Maps to
QMSR / ISO 13485: §820.45
ISO 13485: §7.5.1
Requirement text
Labeling activities shall be controlled. Label accuracy shall be verified before release.
What changed
Part 820 section 820.45 contained detailed, prescriptive labeling control requirements: procedures for label integrity, inspection, storage, and control of labeling operations. It required that labels be designed, printed, and applied under controlled conditions, that each label be inspected for accuracy during application, and that labeling storage areas be controlled to prevent mix-ups. These requirements were among the most prescriptive in Part 820.
ISO 13485:2016 does not have a dedicated labeling clause. Labeling is addressed only generally under clause 7.5.1 (control of production and service provision) which requires documented procedures and work instructions, and clause 7.5.8 (identification). There is no ISO 13485 equivalent to Part 820's explicit requirements for label inspection, label storage controls, or label issuance accountability.
This is a critical QMSR-specific retention. The FDA recognized that ISO 13485 does not adequately address labeling controls for FDA-regulated devices, so the QMSR retains 820.45 as a standalone requirement. The QMSR final rule preamble explicitly states that labeling controls remain essential for device safety and that these requirements go beyond what ISO 13485 provides. Additionally, the QMSR 820.45 requirement now encompasses UDI (Unique Device Identification) labeling requirements, linking labeling controls to the FDA UDI rule (21 CFR Part 830). This means FDA-regulated manufacturers must maintain labeling controls that exceed what an ISO 13485-only certification would require.
Atomic constraints
- •Labeling procedures must be documented
- •Label accuracy must be verified before release
- •Label storage and control must be defined
- •UDI labeling requirements must be addressed
Common gaps
No Dedicated Label Control Procedure
majorCompanies relying solely on ISO 13485 may not have a standalone labeling control procedure. They may address labeling as part of general production work instructions without the specificity needed for FDA compliance — dedicated label inspection steps, storage controls, and issuance accountability.
Missing UDI Integration in Labeling Procedures
majorLabeling procedures do not address UDI assignment, formatting, placement, or GUDID database submission requirements. UDI is now explicitly linked to QMSR labeling controls, and procedures must ensure UDI is correctly applied to every device label.
No 'Designated Individual' check
majorProcedures allow any operator to release labels, missing the 'designated individual' requirement retained from 820.45.
No Label Verification at Point of Application
moderatePart 820 required label inspection during the labeling operation to verify accuracy and correctness. Many QMS libraries lack a defined verification step at the point of label application, relying instead on final inspection to catch label errors after the fact.
Inadequate Label Storage and Segregation Controls
moderateLabels for different products or versions stored together without adequate segregation, version control, or environmental controls. QMSR 820.45 requires that label storage prevent mix-ups and that obsolete labels be controlled.
Evidence signals
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FILE_EXISTS
(Label.*Control|Labeling.*SOP|Label.*Verification|Label.*Procedure)
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CONTENT_MATCH
Does this document describe labeling control procedures, label verification, or UDI labeling requirements?
Audit defense
Labeling controls for [your product] are managed through [your document ID]. All labels are verified for accuracy before release, label storage and issuance are controlled, and UDI requirements are addressed per QMSR 820.45.