本文件规定了在检验医学中执行参考测量程序的能力要求，使用ISO/IEC 17025:2017的要求作为规范性参考，并列出了校准实验室充分执行其任务的附加要求。 附录A总结了本文件中条款与ISO/IEC 17025:2017之间的关系。 不包括以名义或顺序量表报告结果的属性检查。 本文件不适用于医学实验室。 注:ISO 15189[1]规定了医学实验室的要求。

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].