AS ISO 13485-2002

Superseded

Quality systems - Medical devices - Particular requirements for the application of ISO 9001

Available format(s)

Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English

Published date

01-01-2002

Publisher

Standards Australia

Superseded date

04-10-2017

Superseded by

AS ISO 13485-2003

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Summarise this standard

AI-generated summary

Specifies, for suppliers of medical devices, quality systems requirements that are more specific than those given in ISO 9001.

Committee	QR-008
DocumentType	Standard
ISBN	0 7337 4702 7
Pages	10
PublisherName	Standards Australia
Status	Superseded
SupersededBy	AS ISO 13485-2003
Supersedes	DR 02212 CP

Standards	Relationship
ISO 13485:1996	Identical

First published as AS ISO 13485-2002.

Frequently Asked Questions

AS ISO 13485 is indexed in this catalog under medical devices, quality management, regulatory, qms, certification, manufacturing. It is published by Standards Australia.

AS ISO 13485 belongs to the topic area of medical device quality management systems. It is published by Standards Australia.

AS ISO 13485 is Standards Australia's standard for medical device quality management systems, while EN ISO 9001 covers quality management systems (Europe). AS ISO 13485 sets quality management system requirements for organisations involved in the lifecycle of medical devices. EN ISO 9001 sets requirements for establishing, operating and continually improving a quality management system.

AS ISO 13485 is published by Standards Australia.

AS ISO 13485 sets quality management system requirements for organisations involved in the lifecycle of medical devices. It is published by Standards Australia.

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AS ISO 13485-2002

Quality systems - Medical devices - Particular requirements for the application of ISO 9001

Abstract

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