Maps to
QMSR / ISO 13485: §820.30(f)
ISO 13485: §7.3.6
Requirement text
Design verification shall confirm that outputs meet input requirements. Results and follow-up actions shall be recorded.
What changed
Part 820.30(f) required that design verification confirm that design output met design input requirements. The verification had to be documented, including methods used, the date, and the individual(s) performing the verification. Results of verification and any actions taken had to be recorded in the design history file.
ISO 13485:2016 clause 7.3.6 maintains the same fundamental requirement — verification must be performed in accordance with planned arrangements to ensure outputs meet input requirements. However, ISO 13485 adds explicit language requiring that verification be performed 'in accordance with planned and documented arrangements.' This means the verification plan itself must be documented before execution, not just the results.
ISO 13485 also requires that records of the results of verification and any necessary actions be maintained. While Part 820 also required this, the ISO 13485 language more explicitly connects verification to the overall design plan created under 7.3.2 — verification activities should have been planned during design planning, not defined ad hoc when the team is ready to verify.
Another key difference is the emphasis on traceability. Under the QMSR framework, verification evidence must demonstrate point-by-point confirmation that each design output satisfies its corresponding design input. This is more rigorous than the Part 820 approach where some companies performed verification at a system level without granular input-to-output traceability. The integration with risk management also means that risk control measures implemented as design outputs must be individually verified for effectiveness.
Atomic constraints
- •Verification must confirm outputs meet inputs
- •Verification results must be recorded
- •Follow-up actions must be documented
- •Traceability to design inputs must exist
- •Verification must be performed in accordance with planned and documented arrangements, meaning a verification plan or protocol must be documented and approved before verification begins.
- •Each design output must be traceable to the design input requirement(s) it verifies, using a traceability matrix or equivalent record.
- •Statistical rationale for sample sizes used in verification testing must be documented and defensible.
- •Risk control measures implemented as design outputs must each have individual verification evidence demonstrating they function as intended.
- •Verification results and any necessary follow-up actions must be recorded, including the method used, the date, and the individual(s) performing verification.
Common gaps
No documented verification plan prior to execution
majorISO 13485 7.3.6 requires verification 'in accordance with planned and documented arrangements.' Many Part 820-era companies execute verification testing and document results without having a pre-approved verification plan or protocol that defines test methods, acceptance criteria, and sample sizes before testing begins.
Missing statistical rationale
majorVerification reports lack a documented rationale for sample sizes (e.g., why n=30?). ISO 13485 §7.3.6 explicitly requires this rationale.
Verification does not cover all design inputs
moderateUnder ISO 13485 7.3.6, verification must confirm that design outputs meet design input requirements — all of them. Some companies verify key performance requirements but do not systematically verify every design input, particularly usability requirements, regulatory requirements, or requirements derived from risk management outputs.
Risk control measures not individually verified
moderateWith ISO 13485's integration of risk management into design controls, each risk control measure implemented as a design feature should be verified for effectiveness. Many companies verify product performance holistically without specifically confirming that individual risk controls function as intended.
No verification plan
moderateVerification is executed based on a protocol, but no overarching 'Plan' defines the scope of all verification activities. ISO 13485 §7.3.6 requires documented verification plans.
Evidence signals
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FILE_EXISTS
(Verification.*Report|Test.*Report|V.V|Design.*Verification)
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CONTENT_MATCH
Does this document describe design verification activities, test results, or traceability to design inputs?
Audit defense
Design verification for [your product] is documented in [your document ID]. All verification activities confirm outputs meet their corresponding design inputs, with results and follow-up actions formally recorded per QMSR 820.30(f).