ISO 15195:2018 检验医学 校准实验室使用参考测量程序能力的要求

标准编号：ISO 15195:2018

中文名称：检验医学 校准实验室使用参考测量程序能力的要求

英文名称：Laboratory medicine — Requirements for the competence of calibration laboratories using reference measurement procedures

发布日期：2018-12

标准范围

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].

标准预览图