How to Audit ISO 9001:2015

Chad Kymal

Description

ISO 9001:2015 includes many changes that not only affect the companies aiming to achieve certification to it, but also auditors. This book is the resource auditors need to fully understand ISO 9001:2015 and help them perform audits to it.
This book integrates two different types of audit strategies, conformance audits and performance audits, into one process approach audit. Conformance audits confirm that the organization is meeting the requirements of the standard, while performance audits confirm that the QMS is achieving its intended results.
The book includes:
An introduction to ISO 9001:2015
An auditing strategy for ISO 9001:2015
How to conduct a Stage 1 audit for ISO 9001:2015
How to conduct a Stage 2 on-site audit for ISO 9001:2015
Appendices include an introduction to process focus, an assessment report template for Stage 1 audits, a confidential assessment report template for Stage 2 audits, and an example of the format for an ISO 9001:2015 conformance checklist.

Sujets

• Business
• Qualité, hygiène, sécurité, environnement
• Auditing
• Economie gestion
• ISO 9000
• International Organization for Standardization
• Economics
• QMS
• ISO 9001

Informations

• Publié par: ASQ Quality Press
• Date de parution: 04 avril 2016
• Nombre de lectures: 0
• EAN13: 9781953079534
• Langue: English
• Poids de l'ouvrage: 3 Mo

Extrait

How to Audit
ISO 9001:2015Also available from ASQ Quality Press:
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The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices,
Second Edition
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The Biomedical Quality Auditor Handbook, Second Edition
Biomedical Division and Bruce Haggar, editor
The ASQ Auditing Handbook, Fourth Edition
J.P. Russell, editor
To request a complimentary catalog of ASQ Quality Press publications, call 800-248-1946,
or visit our website at http://www.asq.org/quality-press.How to Audit
ISO 9001:2015
A Handbook for Auditors
Chad Kymal
ASQ Quality Press
Milwaukee, WisconsinAmerican Society for Quality, Quality Press, Milwaukee 53203
© 2016 by ASQ
All rights reserved. Published 2016
Printed in the United States of America
22 21 20 19 18 17 16 5 4 3 2 1
Library of Congress Cataloging-in-Publication Data
Names: Kymal, Chad, author.
Title: How to audit ISO 9001:2015 : a handbook for auditors / Chad Kymal.
Description: Milwaukee, Wisconsin : ASQ Quality Press, 2016. | Includes index.
Identifiers: LCCN 2016005431 | ISBN 9780873899277 (soft cover : alk. paper)
Subjects: LCSH: ISO 9000 Series Standards. | Quality control—Auditing. |
Quality assurance—Standards—United States.
Classification: LCC TS156 .K958 2016 | DDC 658.5/620218—dc23
LC record available at http://lccn.loc.gov/2016005431
ISBN 978-0-87389-927-7
No part of this book may be reproduced in any form or by any means, electronic, mechanical, photocopying,
recording, or otherwise, without the prior written permission of the publisher.
Publisher: Seiche Sanders
Acquisitions Editor: Matt T. Meinholz
Managing Editor: Paul Daniel O’Mara
Production Administrator: Randall Benson
ASQ Mission: The American Society for Quality advances individual, organizational, and community
excellence worldwide through learning, quality improvement, and knowledge exchange.
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http://www.asq.org/quality-press.
Printed on acid-free paper 
 
 
Table of Contents
List of Figures and Tables                                                    ix
Preface                                                                   xiii
Chapter 1 Introduction to ISO 9001:2015                                    1
History of the ISO 9001 Standards ......................................... 1
The Quality Management System and Its Processes ............................ 2
QMS Structure and Model ............................................ 2
QMS Processes ..................................................... 3
Requirements of ISO 9001:2015—Becoming Process Focused ................... 4
Context, Interested Party Expectations, and Objectives.......................... 6
Planning and Risk/Opportunities........................................... 7
Understanding Risk ................................................. 7
Use of Risk and Opportunities in ISO 9001:2015 .......................... 8
ISO 9001:2015 Requirements for Risk....................................... 9
QMS Processes and Planning (Clauses 4.4.1 and 6.1) ....................... 9
QMS Processes and Planning Risk (Reference Clauses 4.1 and 6.1) ............ 9
Product and Process Risk and Opportunities (Reference Clause 5.1.2) .......... 9
Summary of ISO 9001:2015 Requirements for Risks and Opportunities
and Risk-Based Thinking............................................... 10
Risk-Based Thinking .................................................... 11
What the Standard Does Not Require 11
What Organizations Need to Do and Auditors Need to Do in Regard to Risk
and Risk-Based Thinking 12
ISO 9001:2015 and the High Level Structure (HLS)............................ 12
Changes to ISO 9001:2015................................................ 14
ISO 9001:2015, Annex A ............................................. 16
v 
 
 
vi Table of Contents
Chapter 2 Auditing Strategy for ISO 9001:2015                               17
Conformance and Performance Audits ...................................... 17
Stage 1 Audit—Document Review or a Documented Information Review and
Audit Planning ....................................................... 17
Stage 2 Audit—Conducting the Audit ....................................... 18
Audit Trails for ISO 9001:2015—Audit Approach ............................. 22
Overall QMS Performance ............................................ 31
Process Performance ................................................. 31
Conducting a Process Performance Audit .................................... 31
Completing the Process Analysis Worksheet .............................. 31
Chapter 3 Conducting the Stage 1 Audit for ISO 9001:2015                     35
Documented Information Review .......................................... 36
Process Approach....................................................... 37
Sequence and Interaction of the Processes ................................... 37
Process Linkages or Process Interfaces ...................................... 39
Clause- or Function-Based Process Maps .................................... 40
A. Documented Information Review ........................................ 41
Process Documentation ............................................... 42
B. Performance Analysis ................................................. 44
Customer Scorecards................................................. 44
Customer Complaints and Problem-Solving Efforts ......................... 46
Intended Results and Customer Satisfaction ............................... 46
Evaluate Internal Audits and System Audit Results ......................... 46
Process Approach versus Clause or Elemental Approach..................... 47
QMS Performance................................................... 47
Measuring Key Indicators and Performance Trends ......................... 49
Identify Suspect Processes ............................................ 50
C. Create an Audit Plan .................................................. 51
D. Determine the Audit Feasibility ......................................... 53
E. Prepare and Deliver the Stage 1 Audit Report .............................. 54
F. Update Process Analysis Worksheet or Audit Checklist ....................... 54
Chapter 4 Stage 2: On-Site Audit                                           57
Audit Procedure ........................................................ 57
A. Conduct Audit of Remote Supporting Functions ......................... 59
B. Opening Meeting ................................................. 59
C. Conducting the Audit .............................................. 60
C.1 Conduct Facility Tour, If Needed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
C.2 Study Customer and Organizational Performance ....................... 67
C.3 Meeting with Top Management ..................................... 67
C.4 Audit Organizational Processes 68
C.5 Verify That All Processes and Clauses Are Audited ..................... 69 
 
 
 
 
Table of Contents vii
D. Write Up Nonconformities .......................................... 69
E. Closing Meeting .................................................. 73
E.1 Determine Audit Team Recommendations ............................. 73
E.2 Prepare the Draft Report 73
E.3 Conduct the Closing Meeting ....................................... 74
F. Audit Report ..................................................... 74
G. Corrective Action and Closeouts ..................................... 76
G.1 Evaluate Root Cause Analysis and Systemic Corrective Action ............ 78
G.2 Complete a Follow-Up Audit as Needed .............................. 80
Conclusion ............................................................ 81
Appendix A Introduction to Process Focus                                   83
Appendix B Assessment Report for Stage 1 91
Appendix C Confidential Assessment Report for Stage 2                       113
Appendix D ISO 9001:2015 Conformance Checklist                           135
Index                                                                    137List of Figures and Tables
Figure P.1 Evolution of quality. .................................................. xiii
Figure 1.1 Quality management system. ........................................... 2
Figure 1.2 Plan–do–check–act cycle in ISO 9001:2015. ............................... 3
Figure 1.3 Schematic representation of the elements of a single process. .................. 4
Figure 1.4 Process map showing sequence a