ISO 13485: 2016: A Complete Guide to Quality Management in the Medical Device Industry, Second

893 Pages·2018·105.67 MB·English

by  Itay Abuhav

ISO 13485:2016
A Complete Guide to
Quality Management in the
Medical Device Industry
Second Edition
ISO 13485:2016
A Complete Guide to
Quality Management in the
Medical Device Industry
Second Edition
Itay Abuhav
CRC Press
Taylor & Francis Group
6000 Broken Sound Parkway NW, Suite 300
Boca Raton, FL 33487-2742
© 2018 by Taylor & Francis Group, LLC
CRC Press is an imprint of Taylor & Francis Group, an Informa business
No claim to original U.S. Government works
Printed on acid-free paper
International Standard Book Number-13: 978-1-138-03917-9 (Hardback)
This book contains information obtained from authentic and highly regarded sources. Reasonable
efforts have been made to publish reliable data and information, but the author and publisher c annot
assume responsibility for the validity of all materials or the consequences of their use. The authors
and publishers have attempted to trace the copyright holders of all material reproduced in this publi-
cation and apologize to copyright holders if permission to publish in this form has not been obtained.
If any copyright material has not been acknowledged please write and let us know so we may rectify
in any future reprint.
Except as permitted under U.S. Copyright Law, no part of this book may be reprinted, repro-
duced, transmitted, or utilized in any form by any electronic, mechanical, or other means, now
known or hereafter invented, including photocopying, microfilming, and recording, or in any
information storage or retrieval system, without written permission from the publishers.
For permission to photocopy or use material electronically from this work, please access www.
copyright.com (http://www.copyright.com/) or contact the Copyright Clearance Center, Inc.
(CCC), 222 Rosewood Drive, Danvers, MA 01923, 978-750-8400. CCC is a not-for-profit organi-
zation that provides licenses and registration for a variety of users. For organizations that have
been granted a photocopy license by the CCC, a separate system of payment has been arranged.
Trademark Notice: Product or corporate names may be trademarks or registered trademarks,
and are used only for identification and explanation without intent to infringe.
Visit the Taylor & Francis Web site at
http://www.taylorandfrancis.com
and the CRC Press Web site at
http://www.crcpress.com
Contents
Preface .................................................................................................................ix
Acknowledgments ............................................................................................xi
Author .............................................................................................................. xiii
1. Scope ............................................................................................................. 1
2. Normative references ................................................................................. 9
3. Terms and defnitions .............................................................................. 11
4. Quality management system ................................................................. 13
4.1 General requirements ..................................................................... 13
4.2 Documentation requirements ....................................................... 94
4.2.1 General ............................................................................... 94
4.2.2 Quality manual ............................................................... 106
4.2.3 Medical device fle .......................................................... 120
4.2.4 Control of documents ..................................................... 124
4.2.5 Control of records ........................................................... 143
5. Management responsibility ................................................................. 161
5.1 Management commitment ...........................................................161
5.2 Customer focus...............................................................................167
5.3 Quality policy ................................................................................ 170
5.4 Planning ..........................................................................................176
5.4.1 Quality objectives ............................................................176
5.4.2 Quality management system planning ....................... 182
5.5 Responsibility, authority, and communication ......................... 185
5.5.1 Responsibility and authority ......................................... 185
5.5.2 Management representative .......................................... 191
5.5.3 Internal communication ................................................ 196
v
vi Contents
5.6 Management review ..................................................................... 203
5.6.1 General ............................................................................. 203
5.6.2 Review inputs .................................................................. 208
5.6.3 Review outputs ............................................................... 215
6. Resource management ........................................................................... 221
6.1 Provision of resources .................................................................. 221
6.2 Human resources .......................................................................... 225
6.3 Infrastructure ................................................................................ 241
6.4 Work environment and contamination control ........................ 266
6.4.1 Work environment .......................................................... 266
6.4.2 Contamination control ................................................... 282
7. Product realization ................................................................................. 295
7.1 Planning of product realization .................................................. 295
7.2 Suitable planning for the organization’s operations:
A practical quality plan ............................................................... 334
7.2.1 Determination of requirements related to product ... 336
7.2.2 Review of requirements related to the product .......... 343
7.2.3 Communication ............................................................... 354
7.3 Design and development ............................................................. 366
7.3.1 General ............................................................................. 366
7.3.2 Design and development planning .............................. 369
7.3.3 Design and development inputs ................................... 381
7.3.4 Design and development outputs ................................ 391
7.3.5 Design and development review .................................. 400
7.3.6 Design and development verifcation .......................... 409
7.3.7 Design and development validation ............................ 425
7.3.8 Design and development transfer ................................ 452
7.3.9 Control of design and development changes ............. 460
7.3.10 Design and development fles ....................................... 470
7.4 Purchasing ..................................................................................... 473
7.4.1 Purchasing process ..........................................................474
7.4.2 Purchasing information ................................................. 495
7.4.3 Verifcation of purchased product ................................ 509
7.5 Production and service provision .............................................. 520
7.5.1 Control of production and service provision .............. 520
7.5.2 Cleanliness of product ................................................... 548
7.5.3 Installation activities ...................................................... 557
7.5.4 Servicing activities .......................................................... 563
7.5.5 Particular requirements for sterile medical devices .... 576
7.5.6 Validation of processes for production and service
provision .......................................................................... 584
Contents vii
7.5.7 Particular requirements for validation
of processes for sterilization and sterile
barrier systems ................................................................ 625
7.5.8 Identifcation .................................................................... 635
7.5.9 Traceability ....................................................................... 652
7.5.10 Customer property ......................................................... 666
7.5.11 Preservation of product ................................................. 671
7.6 Control of monitoring and measuring equipment .................. 681
8. Measurement, analysis, and improvement ....................................... 701
8.1 General ........................................................................................... 701
8.2 Goal of monitoring, measurement, analysis for
improvement ................................................................................. 702
8.2.1 Planning and implementing processes for
monitoring, measurement, analysis, and
improvement ................................................................... 704
8.2.2 Feedback ........................................................................... 707
8.2.3 Complaint handling ....................................................... 717
8.2.4 Reporting to regulatory authorities ............................. 736
8.2.5 Internal audit ................................................................... 740
8.2.6 Monitoring and measurement of processes ................ 757
8.2.7 Monitoring and measurement of product ....................767
8.3 Control of nonconforming product ............................................ 778
8.3.1 General ............................................................................. 779
8.3.2 Actions in response to nonconforming products
detected before delivery ................................................. 795
8.3.3 Actions in response to nonconforming products
detected after delivery ................................................... 805
8.3.4 Rework ...............................................................................816
8.4 Analysis of data ............................................................................. 820
8.5 Improvement ................................................................................. 834
8.5.1 General ............................................................................. 834
8.5.2 Corrective action ............................................................. 843
8.5.3 Preventive action ............................................................. 854
Index ................................................................................................................ 863
Preface
The quality management world of the medical device industry has gone
through a signifcant change represented by the publication of the new
revision of the ISO 13485 Standard, the 2016 revision. This revision brings
new challenges to organizations as well as changes to old challenges. This
book is a complete guide to implementing all of the requirements of the
standard. In order to present the reader with a practical and useful guide,
I have provided a defnition of my quality policy and objectives.
My quality policy
Presenting and reviewing the ISO 13485:2016 standard requirements
through analysis, interpretation, and demonstration, with explanations,
insightful examples, and events from various industries and sectors.
My quality objectives
• Commitment to the highest level of consulting regarding the ISO
13485:2016 standard.
• Reviewing all the topics and issues related to the realization of a
product or service with reference to various types of processes and
products.
• Providing support in the implementation of an effective quality
management system.
• Facilitating the documentation of processes.
• Providing a reference to the new challenges presented in the ISO
13485:2016 standard.
However, a policy and related objectives are ineffective without also
having in place designed and structured tactics and methods to achieve
them:
ix