ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
Clause 6: Resource requirements – ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence 6.4.3: Equipment acceptance procedure
What does 6.4.3 require?
Before equipment enters service, or re-enters it, the laboratory shall confirm it meets defined acceptance criteria, and measuring equipment shall be able to deliver the accuracy or measurement uncertainty that a valid result needs. This applies to equipment in the laboratory, on loan, used for POCT, associated or mobile; where relevant, verification on return may rely on the calibration certificate.
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.
8.01 Medical device implementation and replacement: ensure devices are on the ARTG or, if developed in-house, validated to ISO 15189 and compliant with NPAAC and regulatory requirements; consult and manage change; assess suitability for patient care; evaluate and verify against the manufacturer's claimed specifications; validate performance with recognised reference standards or methods; complete calibration, quality control and quality assurance before implementation; manage ageing or underperforming devices; and monitor and periodically review performance with revalidation after significant change, new evidence or identified risk