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La Rivista Italiana della Medicina di Laboratorio 2021 Settembre;17(3):200-8

DOI: 10.23736/S1825-859X.21.00112-2

Copyright © 2021 EDIZIONI MINERVA MEDICA

language: Italian

Some certainties of measurement uncertainty: new ISO 20914 and SIPMeL recommendations

Marco PRADELLA

Società Italiana di Patologia Clinica e Medicina di Laboratorio, Commissione Nazionale Qualità e Accreditamento SIPMeL, Castelfranco Veneto, Treviso, Italia



The estimation of measurement uncertainty is required for accreditation of medical laboratories, according to the International Organization for Standardization (ISO). ISO provides adequate indications to obtain uncertainty and above all precision and repeatability with simplicity in laboratories of any type and size, both for numerical quantitative and nominal qualitative results. Other consistent guidelines are contained in various documents of the Clinical and Laboratory Standards Institute (CLSI). The Recommendations of the Italian Society of Clinical Pathology and Laboratory Medicine (SIPMeL) with document Q16 bring together the sources and provide a clear and simple description of how they should be applied.


KEY WORDS: Uncertainty; Precision medicine; Qualitative evaluation; Accreditation

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