ISO-14969 › Medical devices - Quality mangement systems - Guidance on the application of ISO 13485: 2003

ISO-14969 - 1ST EDITION - SUPERSEDED -- See the following: ISO-13485
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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.

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03.120.10 (Quality management and quality assurance)

11.040.01 (Medical equipment in general)

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Document Number

ISO/TR 14969:2004

Revision Level

1ST EDITION

Status

Superseded

Publication Date

Oct. 15, 2004

Committee Number

ISO/TC 210