ISO/TR 14969:2004 was withdrawn.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 

  • Status
     : Withdrawn
    Publication date
     : 2004-10
  • Edition
     : 1
    Number of pages
     : 74
  • Technical Committee
     : ISO/TC 210 Quality management and corresponding general aspects for products with a health purpose including medical devices
  • ICS
     :
    03.120.10 Quality management and quality assurance
    11.040.01 Medical equipment in general

Life cycle

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