1、 Reference numberISO 13485:2003(E)ISO 2003Medical devices Quality management systems Requirements for regulatory purposes Dispositifs mdicaux Systmes de management de la qualit Exigences des fins rglementaires National Standard of CanadaCAN/CSA-ISO 13485:03(ISO 13485:2003)International Standard ISO
2、13485:2003 (second edition, 2003-07-15) has been adopted without modification(IDT) as CSA Standard CAN/CSA-ISO 13485:03, which has been approved as a National Standard of Canada by theStandards Council of Canada.ISBN 1-55397-526-X December 2003The Canadian Standards Association (CSA), The Standards
3、Council of Canada is theunder whose auspices this National Standard has been coordinating body of the National Standards system, produced, was chartered in 1919 and accredited by a federation of independent, autonomousthe Standards Council of Canada to the National organizations working towards the
4、furtherStandards system in 1973. It is a not-for-profit, development and improvement of voluntarynonstatutory, voluntary membership association standardization in the national interest.engaged in standards development and certification The principal objects of the Council are to foster activities. a
5、nd promote voluntary standardization as a means CSA standards reflect a national consensus of of advancing the national economy, benefiting theproducers and users including manufacturers, health, safety, and welfare of the public, assisting consumers, retailers, unions and professional and protectin
6、g the consumer, facilitating domestic organizations, and governmental agencies. The and international trade, and furthering internationalstandards are used widely by industry and commerce cooperation in the field of standards.and often adopted by municipal, provincial, and A National Standard of Can
7、ada is a standard whichfederal governments in their regulations, particularly has been approved by the Standards Council ofin the fields of health, safety, building and Canada and one which reflects a reasonableconstruction, and the environment. agreement among the views of a number of capableIndivi
8、duals, companies, and associations across individuals whose collective interests provide to theCanada indicate their support for CSAs standards greatest practicable extent a balance ofdevelopment by volunteering their time and skills to representation of producers, users, consumers, andCSA Committee
9、 work and supporting the Associations others with relevant interests, as may be appropriateobjectives through sustaining memberships. The to the subject in hand. It normally is a standardmore than 7000 committee volunteers and the 2000 which is capable of making a significant and timelysustaining me
10、mberships together form CSAs total contribution to the national interest.membership from which its Directors are chosen. Approval of a standard as a National Standard ofSustaining memberships represent a major source of Canada indicates that a standard conforms to theincome for CSAs standards develo
11、pment activities. criteria and procedures established by the StandardsThe Association offers certification and testing Council of Canada. Approval does not refer to theservices in support of and as an extension to its technical content of the standard; this remains thestandards development activitie
12、s. To ensure the continuing responsibility of the accreditedintegrity of its certification process, the Association standards-development organization.regularly and continually audits and inspects products Those who have a need to apply standards arethat bear the CSA Mark. encouraged to use National
13、 Standards of CanadaIn addition to its head office and laboratory complex whenever practicable. These standards are subject in Toronto, CSA has regional branch offices in major to periodic review; therefore, users are cautioned centres across Canada and inspection and testing to obtain the latest ed
14、ition from the organizationagencies in eight countries. Since 1919, the preparing the standard.Association has developed the necessary expertise to The responsibility for approving National Standards meet its corporate mission: CSA is an independent of Canada rests with theservice organization whose
15、 mission is to provide an Standards Council of Canadaopen and effective forum for activities facilitating the 270 Albert Street, Suite 200exchange of goods and services through the use of Ottawa, Ontario, K1P 6N7standards, certification and related services to meet Canadanational and international n
16、eeds.For further information on CSA services, write toCanadian Standards Association5060 Spectrum Way, Suite 100Mississauga, Ontario, L4W 5N6CanadaCette Norme nationale du Canada est offerte en anglais et en franais.Although the intended primary application of this Standard is stated in its Scope, i
17、t is importantto note that it remains the responsibility of the users to judge its suitability for their particular purpose.Registered trade-mark of Canadian Standards AssociationMedical devices Quality management systems CAN/CSA-ISO 13485:03 Requirements for regulatory purposes December 2003 Canadi
18、an Standards Association CSA/1 CAN/CSA-ISO 13485:03 Medical devices Quality management systems Requirements for regulatory purposes CSA Preface This is the second edition of CAN/CSA-ISO 13485, Medical devices Quality management systems Requirements for regulatory purposes, which is an adoption witho
19、ut modification of the identically titled ISO (International Organization for Standardization) Standard 13485 (second edition, 2003-07-15). It supersedes the first edition published in 1998 under the title Quality systems Medical devices Particular requirements for the application of ISO 9001 (adopt
20、ed ISO 13485:1996), and also replaces CAN/CSA-ISO 13488-98, Quality systems Medical devices Particular requirements for the application of ISO 9002 (adopted ISO 13488:1996). This Standard was reviewed for Canadian adoption by the CSA Technical Committee on Quality Management and General Aspects for
21、Medical Devices, under the jurisdiction of the Strategic Steering Committee on Health Care Technology, and has been formally approved by the Technical Committee. A list of members of the Technical Committee is available upon request. This Standard has been approved as a National Standard of Canada b
22、y the Standards Council of Canada. December 2003 Canadian Standards Association 2003 All rights reserved. No part of this publication may be reproduced in any form whatsoever without the prior permission of the publisher. ISO material is reprinted with permission. Where the words “this International
23、 Standard” appear in the text, they should be interpreted as “this National Standard of Canada”. Inquiries regarding this National Standard of Canada should be addressed to Canadian Standards Association 5060 Spectrum Way, Suite 100, Mississauga, Ontario, Canada L4W 5N6 1-800-463-6727 416-747-4044 w
24、ww.csa.ca Reference numberISO 13485:2003(E)ISO 2003INTERNATIONAL STANDARD ISO13485Second edition2003-07-15Medical devices Quality management systems Requirements for regulatory purposes Dispositifs mdicaux Systmes de management de la qualit Exigences des fins rglementaires ISO 13485:2003(E) PDF disc
25、laimer This PDF file may contain embedded typefaces. In accordance with Adobes licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties
26、accept therein the responsibility of not infringing Adobes licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to t
27、he file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. ISO 2003 All r
28、ights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISOs member body in the country of
29、the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org ii ISO 2003 All rights reservedISO 13485:2003(E) ISO 2003 All rights reserved iiiContents Page Foreword iv 0 Introduction . v 0.1 General. v 0.2
30、Process approach . v 0.3 Relationship with other standards . vi 0.4 Compatibility with other management systems . vi 1 Scope 1 1.1 General. 1 1.2 Application. 1 2 Normative references . 2 3 Terms and definitions. 2 4 Quality management system . 4 4.1 General requirements . 4 4.2 Documentation requir
31、ements 4 5 Management responsibility 6 5.1 Management commitment 6 5.2 Customer focus. 6 5.3 Quality policy. 6 5.4 Planning . 7 5.5 Responsibility, authority and communication. 7 5.6 Management review 8 6 Resource management. 8 6.1 Provision of resources . 8 6.2 Human resources 9 6.3 Infrastructure.
32、 9 6.4 Work environment. 9 7 Product realization 10 7.1 Planning of product realization . 10 7.2 Customer-related processes 10 7.3 Design and development 11 7.4 Purchasing. 13 7.5 Production and service provision . 14 7.6 Control of monitoring and measuring devices 17 8 Measurement, analysis and imp
33、rovement 17 8.1 General. 17 8.2 Monitoring and measurement 18 8.3 Control of nonconforming product . 19 8.4 Analysis of data. 19 8.5 Improvement 20 Annex A (informative) Correspondence between ISO 13485:2003 and ISO 13485:1996. 21 Annex B (informative) Explanation of differences between ISO 13485:20
34、03 and ISO 9001:2000 25 Bibliography . 57 ISO 13485:2003(E) iv ISO 2003 All rights reservedForeword 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 o
35、ut through ISO technical committees. Each member body interested 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 c
36、ollaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International
37、 Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elemen
38、ts of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 13485 was prepared by Technical Committee ISO/TC 210, Quality management and corresponding general aspects for medical devices. This second edition cancels an
39、d replaces the first edition (ISO 13485:1996), which has been technically revised. It also cancels and replaces ISO 13488:1996. Those organizations which have used ISO 13488 in the past may use this International Standard by excluding certain requirements in accordance with 1.2. This edition of ISO
40、13485 has a revised title and addresses quality assurance of product, customer requirements, and other elements of quality system management. ISO 13485:2003(E) ISO 2003 All rights reserved v0 Introduction 0.1 General This International Standard specifies requirements for a quality management system
41、that can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, development, and provision of related services. It can also be used by internal and external parties, including certification bodies, to assess the organizat
42、ions ability to meet customer and regulatory requirements. Information marked “NOTE” is for guidance in understanding or clarifying the associated requirement. It is emphasized that the quality management system requirements specified in this International Standard are complementary to technical req
43、uirements for products. The adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organizations quality management system is influenced by varying needs, particular objectives, the products provided, the processes employed and
44、the size and structure of the organization. It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation. There is a wide variety of medical devices and some of the particular requirements of this International
45、Standard only apply to named groups of medical devices. These groups are defined in Clause 3. 0.2 Process approach This International Standard is based on a process approach to quality management. Any activity that receives inputs and converts them to outputs can be considered as a process. For an o
46、rganization to function effectively, it has to identify and manage numerous linked processes. Often the output from one process directly forms the input to the next. The application of a system of processes within an organization, together with the identification and interactions of these processes,
47、 and their management, can be referred to as the “process approach”. 0.3 Relationship with other standards 0.3.1 Relationship with ISO 9001 While this is a stand-alone standard, it is based on ISO 9001. Those clauses or subclauses that are quoted directly and unchanged from ISO 9001 are in normal fo
48、nt. The fact that these subclauses are presented unchanged is noted in Annex B. Where the text of this International Standard is not identical to the text of ISO 9001, the sentence or indent containing that text as a whole is shown in italics (in blue italics for electronic versions). The nature and
49、 reasons for the text changes are noted in Annex B. ISO 13485:2003(E) vi ISO 2003 All rights reserved0.3.2 Relationship with ISO/TR 14969 ISO/TR 14969 is a Technical Report intended to provide guidance for the application of ISO 13485. 0.4 Compatibility with other management systems This International Standard follows the format of ISO 9001 for the convenience of users in the medical device community. This International Standard does
