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Student Textbook
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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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.
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.
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.
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).
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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.
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.
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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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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.
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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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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.
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.
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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.
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)
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.
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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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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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"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.
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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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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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.
_____________________________________________________
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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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.
_____________________________________________________
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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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.
_____________________________________________________
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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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. .
Design inputs to our ISO 9001 house (standard) includes requirements to ensure it is fit
for its intended purpose.
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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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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
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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.
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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.
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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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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.
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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.
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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.
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).
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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Clause 4 marks the start of the ISO 9001 QMS auditable requirements.
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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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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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.
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disposition includes disposal. A second note explains that records include customer-
specified records.
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.
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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
The top management we are discussing here, is the top management of the
organization who implements and maintains the quality management system.
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5.4 Planning
5.4.1 Quality Objectives
5.4.1.1 Quality objectives: Supplemental
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).
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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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.
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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.
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.
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.
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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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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.
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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.
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.
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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.
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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.
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).
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.
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).
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.
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that.
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.
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.
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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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7 Product Realization
7.1 Planning of Product Realization
7.2 Customer-Related Processes
7.3 Design and Development
7.4 Purchasing
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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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.
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computer language, electronic data exchange, and so on. Organizations must be able
to communicate necessary information in the required method.
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.
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.
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.
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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:
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.
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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The product and process design output shall be expressed in terms that can be verified
and validated against input requirements.
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When you implement or audit, check off the outputs against the prescriptive list.
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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?
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.
7.4. Purchasing
7.4.1 Purchasing Process
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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.
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.
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.
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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).
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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7.4
• Purchasing processes must be planned and developed to ensure product
conforms to purchase requirements.
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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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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
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.
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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.
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.
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 7.5.1.6 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?
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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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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.
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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.
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.
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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.
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.
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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.
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.
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.
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.
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.
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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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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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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.
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
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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
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.
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 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.
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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.
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:
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.
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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 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:
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This applies equally to purchased product. The organization shall agree with any
requests from suppliers before submission to the customer.
The data analysis may show trends and identify improvements (continual improvement)
that can be made to the QMS.
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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.
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.
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 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.
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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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.
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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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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.
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.
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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.
END
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