ISO/TR 14969:2004
Medical devices — Quality management systems — Guidance on the application of ISO 13485: 2003
Reference number
ISO/TR 14969:2004
Edition 1
2004-10
Withdrawn
ISO/TR 14969:2004
33752
Withdrawn (Edition 1, 2004)

ISO/TR 14969:2004 was withdrawn. Guidance for the implementation of ISO 13485:2016 is provided in a Handbook entitled “ISO 13485:2016 — Medical devices — A practical guide"

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.

General information

  •  : Withdrawn
     : 2004-10
    : Withdrawal of International Standard [95.99]
  •  : 1
     : 74
  • ISO/TC 210
  • RSS updates

Got a question?

Check out our FAQs

Customer care
+41 22 749 08 88

Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)