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Implementing the requirements of ISO 9001 can be a daunting task for many organizations. In an attempt to develop a system that will pass the registration audit, we are tempted to establish processes with the primary purpose of conforming to the requirements of ISO 9001. In doing so, however, it is easy to lose sight of the primary intent of the standard: to continually improve the effectiveness of the quality management system (QMS) implemented at our organization.
This book is intended to help managers, quality professionals, internal audit coordinators, and internal auditors implement a practical internal audit process that meets the requirements of ISO 9001:2015 while adding significant, measurable value to the organization. The tools, techniques, and step-by-step guidelines provided in this book can also be used by those organizations that have a well-established internal audit process but are looking for easy ways to make that process more effective.
This book is intended to help managers, quality professionals, internal audit coordinators, and internal auditors implement a practical internal audit process that meets the requirements of ISO 9001:2015 while adding significant, measurable value to the organization. The tools, techniques, and step-by-step guidelines provided in this book can also be used by those organizations that have a well-established internal audit process but are looking for easy ways to make that process more effective.
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| Publié par | ASQ Quality Press |
| Date de parution | 21 septembre 2015 |
| Nombre de lectures | 0 |
| EAN13 | 9781951058951 |
| Langue | English |
| Poids de l'ouvrage | 2 Mo |
Informations légales : prix de location à la page 0,3000€. Cette information est donnée uniquement à titre indicatif conformément à la législation en vigueur.
Extrait
ISO 9001:2015 INTeRNal AUDîTs MaDe EasY
Aso avaîabe from ASQ Quaîty Press:
ASQ/ANSI/ISO 9001:2015: Qualîty management systems—Requîrements ASQ/ANSI/ISO 9000:2015: Qualîty management systems—Fundamentals and vocabulary ASQ/ANSI/ISO 14001:2015: Envîronmental management systems— Requîrements wîth guîdance for use
ISO 9001:2015 Explaîned, Fourth Edîtîon Chares A. Cîanfranî and John E. (Jack) West ISO Lesson Guîde 2015, Fourth Edîtîon J.P. Russe and Dennîs R. Arter How to Establîsh a Document Control System for Complîance wîth ISO 9001:2015, ISO 13485:2016, and FDA Requîrements Stephanîe L. Skîpper ISO 9001:2015 for Small and Medîum Sîzed Busînesses, Thîrd Edîtîon Denîse E. Robîtaîe
Process Drîven Comprehensîve Audîtîng, Thîrd Edîtîon: A New Way to Conduct ISO 9001:2015 Internal Audîts, Thîrd Edîtîon Pau C. Pames
Usîng ISO 9001 în Healthcare, Second Edîtîon: Applîcatîons for Qualîty Systems, Performance Improvement, Clînîcal Integratîon, Accredîtatîon, and Patîent Safety James M. Levett, MD and Robert G. Burney, MD
The ASQ Audîtîng Handbook, Fourth Edîtîon J.P. Russe, edîtor The Qualîty Toolbox, Second Edîtîon Nancy R. Tague The Certîied Manager of Qualîty/Organîzatîonal Excellence Handbook, Fourth Edîtîon Russe T. Westcott, edîtor
To request a compîmentary cataog of ASQ Quaîty Press pubîcatîons, ca 800-248-1946, or vîsît our Web sîte at http://www.asq.org/quaîty-press.
ISO 9001:2015 INTeRNal AUDîTs MaDe EasY
Toos, Technîques, and Step-by-Step Guîdeînes for Successfu Interna Audîts
Fourth Edîtîon
Ann W. Phîîps
ASQ Quaîty Press Mîwaukee, Wîsconsîn
Amerîcan Socîety for Quaîty, Quaîty Press, Mîwaukee 53203 © 2015 by ASQ A rîghts reserved. Prînted în the Unîted States of Amerîca 20 19 18 17 16 15 5 4 3 2 1 Library of Congress CataloginginPublication Data Phîîps, Ann W., author. ISO 9001:2015 înterna audîts made easy : toos, technîques, and step-by-step guîdeînes for successfu înterna audîts / Ann W. Phîîps. — Fourth edîtîon. pages cm Incudes îndex. ISBN 978-0-87389-902-4 (ak. paper) 1. Quaîty contro—Standards. 2. Audîtîng, Interna. 3. ISO 9001 Standard. I. Tîte. TS156.P475 2016 657′.458—dc23 2015033096 No part of thîs book may be reproduced în any form or by any means, eectronîc, mechanîca, photocopyîng, recordîng, or otherwîse, wîthout the prîor wrîtten permîssîon of the pubîsher. Pubîsher: Lynee Korte Acquîsîtîons Edîtor: Matt Meînhoz Managîng Edîtor: Pau Danîe O’Mara Productîon Admînîstrator: Randa Benson ASQ Mîssîon: The Amerîcan Socîety for Quaîty advances îndîvîdua, organîza-tîona, and communîty exceence wordwîde through earnîng, quaîty împrove-ment, and knowedge exchange. Attentîon Bookstores, Whoesaers, Schoos, and Corporatîons: ASQ Quaîty Press books, vîdeo, audîo, and software are avaîabe at quantîty dîscounts wîth buk purchases for busîness, educatîona, or înstructîona use. For înformatîon, pease contact ASQ Quaîty Press at 800-248-1946, or wrîte to ASQ Quaîty Press, P.O. Box 3005, Mîwaukee, WI 53201–3005. To pace orders or to request a free copy of the ASQ Quaîty Press Pubîcatîons Cataog, vîsît our websîte at http://www.asq.org/quaîty-press.
Prînted on acîd-free paper
CoNTeNTs
List of Figures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Chapter 1 Introduction to Internal Auditing for ISO 9001:2015. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Introductîon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Purpose of the Interna Audît . . . . . . . . . . . . . . . . . . . . . . . . . . . Objectîves of the Interna Audît . . . . . . . . . . . . . . . . . . . . . . . . . Beneits of an Effectîve Interna Audît Process . . . . . . . . . . . .
Chapter 2 Creating an Environment for Successful Audits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Gaînîng Management’s Support for the Audît Process . . . . . Gaînîng Empoyees’ Support for the Audît Process . . . . . . . . After the Audît . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Chapter 3 Selecting and Maintaining the Internal Audit Team. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Is Your Audît Poo Adequatey Staffed? . . . . . . . . . . . . . . . . . . WhîchJobFunctîonsShoudBeRepresentedîntheAudît Poo? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . What Persona Attrîbutes Make Good Interna Audîtors? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . How Can an Organîzatîon Maîntaîn the Audît Poo? . . . . . .
Chapter 4 Typical Responsibilities and Authorities in the Audit Process. . . . . . . . . . . . . . . . . . . . . . . . . . . Quaîty Manager/Audît Coordînator . . . . . . . . . . . . . . . . . . . . Audîtee’s Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Audîtors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
V
vii ix
1 1 2 3 4
7 7 12 14
19 19
20
20 22
25 25 31 34
Vî Contents
Chapter 5 Audit Preparation. . . . . . . . . . . . . . . . . . . . . . . . . . . . .Step 1: Deine and Understand the Scope of the Audît . . . . . Step 2: Revîew Appîcabe Standards . . . . . . . . . . . . . . . . . . . . Step 3: Prepare a Process Mode . . . . . . . . . . . . . . . . . . . . . . . . . Step 4: Revîew Appîcabe Documentatîon . . . . . . . . . . . . . . . Step 5: Revîew Prevîous Audît Resuts . . . . . . . . . . . . . . . . . . . Step 6: Create an Effectîve Checkîst . . . . . . . . . . . . . . . . . . . . . Step 7: Conduct a Pre-Audît Meetîng . . . . . . . . . . . . . . . . . . . . Summary of Audît Preparatîon . . . . . . . . . . . . . . . . . . . . . . . . .
Chapter 6 Performing the Audit. . . . . . . . . . . . . . . . . . . . . . . . . .The “Group” Openîng Meetîng . . . . . . . . . . . . . . . . . . . . . . . . . The “Indîvîdua” Openîng Meetîng . . . . . . . . . . . . . . . . . . . . . Intervîew Technîques . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Basîc Communîcatîon Skîs . . . . . . . . . . . . . . . . . . . . . . . . . . . . Keys to Lîstenîng . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Effectîve Use of the Checkîst . . . . . . . . . . . . . . . . . . . . . . . . . . . Sampîng Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Handîng Dîficut Audîtees . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Chapter 7 Reporting the Audit. . . . . . . . . . . . . . . . . . . . . . . . . . .Types of Audît Fîndîngs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Wrîtîng Effectîve CARs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The Audît Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The Cosîng Meetîng . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Summary of Audît Reportîng . . . . . . . . . . . . . . . . . . . . . . . . . . .
Chapter 8 FollowUp Audit Activities . . . . . . . . . . . . . . . . . . . .Summary of Effectîve Interna Audîtîng . . . . . . . . . . . . . . . . . .
Appendix A
Appendix B
Appendix C
Appendix D
Process Models for Common Processes . . . . . . .
Checklists for Common Processes. . . . . . . . . . . .
Equipment Maintenance Case Study. . . . . . . . .
Internal Audit Forms. . . . . . . . . . . . . . . . . . . . . . . .
About the Author. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
39 40 40 41 47 50 50 59 60
63 63 64 66 67 69 72 75 76
81 81 83 85 86 86
87 90
9
3
109
143
153
159 161
Figure A.1 Figure A.2 Figure A.3 Figure A.4 Figure A.5 Figure A.6 Figure A.7 Figure A.8 Figure A.9
Figure A.10 Figure A.11 Figure A.12
Figure A.13 Figure A.14 Figure B.1 Figure B.2
Figure B.3
Figure B.4 Figure B.5
Figure B.6
Figure B.7
Figure B.8 Figure B.9
Figure B.10
LîsT of FîgURes
Acme process map . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94 Caîbratîon process mode . . . . . . . . . . . . . . . . . . . . . . . 95 Correctîve actîon process mode . . . . . . . . . . . . . . . . . 96 Customer satîsfactîon process mode . . . . . . . . . . . . . 97 Interna audît process mode . . . . . . . . . . . . . . . . . . . . 98 Management revîew process mode . . . . . . . . . . . . . . 99 Maîntenance process mode . . . . . . . . . . . . . . . . . . . . . 100 Productîon process mode . . . . . . . . . . . . . . . . . . . . . . . 101 Product desîgn and deveopment process mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102 Purchasîng process mode . . . . . . . . . . . . . . . . . . . . . . . 103 Reease of products and servîces process mode . . . . 104 Requîrements for products and servîces process mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105 Rîsk assessment and mîtîgatîon process mode . . . . . 106 Shîppîng process mode . . . . . . . . . . . . . . . . . . . . . . . . . 107 A processes checkîst . . . . . . . . . . . . . . . . . . . . . . . . . . 110 Desîgn and deveopment of products and servîces checkîst . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116 Contro of externay provîded products and servîces checkîst . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119 Maîntenance checkîst . . . . . . . . . . . . . . . . . . . . . . . . . . 121 Monîtorîng and measurement processes checkîst . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122 Pannîng and contro; deinîtîon of requîrements for products and servîces checkîst . . . . . . . . . . . . . . . 124 Product or servîce provîsîon; contro of nonconformîng product checkîst . . . . . . . . . . . . . . . . 126 Quaîty management checkîst . . . . . . . . . . . . . . . . . . . 130 Reease of products and servîces; contro of nonconformîng outputs checkîst . . . . . . . . . . . . . . . . 138 Senîor eadershîp checkîst . . . . . . . . . . . . . . . . . . . . . . 140
Vîî
Vîîî List of Figures
Figure C.1 Figure C.2 Figure D.1 Figure D.2 Figure D.3 Figure D.4
Acme equîpment maîntenance procedure . . . . . . . . . Acme maîntenance audît checkîst . . . . . . . . . . . . . . . . Audît summary report form . . . . . . . . . . . . . . . . . . . . . Audît actîon îtem îst . . . . . . . . . . . . . . . . . . . . . . . . . . . Correctîve actîon og . . . . . . . . . . . . . . . . . . . . . . . . . . . . Correctîve actîon request . . . . . . . . . . . . . . . . . . . . . . . .
144 146 154 155 156 157
PReface
mpementîng the requîrements of ISO 9001 can be a dauntîng task for many organîzatîons. In an attempt to deveop a system that wî pass I the regîstratîon audît, we are tempted to estabîsh processes wîth the prîmary purpose of conformîng to the requîrements of ISO 9001. In doîng so, however, ît îs easy to ose sîght of the prîmary întent of the standard—to contînuay împrove the effectîveness of the quaîty management system (QMS) împemented at our organîzatîon. Thîs book îs întended to hep managers, quaîty professîonas, înterna audît coordînators, and înterna audîtors împement a practîca înterna audît process that meets the requîrements of ISO 9001:2015 whîe addîng sîgnîicant, measurabe vaue to the organîzatîon. The toos, technîques, and step-by-step guîdeînes provîded în thîs book can aso be used by those organîzatîons that have a we-estabîshed înterna audît process but are ookîng for easy ways to make that process more effectîve. The toos în the appendîces of thîs book have aso been provîded on the encosed CD to facîîtate your customîzîng them to it the specîic needs of your organîzatîon. Perhaps the greatest împedîment to a truy effectîve înterna audît pro-cess îs the notîon that înterna audîts shoud mîmîc the externa audît. We send our înterna audîtors to ead assessor traînîng to earn how to conduct audîts. We then use the externa audîtors as roe modes wîth respect to preparîng for the audît, conductîng the audît, and reportîng the audît. The externa audîtors are, as a rue, extremey professîona and quîte capabe of achîevîng theîr desîred resut. But we faî to apprecîate the sîgnîicant dîfference în the purpose of înterna versus externa audîts and thus faî to achîeve the huge beneits that can be derîved from the înterna audît process. ISO 9001:2015 requîres that eadershîp întegrate QMS requîrements înto busîness processes (ref. 5.1.1.c), promote împrovement (ref. 5.1.1.î), and dîrect the organîzatîon to contrîbute to the effectîveness of the QMS (ref. 5.1.1.h). These requîrements suggest the need for an înterna audît process that îdentîies opportunîtîes to împrove the organîzatîon’s abîîty
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