本文件规定了医学实验室识别和管理与医学实验室检查相关的患者、实验室工作人员和服务提供商风险的流程。该过程包括识别、估计、评估、控制和监控风险。 本文件的要求适用于医学实验室检查和服务的所有方面，包括检查前和检查后方面、检查、将测试结果准确传输到电子病历以及ISO 15189中描述的其他技术和管理过程。交叉引用:ISO/IEC指南63:2012IEC/ISO 31010:2009 ISO/IEC指南51:1999ISO/TR 24971:2019ISO 18113: 2009ISO/TS 22367:2008ISO/IEC指南99:2007ISO指南73:2009IEC 62366-1:2015/COR1:2016IEC 60601-1:2005/COR1:2006ISO 13485:2016ISO 31000:2009ISO 20916:2019IEC 60812:2006ISO 15190:2003IEC 60601-1:2005/COR2:2007ISO 31000:2009（F）IEC 61025:2006ISO 15189:2012ISO 9000:2015高级访问IEC 60601-1:2005/AMD1:2012/COR1:2014ISO 1499000:2019ISO修订版可随时购买包括在购买本文件时。

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.Cross References:ISO/IEC Guide 63:2012IEC/ISO 31010:2009ISO/IEC Guide 51:1999ISO/TR 24971:2019ISO 18113:2009ISO/TS 22367:2008ISO/IEC Guide 99:2007ISO Guide 73:2009IEC 62366-1:2015/COR1:2016IEC 60601-1:2005/COR1:2006ISO 13485:2016ISO 31000:2009ISO 20916:2019IEC 60812:2006ISO 15190:2003IEC 60601-1:2005/COR2:2007ISO 31000:2009 (F)IEC 61025:2006ISO 15189:2012ISO 9000:2015 Advanced AccessIEC 60601-1:2005/AMD1:2012/COR1:2014ISO 14971:2019ISO 9000:2015All current amendments available at time of purchase are included with the purchase of this document.