Table Of ContentImplementing
ISO/IEC 17025:2017
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Implementing
ISO/IEC 17025:2017
Second Edition
Bob Mehta
ASQ Quality Press
Milwaukee, Wisconsin
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American Society for Quality, Quality Press, Milwaukee 53203
© 2019 by ASQ. Printed in 2019.
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Library of Congress Cataloging- in- Publication Data
Names: Mehta, Bob, 1961– author.
Title: Implementing ISO/IEC 17025:2017 / Bob Mehta.
Other titles: ISO/IEC 17025:2017
Description: 2nd edition. | Milwaukee, Wisconsin : ASQ Quality Press, [2019] |
Includes bibliographical references and index.
Identifiers: LCCN 2018051137 | ISBN 9780873899802 (hardcover : alk. paper)
Subjects: LCSH: Laboratories— Accreditation— Standards. | Laboratories— Standards.
Classification: LCC QC100.A2 M44 2019 | DDC 001.402/18— dc23
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Table of Contents
List of Figures and T ables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xi
Acknowl edgments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiii
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xv
Chapter 1 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Chapter 2 Normative References . . . . . . . . . . . . . . . . . . . . . . . 3
Chapter 3 Terms and Definitions . . . . . . . . . . . . . . . . . . . . . . . 5
Chapter 4 General Requirements . . . . . . . . . . . . . . . . . . . . . . 7
Introduction.......................................... 7
Effective Tools for Implementation and Compliance.......... 8
Questions to Consider during an Audit..................... 9
Chapter Review....................................... 9
Chapter 5 Structural Requirements . . . . . . . . . . . . . . . . . . . . 11
Introduction.......................................... 11
Effective Tools for Implementation and Compliance.......... 13
Questions to Consider during an Audit..................... 14
Chapter Review....................................... 15
Chapter 6 .1 Resource Requirements: General . . . . . . . . . . . . . 17
Introduction.......................................... 17
Effective Tools for Implementation and Compliance.......... 18
Questions to Consider during an Audit..................... 18
Chapter Review....................................... 19
Chapter 6 .2 Personnel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Introduction.......................................... 21
Effective Tools for Implementation and Compliance.......... 21
Questions to Consider during an Audit..................... 25
Chapter Review....................................... 26
v
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vvii T Taabbllee ooff CCoonntteennttss
Chapter 6 .3 Facilities and Environmental Conditions . . . . . . . 27
Introduction.......................................... 27
Effective Tools for Implementation and Compliance.......... 27
Questions to Consider during an Audit..................... 30
Chapter Review....................................... 31
Chapter 6 .4 Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Introduction.......................................... 33
Effective Tools for Implementation and Compliance.......... 35
Nonconforming Equipment.............................. 37
Test Uncertainty Ratio/Test Accuracy Ratio 10:1............. 38
Use of Correction F actors............................... 39
Questions to Consider during an Audit..................... 39
Chapter Review....................................... 40
Chapter 6 .5 Metrological Traceability . . . . . . . . . . . . . . . . . . . . 41
Introduction.......................................... 41
Effective Tools for Implementation and Compliance.......... 41
Questions to Consider during an Audit..................... 47
Chapter Review....................................... 47
Chapter 6 .6 Externally Provided Products and Ser vices . . . . . 49
Introduction.......................................... 49
Effective Tools for Implementation and Compliance.......... 49
Questions to Consider during an Audit..................... 54
Chapter Review....................................... 54
Chapter 7 .1 Review of Requests, Tenders, and Contracts . . . . 55
Introduction.......................................... 55
Effective Tools for Implementation and Compliance.......... 56
Questions to Consider during an Audit..................... 59
Chapter Review....................................... 59
Chapter 7 .2 Se lection, Verification, and Validation of Methods . . 61
Introduction.......................................... 61
Effective Tools for Implementation and Compliance.......... 61
Questions to Consider during an Audit..................... 67
Chapter Review....................................... 68
Chapter 7 .3 Sampling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Introduction.......................................... 69
Effective Tools for Implementation and Compliance.......... 69
Questions to Consider during an Audit..................... 73
Chapter Review....................................... 73
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Table of Contents vii
Chapter 7 .4 Handling of Test and Calibration Items . . . . . . . . 75
Introduction.......................................... 75
Effective Tools for Implementation and Compliance.......... 75
Questions to Consider during an Audit..................... 78
Chapter Review....................................... 79
Chapter 7 .5 Technical Rec ords . . . . . . . . . . . . . . . . . . . . . . . . . . 81
Introduction.......................................... 81
Effective Tools for Implementation and Compliance.......... 82
Questions to Consider during an Audit..................... 83
Chapter Review....................................... 83
Chapter 7 .6 Evaluation of Mea surem ent Uncertainty . . . . . . . 85
Introduction.......................................... 85
Effective Tools for Implementation and Compliance.......... 85
Questions to Consider during an Audit..................... 86
Chapter Review....................................... 87
Chapter 7 .7 Assuring the Validity of Results . . . . . . . . . . . . . . . 89
Introduction.......................................... 89
Effective Tools for Implementation and Compliance.......... 89
Questions to Consider during an Audit..................... 96
Chapter Review....................................... 96
Chapter 7 .8 Reporting the Results . . . . . . . . . . . . . . . . . . . . . . . 99
Introduction.......................................... 99
Effective Tools for Implementation and Compliance.......... 99
Questions to Consider during an Audit..................... 104
Chapter Review....................................... 105
Chapter 7 .9 Complaints . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
Introduction.......................................... 107
Effective Tools for Implementation and Compliance.......... 107
Questions to Consider during an Audit..................... 111
Chapter Review....................................... 111
Chapter 7 .10 Nonconforming Work . . . . . . . . . . . . . . . . . . . . . . . 113
Introduction.......................................... 113
Effective Tools for Implementation and
Compliance........................................ 113
Questions to Consider during an Audit..................... 115
Chapter Review....................................... 117
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viii Table of Contents
Chapter 7 .11 Control of Data and Information Management . . . 119
Introduction.......................................... 119
Effective Tools for Implementation and Compliance.......... 119
Questions to Consider during an Audit..................... 121
Chapter Review....................................... 121
Chapter 8 .1 Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123
Introduction.......................................... 123
Effective Tools for Implementation and Compliance.......... 123
Questions to Consider during an Audit..................... 124
Chapter Review....................................... 125
Chapter 8 .2 M anagement System Documentation
(Option A) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127
Introduction.......................................... 127
Effective Tools for Implementation and Compliance.......... 128
Questions to Consider during an Audit..................... 130
Chapter Review....................................... 131
Chapter 8 .3 Control of Management System Documents
(Option A) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133
Introduction.......................................... 133
Effective Tools for Implementation and Compliance.......... 133
Questions to Consider during an Audit..................... 139
Chapter Review....................................... 140
Chapter 8 .4 Control of Rec ords (Option A) . . . . . . . . . . . . . . . . 141
Introduction.......................................... 141
Effective Tools for Implementation and Compliance.......... 142
Questions to Consider during an Audit..................... 145
Chapter Review....................................... 146
Chapter 8 .5 Actions to Address Risks and Opportunities
(Option A) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147
Introduction.......................................... 147
Effective Tools for Implementation and Compliance.......... 147
Questions to Consider during an Audit..................... 151
Chapter Review....................................... 151
Chapter 8 .6 Improvement (Option A) . . . . . . . . . . . . . . . . . . . . . 153
Introduction.......................................... 153
Effective Tools for Implementation and Compliance.......... 153
Questions to Consider during an Audit..................... 156
Chapter Review....................................... 156
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Table of Contents ix
Chapter 8 .7 Corrective Actions (Option A) . . . . . . . . . . . . . . . . 157
Introduction.......................................... 157
Effective Tools for Implementation and Compliance.......... 157
Questions to Consider during an Audit..................... 162
Chapter Review....................................... 162
Chapter 8 .8 Internal Audits (Option A) . . . . . . . . . . . . . . . . . . . 165
Introduction.......................................... 165
Effective Tools for Implementation and Compliance.......... 165
Questions to Consider during an Audit..................... 171
Chapter Review....................................... 171
Chapter 8 .9 Management Reviews (Option A) . . . . . . . . . . . . . . 173
Introduction.......................................... 173
Effective Tools for Implementation and Compliance.......... 173
Questions to Consider during an Audit..................... 178
Chapter Review....................................... 179
Epilogue . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 181
Appendix: Changes between the 2005 and 2017 Versions of
the Standard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 183
Bibliography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 187
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 191
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