Medical devices -- Quality management systems -- Guidance on the application of ISO 13485: 2003
ISO/TR 14969:2004 was withdrawn.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"
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.
A standard is reviewed every 5 years
Revisions / Corrigenda