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 6.5.2: Equipment calibration
What does 6.5.2 require?
The laboratory shall have procedures for calibrating equipment that directly or indirectly affects results, specifying the conditions of use and manufacturer's calibration instructions, recording of metrological traceability, verification of accuracy and functioning at specified intervals, recording of calibration status and re-calibration date, updating and recording of correction factors on re-calibration, and handling of out-of-control calibration to minimise risk to service and patients.
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.
1255 Calibrate each test system per the manufacturer's instructions and the laboratory's established criteria, with traceable materials where possible; verify calibration across the reportable range using at least a low, mid and high value at least every six months and after a complete reagent change, major maintenance or critical part replacement, or when control results trend or shift unexplained; recalibrate whenever calibration verification fails