Medical laboratory accreditation with ISO 15189 has brought up concerns from various interest parties in China. It is a common concern for both Accreditation Body (AB) and Medical Laboratory (ML) on how to ensure and improve the accreditation work scientifically and effectively. It will help us to find a way to solve the problem and to find the right way for the development of the medical laboratory accreditation if we study the drafting, implementation and apphcation of the international standards which found the basis of the accreditation scheme. This article will give the reader a brief introduction of the ISO/ TC212, which is the technical committee of international standard organization responsible for drafting and revising ISO 15189, medical laboratory accreditation related international standard documents, and the recent status and the future development of the medical laboratory accreditation in China. We hope this article can give some information for the medical laboratory stuffs and the professionals in laboratory medicine on their research work of the technique and the trend of development in medical laboratory management and medical laboratory accreditation.%我国医学实验室ISO 15189认可工作在国内得到了各方越来越多的关注,如何确保和提高认可的科学性和有效性,将是认可机构和医学实验室共同面临的课题,从认可制度建立的基础即国际要求和国际标准的制定、实施和应用方面进行分析研究,有利于我们找到正确的解决方案和未来发展方向.本文对负责ISO 15189起草的国际标准化组织(ISO/TC212)、医学实验室认可相关国际标准文件、我国医学类实验室认可的现状及展卑等方面的动态做一个简单而概括的介绍,为医学实验室工作人员及行业专家在医学实验室管理和认可方面的技术及发展趋势研究提供一些基本的信息.
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