ISO 15195:2018Published

Laboratory medicine — Requirements for the competence of calibration laboratories using reference measurement procedures

Biologie médicale — Exigences relatives à la compétence des laboratoires d'étalonnage utilisant des procédures de mesure de référence

Abstract / 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].

Life cycle

Amendments & corrigenda

ISO 15195:2018/DAmd 1Under developmentLaboratory medicine — Requirements for the competence of calibration laboratories using reference measurement procedures — Amendment 1International Standard · ISO/TC 212

Replaces

ISO 15195:2003WithdrawnLaboratory medicine — Requirements for reference measurement laboratoriesInternational Standard · Published 14 Oct 2003 · ISO/TC 212