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BSI - BS EN ISO 13485

Quality Systems - Medical Devices - Particular Requirements for the Application of EN ISO 9001

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Organization: BSI
Publication Date: 15 March 2001
Status: inactive
Page Count: 20
ICS Code (Quality management and quality assurance): 03.120.10
ICS Code (Medical equipment in general): 11.040.01
scope:

To be read in conjunction with BS EN ISO 9001:1994

Document History

March 31, 2016
Medical devices - Quality management systems - Requirements for regulatory purposes
A description is not available for this item.
March 31, 2016
Medical devices - Quality management systems - Requirements for regulatory purposes
A description is not available for this item.
March 31, 2016
Medical devices - Quality management systems - Requirements for regulatory purposes
A description is not available for this item.
March 31, 2016
Medical devices - Quality management systems - Requirements for regulatory purposes
A description is not available for this item.
February 29, 2016
Medical devices - Quality management systems - Requirements for regulatory purposes
A description is not available for this item.
March 31, 2012
Medical devices - Quality management systems - Requirements for regulatory purposes
A description is not available for this item.
March 31, 2012
Medical devices - Quality management systems - Requirements for regulatory purposes
A description is not available for this item.
July 24, 2003
Medical devices - Quality management systems - Requirements for regulatory purposes
General  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...
July 24, 2003
Medical devices Quality management systems Requirements for regulatory purposes
General  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...
July 24, 2003
Medical devices - Quality management systems - Requirements for regulatory purposes
A description is not available for this item.
BS EN ISO 13485
March 15, 2001
Quality Systems - Medical Devices - Particular Requirements for the Application of EN ISO 9001
To be read in conjunction with BS EN ISO 9001:1994
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