ISO 15189:2022 医学实验室 质量和能力要求

标准编号：ISO 15189:2022

中文名称：医学实验室 质量和能力要求

英文名称：Medical laboratories — Requirements for quality and competence

发布日期：2022-12

标准范围

本文件规定了医学实验室的质量和能力要求。本文件适用于医学实验室开发其管理系统和评估其能力。它也适用于实验室使用者、监管机构和认证机构对医学实验室能力的确认或认可。本文件也适用于护理点检测（POCT）。笔记？国际、国家或地区法规或要求也适用于本文档中涵盖的特定主题。

This document specifies requirements for quality and competence in medical laboratories.

This document is applicable to medical laboratories in developing their management systems and assessing their competence. It is also applicable for confirming or recognizing the competence of medical laboratories by laboratory users, regulatory authorities and accreditation bodies.

This document is also applicable to point-of-care testing (POCT).

NOTE            International, national, or regional regulations or requirements can also apply to specific topics covered in this document.

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