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ISO/TR 14969:2004

Medical devices — Quality management systems — Guidance on the application of ISO 13485: 2003 ISO/TR 14969:2004

Publication date:   Oct 18, 2004

95.99   Withdrawal of Standard   Feb 24, 2016

General information

95.99   Withdrawal of Standard   Feb 24, 2016

ISO

ISO/TC 210 Quality management and corresponding general aspects for medical devices

Technical Report

03.120.10   Quality management and quality assurance | 11.040.01   Medical equipment in general

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Scope

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.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 14969:1999

NOW

WITHDRAWN
ISO/TR 14969:2004
95.99 Withdrawal of Standard
Feb 24, 2016




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