Standard

NPR-CEN-ISO/TR 14969:2005 nl

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

  • This norm is withdrawn since 01-03-2016

228,00 248,52 Incl BTW

About norm

Status Withdrawn
Number of pages 94
Committee Medische hulpmiddelen - horizontale onderwerpen
Published on 01-07-2005
Language Dutch
This Technical Report 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. This Technical Report 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.

Details

ICS-code 03.120.10
11.040.01
Dutch title Medische hulpmiddelen - Kwaliteitsmanagementsystemen - Leidraad voor de toepassing van ISO 13485:2003
English title Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003
Replaces
Replaced by

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