Overview of Quality Management Systems

and ISO 9001

 Why is ISO 9001 so popular?
The scope of the Standard specifies requirements
intended to:
demonstrate organizations ability to consistently
provide product meeting customer & applicable
regulatory requirements
enhance customers satisfaction through effective
application of the system including processes for its
continual improvement and assurance of conformity
to customer and applicable regulatory requirements

28-January-2008 2
 New Structure & Focus

Why is ISO 9001 so popular?

Significantly less emphasis on
procedures and records.
Significantly more emphasis on
management involvement and a system
that works to achieve the goals of your
business.

28-January-2008 3
 The ISO 9000 Family
ISO 9000:2005 Quality management - Fundamentals and vocabulary

ISO 9001:2000 Quality management systems - Requirements

ISO 9004:2000 Quality management systems - Guidelines for

performance improvements
ISO 10006:2003 Quality management - Guidelines for quality
management in projects
ISO 10007:2003 Quality management systems - Guidelines for
configuration management
ISO 10012:2003 Measurement management systems - Requirements
for measurement processes and measuring equipment
ISO 19011:2002 Guidelines for quality and/or environmental
management systems auditing

28-January-2008 4
 Relationship with ISO 9004

ISO 9001 & ISO 9004 - consistent pair

Designed to complement each other

Different scope - same structure

ISO 9001 can apply for certification or contractual

purposes and focuses on effectiveness
ISO 9004 aims on improving performance and
efficiency

28-January-2008 5
 The Use of ISO 9004 as a Management Tool

ISO 9004 includes all of ISO 9001 plus additional

items to consider for improvement ideas.
ISO 9004 should be regularly used throughout the
organization to lead beyond the basics of ISO 9001
and improve the QMS.
There is a possibility that we may offer ISO 9004
certification for clients seeking to achieve results
beyond ISO 9001

28-January-2008 6
 New Structure & Focus

The ISO 9001 Standard is modelled for Quality

Management with 5 Major clauses:

Quality Management System (QMS)

Management Responsibility
Resource Management
Product Realization
Measurement, Analysis & Improvement

28-January-2008 7
 System Approach of ISO 9k2k

Continual Improvement of the

C Quality Management System S C
a
U Management t U
I
S R responsibility
s
S
e
T q
f T
a
O u
I
c O
M r Resource Measurement, analysis, t
M
management improvement I
e
E m
o
n
E
e
R n R
S t
Product Product S
s
Input
Output

28-January-2008 8
The Deming Cycle
The Deming Cycle
for improvement is
the cornerstone of all
Management
Systems

28-January-2008 10
1. PLAN: Design or revise business process
components to improve results
2. DO: Implement the plan and measure its
performance
3. CHECK / STUDY: Assess the measurements
and report the results to decision makers
4. ACT: Decide on changes needed to improve
the process

28-January-2008 11
Every organizations
management systems are
comprised of various
processes, each with
their own set of metrics,
goals, targets and
initiatives.
The key is to align each
process PDCA cycle with
the overall strategic effort
of the organization.

28-January-2008 12
As your Management Systems mature, effective use
of the Deming Cycle will ensure continual
improvement

28-January-2008 13
 System Approach of ISO 9k2k

Continual Improvement of the

C Quality Management System S C
a
U Management t U
I
S R responsibility
s
S
e
T q
f T
a
O u
I
c O
M r Resource Measurement, analysis, t
M
management improvement I
e
E m
o
n
E
e
R n R
S t
Product Product S
s
Input
Output

28-January-2008 14
THE VALUE ADDED AUDITING APPROACH

PERFORMANCE
SELL IT!

PROCESS
RISK
AUDITS
WASTE

VARIATION

28-January-2008 15
8 Management Principles
 New Structure & Focus
The intent of ISO 9001 is based on the 8 Management
System Principles described in ISO 9004:
customer focus
leadership
involvement of people
process approach
system approach
continual improvement
factual approach to decision making
mutually beneficial supplier relationships

28-January-2008 17
Customer Focus
 Customer Focus

Customer Focus
Organizations depend on their
customers and therefore should
understand current and future
customer needs, should meet
customer requirements and strive
to exceed customer expectations.

28-January-2008 19
 System Approach of ISO 9k2k

Continual Improvement of the

C Quality Management System S C
a
U Management t U
I
S R responsibility
s
S
e
T q
f T
a
O u
I
c O
M r Resource Measurement, analysis, t
M
management improvement I
e
E m
o
n
E
e
R n R
S t
Product Product S
s
Input
Output

28-January-2008 20
 Customer Focus

Information on Customer perception as to

whether the organization has met their
requirements must be collected, reviewed
and appropriately acted upon (8.2.1).

The methods of doing this are not

prescribed by the standard but should be
objective, representative of the customer
base, and ADD VALUE.

28-January-2008 21
 Customer Focus
The most common methods of collecting Customer
Satisfaction data are customer surveys and
customer report cards (when provided).
Other methods include measuring repeat orders,
market share, industry benchmarking, capturing
info. from sales visits, focus groups, and hiring
consulting firms.
A good system will use multiple methods and
compare data from multiple sources to
comprehensively understand customer perceptions
and balance out any potential biases.

28-January-2008 22
 Customer Focus

Additionally, the organization must

demonstrate that effective
arrangements for communicating
with customers are in place in
relation to:

28-January-2008 23
 Customer Focus
Product Information (7.2.3-a):
How well do you communicate your product
information to your customers?
Consider the experiences of using your favorite
store Catalogue, or browsing Amazon.com or
ebay...
Were you satisfied with these experiences?
How do you know what your customers think about
your ability to communicate information that they
are looking for?

28-January-2008 24
 Customer Focus
Enquiries, contracts, and order handling,
including changes (7.2.3-b):

Now consider the buying experience with these

same companies and ask the same questions
How do you think your customers feel about the
ordering experience with your company? What
about your quoting and order amendment
processes?

28-January-2008 25
 Customer Focus

Customer feedback, including complaints

(7.2.3-c)

Consider that a customer can be more loyal when

you handle their problems to their satisfaction (or
delight) vs. them never having a problem at all.
Your want to know whether your customers are
satisfied with how you handle their feedback
(even positive) and complaints.

28-January-2008 26
Process and System Approach
 The Process Approach

Process Approach
A desired result is
achieved more efficiently
when activities and related
resources are managed as
a process.

28-January-2008 28
 The System Approach to Management

System Approach
Identifying, understanding and
managing interrelated processes
as a system contributes to the
organizations effectiveness and
efficiency in achieving its
objectives.

28-January-2008 29
 ISO 9000 2.4 The Process Approach
Any activity, or set of activities, that uses resources to
transform inputs to outputs can be considered as a
process.
For organizations to function effectively, they have to
identify and manage numerous interrelated and
interacting processes. Often, the output from one
process will directly form the input into the next
process. The systematic identification and management
of the processes employed within an organization and
particularly the interactions between such processes is
referred to as the process approach.

28-January-2008 30
 ISO 9000 2.8.1 Evaluating processes within
the quality management system
When evaluating quality management systems, there are four basic
questions that should be asked in relation to every process being
evaluated.
a) Is the process identified and appropriately defined?
b) Are responsibilities assigned?
c) Are the procedures implemented and maintained?
d) Is the process effective in achieving the required results?
The collective answers to the above questions can determine the
result of the evaluation.

28-January-2008 31
Process Interactions
Inputs and Outputs
 Controls
(procedures, inspections, training, etc.)

Inputs Outputs
Process
Activities
+
Resources

28-January-2008 33
Management Systems must define the sequence and
interactions of processes

Process Process
A C

Process Process
B D
Input
Output
Controls

28-January-2008 34
A Quality Management System is focussed on meeting customer
requirements.

Process Process
A C
Customer Customer
requirements Satisfaction
Process Process
B D

28-January-2008 35
Other Management Systems (Environmental, Safety, SOX, etc.) are
mainly focussed on meeting regulatory requirements.

Process Process
A C
Regulatory Regulatory
requirements Compliance
Process Process
B D

The Process Approach can be used for all Management Systems!

28-January-2008 36
Ultimately every Management System must be seen by Top
Management as an effective method for ensuring financial
performance (even though its not a requirement).

Process Process
A C

Investment Profitability
Process Process
B D

28-January-2008 37
Compatibility with other management systems

Standard is intended to be compatible with other

systems
It is aligned with ISO 14001 and 18001 to enhance
compatibility
Standard does not include requirements for other
management systems such as EMS, OHSM, or
financial management
Integration of management systems is possible

28-January-2008 38
The ultimate goal of any organization is to
fully integrate all
customer
shareholder
regulatory
and any other requirements? (discuss)
into ONE Business Management System.

28-January-2008 39
Ideal scenario:
Our clients Quality, Health & Safety and Environmental
Management Systems operate within their Business Management
System
BMS
Their BMS = QMS
QMS+
OHSMS
FMS+
OHSM+
EMS+
EMS
ERP+
HR

28-January-2008 40
All too common scenario that we need to help change:
Their QMS, OHSMS and EMS are seen as the ISO
systems and operate mostly outside of their BMS.
Management does not see the value of these. Its
something that we have to do for ISO
EMS
BMS
QMS

OHSMS

28-January-2008 41
 Sequence versus Interactions
This example clearly defines the sequence of
processes but does it clearly define their interactions?

How should process interactions be defined?

Process Process
A C

Process Process
B D

28-January-2008 42
 Interaction of Processes
Interaction should be defined using inputs and outputs

Graphical representations such as process maps /

flowcharts are perhaps the most easily understandable
methods of describing interaction between processes,
however not a specific requirement.
Interaction can be described with words if desired

At a minimum, the processes of the organization need

to be identified as per 4.1a and their interaction needs
to be clearly defined in the manual as per 4.2.2c.

28-January-2008 43
Common methods used to define process interactions:
1. Flowcharting
2. SIPOC diagrams (Six Sigma method)
3. Process Turtles (ISO 9001 method)
4. Value Stream Mapping (Lean Manufacturing
method)
NOTE: How many times have your processes been
defined in how many ways? Are all process definitions
linked and do they complement each other (no
redundancy)?

28-January-2008 44
 Personnel/Competency: Tools/Equipment:

Inputs: Outputs:
Process:

Measurements: How/Methods/Controls

28-January-2008 45
 With What? With Who?
Eng. Manager
CAD/CAM systems CAD Technicians
Test equipment Mech/Elec Engineers
Warranty database Administrative assistance
Call center Service Technicians

SUPPLIERS INPUTS PROCESS OUTPUTS CUSTOMERS

Lessons learned Robust design, durability, Internal /
Customer
Consumer
Service/Warranty Engineering reliability, maintainability External
Customer needs BOM/purchasing data Mfg.
Marketing Specifications Consumer
Marketing data
Charter Product standards

How Effective?
Process Interactions How?
CAD systems and Database
Status of projects >90%
Purchasing Engineering procedures
First time capability >96%
Marketing/Sales 5-stage design process
Eng. Warranty claims < 5%
Service Test and build standards
of total
Insp /Test department Warranty/claim data
Budget within 10%
PROCESS FLOW

Charter review and 5 Stage design plan CAD drawings, approval Pre-production run
approval Kick-off meeting multi- Simulation, life cycle Capability Ppk/Cpk
functional Prototype Mfg. Feedback meeting
Supplier evaluation/capability Lessons learned

28-January-2008 46
28-January-2008 47
 Most importantly, does Top
Management use their
process definitions to
effectively manage their
business (not just for audits)?

28-January-2008 48
 Every process has an
owner.

The process outputs

are their job
description!

The process measures

are their performance
review!

28-January-2008 49
 Evidence to find and communicate:
Organization charts are process based and show
clear process ownership
Business metrics are process based and ensure
transparent accountability for process performance
Facility floor plans can be linked to processes
Business plans and budgets align with their process
definitions.
Management reviews of process performance
include ALL processes at some frequency

28-January-2008 50
 Quality Manual
ISO 9001, clause 4.2.2 requires:
The organization shall establish and maintain a
quality manual that includes
A) the scope of the quality management system, including
any details of and justification for any exclusions
B) the documented procedures established for the QMS, or
reference to them
C) a description of the interaction between the processes
of the QMS

28-January-2008 51
 Quality Manual
A QM that simply regurgitates the ISO
clauses is not acceptable!
A QM that includes a process map
showing sequence only is not
acceptable!
The QM must define the process
interactions (outputs & inputs)!

28-January-2008 52
 Quality Manual potential uses
To manage the business as a key input to
organizational planning, resource allocation,
goal setting, problem solving, etc.
The training material for employee
orientation, especially managers!
A communication tool for external parties
(customers, corporate management, board
of directors, regulatory bodies, etc.)

28-January-2008 53
 Process Measurement
and Objective Deployment
 Factual Approach to Decision Making

Factual Approach to
Decision Making
Effective decisions are
based on the analysis of
data and information.

28-January-2008 55
 Analysis of Data & Measurement
Food for Thought:

Consider all the records and data that you

collect and store in your company...
How are each of these used for analysis,
training, and improvement purposes?
If you cant answer this question for nearly
every record you spend time and money
collecting then why do you do it?

28-January-2008 56
 Analysis of Data & Measurement
8.4 - The organization shall determine, collect and analyze
appropriate data to demonstrate the suitability and effectiveness
of the quality management system and to evaluate where
continual improvement of the effectiveness of the quality
management system can be made. This shall include data
generated as a result of monitoring and measurement and from
other relevant sources.
The analysis of data shall provide information relating to
customer satisfaction (see 8.2.1),

conformity to product requirements (see 7.2.1),

characteristics and trends of processes and products including

opportunities for preventive action, and
suppliers.

28-January-2008 57
 Continual Improvement

Continual Improvement
Continual improvement of
the organizations overall
performance should be a
permanent objective of the
organization.
28-January-2008 58
 Continual Improvement
The organization shall implement actions
necessary to achieve planned results and
continual improvement of the QMS processes
(4.1-f).

Top management shall provide evidence of its

commitment to the development and
implementation of the QMS and continually
improve its effectiveness (5.1).

28-January-2008 59
 ISO 9000 2.11 Quality management systems
and other management system focuses
The quality management system is that part of
the organization's management system that
focuses on the achievement of results, in
relation to the quality objectives, to satisfy the
needs, expectations and requirements of
interested parties, as appropriate.

28-January-2008 60
 ISO 9000 - 2.8.2 Auditing the quality
management system

Audit findings are used to assess the

effectiveness of the quality management
system

and to identify opportunities for

improvement.

28-January-2008 61
 THE VALUE ADDED AUDITING APPROACH

PERFORMANCE SELL IT!

PROCESS
RISK AUDIT
WASTE

VARIATION

28-January-2008 62
Process Monitoring and Measurement
EFFECTIVENESS
EFFECTIVENESS
PROCEDURE* OF
OFPROCESS
PROCESS==
Ability
Abilitytotoachieve
(Specified way to carry out an activity or a desired
achieve
desiredresults
results
process - may be documented or not) (Focus
(FocusofofISOISO
9001:2000)
9001:2000)

Input PROCESS Output

(Set of interrelated
PRODUCT
(Includes
Resources) or interacting activities) (Result of a
process)

EFFICIENCY
EFFICIENCYOF OF
MONITORING AND PROCESS
PROCESS = =
MEASUREMENT OPPORTUNITIES Results
Resultsachieved
achieved
vs
vsresources
resourcesused
used
(Before, during and after the process) (Focus of ISO
(Focus of ISO
9004:2000)
9004:2000)
* Note This is the definition of procedure given in ISO 9000:2000.
This does not necessarily mean one of the 6
documented procedures required by ISO 9001:2000

28-January-2008 63
Processes must be monitored and measured -
Measurement categories that need to be considered are:
Quality: Does the process consistently produce desired
outputs?
Delivery: Does the process consistently deliver the outputs on
time?
Efficiency: Does the process produce and deliver the outputs
using the least amount of resources necessary
Others such as Cost, Safety, Regulatory Compliance, etc.
Too often only one of these categories is applied and that misleads
management into thinking that everything is alright.

28-January-2008 64
How does a company implement
their BUSINESS PLAN?

The process approach is one of the

best methods to implement a
business plan

28-January-2008 65
 Top Management
Effective policy
deployment
through Policy Top Management
measurement is
required by all Management
ISO 9001 based System (Business)
standards. Process Owners
Objectives

Process Objectives
Operators

Project / Product / Sub-process objectives

28-January-2008 66
 We try to focus our audits on:
Order
Review
The linkage of the measures and
Process objectives to customer satisfaction
and business results

Production Warehouse
Planning & Process/
The planning and resource
Scheduling Inventory allocation activities that are
Process Management
necessary to achieve any
OTD improvement objective

The leadership and

communications activities that
Purchasing
Process
Maintenance engage the entire organization in
Process
this process

The effective use of the PDCA cycle

in every process that is focused on
company objectives

28-January-2008 67
Policy Defect free product, on time to the customer at a reasonable
price and continually improving all processes in accordance with
the requirements.
Organizational objective 98% on time to customer promise date

Process objectives established to meet organizational goal

Order review processes all orders processed within 2 days of

receipt
Warehouse process 100% compliance with FIFO, 18 inventory
turns
Maintenance Process 97% uptime, no past due scheduled items
Purchasing process 95% of tier 1 suppliers on time and within
window
Production Scheduling all shop routers completed within 1 day of
receipt and all orders scheduled to be completed 2 days prior to
required ship date

28-January-2008 68
Management Communication
and Employee Awareness
 Leadership & Involvement of People
Leadership and Involvement of People
Leaders establish unity of purpose and
direction of the organization. They should
create and maintain the internal environment in
which people can become fully involved in
achieving the organizations objectives.

People at all levels are the essence of an

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

28-January-2008 70
 Leadership & Involvement of People

Top Management shall ensure that appropriate

communication processes are established
within the organization (5.5.3)

Specific requirements for communicating

information regarding the effectiveness of the
QMS and the importance of meeting customer
and regulatory requirements (5.5.3 & 5.1-a).

28-January-2008 71
 Leadership & Involvement of People

The organization shall ensure that all

personnel are aware of the relevance and
importance of their activities and how
they contribute to the achievement of the
quality objectives (6.2.2-d).

28-January-2008 72
Imagine the power of
an organization that
has truly achieved
Unity of Purpose?

28-January-2008 73
Is this enough information to ensure that everyone
clearly understands what must be done to achieve the
improvement goal?
On Time Delivery

100

80

Actual 60
Goal 40

20

0
1st Qtr 2nd Qtr 3rd Qtr 4th Qtr

28-January-2008 74
Too often management only communicates
partial information. To understand the
complete path to improvement everyone
needs to know the following:
Where are we now (measure) and where do we
want to be (goal)?
Why are we here (causes of failure)?
What are we doing to improve (plan)?
How am I personally involved?

28-January-2008 75
 On Time Delivery Causes of Late Deliveries

100 100
80
80
60
Actual 60 machine down
40 part shortage
Goal 40
20 labor shortage
20
0
0 1st 2nd 3rd 4th
1st Qtr 2nd Qtr 3rd Qtr 4th Qtr Qtr Qtr Qtr Qtr

Plan for Improvement

Tasks Resp. Due % Contribution Status
Increase PM frequencies on key Joe K. 2/23/08 50 75% complete, Need more resources
machines
Increase buffer inventories of critical Janice Q. 4/1/08 30 50% complete, no issues
parts

28-January-2008 76
 EFFECTIVE Communication
Too often management only communicates in one way (think -
quarterly all employee meeting)
Does this communication effectively reach everyone (think - kids
in the back of the room)?
To truly achieve unity of purpose shouldnt there be multiple
communication methods happening all the time?
Will management have to adjust their communication methods
and frequencies or do they normally achieve perfection on the
first try?
Can management communication be considered a process with
clear outputs (employee understanding, satisfaction, unity of
purpose, etc.) and measures?

28-January-2008 77
Summary
What is the role of
an auditor?
Especially 3 rd party pros

28-January-2008 79
 To make sure that an organization is doing the
right things, the right ways, all the time.
To find evidence that what the organization
does is conforming, effective and efficient.
To add value by:
Identifying potential problems before they happen
Helping to solve existing problems, and
Identifying opportunities for improvement.

28-January-2008 80
 Hierarchy of Quality
Advanced Auditing covers QA
and QM more effectively Quality
Management

Quality Assurance

Quality Control

Basic conformance
auditing covers QC level

28-January-2008 81
 Course Summary

Its not about the paperwork

Its all about if it works!

28-January-2008 82
 Course Summary

The majority of the efforts

needed to demonstrate
conformance to ISO 9001
lie with Top Management.

28-January-2008 83
 Course Summary

Run properly, by
management, your QMS
will help you achieve your
business goals.

28-January-2008 84