BAS CEN ISO/TR 14969:2009
Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003 (ISO/TR 14969:2004)
General Information
Status: Withdrawn
No. of pages: 77
Language: English
Edition: 1.
Adoption method: Endorsment
Publication date: 04.09.2009
Technical committee:
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Abstract
ISO/TR 14969:2004 provides guidance for the application of the requirements for quality management systems contained in ISO 13485. It does not add to, or otherwise change, the requirements of ISO 13485. It does not include requirements to be used as the basis of regulatory inspection or certification assessment activities.
This guidance can be used to better understand the requirements of ISO 13485 and to illustrate some of the variety of methods and approaches available for meeting the requirements of ISO 13485.
Lifecycle
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Original document and degree of correspondence
- CEN ISO/TR 14969:2005, identical
- ISO/TR 14969:2004, identical