ISO 15195:2018 PDF

Scope: This document specifies the requirements for competence to carry out reference measurement procedures in laboratory medicine, using the requirements of ISO/IEC 17025:2017 as a normative reference and listing additional requirements for calibration laboratories to perform their tasks adequately. The relationship between clauses in this document and ISO/IEC 17025:2017 are summarized in Annex A. Examinations of properties with results reported on a nominal or ordinal scale are not included. This document is not applicable to medical laboratories. NOTE Requirements for medical laboratories are specified in ISO 15189[1].

ISO 15195:2018 Referenced Document

ISO 15193 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures
ISO 15194 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation
ISO 17511 In vitro diagnostic medical devices — Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples*， 2020-04-24 Update
ISO 18153 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned calibrators and control materials
ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories
ISO/IEC Guide 98-3 Uncertainty of measurement - Guide to the expression of uncertainty in measurement (GUM:1995). Extension to any number of output quantities
ISO/IEC Guide 99

2018 ISO 15195:2018 Laboratory medicine — Requirements for the competence of calibration laboratories using reference measurement procedures
2003 ISO 15195:2003 Laboratory medicine - Requirements for reference measurement laboratories