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 7.3.4: Evaluation of measurement uncertainty
What does 7.3.4 require?
Where relevant to intended use, the laboratory shall assess the measurement uncertainty (MU) attached to measured quantity values and kept up to date, compared with the performance specifications and documented (ISO/TS 20914 applies). MU evaluations shall be reviewed on a regular basis. If MU cannot be evaluated or is not relevant, the reasons shall be documented. Users who ask shall be given MU information, and answers to their questions shall take other factors into account, such as biological variation. For qualitative results derived from a quantitative cut-off, the MU of the output quantity shall be estimated from positive and negative samples that are representative. MU should be taken into account for quantitative intermediate steps within qualitative examinations and during verification and validation.
This control maps to 2 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.
10.03 Measurement uncertainty process: for quantitative assays define the measurand, indicate the laboratory's confidence in each measurement, provide information for interpreting results and comparing them over time, set clinically appropriate imprecision goals, identify significant uncertainty sources and reduction opportunities, and use statistically adequate replicate numbers or statistical methods that account for fewer replicates
10.04 Measurement uncertainty use: match the effort spent on uncertainty to the clinical quality requirements, set routine performance goals and reduce uncertainty sources when goals are missed, use the process to show assays meet acceptable performance goals and are clinically applicable and to identify tests where estimation is not possible and minimise their risks, make uncertainty data available to requesters and other providers, and use it for data monitoring and troubleshooting of specific tests