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7/31/2019 As en 46003-2002 Quality Systems - Medical Devices - Particular Requirements for the Application of ISO 9003
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AS EN 460032002EN 46003:1999
Australian Standard
Quality systemsMedical devicesParticular requirements for theapplication of ISO 9003
AS
EN460
03
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This Australian Standard was prepared by Committee QR-008, Quality Systems. It
was approved on behalf of the Council of Standards Australia on 26 June 2002 and
published on 28 June 2002.
The following are represented on Committee QR-008:
Australian Chamber of Commerce and Industry
Australian Electrical and Electronic Manufacturers Association
Australian Industry Group
Australian Information Industry Association
Australian Institute of Petroleum
Australian Organisation for Quality
Boiler and Pressure Vessel Manufacturers Association of Australia
Bureau of Steel Manufacturers of Australia
Certification Bodies (Australia)
Commonwealth Department of Transport and Regional Services
Department of Agriculture, Fisheries and Forestry (Commonwealth)Department of Defence (Australia)
Department of Industry Science and Resources (Commonwealth)
Electricity Supply Association of Australia
Federal Chamber of Automotive Industries
Institute of Materials Engineering Australasia
Institution of Engineers Australia
Main Roads Department
Queensland Master Builders Australia
Plastics and Chemicals Industries Association Incorporated
Quality Society of Australasia
The Royal Australian Chemical Institute
Keeping Standards up-to-date
Standards are living documents which reflect progress in science, technology and
systems. To maintain their currency, all Standards are periodically reviewed, and
new editions are published. Between editions, amendments may be issued.
Standards may also be withdrawn. It is important that readers assure themselves
they are using a current Standard, which should include any amendments which
may have been published since the Standard was purchased.
Detailed information about Standards can be found by visiting the StandardsAustralia web site at www.standards.com.au and looking up the relevant Standardin the on-line catalogue.
Alternatively, the printed Catalogue provides information current at 1 January each
year, and the monthly magazine, The Australian Standard, has a full listing of
revisions and amendments published each month.
We also welcome suggestions for improvement in our Standards, and especially
encourage readers to notify us immediately of any apparent inaccuracies orambiguities. Contact us via email at [email protected], or write to the Chief
Executive, Standards Australia International Ltd, GPO Box 5420, Sydney, NSW
2001.
This Standard was issued in draft form for comment as DR 02211.
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