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ISO 22367:2020现行

Medical laboratories — Application of risk management to medical laboratories

出版:International Organization for Standardization

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基本信息
标准编号: ISO 22367:2020
出版单位:International Organization for Standardization
标准页数:82
标准简介

This document specifies a process for a medical laboratory to identify and manage the risks to patients, laboratory workers and service providers that are associated with medical laboratory examinations. The process includes identifying, estimating, evaluating, controlling and monitoring the risks. The requirements of this document are applicable to all aspects of the examinations and services of a medical laboratory, including the pre-examination and post-examination aspects, examinations, accurate transmission of test results into the electronic medical record and other technical and management processes described in ISO 15189. This document does not specify acceptable levels of risk. This document does not apply to risks from post-examination clinical decisions made by healthcare providers. This document does not apply to the management of risks affecting medical laboratory enterprises that are addressed by ISO 31000, such as business, economic, legal, and regulatory risks.

本标准替代的旧标准

ISO/TS 22367:2008

ISO/TS 22367:2008/Cor 1:2009

等同采用的国际标准

DS/ISO 22367:2020 -