Maps to
FDA QMSR (Part 820): §820.60 / 820.65
ISO 13485: ISO 13485 §7.5.8 / 7.5.9
Requirement text
Product must be identified by suitable means (lot number, batch, serial number, UDI) throughout all stages of product realization. A documented traceability procedure must exist. Traceability records must be maintained to allow investigation of safety-related events.
Atomic constraints
- •Product identification methods (lot, batch, serial number, UDI) must be documented.
- •Product shall be identified throughout all stages of manufacturing.
- •A documented traceability procedure must exist.
- •UDI must be assigned and applied to device labels in accordance with applicable requirements.
- •Traceability records must be maintained to allow investigation of safety-related events.
- •For implantable devices, traceability to components, materials, and environmental conditions must be maintained.
Evidence signals
- •
FILE_EXISTS
(Traceability|UDI.*Procedure|Identification.*Procedure|Lot.*Control|Batch.*Record|Serial.*Number)
- •
CONTENT_MATCH
Does this document describe product identification methods, lot or batch numbering, UDI assignment, or traceability requirements from components to finished devices?
Audit defense
Product identification and traceability for [your product] is documented in [your document ID]. Our traceability system assigns unique lot/batch/serial numbers at defined stages, applies UDI to device labels, and maintains batch records linking each finished device to its component lots and production conditions per ISO 13485 7.5.8/7.5.9 and QMSR 820.65.