ISO 9001:2008 explained and expanded : making your Quality Management System sustainable

177 Pages·2014·10.247 MB·English

by  Cianfrani, Charles A., West, Jack

ISO 9001:2008

E X P L A I N E D &
E XPA N DE D
Making Your Quality Management
System Sustainable
Charles A. Cianfrani
John E. “Jack” West
ISO 9001:2008
Explained and
Expanded
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Also available from ASQ Quality Press:
ISO 9001:2008 Explained, Third Edition
Charles A. Cianfrani, Joseph J. Tsiakals, and John E. (Jack) West
How to Audit the Process Based QMS, Second Edition
Dennis R. Arter, Charles A. Cianfrani, and John E. (Jack) West
Cracking the Case of ISO 9001:2008 for Manufacturing
John E. (Jack) West and Charles A. Cianfrani
Cracking the Case of ISO 9001:2008 for Service
John E. (Jack) West and Charles A. Cianfrani
ISO Lesson Guide 2008: Pocket Guide to ISO 9001-2008, Third Edition
J. P. Russell and Dennis R. Arter
ISO 9001:2008 Internal Audits Made Easy: Tools, Techniques and Step-By-
Step Guidelines for Successful Internal Audits, Second Edition
Ann W. Phillips
The ASQ Auditing Handbook, Fourth Edition
J. P. Russell, editing director
Quality Audits for Improved Performance, Third Edition
Dennis R. Arter
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
George Alukal and Anthony Manos
Root Cause Analysis: Simplified Tools and Techniques, Second Edition
Bjørn Andersen and Tom Fagerhaug
The Certified Manager of Quality/Organizational Excellence Handbook,
Fourth Edition
Russell T. Westcott, editor
To request a complimentary catalog of ASQ Quality Press publications, call
800-248-1946, or visit our website at http://www.asq.org/quality-press.
H1446_Cianfrani_pi_000.indd 2 11/5/13 9:53 AM
ISO 9001:2008
Explained and
Expanded
Making Your
Quality Management System
Sustainable
Charles A. Cianfrani
John E. (Jack) West
ASQ Quality Press
Milwaukee, Wisconsin
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American Society for Quality, Quality Press, Milwaukee 53203
© 2014 by ASQ
All rights reserved.
Printed in the United States of America
19 18 17 16 15 14 5 4 3 2 1
Library of Congress Cataloging-in-Publication Data
Cianfrani, Charles A.
ISO 9001:2008 explained and expanded : making your Quality Management
System sustainable / Charles A. Cianfrani, John E. (Jack) West.
pages cm
Includes bibliographical references and index.
ISBN 978-0-87389-866-9 (alk. paper)
1. ISO 9001 Standard. 2. Quality control—Standards. I. West, Jack, 1944–
II. Title
TS156.6.C45155 2014
658.4′013—dc23
2013038425
No part of this book may be reproduced in any form or by any means, electronic,
mechanical, photocopying, recording, or otherwise, without the prior written
permission of the publisher.
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Managing Editor: Paul Daniel O’Mara
Production Administrator: Randall Benson
ASQ Mission: The American Society for Quality advances individual, organiza-
tional, and community excellence worldwide through learning, quality improve-
ment, and knowledge exchange.
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Printed on acid-free paper
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Contents
List of Figures and Tables ........................ ix
Preface ...................................... xi
Introduction ................................... xv
Chapter 1 Why Bother with Conformity? ....... 1
Why Should an Organization Want to
Expand Beyond the Minimum
Requirements of ISO 9001:2008? ... 4
Where and How to Start the Journey .... 5
A Few Processes That Deserve
Special Attention ................ 12
Summary ......................... 16
Notes ............................ 18
Chapter 2 Building Your Quality Management
System ........................... 19
Basics of Process Management ........ 20
Summary ......................... 29
Notes ............................ 30
Chapter 3 Why Is Quality Auditing Important? .. 31
The Basics—A Summary ............ 33
v
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vi Contents
The Distinction between Audit,
Self-Assessment, and Management
Review ........................ 36
What Are the Minimum Requirements
for Auditing? ................... 38
Tips on How to Pass an ISO 9001:2008
Certification Audit ............... 40
Going Beyond the Minimum? ......... 41
Summary ......................... 44
Notes ............................ 46
Chapter 4 What Is Needed to Be Successful ..... 47
Addressing Effectiveness (Capability
and Capacity) and Efficiency
(Waste Elimination) .............. 47
Addressing Competence: Embedding
Learning as a Formal Process ...... 48
Product and Process Validation ........ 49
Addressing Correction, Corrective
Action, and Preventive Action ...... 56
Managing Incremental and Breakthrough
Improvement ................... 62
The Relationships among Policy,
Objectives, and Alignment ......... 63
Simplicity and Systems Thinking ...... 69
Manage by Facts: The Importance of
Obtaining and Analyzing Data ...... 74
“Output Matters” as a Core Value ...... 77
Summary ......................... 78
Notes ............................ 79
Chapter 5 Go Beyond Where It Matters ........ 81
How to Conduct a Self-Assessment:
A Primer ....................... 82
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Contents vii
Where Can Self- Assessment Results
Indicate a Need to Go Beyond
Minimum Requirements? .......... 90
Summary ......................... 104
Notes ............................ 105
Chapter 6 Future Quality Management System
Challenges ........................ 107
The Communication Challenge ....... . 108
Planning for the Future .............. 112
Summary ......................... 120
Chapter 7 Revitalizing Your Quality
Management System ............... 123
The Stable State .................... 123
How the System Should Work ......... 124
People and the Quality System ........ 127
A Role of Management Review ........ 129
Set the Bar ........................ 131
Each Employee’s Role ............... 132
Shared Vision ...................... 134
Summary ......................... 135
Epilogue ..................................... 137
Appendix Questions an Assessor Can Consider
in Planning and Conducting a
Self‑Assessment to the Contents of
ISO 9004:2009. . . . . . . . . . . . . . . . . . . . 139
Index ........................................ 151
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List of Figures and Tables
Figure I.1 Model for the content of ISO 9001:2008
Explained and Expanded ............. xvi
Figure 1.1 Output matters ..................... 2
Table 1.1 Characteristics of incremental and
breakthrough improvements .......... 14
Figure 1.2 Incremental and breakthrough
improvement ...................... 15
Figure 2.1 Process: A set of interrelated or
interacting activities that transform inputs
into outputs. . . . . . . . . . . . . . . . . . . . . . . . 20
Figure 2.2 Processes are supported by resources and
controls ........................... 21
Figure 2.3 An organization’s process model ....... 23
Figure 2.4 A family of well-managed processes .... 24
Figure 2.5 Process relationship of ISO 9001:2008
to ISO 9004:2009 ................... 27
Figure 3.1 The audit process ................... 35
Figure 3.2 Conducting the audit ................ 35
Figure 3.3 Audit inputs and outputs, resources
required, and management role ........ 39
Figure 4.1 Validation that product designs meet
customer requirements—summary of
requirements ....................... 51
Figure 4.2 Design controls illustrated ............ 52
ix
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