Maps to
QMSR / ISO 13485: §820.60 / 820.65
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.
What changed
Part 820 addressed identification and traceability in two sections: 820.60 (Identification) required that product be identified during all stages of receipt, production, distribution, and installation; 820.65 (Traceability) required traceability for certain devices (those intended for surgical implantation, life-supporting/sustaining devices, and devices where failure could reasonably cause serious injury). The traceability requirement under 820.65 was triggered by device classification and intended use.
ISO 13485:2016 consolidates identification (7.5.8) and traceability (7.5.9) under production and service provision. Clause 7.5.8 requires product identification by suitable means throughout product realization and identification of product status with respect to monitoring and measurement requirements. Clause 7.5.9 requires documented procedures for traceability, with records of the unique identifier of each unit or batch. For implantable devices, the standard requires records of all components, materials, and work environment conditions used, including identity of personnel performing each manufacturing operation.
The QMSR adopts ISO 13485 clauses 7.5.8 and 7.5.9 and adds the UDI requirement. The QMSR final rule integrates UDI as the primary device identification mechanism, linking traceability requirements to 21 CFR Part 830 (UDI rule). This is a significant addition: where Part 820 traceability was about lot/serial numbers and batch records, the QMSR now expects UDI to be the identification backbone. Companies must ensure their traceability systems can accommodate UDI at all levels of packaging and that traceability records reference UDI as the device identifier.
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.
Common gaps
UDI Not Integrated into Traceability System
majorTraceability systems use internal lot/serial numbers but do not incorporate UDI as a primary identifier. The QMSR expects UDI to be the standard device identifier in traceability records, linking production records, distribution records, and complaint/adverse event reports.
Traceability too narrow (Implant only)
majorTraceability procedures only cover implantable devices, missing 'life-sustaining' devices as required by the supplemental QMSR provisions.
Gaps in In-Process Status Identification
moderateProduct status (inspected, pending inspection, rejected, quarantined) is not clearly identified at all stages of production. ISO 13485 clause 7.5.8 explicitly requires identification of product status with respect to monitoring and measurement requirements throughout production.
Incomplete Traceability for Non-Implantable Devices
moderateCompanies that manufacture non-implantable devices may have limited traceability because Part 820.65 traceability was only required for specific device categories. ISO 13485 clause 7.5.9 requires traceability procedures and unique identification for all medical devices, not just implantables.
Missing Environmental Condition Records for Implantable Devices
moderateFor implantable devices, ISO 13485 clause 7.5.9.2 requires records of work environment conditions during manufacturing. Many batch records capture lot numbers and operator IDs but not environmental conditions (temperature, humidity, cleanroom classification) at the time of manufacture.
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.