Abstract

This standard specifies the requirements for the competence to perform 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 so that they can perform their tasks appropriately. Reference laboratories whose test results are presented on nominal and ordinal scales are not within the scope of this standard. This International Standard is not applicable to routine medical laboratories. This document is amendment 1.

Begin

2025-12-05

WI

00140170

Planned document number

DIN EN ISO 15195/A1

Project number

17600219

Responsible national committee

NA 176-08-08 AA - Quality management in medical laboratories  

Responsible european committee

CEN/TC 140 - In vitro diagnostic medical devices  

Responsible international committee

ISO/TC 212/WG 2 - Reference systems  

draft standard

Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures - Amendment 1 (ISO 15195:2018/DAM 1:2026); German and English version EN ISO 15195:2018/prA1:2026
2026-08
Order from DIN Media