method validation

Method validation establishes through objective evidence that an examination procedure is fit for its intended use. It is particularly relevant to laboratory-developed procedures, nonstandard methods, or modifications and applications outside an established validated scope. The work must address the actual clinical purpose, specimen types, measuring conditions, and performance claims that the laboratory intends to support.

A validation plan identifies relevant characteristics, suitable study materials, acceptance criteria, statistical approaches, and responsibilities before testing begins. Depending on the procedure, characteristics may include precision, trueness, analytical specificity, detection capability, measuring interval, and interference effects. Not every characteristic applies in the same way to every examination. Document limitations and residual risks, then authorize use only after reviewing whether the evidence supports the stated clinical application.

For accreditation, validation provides the technical basis for offering a procedure whose suitability cannot simply be assumed from an existing claim. Study depth should match the modification, novelty, and patient risk. Preserve the plan, raw data, analysis, conclusions, and approval, and assess whether subsequent changes require additional validation before their introduction into routine service.