1、 ISO 2016 Medical devices Quality management systems Requirements for regulatory purposes Dispositifs mdicaux Systmes de management de la qualit Exigences des fins rglementaires INTERNATIONAL STANDARD ISO 13485 Third edition 2016-03-01 Reference number ISO 13485:2016(E) ISO 13485:2016(E)ii ISO 2016
2、All rights reserved COPYRIGHT PROTECTED DOCUMENT ISO 2016, Published in Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the in
3、ternet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Ch. de Blandonnet 8 CP 401 CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax +41 22 749 09
4、47 copyrightiso.org www.iso.org ISO 13485:2016(E)Foreword v Introduction vi 1 Scope . 1 2 Normative references 1 3 T erms and definitions . 1 4 Quality management system 6 4.1 General requirements . 6 4.2 Documentation requirements 7 4.2.1 General 7 4.2.2 Quality manual 7 4.2.3 Medical device file 7
5、 4.2.4 Control of documents 8 4.2.5 Control of records . 8 5 Management responsibility 9 5.1 Management commitment 9 5.2 Customer focus . 9 5.3 Quality policy 9 5.4 Planning 9 5.4.1 Quality objectives 9 5.4.2 Quality management system planning . 9 5.5 Responsibility, authority and communication 10 5
6、.5.1 Responsibility and authority 10 5.5.2 Management representative .10 5.5.3 Internal communication .10 5.6 Management review 10 5.6.1 General.10 5.6.2 Review input .10 5.6.3 Review output .11 6 Resource management 11 6.1 Provision of resources .11 6.2 Human resources .11 6.3 Infrastructure 12 6.4
7、 Work environment and contamination control .12 6.4.1 Work environment 12 6.4.2 Contamination control .12 7 Product realization .12 7.1 Planning of product realization .12 7.2 Customer-related processes .13 7.2.1 Determination of requirements related to product 13 7.2.2 Review of requirements relate
8、d to product 13 7.2.3 Communication 14 7.3 Design and development .14 7.3.1 General.14 7.3.2 Design and development planning 14 7.3.3 Design and development inputs 14 7.3.4 Design and development outputs 15 7.3.5 Design and development review .15 7.3.6 Design and development verification .15 7.3.7 D
9、esign and development validation .15 7.3.8 Design and development transfer 16 7.3.9 Control of design and development changes 16 7.3.10 Design and development files 16 ISO 2016 All rights reserved iii Contents Page ISO 13485:2016(E)7.4 Purchasing .17 7.4.1 Purchasing process .17 7.4.2 Purchasing inf
10、ormation 17 7.4.3 Verification of purchased product .17 7.5 Production and service provision 18 7.5.1 Control of production and service provision 18 7.5.2 Cleanliness of product 18 7.5.3 Installation activities .18 7.5.4 Servicing activities 19 7.5.5 Particular requirements for sterile medical devic
11、es19 7.5.6 Validation of processes for production and service provision 19 7.5.7 Particular requirements for validation of processes for sterilization and sterile barrier systems .19 7.5.8 Identification 20 7.5.9 Traceability 20 7.5.10 Customer property 20 7.5.11 Preservation of product 20 7.6 Contr
12、ol of monitoring and measuring equipment 21 8 Measurement, analysis and improvement .22 8.1 General 22 8.2 Monitoring and measurement 22 8.2.1 Feedback 22 8.2.2 Complaint handling 22 8.2.3 Reporting to regulatory authorities .23 8.2.4 Internal audit .23 8.2.5 Monitoring and measurement of processes
13、23 8.2.6 Monitoring and measurement of product .23 8.3 Control of nonconforming product 24 8.3.1 General.24 8.3.2 Actions in response to nonconforming product detected before delivery .24 8.3.3 Actions in response to nonconforming product detected after delivery 24 8.3.4 Rework 24 8.4 Analysis of da
14、ta 24 8.5 Improvement .25 8.5.1 General.25 8.5.2 Corrective action .25 8.5.3 Preventive action 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 .30 Bibliography .36 iv ISO 2016 Al
15、l rights reserved ISO 13485:2016(E) Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body i
16、nterested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechn
17、ical Commission (IEC) on all matters of electrotechnical standardization. The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO d
18、ocuments should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives). Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held respo
19、nsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents). Any trade name used in this document is information given
20、 for the convenience of users and does not constitute an endorsement. For an explanation on the meaning of ISO specific terms and expressions related to conformit y assessment, as well as information about ISOs adherence to the World Trade Organization (WTO) principles in the Technical Barriers to T
21、rade (TBT) see the following URL: www.iso.org/iso/foreword.html. The committee responsible for this document is Technical Committee ISO/TC 210, Quality management and corresponding general aspects for medical devices. This third edition of ISO 13485 cancels and replaces the second edition (ISO 13485
22、:2003) and ISO/TR 14969:2004, which have been technically revised. It also incorporates the Technical Corrigendum ISO 13485:2003/Cor.1:2009. A summary of the changes incorporated into this edition compared with the previous edition is given in Annex A. ISO 2016 All rights reserved v ISO 13485:2016(E
23、) Introduction 0.1 General This International Standard specifies requirements for a quality management system that can be used by an organization involved in one or more stages of the life-cycle of a medical device, including design and development, production, storage and distribution, installation
24、, servicing and final decommissioning and disposal of medical devices, and design and development, or provision of associated activities (e.g. technical support). The requirements in this International Standard can also be used by suppliers or other external parties providing product (e.g. raw mater
25、ials, components, subassemblies, medical devices, sterilization services, calibration services, distribution services, maintenance services) to such organizations. The supplier or external party can voluntarily choose to conform to the requirements of this International Standard or can be required b
26、y contract to conform. Several jurisdictions have regulatory requirements for the application of quality management systems by organizations with a variety of roles in the supply chain for medical devices. Consequently, this International Standard expects that the organization: identifies its role(s
27、) under applicable regulatory requirements; 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 n
28、ation and region to 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 an
29、d external parties, 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
30、International Standard 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 implementat
31、ion of an organizations 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 objectiv
32、es; d) product the 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 stru
33、cture of different 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 group
34、s of medical devices. These groups are defined in Clause 3.vi ISO 2016 All rights reserved ISO 13485:2016(E) 0 . 2 C l a r i f i c a t i o n o f c o n c e p t s In this International Standard, the following terms or phrases are used in the context described below. When a requirement is qualified by
35、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 action
36、; 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 “docu
37、mented”, 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 from a product realization process. When the term “reg
38、ulatory requirements” is used, it encompasses requirements contained in any law applicable to the user of this International Standard (e.g. statutes, regulations, ordinances or directives). The application of the term “regulatory requirements” is limited to requirements for the quality management sy
39、stem and the safety or performance of the medical device. In this International Standard, the following verbal forms are used: “shall” indicates a requirement; “should” indicates a recommendation; “may” indicates a permission; “can” indicates a possibility or a capability. Information marked as “NOT
40、E” is for guidance in understanding or clarifying the associated requirement. 0.3 Process approach This International Standard is based on a process approach to quality management. Any activity that receives input and converts it to output can be considered as a process. Often the output from one pr
41、ocess directly forms the input to the next process. For an organization to function effectively, it needs to identify and manage numerous linked processes. The application of a system of processes within an organization, together with the identification and interactions of these processes, and their
42、 management to produce the desired outcome, can be referred to as the “process approach.” When used within a quality management system, such an approach emphasizes the importance of: a) understanding and meeting requirements; b) considering processes in terms of added value; c) obtaining results of
43、process performance and effectiveness; d) improving processes based on objective measurement. ISO 2016 All rights reserved vii ISO 13485:2016(E) 0.4 Relationship with ISO 9001 While this is a stand-alone standard, it is based on ISO 9001:2008, which has been superseded by ISO 9001:2015. For the conv
44、enience of users, Annex B shows the correspondence between this International Standard and ISO 9001:2015. This International Standard is intended to facilitate global alignment of appropriate regulatory requirements for quality management systems applicable to organizations involved in one or more s
45、tages of the life-cycle of a medical device. This International Standard includes some particular requirements for organizations involved in the life-cycle of medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclu
46、sions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management system meets all the requirements of ISO 9001. 0.5 Compatibility with other management systems This International Standard does not include
47、 requirements specific to other management systems, such as those particular to environmental management, occupational health and safety management, or financial management. However, this International Standard enables an organization to align or integrate its own quality management system with rela
48、ted management system requirements. It is possible for an organization to adapt its existing management system(s) in order to establish a quality management system that complies with the requirements of this International Standard.viii ISO 2016 All rights reserved Medical devices Quality management
49、systems Requirements for regulatory purposes 1 Scope This International Standard 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 and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and
