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 6.5.1: Calibration and traceability: general

What does 6.5.1 require?

Calibration and traceability requirements shall be defined well enough to keep reporting of results consistent. For quantitative methods that measure an analyte, this means requirements for calibration and metrological traceability; for qualitative methods, and for quantitative methods that measure a characteristic rather than a discrete analyte, it means stating the characteristic assessed and what is needed for the results to be reproducible over time.

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