TR 7-2:2002
Technical Reference - Quality system for medical device components - Guide to the application of requirements (Refer to ISO 13485:2003 and ISO/TR 14969:2004)
OVERVIEW
Applies to all component manufacturers including manufacturers of standard or off-the-shelf components who are encouraged to use applicable elements as guidance for their quality management systems. Covers quality management and organisation, component design, facilities, purchase and handling of starting materials, production and process controls, packaging and labelling control, component evaluation, delivery, complaint handling and records.
COMMENTS
Users can refer to ISO 13485:2003 and ISO/TR 14969:2004
PRODUCT DETAILS
| Status | Withdrawn - 29 Jul 2009 |
|---|---|
| Edition | 2002 |
| No. of Pages | 69 |
| ICS Classification | |
| Committee | Medical Technology Standards Committee |
| Available for Purchase | unknown |
| Adoption | - |