ISO/TR 14969:2004

Medical devices -- Quality management systems -- Guidance on the application of ISO 13485: 2003

Media and price

Language	Format	Add to basket
English	PDF (2 444 kB)	CHF 180,00
English	Paper	CHF 180,00
Russian	PDF (911 kB)	CHF 180,00
Russian	Paper	CHF 180,00

General information

Number of Pages: 74

Edition: 1 (Monolingual)	ICS: 03.120.10; 11.040.01
Status: Published	Stage: 90.93 (2007-11-01)
TC/SC: TC 210

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.

Revision information

Revises: ISO 14969:1999

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