DS DS/EN 46003 Quality systems - Medical devices - Particular requirements for the application of EN ISO 9003
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DS DS/EN 46003 Document Information:
Title
Quality systems - Medical devices - Particular requirements for the application of EN ISO 9003
Kvalitetsstyringssystemer. Medicinsk udstyr. Særlige krav for anvendelsen af EN ISO 9003
Dansk Standard
Publication Date:
Sep 13, 1999
Scope:
This standard specifies, in conjunction with EN ISO 9003:1994, the quality system requirements for the final inspection and test of medical devices excluding in vitro diagnostic medical devices and active implantable medical devices, and is applicable when a medical devices supplier's quality system is assessed in accordance with regulatory requirements.
Keywords:
- QUALITY SYSTEM
- MEDICAL DEVICES
- FINAL INSPECTION
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