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SRPS CEN ISO/TR 14969:2012

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

Jun 21, 2012
95.99   Withdrawal of Standard   Feb 28, 2018

General information

95.99     Feb 28, 2018

ISS

Z076

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.

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SRPS CEN ISO/TR 14969:2012
95.99 Withdrawal of Standard
Feb 28, 2018

Related project

Adopted from CEN ISO/TR 14969:2005

Adopted from ISO/TR 14969:2004 IDENTICAL