AS ISO 13485-2003
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Medical devices - Quality management systems - Requirements for regulatory purposes
Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users
12-13-2017
English
01-01-2003
Important note : All end users must be registered with an Account prior to user licenses being assigned.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.
| Committee |
HE-028
|
| DocumentType |
Standard
|
| ISBN |
0 7337 5715 4
|
| Pages |
57
|
| PublisherName |
Standards Australia
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes | |
| UnderRevision |
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).
| 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.
| 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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