内容提示: 国际ISO 标准 15189 第四版 2022-12 医学实验室 — 质量和能力要求 生物医学实验室 - 质量和能力要求 参考编号 ISO 15189:2022(E) (C) ISO 2022 (C) ISO 2022 保留所有权利。除非另有规定或在其实施背景下有要求,否则未经预先书面许可,本出版物的任何部分不得以任何形式或任何方式复制或利用,...
Part 1. In particular, the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 .
ISO 15189, 4th Edition, December 2022 - Medical laboratories — Requirements for quality and competence 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 compet...
ISO 15189:2022 医学实验室 质量和能力的要求 第1部分:通用要求(中文版,64页) 本文件规定了医学实验室质量和能力的要求。 本文件适用于医学实验室建立管理体系和评估自己的能力,也可适用于实验室用户、监管机构和认可机构确认或承认医学实验室的能力。 本文件
Comparisons between this document, ISO 9001:2015 and ISO/IEC 17025:2017 are in Annex B. The comparison of ISO 15189:2012 to ISO 15189:2022 (this document) is in Annex C. Medical laboratories — Requirements for quality and competence
ISO 15189, 4th Edition, December 2022 - Medical laboratories — Requirements for quality and competence 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 compet...