Title Of Document

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

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.

Category of Standards

Category 1

Document number assigned by ASEAN

ISO/TR 14969:2004

ICS

HS

30.0130.0530.0633.0433.0633.0734.0434.0737.0538.0838.2138.2239.2439.2640.1440.1548.1848.2359.0662.1162.1263.0766.0284.1984.2185.3987.1387.1490.0190.0290.0490.0690.1190.1390.1890.1990.2090.2190.2290.2594.0294.05

HS Range

MRA/Harmonised Regulations related to the Standard

ASEAN Agreement on Medical Device Directive (AMDD)

ASEAN Body responsible for Standard

Medical Device Product Working Group (MDPWG)

Member States

 ID   PH 

Date of harmonisation in ASEAN

Date of Latest Review

Links :

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