CAN CSA-ISO 13485-2003 Medical devices - Quality management systems - Requirements for regulatory purposes (Second Edition).pdf
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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
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