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EVS-EN ISO 13485:2012

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)

General information
Withdrawn from 02.03.2016
Base Documents
ISO 13485:2003; EN ISO 13485:2012
Directives or regulations
None
Standard history
Status
Date
Type
Name
02.03.2016
Main + corrigendum
05.09.2012
Corrigendum
03.05.2012
Main + corrigendum
08.10.2009
Corrigendum
EVS-EN ISO 13485:2004/AC:2009
Main + corrigendum
EVS-EN ISO 13485:2004
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 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 (see Annex B).
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