1、 Reference numberISO/TR 14969:2004(E)ISO 2004Medical devices Quality management systems Guidance on the application of ISO 13485:2003 Dispositifs mdicaux Systmes de gestion de qualit Lignes directrices pour lapplication de lISO 13485:2003 National Standard of CanadaCAN/CSA-ISO/TR 14969:05(ISO/TR 149
2、69:2004)Technical Report ISO/TR 14969:2004 (first edition, 2004-10-15) has been adopted without modification(IDT) as CSA Standard CAN/CSA-ISO/TR 14969:05, which has been approved as a National Standard ofCanada by the Standards Council of Canada.ISBN 1-55397-857-9 February 2005The Canadian Standards
3、 Association (CSA), under whose auspices this National Standard has been produced, was chartered in 1919 and accredited by the Standards Council of Canada to the National Standards system in 1973. It is a not-for-profit, nonstatutory, voluntary membership association engaged in standards development
4、 and certification activities. CSA standards reflect a national consensus of producers and users including manufacturers, consumers, retailers, unions and professional organizations, and governmental agencies. The standards are used widely by industry and commerce and often adopted by municipal, pro
5、vincial, and federal governments in their regulations, particularly in the fields of health, safety, building and construction, and the environment. Individuals, companies, and associations across Canada indicate their support for CSAs standards development by volunteering their time and skills to C
6、SA Committee work and supporting the Associations objectives through sustaining memberships. The more than 7000 committee volunteers and the 2000 sustaining memberships together form CSAs total membership from which its Directors are chosen. Sustaining memberships represent a major source of income
7、for CSAs standards development activities. The Association offers certification and testing services in support of and as an extension to its standards development activities. To ensure the integrity of its certification process, the Association regularly and continually audits and inspects products
8、 that bear the CSA Mark. In addition to its head office and laboratory complex in Toronto, CSA has regional branch offices in major centres across Canada and inspection and testing agencies in eight countries. Since 1919, the Association has developed the necessary expertise to meet its corporate mi
9、ssion: CSA is an independent service organization whose mission is to provide an open and effective forum for activities facilitating the exchange of goods and services through the use of standards, certification and related services to meet national and international needs.For further information o
10、n CSA services, write toCanadian Standards Association5060 Spectrum Way, Suite 100Mississauga, Ontario, L4W 5N6CanadaThe Standards Council of Canada is the coordinating body of the National Standards system, a federation of independent, autonomous organizations working towards the further developmen
11、t and improvement of voluntary standardization in the national interest. The principal objects of the Council are to foster and promote voluntary standardization as a means of advancing the national economy, benefiting the health, safety, and welfare of the public, assisting and protecting the consu
12、mer, facilitating domestic and international trade, and furthering international cooperation in the field of standards. A National Standard of Canada is a standard which has been approved by the Standards Council of Canada and one which reflects a reasonable agreement among the views of a number of
13、capable individuals whose collective interests provide to the greatest practicable extent a balance of representation of producers, users, consumers, and others with relevant interests, as may be appropriate to the subject in hand. It normally is a standard which is capable of making a significant a
14、nd timely contribution to the national interest. Approval of a standard as a National Standard of Canada indicates that a standard conforms to the criteria and procedures established by the Standards Council of Canada. Approval does not refer to the technical content of the standard; this remains th
15、e continuing responsibility of the accredited standards development organization. Those who have a need to apply standards are encouraged to use National Standards of Canada whenever practicable. These standards are subject to periodic review; therefore, users are cautioned to obtain the latest edit
16、ion from the organization preparing the standard.The responsibility for approving National Standards of Canada rests with theStandards Council of Canada270 Albert Street, Suite 200Ottawa, Ontario, K1P 6N7CanadaAlthough the intended primary application of this Standard is stated in its Scope, it is i
17、mportantto note that it remains the responsibility of the users to judge its suitability for their particular purpose.Registered trade-mark of Canadian Standards AssociationCAN/CSA-ISO/TR 14969:05Medical devices Quality management systems Guidance on the application of ISO 13485:2003February 2005 Ca
18、nadian Standards Association CSA/1CAN/CSA-ISO/TR 14969:05Medical devices Quality management systems Guidance on the application of ISO 13485:2003CSA PrefaceThis is the first edition of CAN/CSA-ISO/TR 14969, Medical devices Quality management systems Guidance on the application of ISO 13485:2003, whi
19、ch is an adoption without modification of the identically titled ISO (International Organization for Standardization) Technical Report ISO/TR 14969 (first edition, 2004-10-15). At the time of publication, ISO/TR 14969:2004 is available from ISO in English only.This Technical Report was reviewed for
20、Canadian adoption by the CSA Technical Committee on Quality Management and General Aspects for 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 Committe
21、e is available upon request. This Standard has been approved as a National Standard of Canada by the Standards Council of Canada.February 2005 Canadian Standards Association 2005All rights reserved. No part of this publication may be reproduced in any form whatsoever without the prior permission oft
22、he publisher. ISO material is reprinted with permission. Where the words “this Technical Report” appear in the text, they should be interpreted as “this National Standard of Canada”.Inquiries regarding this National Standard of Canada should be addressed toCanadian Standards Association5060 Spectrum
23、 Way, Suite 100, Mississauga, Ontario, Canada L4W 5N61-800-463-6727 416-747-4044www.csa.caReference numberISO/TR 14969:2004(E)ISO 2004TECHNICAL REPORT ISO/TR14969First edition2004-10-15Medical devices Quality management systems Guidance on the application of ISO 13485:2003 Dispositifs mdicaux Systme
24、s de gestion de qualit Lignes directrices pour lapplication de lISO 13485:2003 ISO/TR 14969:2004(E) PDF disclaimer 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 embed
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27、em relating to it is found, please inform the Central Secretariat at the address given below. ISO 2004 All rights 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 microfil
28、m, without permission in writing from either ISO at the address below or ISOs member body in the country of 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 2004 All rights reservedCAN/CS
29、A-ISO/TR 14969:05ISO/TR 14969:2004(E) ISO 2004 All rights reserved iiiContents Page Foreword iv Introduction v 0.1 General. v 0.2 Process approach. v 0.3 Relationship with other standards, guidance documents and regulatory requirements vii 0.4 Compatibility with other management systems . viii 1 Sco
30、pe 1 1.1 General. 1 1.2 Application. 1 2 Normative references . 2 3 Terms and definitions. 2 4 Quality management system . 3 4.1 General requirements. 3 4.2 Documentation requirements 4 5 Management responsibility 9 5.1 Management commitment 9 5.2 Customer focus. 10 5.3 Quality policy. 10 5.4 Planni
31、ng . 11 5.5 Responsibility, authority and communication. 13 5.6 Management review 14 6 Resource management. 17 6.1 Provision of resources . 17 6.2 Human resources 17 6.3 Infrastructure. 19 6.4 Work environment. 19 7 Product realization 22 7.1 Planning of product realization . 22 7.2 Customer-related
32、 processes . 25 7.3 Design and development 27 7.4 Purchasing. 36 7.5 Production and service provision. 39 7.6 Control of monitoring and measuring devices 49 8 Measurement, analysis and improvement 51 8.1 General. 51 8.2 Monitoring and measurement 52 8.3 Control of nonconforming product . 56 8.4 Anal
33、ysis of data. 58 8.5 Improvement 58 Annex A (informative) Terms used in certain regulatory administrations to describe documents referenced in this Technical Report 64 Annex B (informative) Analysis of significant changes from ISO 13485:1996 to ISO 13485:2003. 65 Bibliography . 73 CAN/CSA-ISO/TR 149
34、69:05ISO/TR 14969:2004(E) iv ISO 2004 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 out through ISO technical committee
35、s. 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 collaborates closely with the Inter
36、national 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 Standards. Draft International St
37、andards 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. In exceptional circumstances, when a technical committee has collected data of a different kind
38、 from that which is normally published as an International Standard (“state of the art“, for example), it may decide by a simple majority vote of its participating members to publish a Technical Report. A Technical Report is entirely informative in nature and does not have to be reviewed until the d
39、ata it provides are considered to be no longer valid or useful. Attention is drawn to the possibility that some of the elements of this Technical Report may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO/TR 14969 was prepared by
40、Technical Committee ISO/TC 210, Quality management and corresponding general aspects for medical devices. NOTE ISO/TC 210/WG1 is prepared to accept questions and comments related to the content of ISO 13485:2003 and/or ISO/TR 14969:2004. Please address all such questions and comments to the ISO/TC 2
41、10 secretariat at: hwoehrleaami.org. These questions and comments will be considered for development of additional guidance in the application of ISO 13485:2003 either by revision of ISO/TR 14969 or the development of a “Frequently Asked Questions” document. You will not receive a response to your q
42、uestions or comments, 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 has been technically revised. Throughout this Technical Report, when the text of ISO 13485 is directly quoted, it appears enclosed in bo
43、xes prefaced by: “ISO 13485:2003, Medical devices Quality management systems Requirements for regulatory purposes”. CAN/CSA-ISO/TR 14969:05ISO/TR 14969:2004(E) ISO 2004 All rights reserved vIntroduction 0.1 General 0.1.1 This Technical Report provides guidance to assist in the development, implement
44、ation and maintenance of quality management systems that aim to meet the requirements of ISO 13485 for organizations that design and develop, produce, install and service medical devices, or that design, develop and provide related services. It provides guidance related to quality management systems
45、 for a wide variety of medical devices and related services. Such medical devices include active, non-active, implantable and non-implantable medical devices and in vitro diagnostic medical devices. ISO 13485 specifies the quality management system requirements for medical devices for regulatory pur
46、poses (see Annex A). ISO 13485 accommodates the previous ISO 13488 by permissible exclusion as specified in ISO 13485:2003, 1.2. When judging the applicability of the guidance in this Technical Report, one should consider the nature of the medical device(s) to which it will apply, the risk associate
47、d with the use of these medical devices, and the applicable regulatory requirements. As used in this Technical Report, the term “regulatory requirement” includes any part of a law, ordinance, decree or national and/or regional regulation applicable to quality management systems for medical devices a
48、nd related services. This Technical Report provides some approaches that an organization can use to implement and maintain a quality management system which conforms with ISO 13485. Alternative approaches can be used if they also satisfy the requirements of ISO 13485. 0.1.2 The guidance given in thi
49、s Technical Report is applicable to the design, development, production, installation and servicing of medical devices of all kinds. It describes concepts and methods that can be considered by organizations which are establishing and maintaining quality management systems. An organization can voluntarily incorporate guidance from this Technical Report, wholly or in part, into its quality management system. 0.1.3 Guidance contained in this Technical Report can be useful as background information for those represen
