1、ISO 9001:2008ExplainedThird EditionFM_Cianfrani_575068.indd i 12/9/08 8:20:28 AMAlso available from ASQ Quality Press:Cracking the Case of ISO 9001:2008 for ManufacturingJohn E. (Jack) West and Charles A. CianfraniCracking the Case of ISO 9001:2008 for ServiceJohn E. (Jack) West and Charles A. Cianf
2、raniISO Lesson Guide 2008: Pocket Guide to ISO 90012008, Third EditionJ.P. Russell and Dennis R. ArterISO 9001:2008 Internal Audits Made Easy: Tools, Techniques and Step-By-Step Guidelines for Successful Internal Audits, Second EditionAnn W. PhillipsHow to Audit the Process-Based QMSDennis R. Arter,
3、 John E. (Jack) West, and Charles A. CianfraniUnlocking the Power of Your QMS: Keys to Business Performance ImprovementJohn E. (Jack) West and Charles A. CianfraniThe ASQ Auditing Handbook, Third EditionJ.P. Russell, editing directorQuality Audits for Improved Performance, Third EditionDennis R. Art
4、erThe Quality Toolbox, Second EditionNancy R. TagueMapping Work Processes, Second EditionBjrn Andersen, Tom Fagerhaug, Bjrnar Henriksen, and Lars E. OnsyenLean Kaizen: A Simplifi ed Approach to Process ImprovementsGeorge Alukal and Anthony ManosRoot Cause Analysis: Simplifi ed Tools and Techniques,
5、Second EditionBjrn Andersen and Tom FagerhaugThe Certifi ed Manager of Quality/Organizational Excellence Handbook, Third EditionRussell T. Westcott, editorTo 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
6、FM_Cianfrani_575068.indd ii 12/9/08 8:20:29 AMISO 9001:2008ExplainedThird EditionCharles A. CianfraniJoseph J. TsiakalsJohn E. ( Jack) WestASQ Quality PressMilwaukee, WisconsinFM_Cianfrani_575068.indd iii 12/9/08 8:20:29 AMAmerican Society for Quality, Quality Press, Milwaukee 53203 2009 American S
7、ociety for QualityAll rights reserved. Published 2009Printed in the United States of America13 12 11 10 09 5 4 3 2 1Library of Congress Cataloging-in-Publication DataCianfrani, Charles A.ISO 9001:2008 explained / Charles A. Cianfrani, Joseph J. Tsiakals, John E. (Jack) West. 3rd ed.p. cm.Includes bi
8、bliographical references and index.ISBN 978-0-87389-750-4 (casebound : alk. paper)1. ISO 9001 Standard. I. Tsiakals, Joseph J. II. West, Jack, 1944 III. Title.TS156.6.C45 2009658.4H11032013dc222008045438ISBN-13: 978-0-87389-750-4No part of this book may be reproduced in any form or by any means, ele
9、ctronic, mechanical, photocopying, recording, or otherwise, without the prior written permission of the publisher.Publisher: William A. TroyAcquisitions Editor: Matt MeinholzProject Editor: Paul OMaraProduction Administrator: Randall BensonASQ Mission: The American Society for Quality advances indiv
10、idual, organizational, and community excellence worldwide through learning, quality improvement, and knowledge exchange.Attention Bookstores, Wholesalers, Schools, and Corporations: ASQ Quality Press books, videotapes, audiotapes, and software are available at quantity discounts with bulk purchases
11、for business, educational, or instructional use. For information, please contact ASQ Quality Press at 800-248-1946, or write to ASQ Quality Press, PO Box 3005, Milwaukee, WI 53201-3005.To place orders or to request a free copy of the ASQ Quality Press Publications Catalog, including ASQ membership i
12、nformation, call 800-248-1946. Visit our Web site at www.asq.org or http:/www.asq.org/quality-pressPrinted on acid-free paperFM_Cianfrani_575068.indd iv 12/9/08 8:20:29 AMContentsList of Figures and Tables. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .xiiiPreface . . . . . . . .
13、 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xvChapter 1 Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . 1The Eight Quality Management Principles . . . . . . . . . . . . 3Chapter 2 Quality Management System and General Documentation . . . . . . .
14、 . . . . . 15Clause 4.1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16Implementation Tips and Typical Questions to Ask for Conformity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18Defi nitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
15、 . . . . . . . . 19Clause 4.2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21Implementation Tips and Typical Questions to Ask for Conformity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26Defi nitions . . . . . . . . . . . . . . . . . . . . . . . . . .
16、 . . . . . . . . . . 26Clause 4.2.2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27Implementation Tips and Typical Questions to Ask for Conformity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28Defi nitions . . . . . . . . . . . . . . . . . . . . . . . .
17、 . . . . . . . . . . . . 29Clause 4.2.3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30Clause 4.2.4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30Implementation Tips and Typical Questions to Ask for Conformity . . . . . . . . . . . . . . . . .
18、 . . . . . . . . . . . . . 35Defi nitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36Considerations for Documentation . . . . . . . . . . . . . . . . . 37Chapter 3 Management Responsibility . . . . . . . . . . . . . . 39Clause 5.1. . . . . . . . . . . . . . . . . .
19、 . . . . . . . . . . . . . . . . . . . 40Clause 5.2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40Implementation Tips and Typical Questions to Ask for Conformity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41Defi nitions . . . . . . . . . . . . . . .
20、 . . . . . . . . . . . . . . . . . . . . . . 43Considerations for Documentation . . . . . . . . . . . . . . . . . 44Clause 5.3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44vFM_Cianfrani_575068.indd v 12/9/08 8:20:30 AMImplementation Tips and Typical Questions to Ask f
21、or Conformity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47Defi nitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48Clause 5.4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49Implementation Tips and Typical Questions to
22、Ask for Conformity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50Defi nitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54Considerations for Documentation . . . . . . . . . . . . . . . . . 54Clause 5.5. . . . . . . . . . . . . . . . . . . . . . . . .
23、 . . . . . . . . . . . . . 55Implementation Tips and Typical Questions to Ask for Conformity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57Defi nitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58Clause 5.6. . . . . . . . . . . . . . . . . . . . . .
24、 . . . . . . . . . . . . . . . 59Implementation Tips and Typical Questions to Ask for Conformity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61Defi nitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62Chapter 4 Human and Other Resources . . . . . . .
25、 . . . . . . 65Clause 6.1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66Implementation Tips and Typical Questions to Ask for Conformity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67Defi nitions . . . . . . . . . . . . . . . . . . . . . . . . . . . .
26、 . . . . . . . . 69Considerations for Documentation . . . . . . . . . . . . . . . . . 69Clause 6.2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70Implementation Tips and Typical Questions to Ask for Conformity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
27、 . 71Defi nitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72Considerations for Documentation . . . . . . . . . . . . . . . . . 72Clause 6.2.2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72Implementation Tips and Typical Questions to Ask f
28、or Conformity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74Defi nitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75Considerations for Documentation . . . . . . . . . . . . . . . . . 75Clause 6.3. . . . . . . . . . . . . . . . . . . . . . . . . . .
29、 . . . . . . . . . . 76Implementation Tips and Typical Questions to Ask for Conformity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77Defi nitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78Considerations for Documentation . . . . . . . . . . . . .
30、 . . . 78Clause 6.4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79Implementation Tips and Typical Questions to Ask for Conformity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80Defi nitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
31、 . . . . . . 81Considerations for Documentation . . . . . . . . . . . . . . . . . 81vi ContentsFM_Cianfrani_575068.indd vi 12/9/08 8:20:30 AMChapter 5 Planning of Product Realization and Customer-Related Processes . . . . . . . . . . 83Clause 7.1. . . . . . . . . . . . . . . . . . . . . . . . . . .
32、 . . . . . . . . . . 84Implementation Tips and Typical Questions to Ask for Conformity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86Defi nitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87Considerations for Documentation . . . . . . . . . . . . .
33、 . . . 88Clause 7.2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89Clause 7.2.1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89Implementation Tips and Typical Questions to Ask for Conformity . . . . . . . . . . . . . . . . . . . . . . . . . .
34、 . . . . . 90Defi nitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91Considerations for Documentation . . . . . . . . . . . . . . . . . 91Clause 7.2.2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92Implementation Tips and Typical Questions
35、to Ask for Conformity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93Considerations for Documentation . . . . . . . . . . . . . . . . . 95Clause 7.2.3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95Implementation Tips and Typical Questions to Ask for Confo
36、rmity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96Considerations for Documentation . . . . . . . . . . . . . . . . . 97Chapter 6 Design and Development . . . . . . . . . . . . . . . . 99Clause 7.3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100Clause
37、7.3.1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100Implementation Tips and Typical Questions to Ask for Conformity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101Defi nitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101Consid
38、erations for Documentation . . . . . . . . . . . . . . . . 102Clause 7.3.2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103Implementation Tips and Typical Questions to Ask for Conformity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103Defi nitions . . . . . .
39、 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104Considerations for Documentation . . . . . . . . . . . . . . . . 106Clause 7.3.3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106Implementation Tips and Typical Questions to Ask for Conformity . . . . . . . . . .
40、 . . . . . . . . . . . . . . . . . . . . 108Defi nitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109Considerations for Documentation . . . . . . . . . . . . . . . . 109Clause 7.3.4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110Implementation
41、 Tips and Typical Questions to Ask for Conformity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111Contents viiFM_Cianfrani_575068.indd vii 12/9/08 8:20:30 AMDefi nitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112Considerations for Documentation . . . .
42、 . . . . . . . . . . . . 112Clause 7.3.5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112Implementation Tips and Typical Questions to Ask for Conformity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113Defi nitions . . . . . . . . . . . . . . . . . . . . . . .
43、 . . . . . . . . . . . . 114Considerations for Documentation . . . . . . . . . . . . . . . . 114Clause 7.3.6 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115Implementation Tips and Typical Questions to Ask for Conformity . . . . . . . . . . . . . . . . . . . . . . . . . . .
44、 . . . 115Defi nitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117Considerations for Documentation . . . . . . . . . . . . . . . . 117Clause 7.3.7 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118Implementation Tips and Typical Questions to Ask
45、 for Conformity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118Considerations for Documentation . . . . . . . . . . . . . . . . 119Chapter 7 Purchasing . . . . . . . . . . . . . . . . . . . . . . . . . . . 121Clause 7.4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
46、 . . . . 122Clause 7.4.1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122Implementation Tips and Typical Questions to Ask for Conformity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123Defi nitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
47、 . . . . 124Considerations for Documentation . . . . . . . . . . . . . . . . 124Clause 7.4.2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125Implementation Tips and Typical Questions to Ask for Conformity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125Defi n
48、itions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126Considerations for Documentation . . . . . . . . . . . . . . . . 126Clause 7.4.3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127Implementation Tips and Typical Questions to Ask for Conformity
49、 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128Defi nitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129Considerations for Documentation . . . . . . . . . . . . . . . . 130Chapter 8 Production and Service Provision. . . . . . . . . 131Clause 7.5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132Clause 7.5.1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132Implementation Tips and Typical Questions to Ask for Conformity . . . . . . . . . . . . . . . . . . . . .
