ISO-14969 › Historical Revision Information
Quality systems -- Medical devices -- Guidance on the application of ISO 13485 and ISO 13488
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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.
To find similar documents by classification:
03.120.10 (Quality management and quality assurance)
11.040.01 (Medical equipment in general)
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Document Number
ISO 14969:1999
Revision Level
1999 EDITION
Status
Superseded
Publication Date
June 1, 1999
Committee Number
ISO/TC 210