CAN CSA-ISO TR 14969-2005 Medical devices - Quality management systems - Guidance on the application of ISO 13485 2003 (First Edition).pdf
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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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