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DS CEN ISO/TR 14969:2005

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

Jan 15, 2013
95.99 Withdrawal of Standard   May 11, 2018

General information

95.99     May 11, 2018

DPS

DPS/KT 316

Technical Report

03.120.10     11.040.01  

English  

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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WITHDRAWN
DS CEN ISO/TR 14969:2005
95.99 Withdrawal of Standard
May 11, 2018

REVISED BY

PUBLISHED
SSH EN ISO 13485:2016

Related project

Adopted from CEN ISO/TR 14969:2005

Adopted from CEN ISO/TR 14969:2005