Identification and Traceability Register

This register defines how product is identified and records the links needed to trace finished devices back to their materials, processes and records, and forward to the customers who received them.

What's Inside

• Identification Scheme
• UDI Structure (GS1)
• Status Identification
• Backward Traceability — Finished Lot to Materials and Records
• Forward Traceability — Distribution Records
• Traceability Test (Mock Recall)
• Traceability Requirements by Market
• Register Review

ISO 13485 Alignment

Supports ISO 13485:2016 requirements, including Clauses 7.5.8 and 7.5.9.1. It fits with the rest of the QEHS Vault ISO 13485 document set.

Format

Supplied as a fully editable Microsoft Word (.docx) file. Add your organisation’s name, logo and details, then use it straight away. Instant download after purchase.