria for the
same test. An auditor should verify the source for approval of the methods and
acceptance criteria.

7.6.2 Calibration / verification records. These records must provide evidence of


conformity of product to requirements (also 7.6). The records include employee-owned
and customer-owned test equipment. Then, the standard has a list of information that
must be recorded to meet ISO/TS16949 requirements. For the purposes of this class,
we have created a calibration record form referencing the required information from
clause 7.6 and 7.6.2.

Discussion: Laboratory requirements:


ISO/TS 16949 7.6.3.1 Internal laboratory requires a defined scope, which includes the
capability to perform the required inspection, test, or service and which is included in the
QMS documentation with respect to adequacy of lab procedures, competency of
personnel, product testing, capability to perform these services correctly and review of
records.

7.6.3.2 External laboratory. When external / commercial / independent laboratory


facilities are used by the organization, for inspection, testing, or calibration, they shall
have a defined scope which includes the ability to perform the required inspection test /
calibration and there shall be evidence that the external laboratory is acceptable to the
customer or be accredited to ISO/IEC or its national equivalent . Notes at the end of this
clause state that the evidence that the requirements are fulfilled may be determined by
assessments or customer-approved 2nd-party assessment. If a qualified lab is not
available for individual piece calibration, then the equipment manufacturer may perform
the services, however the organization must ensure that the requirements of 7.6.3.1 are
met.

Baseline: [by-the-book requirements] with ISO/TS 16949 related requirements in blue.

• Provide management control of production and service processes to include:


needed information about the product characteristics, equipment to operate, work
instructions, devices for measuring and monitoring, and support processes
(release, delivery, and post delivery).
• Develop, review and update controls plans for product supplied.

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• Prepare documented work instructions and make sure they are accessible at the
work station.
• Job set-ups shall be verified whenever performed.
• Provide resources for machine-equipment maintenance and develop an effective
planned total preventive maintenance system.
• Establish and implement a system for production tooling management that
includes resources for tool and gauge design, fabrication and verification
activities.
• Production shall be scheduled in order to meet customer requirements.
• Establish and maintain a process for communication of information on service
concerns to manufacturing, engineering and design.
• The effectiveness of customer service agreements shall be verified.
• Validate processes by demonstrating that the process can achieve planned
results.
• Define arrangements for validation and qualify processes, (including production
and service) specify needed methods and procedures, determine required
records, and define re-validation requirements as applicable.
• Identify the product throughout the realization process (when appropriate).
• When traceability is required, control identification method and keep records.
• Identify the product measurement (test) and monitoring status.
• The organization must exercise care with customer property.
• The customer property must be identified, verified, protected, and safeguarded.
Customer owned tools must be permanently marked so that the owner is visible
(i.e., known).
• Lost, stolen, or damaged customer property must be reported to the customer.
• The organization must preserve (protect) its own product (and associated parts)
from damage during all internal processing stages and delivery (includes:
identification, handling, packaging, storage, and protection).
• The condition of product in stock shall be assessed at planned intervals and
there must be an inventory management system.
• To assure the conformity of the product/service, the organization must identify
the measurements to be made and the devices to make the measurements.
• Measuring equipment shall be used in a manner consistent with measuring and
monitoring device requirements.
• Where applicable, establish an instrument calibration program. Keep records of
calibration program checks (see clause 7.6 for prescriptive list).
• Confirm software prior to initial use and reconfirm as needed.
• Statistical studies shall be conducted to analyze the variation present in the
results of each type of measuring and test equipment system.

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• There must be records of the calibration/verification activity for all gauges,


measuring and test equipment, including employee and customer owned
equipment.
• An organization's internal laboratory facility must be managed and include a
defined scope that includes its capability to perform the required inspection, test
or calibration services.
• External/commercial/independent laboratory facilities used for inspection, test or
calibration services by the organization shall have a defined laboratory scope that
includes the capability to perform the required inspection, test or calibration and
either acceptable to the customer or nationally accredited to ISO 17025.

This ends the realization process controls. Next, we shall discuss measuring the
outputs of the processes and how that information will be used for improvement.

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Lesson D12: Measurement, Analysis, and Improvement (8.1-


8.5)

8.1 General
8.2 Monitoring and Measurement
8.2.1 Customer Satisfaction
8.2.2 Internal Audit
8.2.3 Measurement and Monitoring of Processes
8.2.4 Measurement and Monitoring of Product
8.3 Control of Nonconforming Product
8.4 Analysis of Data
8.5 Improvement

Principle Concepts:
• Plan, take measurements and improve processes
• Monitor customer satisfaction
• Plan and conduct internal audits of the quality management system in
accordance with documented procedures
• Report audit results to management and take action
• Measure and monitor processes
• Measure and monitor products
• Control nonconforming product by identifying and making arrangements for
continued processing or scrapping
• Collect and analyze data to verify suitability and effectiveness of the system
• Identify areas for system improvement
• Eliminate the causes of nonconformities
• Eliminate causes of potential nonconformities

8.1 General
Discussion:
Activities must be planned for measuring, monitoring, and analysis to meet
requirements to conform to the QMS, and to continually improve. The organization is
not required to have a procedure. This is the big picture view that matches up nicely
with the sub-clauses for clause 8 [Measuring and monitoring, Analysis of data, and
improvement].

The data and analysis must demonstrate conformity to product requirements, ensure
conformity of the quality management system, and continually improve the effectiveness
of the QMS.

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The organization must ensure that the proper analysis methods are being used for each
process and measurement. Methods can include statistical techniques such as SPC
methods (statistical process control) or histograms or sampling. This is the only mention
of statistical techniques in the standard.

ISO TS 16949 discussion


ISO/TS 16949 8.1.1 Identification of statistical tools. The statistical tools for each
process shall be determined during advance quality planning and included in the control
plan. Supplemental clause: 8.1.2 Knowledge of basic statistical concepts. Basic
statistical concepts must be understood and utilized throughout the organization.

8.2.1 Customer satisfaction


Discussion:
Customer satisfaction information must be monitored. Specifically, the standard requires
the measurement of customer perception regarding meeting requirements as an
indication of customer satisfaction. For customer satisfaction, the customer’s perception
of the product or service is more important than a single metric such as on-time-delivery
or defect-free product. Customer perception is one of the key measures of QMS
performance. The methods for gathering and using the information need to be thought
out (determined). The customer's perception of satisfaction and dissatisfaction may be
measured. For example: customer complaints are a measure of customer
dissatisfaction; other measures, such as a survey or interview, may be needed to
assess customer satisfaction.

The approach for determining the level of customer satisfaction is a primary feedback
loop for organizations. Sources of information that may directly or indirectly reflect
customer satisfaction can be seen below.

A value-added step is to link customer satisfaction data to key processes for future
action. Customer satisfaction may be relative to competitors or competing products

ISO TS 16949 discussion


First, there is a supplemental Note to clarify clause 8.2.1 on Customer satisfaction. The
Note states that consideration should be given to both internal and external customers.
Nothing is required here but if it makes sense, includes internal customers in your
customer satisfaction measurement program. It can be very effective in improving
internal efficiencies.

8.2.1.1 Customer satisfaction.


Quality means different things for different people and nowhere is that more evident
than the customer and supplier. In the book The Quality Master Plan (1) the author
states, "Quality for the customer is getting what you were expecting and quality for the
supplier is doing it right the first time." Here ISO 9001 focuses on the customer part of
quality, while ISO/TS 16949 focuses on the supplier efficiency and performance part of

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quality. Customer satisfaction shall be monitored through continual evaluation of


performance of the realization processes. Performance indicators shall include:

• delivered part quality performance


• customer disruptions including field returns
• delivery schedule performance (including incidents of premium freight)
• customer notifications related to quality or delivery issues

These measures are also closely linked to automotive OEM industry customer
expectations. This clause also requires that manufacturing processes performance be
monitored to demonstrate compliance to product quality requirements and process
efficiency.

(1) Russell, JP, The Quality Master Plan, ASQ Quality Press, 1990, Milwaukee WI

8.2.2 Internal Audit


Discussion:
Audits must be conducted at planned intervals (scheduled) to determine if the quality
management system conforms (are in compliance with) to planned arrangements, QMS
requirements, and the requirements of ISO 9001, and that it has been effectively
implemented and maintained. It is clear that auditors should audit against the ISO 9001
requirements, and the organization's QMS. Additionally, the implementation and
ongoing maintenance of conformance to requirements must be assessed.
The standard requires that the organization determines conformance of the QMS to
planned arrangements. Even though "planned arrangements" is somewhat of an
awkward term, most interpret it to mean the documents in a quality system (manual,
procedures, plans, work instructions) and other non-ISO 9001 standards. The internal
quality auditors should audit against all organizational QMS documents.

Auditors are not required (by ISO 9001 requirements) to determine the effectiveness of
the quality management system. The "effectiveness" wording is not included here due
to potential product liability concerns in regulated industries.
The audit program plan must consider factors such as area status, importance, and
results of prior audits when scheduling audits. An organization could receive a
nonconformity if they only schedule audits of the ISO 9001 clauses and do not consider
area status, importance and prior results.
Auditors must be selected in ways that ensure impartiality and objectivity of the audit
results. Internal auditors must have some level of independence or no invested interest
in the area being audited. Practicality and the nature of the organization must be
considered when determining the level of independence to ensure impartiality and
objectivity. A small organization providing low risk products or services does not need
the same level of independence as a large, complex organization that provides high risk
products or services (law firm versus nuclear power plant).

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There must be a documented procedure for the internal auditing process. The clause
contains several other checklist items as part of the baseline requirements, so you can
cross check your checklist or read (or refer to) in the standard.

Action must be taken by management on audit nonconformities without undue delay.


The implementation of corrective actions must be verified and reported.

Auditors can verify that follow-up actions were taken to address nonconformities.
However, there is no requirement in this clause to verify the effectiveness of the action
or corrective action as a result of the audit. The effectiveness of corrective actions
should be addressed as part of the corrective action review (clause 8.5.2) and
management review (clause 5.6).

ISO TS 16949 discussion


The automotive supplement, 8.2.2.1 Quality management systems audit reminds us
that the internal audits verify compliance to the ISO/TS 16949 and additional quality
management system requirements.

ISO/TS 16949 8.2.2.2. Manufacturing process audits are required to determine the
effectiveness of the manufacturing processes.

ISO/TS 16949 8.2.2.3 Product audits require that the organization shall audit products
to verify conformity to all specified requirements at appropriate stages of production and
delivery. Specified requirements may include required product characteristics such as
product dimensions or functionality, packaging and labeling. Product audits must be
done at a defined frequency such as a routine schedule.

ISO/TS 16949 8.2.2.4 Internal audit plans. This clause states that internal audits should
cover all QMS related processes, activities and shifts and shall be scheduled in an
annual plan. All QMS processes must be audited at least annually. There is a Note that
checklists should be used for internal audits. As an auditor, you should ask to see the
checklists and if none exist, ask why. The issue here is that without a verifiable
checklist, how does management know all requirements are included as part of the
audit criteria for each audit? Next, if there are customer complaints or nonconformities,
the frequency of audits must be increased. Nonconformities can be internal or external
in nature. Poor performing areas must be audited more frequently.

ISO/TS 16949 8.2.2.5 Internal auditor qualifications. Auditors must be qualified to audit
the requirements of the TS standard (see. 6.2.2.2). Taking this class could be part of
that qualification.

8.2.3 Monitoring and Measurement of Processes


Discussion:
The QMS processes necessary to meet customer requirements must be measured and

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monitored to ensure their continued ability to meet planned results. When processes
are found to be nonconforming, action should be taken to ensure the product or service
conformance to requirements. If a process is not performing, immediate action may be
required to keep product in conformance.
The organization must identify the process performance measures. The idea is that
quality is not achieved by end of the line testing before the product goes to the
customer. The processes that create the product must be capable. Or at least the
organization should know they are operating as intended.

While organizations may monitor many processes, they only need to show the auditor
evidence that verifies conformance to the standard.

ISO TS 16949 discussion


ISO/TS 16949 8.2.3.1: Monitoring and measurement of manufacturing processes.
The organization shall perform process capability studies on all new manufacturing
processes. The study is to verify process capability and to provide additional input for
process control. New processes include assembly or sequencing processes. This
means that when a new process is started up, the organization must verify it is capable
of operating within acceptable ranges (within specification limits) to certain confidence
levels such as 99.73% of the time (3 sigma). The standard uses the term verification,
but this may also be validation that the actual process will operate as intended.
The results of process studies shall be documented with specifications. Where
applicable the documentation should include the means of production, measurement
and test, and maintenance instructions. The documents shall include objectives for
manufacturing process capability, reliability, maintainability and availability as well as
acceptance criteria. Objectives mean goals or targets for the process. There may be
objectives to improve effectiveness or efficiency of the process.

Next is another thou shall adhere to customer requirements statement. The organization
shall maintain manufacturing process capability or performance as specified by the
customer part approval process requirements. The control plan and process flow
diagram (required as part of process design 7.3.3.2) must be implemented.
Implementation must include adherence to:

• the specified measurement techniques


• sampling plans
• acceptance criteria
• reaction plans when acceptance criteria are not met

Significant process events shall be recorded. The standard includes tool change and
machine repair as examples of significant events. As an auditor you will want to verify
these two specific types of events are being recorded and ask if there are other
significant events (for example: unscheduled downtime might be a significant event).

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The standard allows for the fact that some supplier processes are not capable and do
not meet customer requirements. That is okay as long as the supplier organization has
a plan to fix it. The organization shall initiate a reaction plan (from the control plan) for
characteristics that are either not statistically capable or are unstable. The reaction
plans shall include containment of product and 100 % inspection as appropriate. A
corrective action plan (see clause 8.5.2) shall be completed by the organization,
indicating specific timing and assigned responsibilities to assure that the process
becomes stable and capable. The plans shall be reviewed with and approved by the
customer when so required. During an audit, you will need to know if the customer
requires approval of corrective action plans in general or just for processes that are not
capable.

Then there is one sentence that states the organization shall keep records of effective
dates of process changes. Since most of this clause is about new processes, process
change records may be found when processes are revalidated after a process change
(clause 7.5.2).

Sidebar:
You must realize by now that ISO/TS 16949 standard places a
strong emphasis on design and control of processes as well as
product. In my opinion this is the most significant contribution
to quality made by the ISO/TS 16949 standard that is not
included in ISO 9001.

Please note that this clause requires a document and two records.

8.2.4 Monitoring and Measurement of Product


Discussion:
The organization must verify that requirements are being met by measuring and
monitoring (testing, inspecting, analyzing) product characteristics in accordance with
planned arrangements (7.1). "Product" means the final product or service intended for
the customer (see ISO 9001, clause 1.1 note). "Product" can be hardware (bolt,
machine, computer), processed materials (food, gasoline, juice), software (computer
program) and as service (banking, insurance, retail sales).
There must be a record of product conformity to requirements and the authority
responsible for release of product. Product must meet all requirements prior to release
unless otherwise approved by the customer (or other relevant authority).

ISO TS 16949 discussion


ISO/TS 16949 8.2.4.1. Layout inspection and functional testing
A layout inspection and a functional verification to applicable customer engineering,
material, and performance standards shall be performed for each product as specified
in the control plans. An auditor should check control plans for the product and verify it is

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being followed regarding layout inspection and functional verification checks. Next the
standard requires that the results (inspection and verification) shall be available for
customer review. Then the ISO/TS16949 Note explains that layout inspection is the
complete measurement of all product dimensions shown on the design records. Layout
inspection applies to product such as parts that have dimensions and does not apply to
product such as paint, circuit boards or electrical wiring.

ISO TS 16949 discussion.

ISO/TS 1649 8.2.4.2: Appearance items. Some organizations may manufacture parts
that are designated by the customer as "appearance items." For example: appearance
items include paint, other coatings, soft trim or upholstery. The organization must
provide appropriate:

• resources such as lighting, control inspection environments, light boxes,


magnifiers, etc.
• masters such as for color, grain, patterns, gloss, hue, metallic brilliance, texture,
distinctness of image (DOI).
• maintenance and control of masters and evaluation equipment. An auditor should
verify that the equipment and masters are being maintained. For example, the
equipment may be on a PM schedule. Masters may be protected by being placed
in a box, case or cabinet.
• verification that test personnel are competent. Personnel making appearance
evaluations must be competent and qualified to do so. Since the testing of
appearance items may require the use of one of our senses (sight), inspection
test personal need to be qualified in some manner to verify competency. Two
people looking at the same color may see two different colors.

8.3 Control of Nonconforming Product


Discussion:
Nonconforming product must be identified to prevent unintended use or delivery. Once
identified, the organization must take action choosing to scrap, rework, reclassify,
repair, or receive permission to use "as is". The organization must define
nonconforming control processes in a documented procedure. Normally, the procedure
would describe how the nonconforming product is identified, dispositioned, and re-
verified if corrected (rework, repair). The procedure must include responsibility and
authority for reviewing and resolving nonconforming product.

The three clauses that provide input to this clause are:


• 8.2.4: Measuring and monitoring of product [fails a test]
• 7.6: Control of measuring and monitoring devices [devices are found to be
nonconforming that result in nonconforming product)
• 7.2.3: Product returned as a result of a customer complaint [customer determines
product is unacceptable]

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The standard proposes four actions to address nonconforming product.


• Eliminate the nonconformity: repair, rework, blend (must re-verify conformance)
• Authorize its use "as is"
• Preclude its original intended use: re-grade, scrap
• Taking action appropriate to the effects when detected after delivery or use
There are consequences if an X Bracket is returned because of a water mark, and
another set of consequences if the X Bracket hole is in the wrong place causing the
customer's production line to be shut down or cause product failure when used.
The organization must maintain records of all nonconformities. The records must
include the nature of the nonconformity (description), actions taken, and concessions
made.
ISO TS 16949 discussion:
TS 8.3.1: Control of nonconforming product. Product with unidentified or suspect status
shall be classified as nonconforming product (see 7.5.3). This requirement makes
sense. If the status of product is unknown or suspect, it should be classified as
nonconforming unless otherwise verified.

TS 8.3.2 Control of reworked product. Rework instructions must be accessible to and


utilized by the appropriate personnel. Plus, rework instructions must include re-
inspection requirements. An auditor should ask personnel doing the rework if they have
rework instructions. Verify that the instructions include re-inspection or test
requirements. Requiring rework instructions and re-inspection are very basic
requirements going back to earlier versions of ISO 9001 and Mil-Q-9858A.

ISO/TS16949 8.3.3 Customer information. If nonconforming product has been shipped


to a customer, the organization must notify the customer right away. Customers shall be
informed promptly in the event that nonconforming product has been shipped.

8.3.4 Customer waiver. The organization shall obtain a customer concession or


deviation permit prior to further processing whenever the product or manufacturing
process is different from that which is currently approved. If a product or manufacturing
process deviates from what was approved, the organization must get customer
approval. The organization shall maintain a record of the expiration date or quantity
authorized. The organization shall also ensure compliance with the original or
superseding specifications and requirements when the authorization expires. As an
auditor, you should ask if there have been any concessions or deviation permits from
customers and if so, verify them and ascertain that either an expiration date or quantity
is specified.

Next, an auditor must verify adherence to requirements stipulated in the concession or


deviation permit by checking information such as production, quality control,
maintenance or process monitoring records. Production after the expired concession or
deviation must either adhere to the original (approved requirements at time of

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concession) or superseded requirements (newly-approved customer requirements or


revision).

Material shipped on an authorization shall be properly identified on each shipping


container. As an auditor you should physically verify that customer waiver product is
identified on each container. If there is no customer waiver product available to observe,
look for other evidence such as tags, placards, or work instructions. It is good practice
for auditors to note any requirements they cannot verify at the time of the audit. In this
case, it may not be a risk issue, just qualification of the audit results. It would be a good
thing if an organization complies with customer requirements all the time.

This applies equally to purchased product. The organization shall agree with any
requests from suppliers before submission to the customer.

8.4 Analysis of Data


Discussion:
Collect and analyze data (from measuring and monitoring) to determine the suitability
and effectiveness of the quality management system. The organization will need to
show how data is collected and analyzed. An effective process is one that achieves the
output goals and objectives.
"Suitability" is determining if the defined (designed) process is the right process for the
organization. There may be a method, the organization may be following it, and the
method may be efficient, but it may not be appropriate or may not meet requirements.
The organization must collect and analyze data for the following:
• Customer satisfaction level (perception of meeting requirements)
• Conformance to customer requirements
• Characteristics of products, processes, and their trends
• Suppliers

The data analysis may show trends and identify improvements (continual improvement)
that can be made to the QMS.

ISO TS 16949 discussion


ISO/TS 16949 8.4.1 Analysis and use of data trends in quality and operational
performance shall be compared with progress toward objectives. Organizations have
goals (recall planning requirements in clause 5.4) and they should monitor their
progress toward achievement of the goals. Plus, achievement of goals must lead to
action to support the following:

• development of priorities for prompt solutions to customer-related problems;


• determination of key customer-related trends and correlation for status review,
decision-making and longer term planning;
• an information system for the timely reporting of product information arising from
usage.

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Simply, organization goals should align with customer needs.

8.5 Improvement
Discussion:
The introductory clause emphasizes the continual improvement linkages in the standard
scope (1.1b), general requirements (4.1f), quality policy (5.3), quality objectives (5.4.1),
quality planning (5.4.2), management review (5.6), audit results (8.2.2), analysis of data
(8.4), and corrective and preventive action. If an organization does not continually
improve the effectiveness of the QMS, a nonconformity could be issued referencing this
clause.

ISO TS 16949 discussion


ISO/TS 16949 8.5.1.1 Continual Improvement. The introductory clause emphasizes the
continual improvement linkages in the standard scope (1.1b), general requirements
(4.1f), quality policy (5.3), quality objectives (5.4.1), quality planning (5.4.2),
management review (5.6), audit results (8.2.2), analysis of data (8.4), and corrective
and preventive action. If an organization does not continually improve the effectiveness
of the QMS, a nonconformity could be issued referencing this clause.

There are two very short supplemental clauses to continual improvement. Clause
8.5.1.1: Continual improvement of the organization requires organizations to define a
process for continual improvement. It does not require a documented procedure, but
does reference Annex B of ISO 9004 titled "Process for continual improvement."

The ISO 9004 document defines the types of improvement such as incremental and
breakthrough. Next it lists the steps for improvement that are similar to six sigma's
Define, Measure, Analyze, Improve and Control (DMAIC). Clause 8.5.1.2:
Manufacturing process improvement requires a continual focus on reducing variation of
product characteristics and manufacturing process parameters. An important part of
quality is consistency. Organizations should know where they stand regarding needs to
reduce variation to continually improve. Many in the automotive industry equate
continual improvement to reduced variation.

8.5.2 Corrective Action and 8.5.3 Preventive Action.


Discussion:
The clauses require establishing a corrective action and a preventive action process.
The corrective and preventive action sub clause steps are identical except that the
preventive action clause does not require reviewing nonconformities as the initial input
step.

The inputs for corrective action include: product nonconformities (8.3), customer
complaints (7.2.3 and 8.5.2), results of audits (8.2.2), and other existing process and
system nonconformities.

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The inputs to preventive action are the results of the analysis of data in 8.4
(measurements and monitoring).
The clause requirements include:
1. a documented procedure
2. need to address cause
3. taking action appropriate to the magnitude of the problem (effects)
4. keeping records

The standard requires that the corrective and preventive action taken be reviewed. The
review can include determination of the effectiveness of the action taken. The review
can be linked to clause 5.6.2 for management review inputs.
Customer complaints are mentioned and linked back to clause 7.2.3.

ISO TS 16949 discussion

ISO/TS 16949 8.5.2.1 on Problem solving requires the organization to have a defined
process for problem solving. The process must include root cause identification and
elimination. Problem solving presupposes a problem and is reactive. If the customer
requires a prescribed problem-solving format such as 8D, the organization must use the
prescribed format.

Supplemental clause 8.5.2.2: Error-proofing. The organization shall use error-proofing


methods in their corrective action process (also called mistake-proofing). An auditor
should see evidence that this practice is part of the corrective action process by
reviewing corrective actions, interviewing, and referencing it in the corrective action
procedure.

8.5.2.3 Corrective action impact. Next, organizations are required to implement


corrective actions and controls to other similar processes and products. This may be
called system-wide implementation. Lessons learned from one corrective action
investigation can be used to eliminate the cause of nonconformities throughout the
organization.

8.5.2.4 Rejected product test / analysis. The organization is required to analyze parts
rejected by the customer's manufacturing plants, engineering facilities, and dealerships.
The organization is required to minimize the cycle time of this process. Analyzing return
or rejected parts can easily become a backlogged activity because it is out of the main
stream of activities and there is no sense of urgency. The parts analysis shall be
recorded and made available upon request. The organization shall perform the analysis
and initiate corrective action to prevent recurrence.

The audit thread is that if there are reject parts there should be: 1) an analysis, 2) a
record of it, 3) a reasonable time-frame for the analysis or the organization's specified

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time-frame, 4) a corrective action request and 5) a subsequent follow-up action to


prevent recurrence.

Okay, we have finished review of all the requirements and there are a lot of them. The
following criteria has been approved for determination of major nonconformities. Major
nonconformities could have significant negative consequences for auditees.

Major Nonconformity: A major nonconformity shall be any or all of the following:

• One or more numbered requirements of ISO/TS 16949 have not been


addressed, or
• One or more numbered requirements of ISO/TS 16949 have not been
implemented, or
• Several nonconformities exist that, taken together, lead a reasonable auditor to
conclude that one or more numbered requirements of ISO/TS 16949 have not
been addressed or implemented
• Any noncompliance that would result in the probable shipment of nonconforming
product

To determine the seriousness of an audit finding, an auditor asks: Is this an isolated


event? Is this an indication of a systemic failure?

Baseline: [by-the-book requirements] with ISO/TS 16949 related requirements in blue]


• Plan and implement measuring and monitoring activities to meet requirements
and for continual improvement.
• Statistical concepts shall understood and utilized.
• Monitor customer perception (satisfaction) and use as an indicator of QMS
performance. Determine how the customer satisfaction information will be
obtained and used.
• Monitor performance of QMS realization process and manufacturing processes.
• There must be a documented procedure for the audit process (program).
• Internal audits must confirm adherence to planned arrangements, QMS
requirements, ISO 9001 requirements, their implementation, and ongoing
maintenance.
• There must be an audit plan showing the audits to be performed. The plan must
consider factors such as: area status, importance, and results of prior audits.
• The selection of auditors and audits must be conducted to ensure impartiality and
objectivity.
• Action must be taken on audit results without undue delay and followed up to
verify implementation.
• Audit results and follow-up actions must be reported/ recorded.

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• Audit each manufacturing process and audit products at appropriate stages of


production and delivery.
• If nonconformities or customer complaints occur, the audit frequency shall be
increased.
• Auditor must be qualified.
• Processes necessary to meet customer requirements must be measured and
monitored to confirm ongoing ability to achieve planned results.
• Conduct process capability studies and ensure that the control plan and process
flow diagram are followed.
• Reaction plans must be developed to address characteristics that are either not
statistically capable or are unstable.
• Product must be measured and monitored to verify that requirements are being
met through appropriate stages of the realization process.
• Product measuring and monitoring must be done in accordance with planned
arrangements.
• There must be a record of product conformity to requirements.
• There must be a record of the authority responsible for release of product.
• Product must meet all requirements prior to release unless otherwise approved
by the customer (or other relevant authority).
• Identify and control nonconforming product to prevent unintended use or delivery.
• Disposition the nonconforming product in accordance with documented
procedures.
• Repaired or reworked product must be re-verified prior to release.
• The organization must respond to the consequences of nonconforming product
discovered after delivery or use [e.g. product returns].
• Collect and analyze data to determine suitability and effectiveness of the quality
management system.
• Collect and analyze data to identify areas for improvement.
• Analyze data for customer satisfaction, meeting customer requirements, key
characteristics of products/processes, and suppliers.
• Take corrective action on nonconformities relative to the impact on the
organization.
• There must be a documented procedure for corrective action (see list in standard
or the steps on page 6).
• Take preventive action on potential nonconformities relative to the potential
impact on the organization.
• There must be a documented procedure for preventive action (see list in
standard or the steps on page 6).
• Follow control plans regarding layout inspection and a functional verification.

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• Appearance item testing must be controlled including the qualification of test


personnel.
• Identify and control nonconforming product to prevent unintended use or delivery.
• Disposition the nonconforming product in accordance with documented
procedures.
• Repaired or reworked product must be re-verified prior to release.
• The organization must respond to the consequences of nonconforming product
discovered after delivery or use [e.g. product returns].
• Rework instructions must be accessible, utilized and include re-inspection
requirements.
• A customer concession or deviation permit is required prior to further processing
whenever the product or manufacturing process is different from that which is
currently approved.
• Collect and analyze data to determine suitability and effectiveness of the quality
management system.
• Collect and analyze data to identify areas for improvement.
• Analyze data for customer satisfaction, meeting customer requirements, key
characteristics of products/processes, and suppliers.
• Trends in quality and operational performance shall be compared with progress
toward objectives and lead to action to support customer needs.
• The continual improvement process must be defined and there should be a focus
on narrowing variation for product characteristics and process parameters.
• Take corrective action on nonconformities relative to the impact on the
organization.
• There must be a documented procedure for corrective action.
• Corrective actions must be implemented system wide and rejected parts must
analyzed and corrective action taken.
• Take preventive action on potential nonconformities relative to the potential
impact on the organization.
• There must be a documented procedure for preventive action.

This ends the clause-by-clause review of ISO 9001 and ISO/TS 16949.
Remember, when questions of interpretation come up, consult the standard
first. The best overall interpretation guideline is that common sense should
prevail because the standard was written to create value for the users.

In the next lesson we bring out information that will link process approach, business
processes and the QMS.

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Lesson D13: Process Approach Explained


Before ending our discussion of ISO/TS 16949 we need to connect the process
approach, ISO 9001 requirements and the QMS. Recall the process model image in
class that we introduced in an earlier lesson.
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The process model starts and ends with the customer. The definition of customer sets
the stage for understanding the process approach. The idea of an “internal” customer is
included in the ‘customer’ definition and supports the linkages of the process approach.

Before you can get the “outputs” and “inputs” right, you need to communicate the
requirements (the criteria 4.1.c) within the organization. To ensure that the output
meets input requirements, you will need a measurement. This measurement becomes
a feedback tool and fulfills the requirements of 4.1.e.

Internal suppliers are providing products and services to internal customers. Internal
customers define requirements to internal customers (see image). Remember clause
ISO 9001, 4.1 establishes the framework for the process approach.

To understand how ISO 9001 and the process approach really work, you need to
understand selected requirements.

You can see the linkage between the requirements.


0.2 Process Approach The application of a system (QMS) of processes within an
organization, together with the identification and interactions of
these processes, and their management, can be referred to as
the “process approach”.
4.1 General Requirements The organization shall establish, document, implement and
maintain a QMS and continually improve its effectiveness.
The organization shall:
a) identify the processes
b) determine the sequence and interaction of these processes
c) determine criteria and methods needed
4.2.2.c The Quality Manual Describe of the interaction between the processes of the QMS.
5.4.1 Quality Objectives Establish quality objectives, including those needed to meet
requirements for product [see 7.1 a)

5.4.2.a Quality Management Planning of the QMS is carried out in order to meet the
System Planning requirements given in 4.1, as well as the quality objectives.
7.1 Planning of Product Realization Planning of product realization shall be consistent with the
requirements of the other processes of the QMS (see 4.1).
In planning product realization, the organization shall determine
quality objectives and requirements for the product.
8.2.3 Monitoring and Measurement The organization shall apply suitable methods for monitoring
of Processes and, where applicable, measurement of the QMS processes.
8.5.1 Continual Improvement The organization shall continually improve the effectiveness of
the QMS through the use of the quality policy, and quality
objectives.

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There are linkages between the clauses and core business processes. First we can tie
requirements for quality to the requirements for the business. Then we can build on the
quality management principles of customer focus and continual improvement. As
organizations became larger or more complex, functions become specialized. The
formation of departments is an effective way to manage function performance. Some
have referred to the evolution of ‘silos’ as a tool to manage large and complex
organizations. Silos serve a purpose by helping assign responsibility and accountability
as well as helping people manage department (silo) results. However managing by
department can create barriers and departments can lose focus of the overall business
objectives. Departments within companies (such as Purchasing, Engineering,
Manufacturing, etc) may act like they were silos, each independent of the other.
Creating specialized departments benefits the organization in some ways but the silo
effect creates other problems.

How we normally think a business works is usually overly simplistic. The reality may be
very different. The real operation of a business can be very complex. For Example:
sales may be taking orders as well as accepting requests for quotes and creating
quotes.

The heartbeat of the business is not what goes on inside the silos but what is happening
outside the silos. The process approach provides the linkages to the customer (5,2)
through planning (5.4.1), internal auditing (8.2.2) and management review (5.6), and it
helps to ensure continual improvement (8.5.1).

The process approach supports the concept of teamwork between different “silos” and
why it is important. The functions of an organization must work together to achieve
objectives.

The process approach helps the organization align with customer and organizational
needs (customer focus). The standard promotes the adoption of the process approach
when developing, implementing, and improving the effectiveness of the QMS to
enhance customer satisfaction (ISO 9001, clause 0.2). Note that in the process model,
in clause 7, the customers give input into the realization processes, and receive the
output. Clause 7 plays a vital role in linking the process approach, QMS and
customers.

Understanding product realization (clause 7) is the first step in the successful


application of the process approach. Clause 7 may involve several departments and
functions such as:
• Sales
• Customer Service
• Design
• Manufacturing
• Manufacturing Engineering
• Purchasing
• Quality

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• Packaging
• Shipping
• Etc.

Each department or function must identify discrete “business” activities Involved in the
realization process.

Once all the realization processes are defined and connected, clause 8 is there to
measure and monitor products and processes. The output of clause 8 is input to
management responsibility (clause 5) for reviewing. Based on management review,
resources are adjusted to support the realization processes in clause 7. The circle is
complete and the process approach is working. The application of a system of
processes within an organization, together with the identification and interactions of
these processes and their management, can be referred to as the “process approach”
(ISO 9001, clause 0.2).

End
Congratulations you have completed all the lessons of the knowledge-based ISO/TS
16949 lead auditor training class. Upon successful completion of all tests and your
assignment you will be able receive your certificate.

The ISO/TS 16949 knowledge-based training has covered:


history
ISO/TS 16949 requirements,
terminology,

END

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