NEN - NPR-CEN-ISO/TR 14969
Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003
active, Most Current
| Organization: | NEN |
| Publication Date: | 1 July 2005 |
| Status: | active |
| Page Count: | 96 |
| ICS Code (Quality management and quality assurance): | 03.120.10 |
| ICS Code (Medical equipment in general): | 11.040.01 |
scope:
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.
Document History
NPR-CEN-ISO/TR 14969
July 1, 2005
Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003
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...
July 1, 2005
Quality systems - Medical devices - Guidance on the application of ISO 13485:2003
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...