ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
Clause 7: Process requirements – ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence 7.3.1: Examination processes: general
What does 7.3.1 require?
Examination methods shall be chosen and used only when validated for their intended purpose, so that clinical accuracy is assured; methods set out in IVD instructions for use, recognised authoritative texts, consensus standards or regulations are preferred. Performance specifications shall reflect the intended use and the effect on patient care. Procedures and supporting documents shall be current and accessible. Staff shall work to the procedures, and the identity of whoever carries out significant activities, POCT operators included, shall be recorded. Authorized staff shall review the methods periodically to confirm they remain clinically appropriate.
This control maps to 3 controls across 2 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.
10.01 Analytical and clinical performance requirements: document for every area of testing the analytical and clinical performance requirements using key indicators for quantitative analysis (including accuracy, precision, limits of detection, units of measure and common interferences) and for qualitative analysis
11.06 PoCT procedures: in addition to the practice's test procedures, ensure PoCT procedures include traceability of samples to the original specimen, patient and device, include reference intervals for identifiable patient groups, and are audited regularly for workforce compliance
1252 Select test systems and perform testing to the manufacturer's instructions within the laboratory's stated performance specifications; define, monitor and document the storage and operating conditions essential to reliable testing (water quality, temperature, humidity, power protection); label reagents and materials with identity, strength, storage, preparation and expiry; never use expired, deteriorated or substandard materials; and do not mix kit components across lots unless the manufacturer allows