New ISO standards for medical biology laboratories, prescriptions and deviations

IF 0.4 4区医学 Q4 MEDICAL LABORATORY TECHNOLOGY

Annales de biologie clinique Pub Date : 2022-09-01 DOI:10.1684/abc.2022.1755

Marco Pradella

引用次数: 0

Abstract

ISO published the draft for final approval of the revision of ISO 15189 standard. Following ISO directives, ISO 15189 must be aligned with ISO/IEC 17025:2017 and should be less prescriptive. Draft ISO/DIS 15189 deviates in some points from ISO 17025 and the ISO indications to limit prescriptiveness: equipment, uncertainty, quality control. This do not seem to be justified by medical specificities and could complicate the understanding of the new requirements in medical laboratories.

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新的ISO医学生物实验室、处方和偏差标准

ISO公布了ISO 15189标准修订的最终批准草案。遵循ISO指令，ISO 15189必须与ISO/IEC 17025:2017保持一致，并且应该减少规定性。ISO/DIS 15189草案在某些方面偏离了ISO 17025和ISO限制规定的指示:设备，不确定度，质量控制。这似乎不符合医学特殊性，并可能使对医学实验室新要求的理解复杂化。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Annales de biologie clinique 医学-医学：研究与实验

CiteScore

0.80

自引率

20.00%

发文量

审稿时长

6-12 weeks

期刊介绍： Multidisciplinary information with direct relevance to everyday practice Annales de Biologie Clinique, the official journal of the French Society of Clinical Biology (SFBC), supports biologists in areas including continuing education, laboratory accreditation and technique validation. With original articles, abstracts and accounts of everyday practice, the journal provides details of advances in knowledge, techniques and equipment, as well as a forum for discussion open to the entire community.