ISO Lesson Guide 2008

Pocket Guide to ISO 9001:2008

Third Edition
Also available from ASQ Quality Press:

Quality Audits for Improved Performance, Third Edition

Dennis R. Arter

Continual Improvement Assessment Guide: Promoting and Sustaining Business Results

J.P. Russell

The Internal Auditing Pocket Guide: Preparing, Performing, Reporting and Follow-up,
Second Edition
J.P. Russell

The Process Auditing Techniques Guide

J.P. Russell

The ASQ Auditing Handbook, Third Edition

J.P. Russell, editing director

How to Audit the Process-Based QMS

Dennis R. Arter, John E. (Jack) West, and Charles A. Cianfrani

ISO 9001:2008 Explained, Third Edition

Charles A. Cianfrani, John E. (Jack) West, and Joseph J. Tsiakals

ISO 9001:2008 Internal Audits Made Easy: Tools, Techniques and Step-By-Step
Guidelines for Successful Internal Audits, Second Edition
Ann W. Phillips

Unlocking the Power of Your QMS: Keys to Business Performance Improvement

John E. (Jack) West and Charles A. Cianfrani

The Quality Toolbox, Second Edition

Nancy R. Tague

Mapping Work Processes, Second Edition

Bjørn Andersen, Tom Fagerhaug, Bjørnar Henriksen, and Lars E. Onsøyen

Lean Kaizen: A Simplified Approach to Process Improvements

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Root Cause Analysis: Simplified Tools and Techniques, Second Edition

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To request a complimentary catalog of ASQ Quality Press publications,

call 800-248-1946, or visit our Web site at http://www.asq.org/quality-press.
ISO Lesson Guide 2008
Pocket Guide to ISO 9001:2008
Third Edition

Dennis R. Arter and J. P. Russell

ASQ Quality Press

American Society for Quality, Quality Press, Milwaukee 53203
© 2009 by American Society for Quality
All rights reserved. Published 2008
Printed in the United States of America
14  13  12  11  10  09  08   5  4  3  2  1

Library of Congress Cataloging-in-Publication Data

Arter, Dennis R., 1947–
  ISO lesson guide 2008 : pocket guide to ISO 9001:2008 / Dennis
Arter and J.P. Russell.—3rd ed.
   p. cm.
  ISBN 978-0-87389-748-8 (alk. paper)
  1. Quality control—Standards—Handbooks, manuals, etc. 2. ISO 9001
  Standard—Handbooks, manuals, etc. I. Russell, J. P. (James P.),
  1945– II. Title.

  TS156.A755 2008
  658.4'013—dc22
2008042958

No part of this book may be reproduced in any form or by any means, electronic,
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Publisher: William A. Tony

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Printed on acid-free paper

 Table of Contents

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Defining Quality . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
What Is a Process? . . . . . . . . . . . . . . . . . . . . . . . . 10
4 Quality management system
4.1 General requirements . . . . . . . . . . . . . . . . 12
4.2 Documentation requirements . . . . . . . . . . 13
4.2.1 General . . . . . . . . . . . . . . . . . . . . . 13
4.2.2 Quality manual . . . . . . . . . . . . . . . 13
4.2.3 Control of documents . . . . . . . . . . . 15
4.2.4 Control of records . . . . . . . . . . . . . . 15

5 Management responsibility
5.1 Management commitment . . . . . . . . . . . . . 18
5.2 Customer focus . . . . . . . . . . . . . . . . . . . . 18
5.3 Quality policy . . . . . . . . . . . . . . . . . . . . . . 18
5.4 Planning . . . . . . . . . . . . . . . . . . . . . . . . . . 18
5.5 Responsibility, authority,
and communication . . . . . . . . . . . . . . . . . 18
5.6 Management review . . . . . . . . . . . . . . . . . 21

6 Resource management
6.1 Provision of resources . . . . . . . . . . . . . . . . 23
6.2 Human resources . . . . . . . . . . . . . . . . . . . 23
6.3 Infrastructure . . . . . . . . . . . . . . . . . . . . . . 23
6.4 Work environment . . . . . . . . . . . . . . . . . . 23

7 Product realization
7.1 Planning of product realization . . . . . . . . . 27
7.2 Customer-related processes . . . . . . . . . . . 28
7.3 Design and development . . . . . . . . . . . . . . 30
7.4 Purchasing . . . . . . . . . . . . . . . . . . . . . . . . 33

5
 7.5 Production and service provision . . . . . . . 35
7.5.1  Control of production and service
provision . . . . . . . . . . . . . . . . . . . . 35
7.5.2 Validation of processes for production
and service
provision . . . . . . . . . . . . . . . . . . . . 37
7.5.3 Identification and traceability . . . . . 38
7.5.4 Customer property . . . . . . . . . . . . . 41
7.5.5 Preservation of product . . . . . . . . . 43
7.6 Control of monitoring and measuring
equipment . . . . . . . . . . . . . . . . . . . . . . . . 45

8 Measurement, analysis, and improvement

8.1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
8.2 Monitoring and measurement . . . . . . . . . . 50
8.2.1 Customer satisfaction . . . . . . . . . . . 50
8.2.2 Internal audit . . . . . . . . . . . . . . . . . 52
8.2.3 Monitoring and measurement
of processes . . . . . . . . . . . . . . . . . . . 55
8.2.4 Monitoring and measurement
of product . . . . . . . . . . . . . . . . . . . 55
8.3 Control of nonconforming product . . . . . . 57
8.4 Analysis of data . . . . . . . . . . . . . . . . . . . . 59
8.5 Improvement . . . . . . . . . . . . . . . . . . . . . . 61
8.5.1 Continual improvement . . . . . . . . . 61
8.5.2 Corrective action . . . . . . . . . . . . . . 61
8.5.3 Preventive action . . . . . . . . . . . . . . 61

ISO 9001 Conspectus

(Simplified summary of requirements) . . . . . . . 64
Quality Management Principles . . . . . . . . . . . 68
A Fable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

6
 Introduction

The ISO Lesson Guide translates ISO 9001 into

easy to understand words. This pocket edition was
designed as a quick reference for anyone to carry
around conveniently.
Each element containing requirements is discussed,
and key concepts are highlighted at the beginning
of each section.
Here is a rundown of the Lesson Guide features:
• Quality is defined
• The ISO process approach is explained
• Key concepts are accompanied by an illustration
• Concepts are described in easy to understand
words
• A brief conspectus summarizes ISO 9001
requirements
• Quality management principles are described in
easy to understand words
• An entertaining fable explains the difference
between ISO 9001 and ISO 9004
Ideal for handing out to existing and new employees,
this pocket guide can also be used as supplemental
study material for ISO 9001 training courses. Web-
based training using the concepts in this pocket
guide is available at www.QualityWBT.com.
Pocket guides can be purchased individually or
in bulk.

7
 Defining Quality

This pocket guide is a series of discussions on qual-

ity and the common methods used to achieve qual-
ity using the ISO 9001 standard. The first step is to
define quality. That is not easy.
A popular book at the time I was going to college
was Zen and the Art of Motorcycle Maintenance, by
Robert Pirsig. Those of you who got past the first
two chapters will recall that the hero was pursuing
the definition of quality. It caused him to become
mentally unbalanced. I hope that doesn’t happen
to you!
Let’s take the simple approach in our definition of
quality. Let’s use the approach of ISO 9001, which is
an extremely popular worldwide standard: Quality
is what the customer says it is. Quality has another
characteristic: It can be physically measured. If all
the measurements add up to what the customer
defined or needed, then what you just provided is
quality.
Philip B. Crosby stated this many years ago in his
book Quality Is Free. He defined quality as “con-
formance to requirements.” Simple. The ISO 9001
standard builds on this concept of requirements for
product, process, or system. Requirements either
come directly from the customer or they come from
you and are agreed to by the customer.
The second component of quality has to do with
measurable characteristics. If something cannot be
measured, it cannot possess quality. These measure-

8
ments are physical and testable. This goes back to
the military concept of form, fit, and function. Later
on in this series, you will see just how important this
concept of measurement is. If you can measure it,
you can maintain it and improve it.
This approach implies that you could manufacture
hat boxes that didn’t hold hats (designer hat boxes)
or video cameras without imaging devices (fake sur-
veillance cameras). If you took steps to make sure
that the physical characteristics of the said box or
camera were defined and actually achieved, then you
would have indeed made something of quality. If a
hotel guest wanted to sleep on the floor and asked to
have the bed removed, you would still be providing
a quality service even though you were charging for
a room with no bed. Everything must be seen from
the eyes of the customer. Remember pet rocks? They
served no practical function, but they were exactly
what the customer wanted. This leads to the first
rule of quality: Quality is defined by the customer.
Your customers know what they want, but you must
also comply with the law of the land. Governments
issue laws, ordinances, and regulations for the well-
being, safety, and health of the public and to protect
our environment.
Customer focus and improvement are critical when
discussing quality. You have to provide quality or
customers will take their business elsewhere. Sure,
achievement of customer satisfaction is necessary,
but to realize this higher level of performance, you
must first have a command of the concepts. That’s
what this guide is about.

9
 What Is a Process?

The current quality management system standard

takes the process approach. This simply means that
the standard is organized in the order in which you
would normally do something. First you would plan
it. Then you would do it. Then you would check and
analyze what you did. Finally, you would improve
on any weaknesses. The clauses of ISO 9001 are
likewise organized from start to finish instead of as
a random list of tasks. In our discussions you will
see the letters PDCA. The letters stand for Plan-
Do-Check-Act. The PDCA cycle is an old idea first
published in the 1930s, yet we are still learning how
powerful it can be.
A process is a series of steps or actions that do some-
thing. The something could be sawing, stamping,
massaging, mixing, registering, or painting. A pro-
cess represents action and usually ends with -ing.
Henry Ford is well known for having lined up several
processes to form an assembly line. Putting the pro-
cesses in sequential order allowed Ford to provide
affordable and reliable automobiles. When all the
processes and assembly lines are put together, you
have a system or organization that must be man-
aged. For best quality results, the system should be
managed according to certain quality management
principles (see page 68).
A system is a group of processes working together to
achieve a common objective. The processes must be
managed to achieve the organization’s goals, such
as meeting a budget or realizing a profit. The fol-

10
lowing diagram shows the management system and
processes that are part of this quality management
standard (note the ISO 9001 clause numbers in the
diagram).

Management
responsibility 5

4 Measurement,
Resource
management 6 ISO 9001
analysis, and 8
improvement
system model

Customer Product Customer

requirements realization 7 satisfaction
Input Output

Quality management system diagram

The important stuff really starts with clause 4 of the

standard and continues through clause 8. Clauses
0 through 3 are introductory and administrative
clauses that contain no requirements. You can see
how the all-important customer fits into the system.
The customer starts and ends the process. Your ulti-
mate goal is to end up with a satisfied customer.

11
 4 Quality management system

4.1 General requirements

• Say what you do
• Do what you say

Have you ever gone through a great deal of effort

to figure out how to do a particular task? Have you
ever had a key employee leave the company? Have
you ever had goods returned because the tooling
setups weren’t quite right? These are all good rea-
sons to develop a formal and structured approach
to your operations.
You need to identify the important tasks and
establish the sequence in which they should be
performed. Important tasks farmed out to others
(outsourcing) must be included, too. When you are
able to perform the processes correctly the first
time around, you have an effective operation. You
will need to identify measures and record informa-
tion so that you know how you are doing from time

12