GLOSSARYGlobal

Process Validation

Establishing by objective evidence that a process consistently produces a result or product that meets its predetermined specifications. Validation is required where a process's output cannot be fully verified by later inspection or testing.

Where it is written: ISO 13485:2016 clause 7.5.6; definition as in 21 CFR 820.3(z)(1) before February 2, 2026
Old rule: 21 CFR 820.3(z)(1) and 820.75, in Part 820 before February 2, 2026

Avoid This Mistake

Clause 7.5.6 requires validation where a process's output cannot be verified by later monitoring or measurement, or is not verified that way.

Related terms

Design Validation Design Verification

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