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 7.3.2: Verification of examination methods
What does 7.3.2 require?
Before a method is put into use, a procedure shall be followed to confirm that the laboratory can reach the performance claimed by the manufacturer or set for the method. The specifications confirmed shall be the ones that matter for the intended use, and verification shall go far enough to support results used in clinical decisions. Competent, authorized staff shall review the outcome and record whether requirements are met. A method that is revised shall be verified again as needed. Records shall show the target performance specifications, the results obtained, and a statement of whether the targets were met, with any action taken.
This control maps to 1 controls across 1 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.
1253 Before reporting patient results on an unmodified FDA-cleared or approved test system, verify accuracy, precision and reportable range and confirm the manufacturer's reference intervals suit the patient population; for a modified, in-house or non-FDA test system, establish accuracy, precision, analytical sensitivity and specificity including interferences, reportable range, reference intervals and any other needed characteristic; set calibration and control procedures from those specifications; and document everything