Validation

Verification asks whether the product was built as specified; validation asks whether it does what users need for its intended use. Validation can be done under real or simulated use conditions.

confirmation, through the provision of objective evidence, that the requirements for a specific INTENDED USE or application have been fulfilled Note 1 to entry: The objective evidence needed for a VALIDATION is the result of a test or other form of determination such as performing alternative calculations or reviewing documents. Note 2 to entry: The word “validated” is used to designate the corresponding status. Note 3 to entry: The use conditions for VALIDATION can be real or simulated. [SOURCE: ISO 9000:2015, 3.8.13]

IEC 82304-1:2016, clause 3.23

confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled

ISO 14155:2020, clause 3.53