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制定其管理体系和评估其能力。它也适用于实验室用户、监管机构和认证机构确认或认可医学实验室的能力。 本文件也适用于护理点测试（POCT）。 注:国际、国家或地区法规或要求也适用于本文件所涵盖的特定主题。

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.