In general, two stages are needed before a method can be used in a laboratory: first, to prove that the method is fit for purpose and secondly, to demonstrate that the laboratory can properly perform the method.
— The first stage is the validation of the method. Validation is conducted by performing a method comparison study, usually by one laboratory, followed by an interlaboratory study (see ISO 16140-2, ISO 16140-5 and ISO 16140-6). In the case when a method is validated within one laboratory only (see ISO 16140-4), no interlaboratory study is conducted.
— The second stage is method verification, where a laboratory demonstrates that it can satisfactorily perform a validated method. This is described in ISO 16140-3 (publication planned in January 2021). Verification is only applicable to methods that have been validated using an interlaboratory study.
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