ISO/TR 14969:2004 PDF
Medical devices — Quality management systems — Guidance on the application of ISO 13485: 2003
Open preview (PDF)Medical devices — Quality management systems — Guidance on the application of ISO 13485: 2003Title (English):
ISO/TR 14969:2004
Medical devices — Quality management systems — Guidance on the application of ISO 13485: 2003
- Document status:
- Withdrawn
- Format:
- Electronic (PDF)
- Number of pages:
- 74
- Publication date:
- October 18, 2004
- Edition:
- ISO TR 14969 edition 1 version 1
- ICS:
- 03.120.10
Description (English):
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.
Technical details
- Technical committee
- ISO/TC 210 - Quality management and corresponding general aspects for medical devices
- SKU
- ISO/TR 14969:2004
