1、Implementing ISO/IEC 17025:2005H1448_Mehta.indd 1 3/13/13 4:57 PMAlso available from ASQ Quality Press:The Quality Calibration Handbook Jay L. BucherThe Uncertainty of Measurements: Physical and Chemical Metrology Impact and Analysis S.K. KimothiThe Metrology Handbook, Second Edition Jay L. Bucher,
2、editorThe Certified Quality Technician Handbook, Second Edition H. Fred Walker, Donald W. Benbow, and Ahmad K. ElshennawyThe Certified Quality Inspector Handbook, Second Edition H. Fred Walker, Ahmad K. Elshennawy, Bhisham C. Gupta, and Mary McShane VaughnThe Quality Toolbox, Second Edition Nancy R.
3、 TagueThe Certified Six Sigma Green Belt Handbook Roderick A. Munro, Matthew J. Maio, Mohamed B. Nawaz, Govindarajan Ramu, and Daniel J. ZrymiakThe Certified Manager of Quality/Organizational Excellence Handbook: Third Edition Russell T. Westcott, editorThe Certified Six Sigma Black Belt Handbook, S
4、econd Edition T.M. Kubiak and Donald W. BenbowThe ASQ Auditing Handbook, Fourth Edition J.P. Russell, editorThe Internal Auditing Pocket Guide: Preparing, Performing, Reporting and Follow-up, Second Edition J.P. RussellRoot Cause Analysis: Simplified Tools and Techniques, Second Edition Bjrn Anderse
5、n and Tom FagerhaugTo request a complimentary catalog of ASQ Quality Press publications, call 800-248-1946, or visit our website at http:/www.asq.org/quality-press.H1448_Mehta.indd 2 3/14/13 12:06 PMImplementing ISO/IEC 17025:2005A Practical GuideBob (Bhavan) MehtaASQ Quality PressMilwaukee, Wiscons
6、inH1448_Mehta.indd 3 3/13/13 4:57 PMAmerican Society for Quality, Quality Press, Milwaukee 53203 2013 by ASQAll rights reserved. Printed in the United States of America18 17 16 15 14 13 5 4 3 2 1Library of Congress Cataloging-in-Publication DataMehta, Bob, 1961 Implementing ISO/IEC 17025:2005 : a pr
7、actical guide / Bob (Bhavan) Mehta. pages cm Includes bibliographical references and index. ISBN 978-0-87389-854-6 (alk. paper) 1. LaboratoriesAccreditationStandards. 2. LaboratoriesStandards. I. Title. II. Title: ISO/IEC 17025:2005. QC100.A2M44 2013 001.40218dc23 2013004340No part of this book may
8、be reproduced in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior written permission of the publisher.Publisher: William A. TonyAcquisitions Editor: Matt MeinholzProject Editor: Paul Daniel OMaraProduction Administrator: Randall BensonASQ Mis
9、sion: The American Society for Quality advances individual, organiza-tional, and community excellence worldwide through learning, quality improve-ment, and knowledge exchange.Attention Bookstores, Wholesalers, Schools, and Corporations: ASQ Quality Press books, video, audio, and software are availab
10、le at quantity discounts with bulk purchases for business, educational, or instructional use. For information, please contact ASQ Quality Press at 800-248-1946, or write to ASQ Quality Press, P.O. Box 3005, Milwaukee, WI 53201-3005.To place orders or to request a free copy of the ASQ Quality Press P
11、ublications Catalog, visit our website at http:/www.asq.org/quality-press.Printed on acid-free paperH1448_Mehta.indd 4 3/13/13 4:57 PMFirst, to my late father, who passed away when I was in college in India. He taught me to believe in myself, work hard, and stay determined in everything that I do. I
12、 kept these values with me when I came to the United States in 1986. Since then, I never looked back. You are the inspiration for my lifelong passion for learning and for sharing my knowledge with others. You were strict, but you nurtured love and support to make me what I am today. Thank you, Dad.T
13、o my wife Nina, for her love and support for over two decades. Your support while I wrote this book after working long hours as a consultant was invaluable to me.To my son Jay, for his love and support, including proofreading the manuscript for this book and sharing ideas as a young quality professi
14、onal.And to the American Society for Quality sections around the world and the members of the Orange Empire Section, to which I belong.H1448_Mehta.indd 5 3/13/13 4:57 PMviThe author has put forth his best effort in compiling the content of this book; however, no warranty with respect to the material
15、s accuracy or completeness is made. Additionally, no warranty is made in regard to applying the recommendations made in this book to any business structure or environment. The advice and recommendations provided within this book may not be suitable for all business structures or environments. Busine
16、sses should consult regulatory, quality, and/or legal professionals prior to deciding on the appropriate-ness of advice and recommendations made within this book. The author shall not be held liable for loss of profit or other commercial damages resulting from the employment of recom-mendations made
17、 within this book including special, inciden-tal, consequential, or other damages.Limit of Liability/Disclaimer of WarrantyH1448_Mehta.indd 6 3/13/13 4:57 PMviiContentsList of Figures and Tables xiiiPreface xvPArt I MAnAGeMent requIreMents . . . . . . . . . . . . . . . . . 1Chapter 1 Organization 3E
18、ffective Tools for Implementation and Compliance 5Questions to Consider During an Audit 7Chapter Review 7Chapter 2 Management system . 9Effective Tools for Implementation and Compliance 11Questions to Consider During an Audit 15Chapter Review 17Chapter 3 Document Control . 18Effective Tools for Impl
19、ementation and Compliance 20Questions to Consider During an Audit 25Chapter Review 26Chapter OneH1448_Mehta.indd 7 3/13/13 4:57 PMviii ContentsChapter 4 review of requests, tenders, and Contracts . 27Effective Tools for Implementation and Compliance 28Questions to Consider During an Audit 32Chapter
20、Review 33Chapter 5 subcontracting of tests and Calibrations . 34Effective Tools for Implementation and Compliance 35Questions to Consider During an Audit 39Chapter Review 39Chapter 6 Purchasing services and supplies 41Effective Tools for Implementation and Compliance 42Questions to Consider During a
21、n Audit 49Chapter Review 50Chapter 7 service to the Customer . 51Effective Tools for Implementation and Compliance 52Questions to Consider During an Audit 53Chapter Review 55Chapter 8 Complaints . 56Effective Tools for Implementation and Compliance 57Questions to Consider During an Audit 60Chapter R
22、eview 60H1448_Mehta.indd 8 3/13/13 4:57 PMContents ixChapter 9 Control of nonconforming testing and/or Calibration Work 62Effective Tools for Implementation and Compliance 63Questions to Consider During an Audit 66Chapter Review 67Chapter 10 Improvement . 68Effective Tools for Implementation and Com
23、pliance 69Questions to Consider During an Audit 71Chapter Review 71Chapter 11 Corrective Action 73Effective Tools for Implementation and Compliance 74Questions to Consider During an Audit 78Chapter Review 79Chapter 12 Preventive Action 80Effective Tools for Implementation and Compliance 81Questions
24、to Consider During an Audit 84Chapter Review 84Chapter 13 Control of records . 85Effective Tools for Implementation and Compliance 87Questions to Consider During an Audit 89Chapter Review 90H1448_Mehta.indd 9 3/13/13 4:57 PMx ContentsChapter 14 Internal Audits 92Effective Tools for Implementation an
25、d Compliance 93Questions to Consider During an Audit 98Chapter Review 99Chapter 15 Management reviews 100Effective Tools for Implementation and Compliance 102Questions to Consider During an Audit 106Chapter Review 107PArt II teChnICAL requIreMents . . . . 109Chapter 16 technical requirementsGeneral
26、111Effective Tools for Implementation and Compliance 112Questions to Consider During an Audit 113Chapter Review 113Chapter 17 Personnel . 114Effective Tools for Implementation and Compliance 116Questions to Consider During an Audit 118Chapter Review 120Chapter 18 Accommodation and environmental Cond
27、itions 122Effective Tools for Implementation and Compliance 123Questions to Consider During an Audit 126Chapter Review 127H1448_Mehta.indd 10 3/13/13 4:57 PMContents xiChapter 19 test and Calibration Methods and Method Validation . 128Effective Tools for Implementation and Compliance 133Questions to
28、 Consider During an Audit 138Chapter Review 139Chapter 20 equipment . 140Effective Tools for Implementation and Compliance 142Questions to Consider During an Audit 146Chapter Review 147Chapter 21 Measurement traceability . 149Effective Tools for Implementation and Compliance 152Questions to Consider
29、 During an Audit 156Chapter Review 156Chapter 22 sampling . 158Effective Tools for Implementation and Compliance 159Questions to Consider During an Audit 162Chapter Review 163Chapter 23 handling of test and Calibration Items 164Effective Tools for Implementation and Compliance 165Questions to Consid
30、er During an Audit 169Chapter Review 169H1448_Mehta.indd 11 3/13/13 4:57 PMxii ContentsChapter 24 Assuring the quality of test and Calibration results . 171Effective Tools for Implementation and Compliance 173Questions to Consider During an Audit 180Chapter Review 180Chapter 25 reporting the results
31、 182Effective Tools for Implementation and Compliance 187Questions to Consider During an Audit 189Chapter Review 191Epilogue . 193 Bibliography 195 Index 199H1448_Mehta.indd 12 3/13/13 4:57 PMxiiiList of Figures and TablesFigure 1 .1 Typical laboratory organizational chart . 6table 2 .1 Sample requi
32、rements matrix 12Figure 2 .1 Metal Test Incorporated quality policy statement . 14Figure 3 .1 ECR form . 23Figure 3 .2 Document status stamp 25Figure 5 .1 Sample questionnaire 36table 6 .1 Typical use of supplier categories 43Figure 6 .1 Example of an ISO 9001/13485style questionnaire 44Figure 6 .2
33、Example of a SCAR . 47Figure 6 .3 Example of a purchase order 48Figure 7 .1 Customer satisfaction survey 54Figure 8 .1 Four-step closed-loop process . 57Figure 8 .2 Sample complaint form 59Figure 9 .1 Example of an NCR tag 64Figure 9 .2 Example of an NCR form 65Figure 11 .1 Example of a CAPA form 76
34、Figure 11 .2 Example of CAPA log sheet 77table 12 .1 FMEA example 82table 13 .1 Sample document matrix for a laboratory . 88H1448_Mehta.indd 13 3/13/13 4:57 PMxiv List of Figures and TablesFigure 14 .1 Example of an internal auditing schedule 94Figure 14 .2 Example of an internal audit checklist 96F
35、igure 15 .1 Example of a management review agenda . 104Figure 17 .1 Sample training matrix . 117Figure 17 .2 Example of an ISO/IEC-compliant job description 119Figure 20 .1 Traceability block diagram . 143Figure 20 .2 Sample label . 144Figure 21 .1 The seven baseline SI units . 153table 22 .1 Zero A
36、cceptance Number Sampling Plan . 161Figure 23 .1 Example of an electronic calibration system menu . 167Figure 24 .1 Example of a NIST CRM certificate 175Figure 24 .2 Example of a Sigma-Aldrich traceability certification 176Figure 25 .1 Example of a test report 188Figure 25 .2 Example of a calibratio
37、n certificate . 189H1448_Mehta.indd 14 3/13/13 4:57 PMxvPrefaceThe purpose of this book is to demystify the requirements delineated within ISO/IEC 17025:2005 while provid-ing a road map for organizations that wish to receive accreditation for their laboratories. AS9100, ISO 9001, and ISO 13485 are s
38、tandards that support the development and implementation of effective approaches to quality manage-ment and are recognized blueprints for the establishment of a quality management system (QMS) for diverse industries. Although similar to these recognized QMS standards, ISO/IEC 17025 serves a unique p
39、urpose: laboratory accreditation. It is not unusual for laboratories to retain dual certification in ISO 9001 and ISO/IEC 17025. However, ISO/IEC 17025 con-tains requirements specific to the laboratory environment not addressed by ISO 9001. This book highlights the differences between ISO 9001 and I
40、SO/IEC 17025 while providing the practical insight and tools needed for laboratories wishing to achieve or sustain ISO/IEC 17025 accreditation.ACknOWLEDgmEnTSI have worked for organizations that design, develop, and man-ufacture products regulated by the FDA and global regulatory agencies. While I w
41、as working in analytical and quality control H1448_Mehta.indd 15 3/13/13 4:57 PMxvi Prefacelabs, it became apparent that reliable and properly calibrated equipment was critical to consistently generate accurate data for identity, strength, purity, and efficacy of products. I was inspired to write th
42、is book when providing services as a con-sultant to my pharmaceutical, biotechnology, medical device, active pharmaceutical ingredient, dietary supplement, food, and aerospace clients. I would like to acknowledge Orest Ole-jnik (Allergan), Gary Swanson (Herbalife), and Lance Harding (Herbalife) for
43、inspiring me to gain the knowledge to create this book. I would also like to acknowledge my direct reports, colleagues, supervisors, professors, students, relatives, and friends for their support, and the staff at ASQ Quality Press and Kinetic Publishing Services.H1448_Mehta.indd 16 3/13/13 4:57 PMP
44、Art IManagement requirementsH1448_Mehta.indd 1 3/13/13 4:57 PMH1448_Mehta.indd 2 3/13/13 4:57 PM31OrganizationClause 4.1 of ISO/IEC 17025:2005 identifies the salient requirements for establishing an effective organiza-tion. If an organization is seeking accreditation to ISO/IEC 17025 and an approved
45、 ISO 9001:2008 quality manage-ment system (QMS) has already been certified by a recog-nized registrar, then the chances are good that an acceptable organizational infrastructure has already been established. The legal entity of the laboratory and its relationship to a parent organization or subsidia
46、ries must be clearly identified. Addi-tionally, the laboratorys management system, policies, proce-dures, organizational structure, personnel responsibilities and interrelationships, key management personnel, and methods of communication must be defined and developed in the context of complying with
47、 ISO/IEC 17025. Furthermore, the primary task of a laboratory is to perform testing and calibration activi-ties in accordance with ISO/IEC 17025. Finally, arguably the most important point for a laboratory is the ability to meet and hopefully exceed the expectations of its customers, including meeti
48、ng all applicable regulatory and statutory requirements. This initial chapter will examine the requirements and the steps necessary for a laboratory to comply with clause 4.1 of ISO/IEC 17025:2005Organization.Chapter OneH1448_Mehta.indd 3 3/13/13 4:57 PM4 Chapter OneSummary of ISO/IEC 17025:2005 Req
49、uirement 4.1 (Organization) An organization is classified as a stand-alone laboratory or the legal entity that is legally responsible for the laboratory. The laboratory performing testing and calibration must do so in accordance with ISO/IEC 17025:2005 and applicable regulatory and statutory requirements. Meeting customer requirements is a fundamental expectation. When laboratories are part of organizations that perform more than just testing and calibration, responsibilities of key personnel must be cle
