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 7.3.7.1: Ensuring the validity of results: general
What does 7.3.7.1 require?
A procedure shall govern how the validity of results is monitored; the data produced shall be recorded in a way that allows trends and shifts to be seen and, where practicable, analysed statistically, and the monitoring shall be planned and reviewed.
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.
10.02 Analytical and clinical performance: ensure analytical performance meets the assay's clinical application, support morphological and interpretive diagnostic performance through peer review, internal and external quality assurance, confine unverified tests to exceptional circumstances or rare or new diseases, use peer consultation for new or uncommon morphological assessments, confirm comparability across methods and devices, support morphological comparability through documented peer review and case comparison, and keep authorised test procedures available including which specimen types or diagnoses need mandatory peer review, the peer review process and the handling of discordant diagnoses