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CEN ISO/TR 14969:2005

Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003 (ISO/TR 14969:2004) CEN ISO/TR 14969:2005

General information

99.60 Withdrawal effective   Mar 2, 2016

CEN/CENELEC

CEN/CLC/JTC 3 Quality management and corresponding general aspects for medical devices

Technical Report

03.120.10   Quality management and quality assurance | 11.040.01   Medical equipment in general

Scope

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.

Life cycle

NOW

WITHDRAWN
CEN ISO/TR 14969:2005
99.60 Withdrawal effective
Mar 2, 2016

REVISED BY

PUBLISHED
EN ISO 13485:2016

Relations

Adopted from ISO/TR 14969:2004 IDENTICAL