DR 03526 CP
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
04-10-2017
14-10-2003
Proposes the adoption of ISO 13485:2003 to specify 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.
| CommentClosesDate |
02-12-2003
|
| Committee |
HE-028
|
| DocumentType |
Draft
|
| PublisherName |
Standards Australia
|
| Status |
Superseded
|
| SupersededBy |
To be AS ISO 13485
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