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AS ISO 13485-2003

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Medical devices - Quality management systems - Requirements for regulatory purposes
Available format(s)

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

Superseded date

12-13-2017

Language(s)

English

Published date

01-01-2003

Publisher

Standards Australia

Preview

Specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. The primary objective is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001. It is identical with and reproduced from ISO 13485:2003.

This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.The primary objective of this International Standard is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatoryrequirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001 (see Annex B).

Committee
HE-028
DocumentType
Standard
ISBN
0 7337 5715 4
Pages
57
PublisherName
Standards Australia
Status
Superseded
SupersededBy
Supersedes
UnderRevision

Standards Relationship
ISO 13485:2003 Identical
ISO 13485:2016 Identical

First published as AS ISO 13485-2002 and AS ISO 13488-2002.AS ISO 13485-2002 and AS ISO 13488 revised, amalgamated and redesignated as AS ISO 13485-2003. First published as AS ISO 13485-2002 and AS ISO 13488-2002. AS ISO 13485-2002 and AS ISO 13488 revised, amalgamated and redesignated as AS ISO 13485-2003.

AS 5483-2012 Minimizing the risk of contamination in products used to collect and analyse biological material for forensic DNA purposes
AS/NZS 3551:2012 Management programs for medical equipment

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Hardcopy - English
PDF 1 User - English
PDF 3 Users - English
PDF 5 Users - English
PDF 9 Users - English
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