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Norm

ÖNORM EN ISO 13485

Issue date: 2012 11 01

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 + Cor 1:2009) (consolidated version)

This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and ...
Withdrawn: 2016 07 01
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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Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)...
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ÖVE/ÖNORM EN ISO 13485
2017 08 01
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ÖVE/ÖNORM EN ISO 13485
2016 07 01
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Norm
ÖNORM EN ISO 13485
2012 11 01
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 ...
Norm
ÖNORM EN ISO 13485
2010 02 15
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 ...
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ÖNORM EN ISO 13485
2007 11 01
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)...
Norm
ÖNORM EN ISO 13485
2003 11 01
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)...
Norm
ÖVE/ÖNORM EN ISO 13485
2001 04 01
Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001 (revi...
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ÖVE/ÖNORM EN ISO 13488
2001 04 01
Quality systems - Medical devices - Particular requirements for the application of EN ISO 9002 (revi...
Norm
ÖVE/ÖNORM EN 46003
2000 02 01
Quality systems - Medical devices - Particular requirements for the application of EN ISO 9003
Norm
ÖNORM EN 46001
1996 12 01
Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001
Norm
ÖNORM EN 46001
1996 12 01
Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001
Norm
ÖNORM EN 46002
1996 12 01
Quality systems - Medical devices - Particular requirements for the application of EN ISO 9002
Norm
ÖNORM EN 46002
1996 12 01
Quality systems - Medical devices - Particular requirements for the application of EN ISO 9002
Norm
ÖNORM EN 46001
1994 02 01
Quality systems - Medical devices - Particular requirements for the application of EN 29001
Norm
ÖNORM EN 46002
1994 02 01
Quality systems - Medical devices - Particular requirements for the application of EN 29002
Norm
ÖNORM EN 46002
1994 02 01
Quality systems - Medical devices - Particular requirements for the application of EN 29002
Norm
ÖNORM EN 46001
1994 02 01
Quality systems - Medical devices - Particular requirements for the application of EN 29001
Norm
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Norm
ISO 9000:2005
Issue date : 2005 09 20
Quality management systems — Fundamentals and vocabulary
Norm
ISO 9000:2015
Issue date : 2015 09 22
Quality management systems — Fundamentals and vocabulary
Norm
ÖVE/ÖNORM EN ISO 13485
Issue date : 2016 07 01
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)