The ASQ Certified Medical Device Auditor Handbook , livre ebook

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Description

The ASQ Certified Medical Device Auditor Handbook (formerly The Biomedical Quality Auditor Handbook) was developed by the ASQ Medical Device Division (formerly Biomedical Division) in support of its mission to promote the awareness and use of quality principles, concepts, and technologies in the medical device community. It principally serves as a resource to candidates preparing for the Certified Medical Device Auditor (CMDA) certification exam. The fourth edition of this handbook has been reorganized to align with the 2020 certification exam Body of Knowledge (BoK) and reference list. The combination of this handbook with other reference materials can provide a well-rounded background in medical device auditing.
Updates to this edition include:
• A discussion of data privacy, data integrity principles, and the Medical Device Single Audit Program (MDSAP)
• Current information about federal and international regulations
• New content regarding human factors and usability engineering, general safety and performance requirements, labeling, validation, risk management, and cybersecurity considerations
• A thorough explanation of quality tools and techniques

Sujets

Auditing

Economie gestion

Economics

Business

Informations

Publié par	ASQ Quality Press
Date de parution	05 février 2021
Nombre de lectures	1
EAN13	9781953079978
Langue	English

Informations légales : prix de location à la page 0,7500€. Cette information est donnée uniquement à titre indicatif conformément à la législation en vigueur.

Extrait

The ASQ Certified Medical Device Auditor Handbook
Fourth Edition
ASQ Medical Device Division Scott A. Laman, Editor
Supports preparation for the ASQ Certified Medical Device Auditor (CMDA) certification

ASQExcellence Milwaukee, Wisconsin

Published by ASQExcellence, Milwaukee, WI
Produced and distributed by Quality Press, ASQ, Milwaukee, WI
© 2021 by ASQExcellence
Publisher’s Library of Congress Cataloging-in-Publication data
Names: Laman, Scott, editor.
Title: The ASQ certified medical device auditor handbook , fourth edition / ASQ Medical Device Division , Scott A. Laman, editor
Description: Includes bibliographical references and index. | Milwaukee, WI: ASQExcellence, 2021.
Identifiers: LCCN: 2020952290 | ISBN: 978-1-952236-09-9 (Hardcover) | 978-1-953079-96-1 (Hardcover) | 978-1-952236-10-5 (epub) | 978-1-953079-98-5 (epub) | 978-1-952236-11-2 (pdf) | 978-1-953079-97-8 (pdf)
Subjects: LCSH Medical instruments and apparatus—Standards. | Medical instruments and apparatus—Safety regulations. | Medical instruments and apparatus industry—Quality control. | Medical instruments and apparatus—Design and construction—Quality control. | BISAC BUSINESS & ECONOMICS / Auditing | BUSINESS & ECONOMICS / Industries / Manufacturing
Classification: LCC R856.6 A77 2021 | DDC 610.28—dc23
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.
ASQ and ASQExcellence advance individual, organizational, and community excellence worldwide through learning, quality improvement, and knowledge exchange.
Attention bookstores, wholesalers, schools, and corporations: Quality Press and ASQExcellence books are available at quantity discounts with bulk purchases for business, trade, or educational uses. For information, please contact Quality Press at 800-248-1946 or books@asq.org.
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Printed on acid-free paper
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Table of Contents
Cover
Title page
CIP data
Acknowledgments
Part I: Auditing
Chapter 1 Auditing Fundamentals
Chapter 2 Auditing and Inspection Processes
Chapter 3 Audit Procedural References
Part II: Medical Device Quality Management System Requirements
Chapter 4 FDA--Code of Federal Regulations (CFR) Title 21
Chapter 5 U.S. Requirements (FD&C Act, 201, 301-304, 501-502, 510, 513, 518, 522, 704)
Chapter 6 The EU Medical Device Regulation
Chapter 7 Other International Regulations
Chapter 8 Requirements for In Vitro Diagnostic (IVD) Devices
Chapter 9 International Standards for Quality Systems
Chapter 10 Quality System Regulation (QSR) Requirements
Chapter 11 Post-market Surveillance
Part III: Technical Medical Device Knowledge
Chapter 12 Risk Management
Chapter 13 Human Factors and Usability Engineering
Chapter 14 Biological Evaluation
Chapter 15 Packaging
Chapter 16 General Safety and Performance Requirements
Chapter 17 Software Development and Maintenance for Products
Chapter 18 Labeling
Chapter 19 Controlled Environments and Utility Systems
Chapter 20 Sterile Medical Devices
Chapter 21 Laboratory Testing and Failure Analysis
Chapter 22 Validation
Chapter 23 Reprocessing/Reuse and Cleaning of Medical Devices
Chapter 24 Common Medical Device Directives and Standards
Chapter 25 Sources for New and Evolving Standards
Part IV: Quality Tools and Techniques
Chapter 26 Quality Control and Problem-Solving Tools
Chapter 27 Process Improvement Techniques
Chapter 28 Data Types and Sampling
Part V: Appendices
Appendix A: Glossary of Terms
Appendix B: Certified Medical Device Auditor (CMDA) Body of Knowledge (2020) .
Appendix C: Certified Medical Device Auditor (CMDA) References (2020)
Endnotes
About the Editor

Preface
T he ASQ Certified Medical Device Auditor Handbook (formerly The Biomedical Quality Auditor Handbook) was developed by the American Society for Quality (ASQ) Medical Device Division (formerly Biomedical Division) in support of its mission to promote the awareness and use of quality principles, concepts, and technologies in the medical device community. It principally serves as a resource to candidates preparing for the Certified Medical Device Auditor (CMDA) certification exam.
The original Certified Biomedical Auditor (CBA) certification was initially introduced as an add-on to the Certified Quality Auditor (CQA) certification in 2000 and became the stand-alone CBA certification in 2005. In 2020, recognizing that the membership of the division is better represented by the description “medical device” than by “biomedical,” division leadership proposed and the ASQ Board of Directors approved the name change to Medical Device Division. For consistency and to attract appropriate candidates for certification, the ASQ Certification Board followed suit with a change to the name of the certification exam to Certified Medical Device Auditor.
Obtaining the CMDA credential establishes the competence of an auditor in the medical device industry, with the CMDA described as understanding the principles of standards, regulations, directives, and guidance for auditing a medical device quality system. The CMDA certification exam is supported by its Body of Knowledge (BoK) and reference list that define the exam scope, with both elements maintained concurrently and generally updated every five years.
Regulations and guidance affecting the medical device industry continually evolve. Although new or updated requirements may be introduced at any time, revisions to the exam BoK, reference list, and exam maintain their five-year review cycle. Consequently, contents of this handbook and CMDA certification differ from the current state of the medical device industry.
The fourth edition of The ASQ Certified Medical Device Auditor Handbook , as a primary source of information for certification exam preparation, correlates to the 2020 certification exam BoK and reference list. This edition has been reorganized to align more closely with the BoK and includes a significant amount of brand-new material. As a result, the number of chapters in the fourth edition has increased from 24 to 28. Many other chapters and parts of chapters have been substantially rewritten, and all have been reviewed for accuracy and to reference current versions of the standards and regulations.
Each chapter of the third edition was initially compared to the requirements of the 2020 BoK via a gap analysis. Existing chapters were classified as:
•Review and update as necessary when there were no changes to the BoK topic addressed, or if there were only minor changes to content.
•Update the new BoK when there were significant content changes to the BoK topic addressed.
•Write new content when the new BoK covered a subject that was not in the third edition.
Part I on Auditing contains new content on data privacy, data integrity principles, and the Medical Device Single Audit Program (MDSAP).
Part II on Medical Device Quality Management System Requirements contains an entirely new Chapter 6, as the subject of “The EU Medical Device Regulation” has replaced “The EU Medical Device Directives.” Chapters 4 and 5 have been switched to be consistent with the sequencing in the 2020 BoK. Chapter 4 has been rewritten and enhanced with new content on various codes of federal regulations that were not in the third edition. Chapter 8 on In Vitro Diagnostic (IVD) devices has also been substantially rewritten.
Part III on Technical Medical Device Knowledge contains new content for Chapter 13 (Human Factors and Usability Engineering), Chapter 16 (General Safety and Performance Requirements, 18 (Labeling), and Chapter 22 (Validation). Chapter 12 (Risk Management) has been rewritten to cover ISO 14971:2019 and the risk management requirements in IEC 62366 for usability engineering and ISO 13485 for quality system risk management. Chapter 17 (Software Development and Maintenance for Products) has been rewritten with additional content on the applicable guidances, as well as cybersecurity considerations.
Part IV on Quality Tools and Techniques has been improved with additional details and explanations. New content includes 5 Whys, is/is not (Kepner-Tregoe), setting alert and action limits, levels of measurement, and sampling. A related subject, test method validation and measurement systems analysis, is covered in Chapter 22 as part of validation.
Topics in this handbook are described in summary fashion and are not intended as a stand-alone tool for exam preparation. It is suggested that exam candidates read and understand the reference material to have a complete background in any one topic. The combination of this publication and reference materials is intended to provide a well-rounded background in medical device auditing.
The ASQ Medical Device Division believes this handbook will be a useful resource to those medical device professionals preparing for the CMDA exam.
Scott A. Laman General Editor, Fourth Edition

Acknowledgments
M any people contributed to the fourth edition of this book, including some who were involved in the development of previous editions.
First, an effort of this magnitude begins with obtaining the wisdom and advice of previous editors of similar handbooks. Initial discussions with Grace Duffy, Mark Durivage, and Heather Crawford were immensely valuable to provide direction and, more importantly, instill vision and confidence that the task was achievable.
The ASQ Medical Device Division leadership has been fully supportive and involved with recommendations for contributors and stepping u