method verification

Method verification confirms, with objective evidence, that an already validated examination procedure achieves specified performance in the laboratory's own conditions. It is typically appropriate when implementing an established procedure without changes that alter its intended use or performance characteristics. The study addresses relevant manufacturer claims and the laboratory's clinical requirements rather than attempting to repeat every element of the original validation.

Plan the work before routine use, specifying characteristics, materials, acceptance criteria, data analysis, and authorization. Depending on the examination, this may include precision, bias or comparison, measuring interval, and verification of relevant reference intervals. The scope must reflect the actual application, equipment, staff, and specimen types. Verification is not satisfied merely by installation checks or a few control results within manufacturer ranges.

Accreditation requires evidence that the laboratory has established fitness for local use before introducing the procedure. Assessors can follow the link from intended use to acceptance criteria, results, limitations, and approval. If verification reveals a clinically important shortfall, resolve it or restrict use; do not redefine acceptance criteria afterward simply to obtain a pass.