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 6.5.3: Metrological traceability of measurement results

What does 6.5.3 require?

Measurement results shall be made metrologically traceable, and kept so, through a documented, unbroken sequence of calibrations linking them to a suitable reference, with each step adding to the measurement uncertainty. Traceability shall reach the highest level achievable and the SI, either by calibration from a competent laboratory (ISO/IEC 17025) or by certified reference materials from a competent producer (ISO 17034, ISO 15194). A manufacturer's traceability statement can be relied on only if the manufacturer's system and calibration procedure are used without alteration. Where traceability to the SI cannot be achieved, other routes shall be used, such as reference measurement procedures, specified methods, consensus standards, or measuring the calibrator with a different procedure (ISO 17511). Genetic examinations shall trace to genetic reference sequences, and qualitative methods may show traceability by testing material of known result.

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