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American National Standard ANSI Store order #X Downloaded: 4/1/2005 7:47:09 AM ET ANSI/AAMI/ISO 13485:2003 Medical devices Quality management systems Requirements for regulatory purposes AAMI Association
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American National Standard ANSI Store order #X Downloaded: 4/1/2005 7:47:09 AM ET ANSI/AAMI/ISO 13485:2003 Medical devices Quality management systems Requirements for regulatory purposes AAMI Association for the Advancement of Medical Instrumentation The Objectives and Uses of AAMI Standards and Recommended Practices It is most important that the objectives and potential uses of an AAMI product standard or recommended practice are clearly understood. The objectives of AAMI's technical development program derive from AAMI's overall mission: the advancement of medical instrumentation. Essential to such advancement are (1) a continued increase in the safe and effective application of current technologies to patient care, and (2) the encouragement of new technologies. It is AAMI's view that standards and recommended practices can contribute significantly to the advancement of medical instrumentation, provided that they are drafted with attention to these objectives and provided that arbitrary and restrictive uses are avoided. A voluntary standard for a medical device recommends to the manufacturer the information that should be provided with or on the product, basic safety and performance criteria that should be considered in qualifying the device for clinical use, and the measurement techniques that can be used to determine whether the device conforms with the safety and performance criteria and/or to compare the performance characteristics of different products. Some standards emphasize the information that should be provided with the device, including performance characteristics, instructions for use, warnings and precautions, and other data considered important in ensuring the safe and effective use of the device in the clinical environment. Recommending the disclosure of performance characteristics often necessitates the development of specialized test methods to facilitate uniformity in reporting; reaching consensus on these tests can represent a considerable part of committee work. When a drafting committee determines that clinical concerns warrant the establishment of minimum safety and performance criteria, referee tests must be provided and the reasons for establishing the criteria must be documented in the rationale. A recommended practice provides guidelines for the use, care, and/or processing of a medical device or system. A recommended practice does not address device performance per se, but rather procedures and practices that will help ensure that a device is used safely and effectively and that its performance will be maintained. Although a device standard is primarily directed to the manufacturer, it may also be of value to the potential purchaser or user of the device as a fume of reference for device evaluation. Similarly, even though a recommended practice is usually oriented towards health care professionals, it may be useful to the manufacturer in better understanding the environment in which a medical device will be used. Also, some recommended practices, while not addressing device performance criteria, provide guidelines to industrial personnel on such subjects as sterilization processing, methods of collecting data to establish safety and efficacy, human engineering, and other processing or evaluation techniques; such guidelines may be useful to health care professionals in understanding industrial practices. In determining whether an AAMI standard or recommended practice is relevant to the specific needs of a potential user of the document, several important concepts must be recognized: All AAMI standards and recommended practices are voluntary (unless, of course, they are adopted by government regulatory or procurement authorities). The application of a standard or recommended practice is solely within the discretion and professional judgment of the user of the document. Each AAMI standard or recommended practice reflects the collective expertise of a committee of health care professionals and industrial representatives, whose work has been reviewed nationally (and sometimes internationally). As such, the consensus recommendations embodied in a standard or recommended practice are intended to respond to clinical needs and, ultimately, to help ensure patient safety. A standard or recommended practice is limited, however, in the sense that it responds generally to perceived risks and conditions that may not always be relevant to specific situations. A standard or recommended practice is an important reference in responsible decision-making, but it should never replace responsible decisionmaking. Despite periodic review and revision (at least once every five years), a standard or recommended practice is necessarily a static document applied to a dynamic technology. Therefore, a standards user must carefully review the reasons why the document was initially developed and the specific rationale for each of its provisions. This review will reveal whether the document remains relevant to the specific needs of the user. Particular care should be taken in applying a product standard to existing devices and equipment, and in applying a recommended practice to current procedures and practices. While observed or potential risks with existing equipment typically form the basis for the safety and performance criteria defined in a standard, professional judgment must be used in applying these criteria to existing equipment. No single source of information will serve to identify a particular product as unsafe . A voluntary standard can be used as one resource, but the ultimate decision as to product safety and efficacy must take into account the specifics of its utilization and, of course, cost-benefit considerations. Similarly, a recommended practice should be analyzed in the context of the specific needs and resources of the individual institution or firm. Again, the rationale accompanying each AAMI standard and recommended practice is an excellent guide to the reasoning and data underlying its provision. In summary, a standard or recommended practice is truly useful only when it is used in conjunction with other sources of information and policy guidance and in the context of professional experience and judgment. INTERPRETATIONS OF AAMI STANDARDS AND RECOMMENDED PRACTICES Requests for interpretations of AAMI standards and recommended practices must be made in writing, to the Manager for Technical Development. An official interpretation must be approved by letter ballot of the originating committee and subsequently reviewed and approved by the AAMI Standards Board. The interpretation will become official and representation of the Association only upon exhaustion of any appeals and upon publication of notice of interpretation in the Standards Monitor section of the AAMI News. The Association for the Advancement of Medical Instrumentation disclaims responsibility for any characterization or explanation of a standard or recommended practice which has not been developed and communicated in accordance with this procedure and which is not published, by appropriate notice, as an official interpretation in the AAMI News. American National Standard ANSI/AAMI/ISO 13485:2003 (Revision of ANSI/AAMI/ISO 13485:1996) Medical devices Quality management systems Requirements for regulatory purposes Approved 6 June 2003 by Association for the Advancement of Medical Instrumentation Approved 18 June 2003 by American National Standards Institute Abstract: Keywords: Specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. medical device, quality management system AAMI Standard This Association for the Advancement of Medical Instrumentation (AAMI) standard implies a consensus of those substantially concerned with its scope and provisions. The existence of an AAMI standard does not in any respect preclude anyone, whether they have approved the standard or not, from manufacturing, marketing, purchasing, or using products, processes, or procedures not conforming to the standard. AAMI standards are subject to periodic review, and users are cautioned to obtain the latest editions. CAUTION NOTICE: This AAMI standard may be revised or withdrawn at any time. AAMI procedures require that action be taken to reaffirm, revise, or withdraw this standard no later than five years from the date of publication. Interested parties may obtain current information on all AAMI standards by calling or writing AAMI. All AAMI standards, recommended practices, technical information reports, and other types of technical documents developed by AAMI are voluntary, and their application 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 regulations. Published by Association for the Advancement of Medical Instrumentation 1110 N. Glebe Road, Suite 220 Arlington, VA 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, without the prior written permission of AAMI. All requests pertaining to this draft 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 the 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 Phone: (703) ; Fax: (703) Printed in the United States of America ISBN X Contents Glossary of equivalent standards...v Committee representation... vii Background of ANSI/AAMI adoption of ISO 13485: ix Foreword...x Introduction... xi 0.1 General... xi 0.2 Process approach... xi 0.3 Relationship with other standards... xi Relationship with ISO xi Relationship with ISO/TR xi 0.4 Compatibility with other management systems... xi 1 Scope General Application Normative references Terms and definitions Quality management system General requirements Documentation requirements General Quality manual Control of documents Control of records Management responsibility Management commitment Customer focus Quality policy Planning Quality objectives Quality management system planning Responsibility, authority, and communication Responsibility and authority Management representative Internal communication Management review General Review input Review output Resource management Provision of resources Human resources General Competence, awareness, and training Infrastructure Work environment Product realization Planning of product realization Customer-related processes...8 7.2.1 Determination of requirements related to the product Review of requirements related to the product Customer communication Design and development Design and development planning Design and development inputs Design and development outputs Design and development review Design and development verification Design and development validation Control of design and development changes Purchasing Purchasing process Purchasing information Verification of purchased product Production and service provision Control of production and service provision Validation of processes for production and service provision Identification and traceability Customer property Preservation of product Control of monitoring and measuring devices Measurement, analysis, and improvement General Monitoring and measurement Feedback Internal audit Monitoring and measurement of processes Monitoring and measurement of product Control of nonconforming product Analysis of data Improvement General Corrective action Preventive action...16 Annexes A Correspondence between ISO 13485:2003 and ISO 13485: B Explanation of differences between ISO 13485:2003 and ISO 9001: Bibliography...50 Tables A.1 Correspondence between ISO 13485:1996 and ISO 13485: A.2 Correspondence between ISO 13485:2003 and ISO 13485: 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 AAMI (and ANSI), the table below gives the corresponding U.S. designation and level of equivalency to the international standard. (Note: Documents are sorted by international designation.) Other normatively referenced international standards may be under consideration for U.S. adoption by AAMI; therefore, this list should not be considered exhaustive. International designation U.S. designation Equivalency IEC :2001 ANSI/AAMI/IEC :2001 Identical IEC :1994 and Amendment 1:1996 ANSI/AAMI/IEC & Amendment 1:2000 (consolidated texts) Identical IEC :1998 ANSI/AAMI ID26:1998 Major technical variations ISO 5840:1996 ANSI/AAMI/ISO 5840:1996 Identical ISO 7198:1998 ANSI/AAMI/ISO 7198:1998/2001 Identical ISO 7199:1996 ANSI/AAMI/ISO 7199:1996/(R)2002 Identical ISO :1997 ANSI/AAMI/ISO :1997 Identical ISO :1992 ANSI/AAMI/ISO :1993/(R)2001 Identical ISO :1992 ANSI/AAMI/ISO :1993 Identical ISO :2002 ANSI/AAMI/ISO :2002 Identical ISO :1999 ANSI/AAMI/ISO :1999 Identical ISO :1994 ANSI/AAMI/ISO :1995/(R)2001 Identical ISO :1995 ANSI/AAMI/ISO :1995/(R)2001 Identical ISO :2000 ANSI/AAMI/ISO :2000 Identical ISO :1999 ANSI/AAMI/ISO :1999 Identical ISO :2002 ANSI/AAMI BE78:2002 Minor technical variations ISO :1993 ANSI/AAMI :1993 Minor technical variations ISO :2002 ANSI/AAMI/ISO :2002 Identical ISO :1998 ANSI/AAMI/ISO :1999 Identical ISO :2001 ANSI/AAMI/ISO :2001 Identical ISO :2000 ANSI/AAMI/ISO :2000 Identical ISO :1997 ANSI/AAMI/ISO :1997/(R)2003 Identical ISO :2002 ANSI/AAMI/ISO :2002 Identical ISO 11134:1994 ANSI/AAMI/ISO 11134:1993 Identical ISO 11135:1994 ANSI/AAMI/ISO 11135:1994 Identical ISO 11137:1995 and Amdt 1:2001 ANSI/AAMI/ISO 11137:1994 and A1:2002 Identical 2003 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 13485:2003 v International designation U.S. designation Equivalency ISO :1994 ANSI/AAMI ST59:1999 Major technical variations ISO :1994 ANSI/AAMI ST21:1999 Major technical variations ISO :1995 ANSI/AAMI ST19:1999 Major technical variations ISO TS 11139:2001 ANSI/AAMI/ISO 11139:2002 Identical ISO :1995 and Technical Corrigendum 1:1998 ANSI/AAMI ST60:1996 Major technical variations ISO 11607:2003 ANSI/AAMI/ISO 11607:2000 Identical ISO :1995 ANSI/AAMI/ISO :1995 Identical ISO :1998 ANSI/AAMI/ISO :1998 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 ISO :2003 ANSI/AAMI/ISO :2003 Identical ISO :2003 ANSI/AAMI/ISO :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 14969:1999 ANSI/AAMI/ISO 14969:1999 Identical ISO 14971:2000 and A1:2003 ANSI/AAMI/ISO 14971:2000 and A1:2003 Identical ISO 15223:2000 ANSI/AAMI/ISO 15223:2000 Identical ISO 15223/A1:2002 ANSI/AAMI/ISO 15223:2000/A1:2001 Identical ISO 15225:2000 ANSI/AAMI/ISO 15225:2000 Identical ISO 15674:2001 ANSI/AAMI/ISO 15674:2001 Identical 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 :2003 ANSI/AAMI/ISO :2003 Identical vi 2003 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 13485:2003 Committee representation Association for the Advancement of Medical Instrumentation Quality Management and Corresponding General Aspects for Medical Devices Committee The adoption of ISO 13485:2003 as an American National Standard 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 (TAG) to the relevant work in the International Organization for Standardization (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, representative of Roche Diagnostics, and Kimberly A. Trautman of the U.S. Food and Drug Administration, played an active part in developing the ISO standard and were included, along with the committee, in the ballot of the U.S. adoption. Committee approval does not necessarily imply that all committee members voted for its approval. At the time this document was published, the AAMI Quality Management and Corresponding General Aspects for Medical Devices Committee had the following members: Chair: Members: Alternate: Charles B. Sidebottom, PE Leighton W. Hansel, Abbott Laboratories Edward R. Kimmelman, 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 Ken Slickers, PhD, DABCC, Roche Diagnostics Corp. At the time this document was published, the AAMI Application of Quality Systems to Medical Devices Working Group had the following members: Cochairs: Members: Edward R. Kimmelman, BME, JD Kimberly A. Trautman Robert G. Britain, National Electrical Manufacturers Association Marge F. Brown, Baxter Healthcare Corporation Cynthia A. Burns, Smith & Nephew Endoscopy Division Charles R. Burr, MS, MBA, Charles Burr Q/R Services, Inc. Christopher E. Danford, Alcon Laboratories, Inc. Ira D. Duesler, Conmed Corporation Ronald Fisher, Bausch & Lomb, Inc. Brian J. Fitzgerald, Eur. Ing., MIMM, Underwriters Laboratories, Inc. Christine M. Flahive, Chris Flahive Associates Richard C. Fries, Instrumentarium USA, Inc. Christopher D. Ganser, CR Bard Nancy George, MS, BS, CSQE, CQA, Software Quality Management, Inc. Carrie Hartill, SGS International Certification Services, Inc. Jerry Hegarty, Guidant Corporation Hyman B. Katz, PhD, Pall Corporation Edward R. Kimmelman, BME, JD, Roche Diagnostics Corp. Ariel Kopelioff, St. Jude Medical CRMD Kenneth F. Kopesky, Medtronic, Inc. Martin J. Leighton, RA/QA International LLC David M. Link, Concord, MA Christof Z. Littwitz, Philips Medical Systems David Liu, Johnson & Johnson Mark Marley, Pharmaceutical Delivery Systems Susan Moritz, Boston Scientific Corporation Dale Munday, Instrumentarium USA, Inc. Barry F.J. Page, Garner, NC George Peters, Datascope Corporation George O. Phariss, BS, MS, Abbott Laboratories Geetha Rao, PhD, PE, CRE, Macronus Group Rebecca Rickey, Ion Beam Applications Leslie S. Schnoll, MS, Hill-Rom Company Mark N. Smith, Getinge USA 2003 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 13485:2003 vii Alternates: Kimberly A. Trautman, U.S. Food and Drug Administration/Center for Devices and Radiological Health Bradley S. Amundson, SGS International Certification Services, Inc. Jeffrey A. Beck, Johnson & Johnson Corporation Leonard S. Berman, PhD, Pall Corporation Frank Bernardo, Datascope Corporation Lisa Foster, Ion Beam Applications Thomas Gonzalez, Jr., Abbott Laboratories Pam Jennings, Pharmaceutical Delivery Systems Gordon Leichter, Getinge USA Daniel M. Newhart, Bausch & Lomb, Inc. David Porter, PhD, US Pharmacopeia Convention, Inc. Ken Slickers, PhD, DABCC, Roche Diagnostics Corporation Jacqueline Welch, U.S. Food an
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