1、ANSI/AAMI/ISO 13485:2016Medical devices Quality management systems Requirements for regulatory purposes American National StandardObjectives 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 pra
2、ctice are clearly understood. The objectives of AAMIs technical development program derive from AAMIs 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,
3、 and (2) the encouragement of new technologies. It is AAMIs 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
4、 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 use
5、d 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,
6、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 report
7、ing; 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 m
8、ust 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
9、 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 frame of reference for device evaluation. Similarly, even though a recommended practice is
10、 usually oriented towards healthcare 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 s
11、uch 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 st
12、andard 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). T
13、he 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 w
14、ork 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
15、 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 decision-making. Despite periodic revie
16、w 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 prov
17、isions. 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 pot
18、ential 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
19、 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
20、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 conjunct
21、ion 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 AAMI Vice Preside
22、nt, Standards Policy and Programs. 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 a
23、ppeals 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 develo
24、ped 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 13485:2016 Medical devicesQuality management systemsRequirements for regulatory purposes Approved 25 Marc
25、h 2016 by Association for the Advancement of Medical Instrumentation Registered 8 June 2016 by American National Standards Institute Abstract: Specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services
26、 that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. Keywords: medical device, quality management system Published by Association for the Advancement of Medical Instrumentation 4301 N. Fairfax Dr., Suite. 301 Arlington, VA 2220
27、3-1633 www.aami.org 2016 by the Association for the Advancement of Medical Instrumentation All Rights Reserved This publication is subject to copyright claims of ISO and AAMI. No part of this publication may be reproduced or distributed in any form, including an electronic retrieval system, without
28、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 the Assoc
29、iation 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, complete the reprint request form at www.aami.org or contact AAMI, 43
30、01 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. Phone: (703) 525-4890; Fax: (703) 525-1067. Printed in the United States of America ISBN 1-57020-604-X Contents Page Glossary of equivalent standards iv Committee representation . v Foreword vii Introduction viii 1 Scope . 1 2 Normative refer
31、ences . 1 3 Terms and definitions . 1 4 Quality management system 6 4.1 General requirements 6 4.2 Documentation requirements . 7 5 Management responsibility 9 5.1 Management commitment 9 5.2 Customer focus 9 5.3 Quality policy 9 5.4 Planning . 10 5.5 Responsibility, authority and communication . 10
32、 5.6 Management review . 10 6 Resource management 11 6.1 Provision of resources 11 6.2 Human resources . 12 6.3 Infrastructure 12 6.4 Work environment and contamination control 12 7 Product realization . 13 7.1 Planning of product realization . 13 7.2 Customer-related processes 13 7.3 Design and dev
33、elopment . 14 7.4 Purchasing . 17 7.5 Production and service provision . 18 7.6 Control of monitoring and measuring equipment . 21 8 Measurement, analysis and improvement 22 8.1 General 22 8.2 Monitoring and measurement 22 8.3 Control of nonconforming product 24 8.4 Analysis of data 24 8.5 Improveme
34、nt 25 Annex A (informative) Comparison of content between ISO 13485:2003 and ISO 13485:2016 . 27 Annex B (informative) Correspondence between ISO 13485:2016 and ISO 9001:2015 . 31 Bibliography . 38 iv 2016 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 13485:2016 Glossary o
35、f equivalent standards International Standards adopted in the United States may include normative references to other International Standards. AAMI maintains a current list of each International Standard that has been adopted by AAMI (and ANSI). Available on the AAMI website at the address below, th
36、is list gives the corresponding U.S. designation and level of equivalency to the International Standard. www.aami.org/standards/glossary.pdf 2016 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 13485:2016 v Committee representation Association for the Advancement of Medical
37、Instrumentation Application of quality systems to medical devices The publication of ANSI/AAMI/ISO 13485:2016 as a new American National Standard was initiated by the AAMI Application of quality systems to medical devices Work Group, which also functions as a U.S. Technical Advisory Group to the rel
38、evant work in the International Organization for Standardization (ISO) TC210 and provides U.S. representatives from the AAMI Symbols and nomenclature for medical devices Work Group . At the time this document was published, the AAMI Application of Quality Systems to Medical Devices Work Group had th
39、e following members: Co-chair: Ed Kimmelman Kim Trautman, FDA/CDRH Members: John Abbott Krisann Anderson, St Jude Medical Inc Ed Bills, ELB Consulting Ujjal Chakravartty, Halyard Health Lena Cordie, Qualitas Professional Services Heather Crawford, ASQ Biomedical Division Mary Dadone, Noxilizer Inc V
40、ijay Damodaran, Eli Lilly identifies the regulatory requirements that apply to its activities under these roles; incorporates these applicable regulatory requirements within its quality management system. The definitions in applicable regulatory requirements differ from nation to nation and region t
41、o region. The organization needs to understand how the definitions in this International Standard will be interpreted in light of regulatory definitions in the jurisdictions in which the medical devices are made available. This International Standard can also be used by internal and external parties
42、, including certification bodies, to assess the organizations ability to meet customer and regulatory requirements applicable to the quality management system and the organizations own requirements. It is emphasized that the quality management system requirements specified in this International Stan
43、dard are complementary to the technical requirements for product that are necessary to meet customer and applicable regulatory requirements for safety and performance. The adoption of a quality management system is a strategic decision of an organization. The design and implementation of an organiza
44、tions quality management system is influenced by the: a) organizational environment, changes in that environment, and the influence that the organizational environment has on the conformity of the medical devices; b) organizations varying needs; c) organizations particular objectives; d) product the
45、 organization provides; e) processes the organization employs; f) organizations size and organizational structure; g) regulatory requirements applicable to the organizations activities. It is not the intent of this International Standard to imply the need for uniformity in the structure of different
46、 quality management systems, uniformity of documentation or alignment of documentation to the clause structure of this International Standard. There is a wide variety of medical devices and some of the particular requirements of this International Standard only apply to named groups of medical devic
47、es. These groups are defined in Clause 3. 2016 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 13485:2016 ix 0.2 Clarification of concepts In this International Standard, the following terms or phrases are used in the context described below. When a requirement is qualified
48、by the phrase “as appropriate”, it is deemed to be appropriate unless the organization can justify otherwise. A requirement is considered appropriate if it is necessary for: product to meet requirements; compliance with applicable regulatory requirements; the organization to carry out corrective act
49、ion; the organization to manage risks. When the term “risk” is used, the application of the term within the scope of this International Standard pertains to safety or performance requirements of the medical device or meeting applicable regulatory requirements. When a requirement is required to be “documented”, it is also required to be established, implemented and maintained. When the term “product” is used, it can also mean “service”. Product applies to output that is intended for, or required by, a customer, or any intended output resulting
