ANSI TIR14969-2004 Medical devices-Quality management systems- Guidance on the application of ISO 13485 2003.pdf

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1、 Technical Information Report ANSI/AAMI/ISO TIR14969:2004Medical devicesQuality management systemsGuidance on the application of ISO 13485:2003 An ANSI Technical Report prepared by AAMI ANSI/AAMI/ISO TIR14969:2004 (Revision of ANSI/AAMI/ISO 14969:1999) Medical devicesQuality management systemsGuidan

2、ce on the application of ISO 13485:2003 Approved 15 July 2004 by Association for the Advancement of Medical Instrumentation Registered on 15 August 2004 by American National Standards Institute, Inc. Abstract: Provides guidance on the application of requirements contained in ISO 13485:2003, includin

3、g detailed guidance related to process validation, design control, and quality planning. Keywords: medical devices, quality management systems, design control, process control, quality records Published by Association for the Advancement of Medical Instrumentation 1110 N. Glebe Road, Suite 220 Arlin

4、gton, VA 22201-4795 2004 by the Association for the Advancement of Medical Instrumentation All Rights Reserved This publication is subject to copyright claims of ISO, ANSI, and AAMI. No part of this publication may be reproduced or distributed in any form, including an electronic retrieval system, w

5、ithout the prior written permission of AAMI. All requests pertaining to this document should be submitted to AAMI. It is illegal under federal law (17 U.S.C. 101, et seq.) to make copies of all or any part of this document (whether internally or externally) without the prior written permission of th

6、e Association for the Advancement of Medical Instrumentation. Violators risk legal action, including civil and criminal penalties, and damages of $100,000 per offense. For permission regarding the use of all or any part of this document, contact AAMI, 1110 N. Glebe Road, Suite 220, Arlington, VA 222

7、01-4795. Phone: (703) 525-4890; Fax: (703) 525-1067. Printed in the United States of America ISBN 1570202214 AAMI Technical Information Report A technical information report (TIR) is a publication of the Association for the Advancement of Medical Instrumentation (AAMI) Standards Board that addresses

8、 a particular aspect of medical technology. Although the material presented in a TIR may need further evaluation by experts, releasing the information is valuable because the industry and the professions have an immediate need for it. A TIR differs markedly from a standard or recommended practice, a

9、nd readers should understand the differences between these documents. Standards and recommended practices are subject to a formal process of committee approval, public review, and resolution of all comments. This process of consensus is supervised by the AAMI Standards Board and, in the case of Amer

10、ican National Standards, by the American National Standards Institute. A TIR is not subject to the same formal approval process as a standard. However, a TIR is approved for distribution by a technical committee and the AAMI Standards Board. Another difference is that, although both standards and TI

11、Rs are periodically reviewed, a standard must be acted onreaffirmed, revised, or withdrawnand the action formally approved usually every five years but at least every 10 years. For a TIR, AAMI consults with a technical committee about five years after the publication date (and periodically thereafte

12、r) for guidance on whether the document is still usefulthat is, to check that the information is relevant or of historical value. If the information is not useful, the TIR is removed from circulation. A TIR may be developed because it is more responsive to underlying safety or performance issues tha

13、n a standard or recommended practice, or because achieving consensus is extremely difficult or unlikely. Unlike a standard, a TIR permits the inclusion of differing viewpoints on technical issues. CAUTION NOTICE: This AAMI TIR may be revised or withdrawn at any time. Because it addresses a rapidly e

14、volving field or technology, readers are cautioned to ensure that they have also considered information that may be more recent than this document. All standards, recommended practices, technical information reports, and other types of technical documents developed by AAMI are voluntary, and their a

15、pplication is solely within the discretion and professional judgment of the user of the document. Occasionally, voluntary technical documents are adopted by government regulatory agencies or procurement authorities, in which case the adopting agency is responsible for enforcement of its rules and re

16、gulations. Comments on this technical information report are invited and should be sent to AAMI, Attn: Standards Department, 1110 N. Glebe Road, Suite 220, Arlington, VA 22201-4795. ANSI Technical Report This AAMI TIR has been registered by the American National Standards Institute as an ANSI Techni

17、cal Report. Publication of this ANSI Technical Report has been approved by the accredited standards developer (AAMI). This document is registered as a Technical Report series of publications according to the Procedures for the Registration of ANSI Technical Reports. This document is not an American

18、National Standard and the material contained herein is not normative in nature. Contents Page Glossary of equivalent standards vi Committee representation. viii Background of AAMI adoption of ISO/TR14969:2004x Foreword.xi Introduction xii 1 Scope1 1.1 General 1 1.2 Application1 1.2.1 General2 1.2.2

19、Exclusions2 1.2.3 Non-applicability.2 2 Normative references2 3 Terms and definitions2 4 Quality management system.3 4.1 General requirements 3 4.2 Documentation requirements .4 4.2.1 General4 4.2.2 Quality manual.6 4.2.3 Control of documents.6 4.2.4 Control of records 8 5 Management responsibility

20、.9 5.1 Management commitment9 5.2 Customer focus10 5.3 Quality policy10 5.4 Planning .11 5.4.1 Quality objectives.11 5.4.2 Quality management system planning .12 5.5 Responsibility, authority, and communication.13 5.5.1 Responsibility and authority .13 5.5.2 Management representative 13 5.5.3 Intern

21、al communication14 5.6 Management review.14 5.6.1 General14 5.6.2 Review input 15 5.6.3 Review output 16 6 Resource management.17 6.1 Provision of resources17 6.2 Human resources.17 6.2.1 General17 6.2.2 Competence, awareness, and training.18 6.3 Infrastructure19 6.4 Work environment 20 6.4.1 Genera

22、l20 6.4.2 Environmental control in product realization 20 6.4.3 Personnel.21 6.4.4 Contaminated or potentially contaminated product 22 7 Product realization 22 7.1 Planning of product realization .22 7.1.1 General23 7.1.2 Risk management24 7.1.3 Lifetime of the medical device24 7.2 Customer-related

23、processes 25 7.2.1 Determination of requirements related to the product 25 7.2.2 Review of requirements related to the product.26 7.2.3 Customer communication 27 7.3 Design and development27 7.3.1 Design and development planning.27 7.3.2 Design and development inputs.29 7.3.3 Design and development

24、outputs.31 7.3.4 Design and development review32 7.3.5 Design and development verification .33 7.3.6 Design and development validation .34 7.3.7 Control of design and development changes.35 7.4 Purchasing .36 7.4.1 Purchasing process .36 7.4.2 Purchasing information 37 7.4.3 Verification of purchase

25、d product.38 7.5 Production and service provision .39 7.5.1 Control of production and service provision .39 7.5.2 Validation of processes for production and service provision.43 7.5.3 Identification and traceability46 7.5.4 Customer property .48 7.5.5 Preservation of product49 7.6 Control of monitor

26、ing and measuring devices 50 8 Measurement, analysis, and improvement51 8.1 General 51 8.2 Monitoring and measurement.53 8.2.1 Feedback.53 8.2.2 Internal audit 54 8.2.3 Monitoring and measurement of processes .55 8.2.4 Monitoring and measurement of product .55 8.3 Control of nonconforming product 57

27、 8.4 Analysis of data59 8.5 Improvement 60 8.5.1 General60 8.5.2 Corrective action62 8.5.3 Preventive action .64 Annexes A Terms used in certain regulatory administrations to describe documents referenced in this Technical Report66 B Analysis of significant changes from ISO 13485:1996 to ISO 13485:2

28、003 .67 Bibliography .75 Figure 1 Model of a process-based quality management system. xiii Glossary of equivalent standards International Standards adopted in the United States may include normative references to other International Standards. For each International Standard that has been adopted by

29、 AAMI (and ANSI), the table below gives the corresponding U.S. designation and level of equivalency to the International Standard. NOTEDocuments are sorted by international designation. Other normatively referenced International Standards may be under consideration for U.S. adoption by AAMI; therefo

30、re, this list should not be considered exhaustive. International designation U.S. designation Equivalency IEC 60601-1-2:2001 and Amendment 1:2004 ANSI/AAMI/IEC 60601-1-2:2001 and Amendment 1:2004 Identical IEC 60601-2-04:2002 ANSI/AAMI DF80:2003 Major technical variations IEC 60601-2-21:1994 and Ame

31、ndment 1:1996 ANSI/AAMI/IEC 60601-2-21 and Amendment 1:2000 (consolidated texts) Identical IEC 60601-2-24:1998 ANSI/AAMI ID26:1998 Major technical variations IEC TR 60878:2003 ANSI/AAMI/IEC TIR60878:2003 Identical IEC TR 62296:2003 ANSI/AAMI/IEC TIR62296:2003 Identical ISO 5840:1996 ANSI/AAMI/ISO 58

32、40:1996 Identical ISO 7198:1998 ANSI/AAMI/ISO 7198:1998/2001 Identical ISO 7199:1996 ANSI/AAMI/ISO 7199:1996/(R)2002 Identical ISO 10993-1:2003 ANSI/AAMI/ISO 10993-1:2003 Identical ISO 10993-2:1992 ANSI/AAMI/ISO 10993-2:1993/(R)2001 Identical ISO 10993-3:2003 ANSI/AAMI/ISO 10993-3:2003 Identical ISO

33、 10993-4:2002 ANSI/AAMI/ISO 10993-4:2002 Identical ISO 10993-5:1999 ANSI/AAMI/ISO 10993-5:1999 Identical ISO 10993-6:1994 ANSI/AAMI/ISO 10993-6:1995/(R)2001 Identical ISO 10993-7:1995 ANSI/AAMI/ISO 10993-7:1995/(R)2001 Identical ISO 10993-9:1999 ANSI/AAMI/ISO 10993-9:1999 Identical ISO 10993-10:2002

34、 ANSI/AAMI BE78:2002 Minor technical variations ISO 10993-11:1993 ANSI/AAMI 10993-11:1993 Minor technical variations ISO 10993-12:2002 ANSI/AAMI/ISO 10993-12:2002 Identical ISO 10993-13:1998 ANSI/AAMI/ISO 10993-13:1999/(R)2004 Identical ISO 10993-14:2001 ANSI/AAMI/ISO 10993-14:2001 Identical ISO 109

35、93-15:2000 ANSI/AAMI/ISO 10993-15:2000 Identical ISO 10993-16:1997 ANSI/AAMI/ISO 10993-16:1997/(R)2003 Identical ISO 10993-17:2002 ANSI/AAMI/ISO 10993-17:2002 Identical ISO 11134:1994 ANSI/AAMI/ISO 11134:1993 Identical ISO 11135:1994 ANSI/AAMI/ISO 11135:1994 Identical vi 2004 Association for the Adv

36、ancement of Medical Instrumentation ANSI/AAMI/ISO TIR14969:2004 International designation U.S. designation Equivalency ISO 11137:1995 and Amdt 1:2001 ANSI/AAMI/ISO 11137:1994 and A1:2002 Identical ISO 11138-1:1994 ANSI/AAMI ST59:1999 Major technical variations ISO 11138-2:1994 ANSI/AAMI ST21:1999 Ma

37、jor technical variations ISO 11138-3:1995 ANSI/AAMI ST19:1999 Major technical variations ISO TS 11139:2001 ANSI/AAMI/ISO 11139:2002 Identical ISO 11140-1:1995 and Technical Corrigendum 1:1998 ANSI/AAMI ST60:1996 Major technical variations ISO 11607:2003ANSI/AAMI/ISO 11607:2000 Identical ISO 11737-1:

38、1995 ANSI/AAMI/ISO 11737-1:1995 Identical ISO 11737-2:1998 ANSI/AAMI/ISO 11737-2:1998 Identical ISO 11737-3:2004 ANSI/AAMI/ISO 11737-3:2004 Identical ISO TR 13409:1996 AAMI/ISO TIR13409:1996 Identical ISO 13485:2003 ANSI/AAMI/ISO 13485:2003 Identical ISO 13488:1996 ANSI/AAMI/ISO 13488:1996 Identical

39、 ISO 14155-1:2003 ANSI/AAMI/ISO 14155-1:2003 Identical ISO 14155-2:2003 ANSI/AAMI/ISO 14155-2:2003 Identical ISO 14160:1998 ANSI/AAMI/ISO 14160:1998 Identical ISO 14161:2000 ANSI/AAMI/ISO 14161:2000 Identical ISO 14937:2000 ANSI/AAMI/ISO 14937:2000 Identical ISO TR 14969:2004 ANSI/AAMI/ISO TIR14969:

40、2004 Identical ISO 14971:2000 and A1:2003 ANSI/AAMI/ISO 14971:2000 and A1:2003 Identical ISO 15223:2000, A1:2002, and A2:2004 ANSI/AAMI/ISO 15223:2000, A1:2001, and A2:2004 Identical ISO 15225:2000 and A1:2004 ANSI/AAMI/ISO 15225:2000 and A1:2004 Identical ISO 15674:2001 ANSI/AAMI/ISO 15674:2001 Ide

41、ntical ISO 15675:2001 ANSI/AAMI/ISO 15675:2001 Identical ISO TS 15843:2000 ANSI/AAMI/ISO TIR15843:2000 Identical ISO TR 15844:1998 AAMI/ISO TIR15844:1998 Identical ISO TR 16142:1999 ANSI/AAMI/ISO TIR16142:2000 Identical ISO 25539-1:2003 ANSI/AAMI/ISO 25539-1:2003 Identical 2004 Association for the A

42、dvancement of Medical Instrumentation ANSI/AAMI/ISO TIR14969:2004 vii Committee representation Association for the Advancement of Medical Instrumentation Quality Management and Corresponding General Aspects for Medical Devices Committee The adoption of ISO Technical Report (TR) 14969:2004 as an AAMI

43、 Technical Information Report and revision of ANSI/AAMI/ISO 14969:1999 was initiated by the AAMI Quality Management and Corresponding General Aspects for Medical Devices Committee, which also functions as a U.S. Technical Advisory Group to the relevant work in the International Organization for Stan

44、dardization (ISO). U.S. representatives from the AAMI Application of Quality Systems to Medical Devices Working Group (U.S. Sub-TAG for ISO/TC 210/WG 1), chaired by Edward R. Kimmelman, BME, JD of Roche Diagnostics and Kimberly A. Trautman of the U.S. Food and Drug Administration, played an active p

45、art in developing the ISO Technical Report. At the time this document was published, the AAMI Quality Management and Corresponding General Aspects for Medical Devices Committee had the following members: Chair: Charles B. Sidebottom, PE Members: Leighton W. Hansel, Abbott Laboratories Edward R. Kimm

46、elman, BME, JD, Roche Diagnostics Corp. Harvey Rudolph, PhD, Underwriters Laboratories, Inc. Charles B. Sidebottom, PE, Medtronic, Inc. Kimberly A. Trautman, U.S. Food and Drug Administration/Center for Devices and Radiological Health Alternate: Ken Slickers, PhD, DABCC, Roche Diagnostics Corp. At t

47、he time this document was published, the committees Application of Quality Systems to Medical Devices Working Group had the following members: Cochairs: Edward R. Kimmelman, BME, JD Kimberly A. Trautman Members: Bradley S. Amundson, SGS International Certification Services, Inc. Krissan Anderson, St

48、. Jude Medical, Inc. Robert G. Britain, National Electrical Manufacturers Association Marge F. Brown, Baxter Healthcare Corporation Cynthia A. Burns, Smith however, they will be considered for future use as noted above. This first edition of ISO/TR 14969 cancels and replaces ISO 14969:1999, which ha

49、s been technically revised. Throughout this Technical Report, when the text of ISO 13485 is directly quoted, it appears enclosed in boxes prefaced by: “ISO 13485:2003, Medical devicesQuality management systemsRequirements for regulatory purposes.” 2004 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO TIR14969:2004 xi Introduction 0.1 General 0.1.1 This Technical Report provides guidance to assist in the development, implementation, and maintenance of quality management systems that aim to meet the requirements of ISO 13485 for organizat