Traceability & UDI Essentials Kit

Traceability is frequently underbuilt until a complaint, recall, or audit exposes missing product identity records, weak status labelling, or poor distribution linkage. This kit gives you the core controls for clause 7.5.9, including product identity, warehousing, UDI logic, and traceability records that can scale with the business. That means less time spent rebuilding documents from scratch and a stronger line of evidence when the process is sampled under audit.

What's included

• Identification and Traceability SOP.docx
• UDI and Distribution Register.xlsx
• Sample Identification Labels.pdf
• Traceability Warehousing Registers.xlsx
• Status Labelling Guide.pdf
• Implementation Guide.pdf

Best suited to: Distributor, Startup manufacturer, Warehouse lead, and Quality manager.

Useful in audit situations where you need to:

• Show a structured traceability and UDI process during ISO 13485 certification, surveillance, supplier, or internal audits.
• Support FDA inspections with controlled records, traceability, and process evidence related to traceability and UDI.
• Support EU MDR technical documentation or quality-system reviews where traceability and UDI records need to be complete, controlled, and consistent.

Use this toolkit to move faster, create cleaner evidence, and reduce the time it takes to stand up or repair this part of your ISO 13485 system.