EN ISO 15189:2022
医学实验室.质量和资格的要求

Medical laboratories - Requirements for quality and competence (ISO 15189:2022)

EN ISO 15189:2022 发布历史

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.

EN ISO 15189:2022由欧洲标准化委员会 IX-CEN 发布于 2022-12-14，并于 2023-03-31 实施，于 2025-12-31 废止。

EN ISO 15189:2022在国际标准分类中归属于: 03.120.10 质量管理和质量保证。

EN ISO 15189:2022的历代版本如下：

• 2022年 EN ISO 15189:2022 医学实验室.质量和资格的要求
• 2012年 EN ISO 15189:2012 医学实验室.质量和资格的要求
• 2007年 EN ISO 15189:2007 医学实验室.质量和资格的要求
• 2003年 EN ISO 15189:2003 医学实验室.质量和资格的要求

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标准号

EN ISO 15189:2022

发布

2022年

发布单位

欧洲标准化委员会

当前最新

EN ISO 15189:2022

 

 

适用范围

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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