validation

confirmation, through the provision of objective evidence (3.8.3), that the requirements (3.6.4) for a specific intended use or application have been fulfilled

Note 1

The objective evidence needed for a validation is the result of a test (3.11.8) or other form of determination (3.11.1) such as performing alternative calculations or reviewing documents (3.8.5).

Note 2

The word “validated” is used to designate the corresponding status.

Note 3

The use conditions for validation can be real or simulated.

Norm

NEN-EN-ISO 9000:2015 en

Titel

Quality management systems - Fundamentals and vocabulary

Paragraaf

3.8.13

validation

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