ISO15189-2013-《医学实验室质量和能力认可准则》
ISO15189-2013- "accreditation criteria of medical laboratory quality and ability"
ISO15189:2013医学实验室—质量和能力的专用要求，是由国际标准化组织ISOTC 212临床实验室检验及体外诊断检测系统技术委员会起草。以及ISO17025中检验与核准实验室的一般要求。
The special requirements of ISO15189:2013 medical laboratory quality and ability, was drafted by the international organization for Standardization Technical Committee ISOTC 212 clinical laboratory testing and in vitro diagnostic detection system. General requirements and ISO17025 inspection and approval of the laboratory.
在国际上存在一段时间的争论：到底医学实验室是采用通用的检测实验室认可要求ISO/IEC17025还是应该使用专用的ISO15189。
The existence of a period of controversy in the international: whether medical laboratory is based on general ISO15189 testing laboratory accreditation requirements ISO/IEC17025 should use special.
因为即使是作为通用的检测实验室认可要求的ISO/IEC 17025也是在其特殊领域的应用说明文件中列出了医学实验室的特殊要求。
Because even as a universal ISO/IEC testing laboratory accreditation requirements of 17025 is used in the special field of documentation listed in the special requirements of laboratory medicine.
ISO15189医学试验室——关于质量和能力的特殊要求，是由国际标准化组织TC-212技术委员会经过7年的时间研发出来的有关临床和诊断的测试体系。是在ISO9001:2000版的基础上增加了对特殊部门要求，以及ISO17025中检验与核准实验室的一般要求。
ISO15189 medical laboratory - special requirements on quality and ability, is by the international organization for Standardization Technical Committee TC-212 after time developed clinical and diagnostic test system for 7 years. Is based on the ISO9001:2000 version of the increased requirements on special department, general requirements and ISO17025 inspection and approval of the laboratory.
其文字表述更适用于医药实验室， 同时在相关的章节中还添加了对医药实验室的有关技术方面的附加要求，如“先于测试样本采集的病人准备，确证，收集病人样本的程序，运输，紧急医疗救护中病人样本的储存和处理等”。
The wording is more suitable for the medical laboratory, while also adding additional requirements relating to technical aspects of medical laboratory in the relevant chapters, such as "before the test sample collection patient preparation, confirmation, collect patient sample program, transport, storage and handling of emergency medical rescue in support of patient samples etc.".
ISO15189提供了一个框架，从而使得医药实验室可以按照质量管理体系的思路，改进他们的工作流程。
ISO15189 provides a framework, which makes the medical laboratory can according to the quality management system of thinking, improve their work flow.
与ISO17025检验与核准实验室的一般要求相比，他包含了更多的内容，增加了一些医药实验室的特殊要求。
Compared with the general requirements of ISO17025 inspection and approval of the laboratory, it contains more content, increase the special requirements of medical laboratory.
ISO15189将成为实验室获ISO9000认证的基础。
ISO15189 will become the basic laboratory of certification by the ISO9000.
它将成为医药实验室获得专业服务的技术能力和有效质量管理认证的一块模板,同时，医药实验室也可以据此规范他们的质量管理及其他各项工作。
It will become a template, the technical ability of medical laboratory to obtain professional service and effective quality management certification at the same time, medical laboratory can standardize their management quality and other work.
ISO15189-2013-《医学实验室质量和能力认可准则》
ISO15189-2013- "accreditation criteria of medical laboratory quality and ability"