1、A PrActicAl Field Guide For iSo 13485:2003(This page intentionally left blank)Also available from ASQ Quality Press:The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices, Second EditionAmiram Daniel and Ed KimmelmanDevelopment of FDA-Regulated Medical Products: A Translatio
2、nal Approach, Second EditionElaine WhitmoreQuality Risk Management in the FDA-Regulated IndustryJos Rodrguez-PrezCAPA for the FDA-Regulated IndustryJos Rodrguez-PrezA Practical Field Guide for AS9100CErik V. Myhrberg, Dawn Holly Crabtree, and Rudy “RE” HackerA Practical Field Guide for ISO 9001:2008
3、Erik V. MyhrbergProduct Safety Excellence: The Seven Elements Essential for Product Liability PreventionTimothy A. PineAchieving a Safe and Reliable Product: A Guide to Liability PreventionE. F. “Bud” GookinsThe Certified Quality Engineer Handbook, Third EditionConnie M. Borror, editorRoot Cause Ana
4、lysis: Simplified Tools and Techniques, Second EditionBjrn Andersen and Tom FagerhaugThe Certified Manager of Quality/Organizational Excellence Handbook, Third EditionRussell T. Westcott, editorTo request a complimentary catalog of ASQ Quality Press publications, call 800-248-1946, or visit our webs
5、ite at http:/www.asq.org/quality-press.(This page intentionally left blank)ASQ Quality PressMilwaukee, WisconsinA PrActicAl Field Guide For iSo 13485:2003 Management Guidance Implementation Support Documentation Assistance Auditing TechniqueErik Valdemar Myhrberg with Joseph RacitiAmerican Society f
6、or Quality, Quality Press, Milwaukee 53203 2013 by ASQAll rights reserved. Published 2012Printed in the United States of America18 17 16 15 14 13 12 5 4 3 2 1Library of Congress Cataloging-in-Publication DataMyhrberg, Erik V.A practical field guide for ISO 13485:2003 / Erik V. Myhrberg with Joseph R
7、aciti. pages cm“Management Guidance, Implementation Support, Documentation Assistance, Auditing Technique.” Includes bibliographical references.ISBN 978-0-87389-846-1 (soft cover, ring bound : alk. paper)1. Medical instruments and apparatusStandardsHandbooks, manuals, etc. 2. Medical instruments and
8、 apparatus industryQuality controlStandardsHandbooks, manuals, etc. I. Raciti, Joseph. II. Title. III. Title: ISO 13485:2003.R856.15.M94 2012610.284dc23 2012039034ISBN: 978-0-87389-846-1No part of this book may be reproduced in any form or by any means, electronic, mechanical, photocopying, recordin
9、g, or otherwise, without the prior written permission of the publisher.Publisher: William A. TonyAcquisitions Editor: Matt T. MeinholzProject Editor: Paul Daniel OMaraProduction Administrator: Randall BensonASQ Mission: The American Society for Quality advances individual, organizational, and commun
10、ity excellence worldwide through learning, quality improvement, and knowledge exchange.Attention Bookstores, Wholesalers, Schools, and Corporations: ASQ Quality Press books, video, audio, and software are available at quantity discounts with bulk purchases for business, educational, or instructional
11、 use. For information, please contact ASQ Quality Press at 800-248-1946, or write to ASQ Quality Press, P.O. Box 3005, Milwaukee, WI 53201-3005.To place orders or to request ASQ membership information, call 800-248-1946. Visit our website at http:/www.asq.org/quality-press.Printed on acid-free paper
12、To the next generation as seen in our children!(This page intentionally left blank)ixcontentSIntroduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiHow to Use This Field Guide . . . . . . . . . . . . . . .
13、. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiiiISO 13485 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xviiSection 4: Quality Management System . . . . . . . . . . . . . . . . . .
14、. . . . . . . . . . . . . . . . . . . . . . . . . . 14.1 General Requirements 24.2 Documentation Requirements 4Section 5: Management Responsibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115.1 Management Commitment 125.2 Customer Focus . 145.3 Quali
15、ty Policy 165.4 Planning 185.5 Responsibility, Authority and Communication . 225.6 Management Review . 28Section 6: Resource Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 356.1 Provision of Resources . 366.2 Human Resources . 386.3 Infra
16、structure 426.4 Work Environment . 44Section 7: Product Realization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 477.1 Planning of Product Realization 487.2 Customer-Related Processes . 507.3 Design and Development 567.4 Purchasing . 707.5 P
17、roduction and Service Provision . 767.6 Control of Monitoring and Measuring Devices 87Section 8: Measurement, Analysis and Improvement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 918.1 General . 928.2 Monitoring and Measurement 948.3 Control of Nonconforming Product . 1038.4 An
18、alysis of Data 1058.5 Improvement . 107ISO 13485:2003 Documented Requirements by Section . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115Sources of Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
19、 119x ContentsxiintroductionOver 20 years have passed (and almost 150 projects) since we first became aware of, and started using, the ISO 9000 standards. So much has changed and evolved during this time: The advent of the ISO 14000 series of environmental management standards, the addition and dele
20、tion of stan-dards within the ISO 9000 series, and the creation of a host of industrial and sector-specific standards and “reports” based on ISO 13485. A natural extension of the standard has been prepared for the management of quality systems for the manufacture of medical devices.It is my hope tha
21、t, through my years of extensive field and classroom experience, the readers and users of this field guide will benefit from it in their application of the ISO 9000 quality management system series standards.Even with all this progress, the fundamental use of the ISO 9000 series (up to and including
22、 ISO 13485) has not changed. Companies, teams, and individuals are still trying to meet customer expectations, worldwide competition still drives the need for innovation, and internal process pressures still demand continual improvement in order to remain functional.This field guide has been created
23、 in order to foster an inner reliance between senior management, middle management, functional teams, and the individual. Users of the field guide will find within it prac-tical tools, tips, and techniques useful not only for implementing a quality management system but also for maintaining one.With
24、 the dawning of the twenty-first century, companies are being pushed to the extremes of their limited resources. At one time it was sufficient to meet most of our customers requirements, but not now. On a global scale, we are all being asked to do more with lessand for less. At some point soon, the
25、cur-rent internal systems will not be able to hold back the deluge, and companies will be faced with a stark decisionconsistently improve or perish.One of the best and most widely accepted ways in which companies can face these challenges is to implement an effective and efficient quality management
26、 system, which not only adds value to the orga-nization but also satisfies the customer. Indeed, this is already the century of international standards. The soon to be revised ISO 13485:2003 series of standards is both useful to the organization and here to stay.Work diligently in your ongoing ISO e
27、fforts!Erik Myhrberg and Joseph Racitihttp:/ xii PrefacexiiiThe purpose of this field guide is to assist organizations, step-by-step, in implementing a quality management system (QMS) in conformance with ISO 13485:2003, whether “from scratch” or by transitioning from variations of the ISO 13485 fami
28、ly. In keeping with ISO 9000:2005s definition of quality as the “degree to which a set of inherent characteristics fulfils requirements,” I have identified the requirements and inherent characteristics (distinguishing features) for this field guide. Within the guide, each subclause containing requir
29、ements is the focus of a two-page spread that consistently presents features that fulfill the requirements listed below.requirementS (or WhAt the Field Guide Will do) Provide a user-friendly guide to ISO 13485:2003s requirements for implementation purposes Identify the documents/documentation requir
30、ed, along with recommendations on what to consider retaining/adding to a QMS during ISO 13485:2003 implementation Guide internal auditor(s) regarding what to ask to verify that a conforming and effective QMS exists Direct management on what it must do and should consider to satisfy ISO 13485:2003s e
31、nhanced requirements as well as responsibilities for top management Depict step-by-step what must occur to create an effective, conforming QMShoW to uSe thiS Field Guidexiv A Practical Field Guide for ISO 13485:2003inherent chArActeriSticS (or WhAt the Field Guide ProvideS) The standardA paraphrase
32、of what a subclause of ISO 13485:2003 requires in easy-to-understand language, with references to information in ISO 9000:2008 and guidance in ISO 9004:2008 to enhance the users understanding of what ISO 13485:2003 requires and what possible added steps the user can take to improve performance. Docu
33、ment requirementsA list of the documentation/documents required by the subclause, with some ideas to consider in satisfying those requirements that will take the system beyond the requirements toward continual improvement. Internal audit questionsWhat every internal audit team needs to ask at a mini
34、mum when assessing the QMS for conformance with the subclause. Management summaryA concise description of what management must do and/or is responsible for in order to achieve conformance to the subclause, along with some guidance on additional steps management can take to enhance the system. Subcla
35、use flowchartA depiction of the steps that need to be undertaken during an implementation/transition effort to effectively and efficiently satisfy the requirements of the subclause of ISO 13485:2003, along with a box providing guidance on use of the flowchart.This medical device field guide is desig
36、ned to provide you with a consistent approach to implementing an ISO 13485:2003conforming QMS, which is appropriate since ISO 13485:2003 continues to view qual-ity as the ability of an organization to consistently deliver product that meets customer requirements. The field guide examines each subcla
37、use of Sections 48 of ISO 13485:2003, which contain the requirements, with characteristics 14 presented on the even page and characteristic 5 presented on the facing odd page. The example on the following pages presents subclause 1.2, ScopeApplication, which does not con-tain requirements, but is cr
38、itical to properly excluding any requirements of ISO 13485:2003 that do not apply to your organizations QMS, and should therefore be treated as an important part of the field guide due to the importance of establishing the QMSs scope.What separates this field guide from most other books on ISO 13485
39、:2003 and its implementation are the flowcharts showing the steps to be taken in implementing a QMS to meet a subclauses requirements, but the flowcharts themselves can be overwhelming when you first look at them. For this reason, a box appears with each flowchart that explains pertinent facts and/o
40、r what the flowchart represents and how it is to be used.Remember, the QMS your organization implements must meet the needs of its usersyou and the rest of your organizations employees, from senior management to the most junior employee. So, the QMS you create using this field guide will not only sa
41、tisfy ISO 13485:2003s requirements, but will provide a set of processes that suits your organization and will foster improved use of the system and improvement in the processes of the organization as it matures.A Practical Field Guide for ISO 13485:2003 xvend oF eAch Field Guide Section (end thouGht
42、S)Each section ends with “Notes,” which is an outlined way of thinking and/or looking at the standard. Reading these sections of the field guide will not only help prepare your company for a new implementa-tion of the medical device standard but will also aid those companies already involved with th
43、e standard in drastically improving the current management system by providing specific points to consider.(This page intentionally left blank)xviiiSo 13485 overvieWby Scott Pletzer Independent standard for medical device organizations First edition released in 1996 Second and latest edition release
44、d in 2003, which became effective in 2006 Current edition prepared by technical committee ISO/TC 210, Quality management and corresponding general aspects for medical devices Developed with ISO 9001 in mind Stand-alone quality standard, not linked to ISO 9001 ISO 13485:2003 and ISO 9001 are mutually
45、 exclusive (that is, certification to one does not imply certification to the other) Focus on how processes work together to improve the business Focus on activities that follow a trigger event, and the interactions between those activities Not bound or defined by procedures or departments Moved fro
46、m a procedure-based approach to a process-based approach 1996 Version: Procedure BasedDivide company into proceduresby the 20 sections of the standard2003 Version: Process BasedFocus on how processes work together toimprove the effectiveness of the QMS Requires maintaining effectiveness of QMS, not
47、continual improvement of QMS Focus on meeting customer requirements, not achieving customer satisfaction Explanation of differences in Annex B of standard Appendix A shows the changes from the 1996 version to the current 2003 version. Appendix B illustrates the differences between the 13485 and 9001
48、 versions.xviii A Practical Field Guide for ISO 13485:20030.1 General Requirements for a quality management system (QMS) used by organizations for design, development, production, installation, and servicing of medical devices, including related services0.2 Process approach Basis for this standard;
49、any activity that receives inputs and converts them to outputs is a process0.3 Relationship with other standards While this is a stand-alone standard, its based on ISO 90010.4 Compatibility with other management systems Standard does not include requirements specific to other management systems1.1 Requirements of a QMS for organizations providing medical devices and related services that consistently meet customer requirements and applicable regulatory requirements1.1 Facilitates harmonized
