ISO 13485 audit checklist about identification and traceability
ISO 13485 audit checklist about identification and traceability
Clause 7.5.3
7.5.3.1 Identification
• How do you identify product throughout your processes? (Verify in production, storage, segregation areas, etc.)
• Can you show me documented procedures for this?
• Documented procedures?
7.5.3.2 Traceability
7.5.3.2.1 General
• Documented procedures for traceability?
• Can you show me unique identification records for products requiring traceability?
7.5.3.2.2 Particular requirements for active implantable medical devices and implantable medical devices
• Records of all components, materials and work environment conditions?
• Records of the name and address of consignee
7.5.3.3 Status identification
• How is product inspection status identified? (Verify in production, storage, segregation areas, etc.)
Related documents:
Advertisement
Sponsor sites:
1. Phrases For Performance Appraisals.
2. Interview questions and answers.
This entry was posted
on Sunday, November 22nd, 2009 at 4:09 am and is filed under ISO 13485 checklist.
You can leave a response, or trackback from your own site.
