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 7.3.3: Validation of examination methods
What does 7.3.3 require?
Validation is required for methods the laboratory designs itself, for methods applied beyond their original scope (for example outside the instructions for use or the measuring range, or third-party reagents on instruments for which no validation data exist) and for validated methods that have been modified. Validation shall go as far as needed to show, with objective evidence expressed as performance specifications, that intended-use needs are met well enough for clinical decisions. Competent, authorized staff shall review and record the outcome. Before any change is adopted, its clinical impact shall be reviewed. Records shall hold the validation procedure, the requirements of the intended use, the performance specifications established, the results, and a statement on whether the method is fit for its intended use.
This control maps to 2 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.
8.04 In-house IVD medical devices: validate clinical and analytical performance, comply with TGA requirements for in-house IVDs, assess against the NPAAC in-house IVD requirements, demonstrate through validation that performance is fit for purpose and supports safe care, hold documented validation evidence covering methodology, performance characteristics and acceptance criteria, and keep in-house IVDs under ongoing quality assurance
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