1、A PRACTICAL FIELD GUIDE FOR ISO 9001:200800_FM_Myhrberg_8.5X11_575019.indi i 4/30/09 2:15:12 PMAlso available from ASQ Quality Press:ISO 9001:2008 Explained, Third EditionCharles A. Cianfrani, John E. “Jack” West, and Joseph J. TsiakalsISO Lesson Guide 2008: Pocket Guide to ISO 9001-2008, Third Edit
2、ionJ. 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. PhillipsProcess Driven Comprehensive Auditing: A New Way to Conduct ISO 9001:2008 Internal Audits, Second EditionPaul C. Pal
3、mesISO 9001:2008 Interpretive Guide for the Design and Construction Project Team (e-Book)Prepared by members of the ASQ Design and Construction Division and edited by John R. BroomfieldHow to Audit the Process-Based QMSDennis R. Arter, John E. (Jack) West, and Charles A. CianfraniThe ASQ Auditing Ha
4、ndbook, Third EditionJ. P. Russell, editing directorQuality Audits for Improved Performance, Third EditionDennis R. ArterThe Quality Toolbox, Second EditionNancy R. TagueMapping Work Processes, Second EditionBjrn Andersen, Tom Fagerhaug, Bjrnar Henriksen, and Lars E. OnsyenLean Kaizen: A Simplified
5、Approach to Process ImprovementsGeorge Alukal and Anthony ManosRoot Cause Analysis: Simplified Tools and Techniques, Second EditionBjrn Andersen and Tom FagerhaugThe Certified Manager of Quality/Organizational Excellence Handbook, Third EditionRussell T. Westcott, editorTo request a complimentary ca
6、talog of ASQ Quality Press publications,call 800-248-1946, or visit our Web site at http:/www.asq.org/quality-press.00_FM_Myhrberg_8.5X11_575019.indii ii 4/30/09 2:15:12 PMA PRACTICAL FIELD GUIDE FOR ISO 9001:2008Erik Valdemar MyhrbergASQ Quality PressMilwaukee, Wisconsin00_FM_Myhrberg_8.5X11_575019
7、.indiii iii 4/30/09 2:15:12 PMAmerican Society for Quality, Quality Press, Milwaukee 53203 2009 American Society 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 DataMyhrberg, Erik V.A practical
8、 field guide for ISO 9001:2008 / Erik V. Myhrberg.p. cm.Includes bibliographical references.ISBN 978-0-87389-770-9 (pbk. : alk. paper)1. ISO 9001 Standard. I. Title.TS156.6.M96 2009658.4013dc222009011714ISBN-13: 978-0-87389-770-9No 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. TonyAcquisitions 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 8002481946, or write to ASQ Quality Press, P.O. Box 3005, Milwaukee, WI 532013005.To place orders or to request a free copy of the ASQ Quality Press Publications Catalog, including ASQ membership in
12、formation, call 8002481946. Visit our Web site at www.asq.org or http:/www.asq.org/quality-pressPrinted on acid-free paper00_FM_Myhrberg_8.5X11_575019.indiv iv 4/30/09 2:15:12 PMTo my blessed family:MarcenaBrandonHeatherTo my esteemed colleagues:Dave RiggLarry Whittington00_FM_Myhrberg_8.5X11_575019
13、.indv v 4/30/09 2:15:13 PM00_FM_Myhrberg_8.5X11_575019.indvi vi 4/30/09 2:15:13 PMCONTENTSIntroduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ixHow to Use This Field Guide . . . . . . . . . . . . . . .
14、 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiSection 4: Quality Management System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14.1 General Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
15、. . . . . . . . . . . . . . . . . . . . . . . 24.2 Documentation Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4Section 5: Management Responsibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
16、. . . 135.1 Management Commitment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145.2 Customer Focus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 165.3 Quality Policy .
17、. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 185.4 Planning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 205.5 Responsibility, Authority,
18、and Communication. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 245.6 Management Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30Section 6: Resource Management . . . . . . . . . . . . . . . . . . . . .
19、. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 376.1 Provision of Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 386.2 Human Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
20、 . . . . . . . . . . . . . . . . 406.3 Infrastructure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 446.4 Work Environment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
21、. . . . . . . . 46Section 7: Product Realization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 517.1 Planning of Product Realization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 527.2 Custome
22、r-related Processes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 547.3 Design and Development. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 607.4 Purchasing . . . . . . . . . . . . . .
23、 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 747.5 Production and Service Provision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 807.6 Control of Monitoring and Measuring Devices . . . . . . . . .
24、. . . . . . . . . . . . . . . . . . . . . . . . . . 90Section 8: Measurement, Analysis, and Improvement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 978.1 General. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
25、 . . . . . . . . 988.2 Monitoring and Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1008.3 Control of Nonconforming Product. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1088.4 Analysis of Data
26、. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1108.5 Improvement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112ISO 9001:2008 Documented Requireme
27、nts by Section . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123Sources of Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125vii00_FM_Myhrberg_8.5X11_575019.indvii vii 4/30/09 2:15:13 PM00_FM
28、_Myhrberg_8.5X11_575019.indviii viii 4/30/09 2:15:13 PMINTRODUCTIONixAlmost 20 years have passed (and over 135 projects) since I first became aware of, and started using, the ISO 9000 standards. So much has changed and evolved during this time. The advent of the ISO 14000 series of environmental man
29、agement stan-dards, the addition and deletion of standards within the ISO 9000 series, and the creation of a host of industrial and sector-specific standards and “reports” based on ISO 9001 have emerged.It is my hope that, through my years of extensive field and classroom experience, the readers and
30、 users of this field guide will benefit from it in their application of the ISO 9000 Quality Management System series standards.Even with all this progress, the fundamental use of the ISO 9000 series has not changed. Companies, teams, and individuals are still trying to meet customer expectations; w
31、orldwide competition still drives the need for innovation; and internal process pressures still demand continual improvement in order to remain functional.This field guide has been created in order to foster an inner reliance between senior management, middle management, functional teams, and the in
32、dividual. Users of the field guide will find within it practical tools, tips, and techniques useful for not only implementing a Quality Management System but also for maintaining one.With the dawning of the 21st century, companies are being pushed to the limits of their resources. At one time, it wa
33、s suf-ficient to meet most of our customers requirements, but not now. On a global scale, we are all being asked to do more with lessand for less. At some point soon, the current internal systems will not be able to hold back the deluge, and companies will be faced with a stark decisionconsistently
34、improve or perish.One of the best and most widely accepted ways in which companies can face these challenges is to implement an effective and efficient Quality Management System, which not only adds value to the organization but also satisfies the customer.Indeed, this is already the century of inte
35、rnational standards. The revised ISO 9001:2008 series of standards is both useful to the organization and here to stay.Work diligently with regard to your ongoing ISO efforts!Erik Valdemar Myhrberg00_FM_Myhrberg_8.5X11_575019.indix ix 4/30/09 2:15:13 PM00_FM_Myhrberg_8.5X11_575019.indx x 4/30/09 2:1
36、5:14 PMHOW TO USE THIS FIELD GUIDExiThe purpose of this field guide is to assist organizations, step by step, in implementing a QMS in conformance with ISO 9001:2008, whether from scratch or by transitioning from ISO 9001:2000. In keeping with ISO 9000:2005s definition of “quality” as the “degree to
37、 which a set of inherent characteristics fulfils requirements,” I have identified the requirements and inherent characteristics (distinguishing features) for this field guide. Within the guide, each sub-clause containing requirements is the focus of a two-page spread that consistently presents featu
38、res that fulfill the requirements listed below.Requirements (or what the field guide will do) Provide a user-friendly guide to ISO 9001:2008s requirements for implementation purposes Identify the documents/documentation required, along with recommendations on what to consider retaining or adding to
39、a QMS during ISO 9001:2008 implementation Guide internal auditor(s) regarding what to ask to verify that a conforming and effective QMS exists Direct management on what it must do and should consider to satisfy ISO 9001:2008s enhanced requirements and responsibilities for top management Depict step
40、by step what must occur to create an effective, conforming QMS.Inherent Characteristics (or what the field guide provides) The StandardA paraphrase of what a sub-clause of ISO 9001:2008 requires in easy-to-understand language, with references to information in ISO 9000:2008 and guidance in ISO 9004:
41、2008 to enhance the users understanding of what ISO 9001:2008 requires and what possible added steps the user can take to improve performance. Document RequirementsA list of the documentation/documents required by the sub-clause, with some ideas to consider in satisfying those requirements that will
42、 take the system beyond the requirements toward continual improvement. Internal Audit QuestionsWhat every internal audit team needs to ask at a minimum when assessing the QMS for conformance with the sub-clause. Management SummaryA concise description of what management must do and/or is responsible
43、 for in order to achieve conformance to the sub-clause, along with some guidance on additional steps management can take to enhance the system. Sub-clause Flow ChartA depiction of the steps that need to be undertaken during an implementation/transition effort to effectively and efficiently satisfy t
44、he requirements of the sub-clause of ISO 9001:2008, along with a box providing guidance on use of the flowchart. A Sectional Cross-EvaluationA matrix that shows where the requirements in each sub-clause within a section of ISO 9001:2000 appear in ISO 9001:2008. These cross-evaluations are provided t
45、o assist the user if his/her organization is transitioning from ISO 9001:2000 and appear at the end of the field guides coverage of each section of ISO 9001:2008 (Sections 48).00_FM_Myhrberg_8.5X11_575019.indxi xi 4/30/09 2:15:14 PMxii A Practical Field Guide for ISO 9001:2008This field guide is des
46、igned to provide you with a consistent approach to implementing an ISO 9001:2008conforming QMS, which is appropriate because ISO 9001:2008 continues to view quality as the ability of an organization to consistently deliver product that meets customer specifications. The field guide examines each sub
47、-clause of Sections 48 of ISO 9001:2008, which contain the requirements with characteristics 14 listed above presented on the even page, and characteristic 5 presentedon the facing odd page.Sub-clause 1.2, ScopeApplication, which does not contain requirements but is critical to properly excluding an
48、y require-ments of ISO 9001:2008 that do not apply to your organizations QMS, and should therefore be treated as an important part of the field guide, due to the importance of establishing the QMSs scope and subsequent “permissible exclusions.”What separates this field guide from most other books on
49、 ISO 9001:2008 and its implementation are the flow charts show-ing the steps to be taken in implementing a QMS to meet a sub-clauses requirements. But the flow charts themselves can be overwhelming when you first look at them. For this reason, a box appears with each flow chart that explains pertinent facts and/or what the flow chart represents and how it is to be used.Remember, the QMS your organization implements must meet the needs of its usersyou and the rest of your organiza-tions employees, from senior management t
