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
HS
30.01 , 30.05 , 30.06 , 33.04 , 33.06 , 33.07 , 34.04 , 34.07 , 37.05 , 38.08 , 38.21 , 38.22 , 39.24 , 39.26 , 40.14 , 40.15 , 48.18 , 48.23 , 59.06 , 62.11 , 62.12 , 63.07 , 66.02 , 84.19 , 84.21 , 85.39 , 87.13 , 87.14 , 90.01 , 90.02 , 90.04 , 90.06 , 90.11 , 90.13 , 90.18 , 90.19 , 90.20 , 90.21 , 90.22 , 90.25 , 94.02 , 94.05
HS Range
MRA/Harmonised Regulations related to the Standard
ASEAN Agreement on Medical Device Directive (AMDD)
ASEAN Body responsible for Standard
ASEAN Medical Device Committee (AMDC)
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