The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices

Ed Kimmelman, Amiram Daniel

Description

This new and expanded second edition maintains the organizational approach of the first and includes the requirements and guidance contained in the Quality System Regulation (QSReg), the ISO 13485:2003 standard, the ISO/TR 14969:2004 guidance document, and, as appropriate, a number of the FDA and Global Harmonization Task Force (GHTF) guidance documents.This second edition also addresses a number of additional topics, such as the incorporation of risk management into the medical device organization’s QMS, QMS issues related to combination products, the key process interactions within a QMS, effective presentation of and advocacy for a QMS during FDA inspections and third-party assessments, and future FDA compliance and standards activities. The organization of the guidebook is based on the order of the requirements in the QSReg. For each substantive requirement section there is: A verbatim statement of the QSReg requirement. A description of the comparable requirement in ISO 13485:2003, focusing on any additions to or differences from the requirements contained in the QSReg.Excerpts of the FDA responses to relevant comment groups contained in the Preamble to the QSReg. Excerpts from various FDA guidance documents related to quality management systems. A description of the relevant guidance contained in ISO/TR 14969:2004, focusing on any additions to or differences from the guidance in the Preamble and other FDA guidance documents, and, if useful, excerpts from relevant GHTF guidances. Authors’ notes giving guidance derived from the authors’ sixty years of regulatory compliance experience. This guidance book is meant as a resource to manufacturers of medical devices, providing up-to-date information concerning required and recommended quality system practices. It should be used as a companion to the regulations/standards themselves and texts on the specific processes and activities contained within the QMS.

Sujets

• Business
• Qualité, hygiène, sécurité, environnement
• Medical
• Médecine
• Biotechnology

Informations

• Publié par: ASQ Quality Press
• Date de parution: 21 février 2008
• Nombre de lectures: 1
• EAN13: 9780873892049
• Langue: English
• Poids de l'ouvrage: 9 Mo

Extrait

The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices

Second Edition

Compiled and Written by

Amiram Daniel

&

Ed Kimmelman

ASQ Q UALITY P RESS Milwaukee, Wisconsin

American Society for Quality, Quality Press, Milwaukee 53203

© 2008 by American Society for Quality

All rights reserved. Published 2008

Library of Congress Cataloging-in-Publication Data

Daniel, Amiram.

The FDA and worldwide quality system requirements guidebook for medical devices / compiled and written by Amiram Daniel & Ed Kimmelman.—2nd ed.

p. cm.

Rev. ed. of: FDA and worldwide quality system requirements guide book for medical devices / Kimberly A. Trautman. c1997.

ISBN 978-0-87389-740-2

1. Medical instruments and apparatus industry—Law and legislation—United States. 2. Quality control—Law and legislation—United States. 3. Medical instruments and apparatus industry—United States—Quality control. 4. Medical instruments and apparatus industry—Law and legislation. 5. Quality control—Law and legislation. 6. Medical instruments and apparatus industry—Quality control. I. Kimmelman, Ed. II. Trautman, Kimberly A., 1964—FDA and worldwide quality system requirements guide book for medical devices. III. Title.

KF3827.M4T73 2008

344.7304'2—dc22 2008013052

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.

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Contents

Introduction An At-a-Glance Comparison of the 1996 QSReg and ISO 13485:2003 Detailed Analysis of the Requirements and Guidances Subpart A. General Provisions § 820.1 Scope § 820.3 Definitions Subpart B. Quality System Requirements § 820.5 Quality system § 820.20 Management responsibility § 820.22 Quality audit § 820.25 Personnel Subpart C. Design Controls § 820.30 Design controls Subpart D. Document Controls § 820.40 Document controls Subpart E. Purchasing Controls § 820.50 Purchasing controls Subpart F. Identification and Traceability § 820.60 Identification § 820.65 Traceability Subpart G. Production and Process Controls § 820.70 Production and process controls § 820.72 Inspection, measuring, and test equipment § 820.75 Process validation Subpart H. Acceptance Activities § 820.80 Receiving, in-process, and finished device acceptance § 820.86 Acceptance status Subpart I. Nonconforming Product § 820.90 Nonconforming product Subpart J. Corrective and Preventive Action § 820.100 Corrective and preventive action Subpart K. Labeling and Packaging Control § 820.120 Device labeling § 820.130 Device packaging Subpart L. Handling, Storage, Distribution, and Installation § 820.140 Handling § 820.150 Storage § 820.160 Distribution § 820.170 Installation Subpart M. Records § 820.180 General requirements § 820.181 Device master record § 820.184 Device history record § 820.186 Quality system record

§ 820.198 Complaint files Subpart N. Servicing § 820.200 Servicing Subpart O. Statistical Techniques § 820.250 Statistical techniques Additional Subjects Risk Management Combination Products Process Interactions within the QMS How to Present and Advocate for Your QMS During Inspections and Assessments Future FDA Compliance Activities and Use of Standards

Introduction

It has been more than 11 years since the U.S. Food and Drug Administration (FDA) published its Medical Devices: Current Good M anufacturing Practice (CGMP) Final Rule: Quality System Regulation (QSReg ) (October 1996). Through the QSReg, FDA profoundly changed its appro ach. It focused its attention on the various processes contained within a compliant quality management system (QMS), with a new emphasis on the design and development process. By doing so it moved much clos er to the approach taken by the International Organization for Standardizati on (ISO) quality system standard ISO 9001:2000, which was being developed c oncurrently with the new regulation. After publication of the new QSReg, the QMS standard for medical device organizations, ISO 13485:2003, and an associ ated guidance document, ISO/TR 14969:2004, were published.

Since the publication of ISO 13485:2003, FDA has be en asked why it hasn’t simply adopted this international standard as its q uality system regulation. FDA explains that it is constrained from doing so by th e statutes under which it operates. In addition, it is discouraged from furth er revising the QSReg by the complicated process for such revision and by the im pact on other FDA compliance activities. FDA correctly maintains that there are few substantive differences between the QSReg and the Standard. The text in this book confirms that there are no conflicting requirements between the QSReg and the Standard, and that an effective QMS can be constructed by com bining requirements of both documents or following either.

In 1997, the American Society for Quality (ASQ) pub lished the first edition of The FDA and Worldwide Quality System Requirements G uidebook for Medical Devices, compiled by Kimberly A. Trautman, FDA GMP/Quality Systems Expert. TheGuidebooktive source ofhas served the medical device industry as a defini “FDA thinking” on quality system processes. There a re well-worn, dog-eared, and annotated copies of this book on the desks of m edical device manufacturers in the United States and around the world.

In the years since the first edition was published, regulatory agencies in key countries and regions have incorporated the require ments contained in the ISO 13485:2003 standard into their quality system regul ations. In addition, Global Harmonization Task Force (GHTF) study groups have b een effective in developing guidance documents intended to harmonize the regulation of medical devices sold in the international market.

This new and expanded second edition of theGuidebook maintains the organizational approach of the first edition and in cludes the requirements and guidance contained in the QSReg, the ISO 13485:2003 standard, the ISO/TR 14969:2004 guidance document, and, as appropriate, the GHTF guidance documents. The organization of the book is based on the order of requirements in the QSReg. For each substantive requirement section, there is:

A verbatim statement of the QSReg and the U.S. Food , Drug, and Cosmetic Act requirement.

A description of the comparable requirement in ISO 13485:2003, including, as appropriate, brief excerpts from the Standard, focusing on any additions to or differences from the require ments contained

in the QSReg.

FDA Guidance.Excerpts of the FDA responses to relevant comment groups contained in the preamble to the QSR eg, as well as excerpts from various FDA guidance documents rel ated to QMSs. These guidance documents can be searched by a ccessing the FDA Web site, http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/c fggp/search.cfm, and clicking on the Office of Compliance page or a page from other FDA offices of interest.

AAMI/ANSI/ISO TR 14969:2004.A description of the relevant guidance contained in ISO/TR 14969:2004, including, as appropriate, excerpts from the TR, focusing on any additions to or differences from the guidance in the preamble and o ther FDA guidance documents.

GHTF Guidance.Excerpts from relevant GHTF guidances (if useful). A number of original GHTF guidance documen ts have been retired since the publication of ISO/TR 14969:2004. The contents of the TR cover many of the topics discussed in these original guidances. Access to GHTF guidances is available from its Web site,http://www.GHTF.org.

“Authors’ Notes,” which include guidance derived from the authors’ 60 years of regulatory compliance experience.

The second edition also addresses a number of additional topics:

The incorporation of risk management into the medic al device organization’s QMS QMS issues related to combination products The key process interactions within a QMS Effective presentation of and advocacy for a QMS du ring FDA inspections and third-party assessment Future FDA compliance and standards activities

The discussion of requirements contained in ISO 900 1 has been eliminated in this edition. ISO 13485:2003 is based on the requir ements contained in ISO 9001, but it stands independent of ISO 9001 in orde r to fulfill its objective of being a model for device quality system regulation around the world.

Immediately following this introduction is a side-b y-side, at-a-glance comparison of the FDA Quality System Regulation and the ISO Quality Standard 13485:2003.

The reader should note the following for the purpos es of this book:

When the term “Standard” is used, it refers to ISO 13485:2003. When the term “QSReg” is used, it refers to the FDA Quality System Regulation, 1996. “QSReg” is used in this book inst ead of “QSR” to avoid any confusion with QSR meaning either the “Quality System Regulation” or the “Quality System Record” required by § 820.186 o f the QSReg. When the term “TR” is used, it refers to the ISO/TR 14969:2004 technical

report. When the term “Statute” is used, it refers to the U .S. Food, Drug, and Cosmetics Act.

This guidance book is a resource for manufacturers of medical devices, those who provide support services to these manufacturers , and the users of medical devices. It provides up-to-date information concern ing required and recommended quality system practices. It should be used as a companion to the regulations/standards themselves and the texts on t he specific processes and activities contained within the QMS.

Another useful guidance book is published by the Ca nadian Standards Association:The ISO 13485 Essentials:A Practical Handbook for Implementing the ISO 13485 Standard for Manufacturers of Medical Devices. This handbook is part of a series of guidances published by the Cana dian Standards Association. A complete listing of these handbooks and the Canad ian standards relevant to health and safety can be found at http://www.csa.ca/electronic_catalogue/health_and_s afety.pdf.

Users should ensure that their organization possess es the most up-to-date, relevant regulations and standards.

AnAt-a-Glance Comparison of the 1996 QSReg and ISO 13485:2003

This at-a-glance comparison of the 1996 QSReg and t he ISO 13485:2003 Standard is intended to align the comparable subcla uses of the two documents and quickly highlight their similarities and differ ences. Additional, more detailed comparisons are explained in the subpart chapters that follow.