ISO/IEC 27041:2015
Clause 5: Method development and assurance – ISO/IEC 27041:2015

ISO/IEC 27041:2015 5.9.1: 5.9.1 General principles of validation

Validation shows that the process in the work instruction meets the requirements agreed with the client, by evidence that it gives correct outputs for the defined inputs, without looking at how it is implemented; where possible it also establishes boundary conditions and error rates. It is usually done by black box testing so that implementation knowledge cannot steer the tests or results. The validation plan and its data are produced independently of design and implementation and rest only on the agreed requirements. Processes built on unverified tools or methods can still be validated if they give consistent results (compare the repeatability and reproducibility expectations of ISO/IEC 27037).

Maintained by Gerard Blokdyk

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ISO/IEC 27043:2015 · 1 control

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