ISO15189认证 珠海人民医院首家通过ISO15189现场评审

The first people's Hospital of Zhuhai ISO15189 certification through the ISO15189 site assessment

日前，珠海市人民医院实验科以优异成绩顺利通过ISO15189医学实验室认可，经中国合格评定国家认可委员会批准，成为珠海市首家ISO15189医学实验室。

Recently, laboratory of Zhuhai People's Hospital with honors smoothly through the ISO15189 accreditation of medical laboratories, by the China National Accreditation Committee for approval, became the first ISO15189 medical laboratory in Zhuhai city.

近年来，国际医学界非常重视医学实验室的质量管理，国际标准化组织颁布了《医学实验室质量和能力专用要求》，即ISO15189，该标准是用于加强医学实验室质量管理的程序化标准，从而推动全球医学实验室标准化、规范化建设。申请ISO15189认可具有极其重要的意义。

In recent years, the international medical community attaches great importance to quality management in medical laboratory, the international organization for standardization issued "medical laboratory quality and ability requirements", namely ISO15189, the standard is used to strengthen the procedural standard quality management in medical laboratory, so as to promote the global medical laboratory standardization construction. Apply for ISO15189 approval has extremely important significance.

人民医院检验科获ISO15189医学实验室认可，今后，该院实验室给患者出具的检验报告将能得到世界56个国家的医疗机构的认可，为外籍患者和跨国就医者提供极大方便。标志着该院已具备了国际标准的管理与技术水平，迈进国际一流临床实验室的行列。

Laboratory of people's hospital accreditation, medical laboratory in ISO15189, the laboratory for inspection report issued by the patients will be able to get the medical institutions in 56 countries in the world recognized, which provides great convenience for foreign patients and transnational medical treatment. Marks the Institute has management and technical level of international standard, into the international first-class ranks of clinical laboratory.

据悉，在2014年6月27日-29日期间，以安徽省临床检验中心沈佐君教授为组长的评审专家组对该院检验科进行现场评审，经过3天紧张有序的核查、查阅质量体系文件、抽查实验室质量和技术记录、现场试验、医护座谈会、现场检查临床科室分析前质量控制、授权签字人考核及生物安全等评审工作，一致认为检验科的认可工作质量体系健全、运行有效，各项质量和技术记录较为完整，能够满足临床实验诊断需求，同意通过国家认可委员会质量和能力认可的现场评审。

It is reported that in June 27, 2014 -29 period in Anhui Province, Professor of clinical inspection center Shen Zuojun to review group leader of group of expert on-site review of Laboratory Department of the hospital, after 3 days of intense and orderly verification, referring to the analysis of on-site inspection of clinical department quality system documents and checks of laboratory quality and technical records, field testing, medical symposium, before quality control, authorized signatory examination and biological safety evaluation work, agreed that the quality system accreditation laboratory sound and effective operation, the quality and technical records more complete, can meet the demand of clinical experimental diagnosis, agreed to by the site quality and the ability of national Accreditation Committee accreditation review.

在现场评审中发现的不符合项，经过几个月的纠正和不断整改，专家组已于2015年1月1日进行了现场验收，并对检验科的团队凝聚力和发展潜力给予了高度评价。

Found in the on-site assessment of nonconformity, after several months of correct and continuous rectification, the expert group in January 1, 2015 was carried out on-site inspection, and the inspection of team cohesion and development potential and gave high evaluation.

据该院检验科主任唐发清介绍，该科从2013年5月开始按照ISO15189的要求计划筹备，2013年6月8日正式运行质量管理体系。在结合实际情况及自身特点的基础上，该科按照ISO15189的要求制定或完善了一系列质量管理体系文件、各个专业室的作业指导书及记录表格，并根据认可文件要求将工作落实到每个细节。

According to the director of the Institute of laboratory department Tang Faqing introduced, the Department from 2013 May to begin preparations in accordance with the requirements of ISO15189 plan, in June 8, 2013 the formal operation of the quality management system. On the basis of combining with the actual situation and its characteristics, the Department in accordance with the requirements of ISO15189 to develop or improve the operation instructions and records form a series of quality management system documents, various professional chamber, and according to the approval document requirements will work to implement every detail.

自开始筹备ISO15189认可，检验科全体工作人员克服重重困难，经过一年多的辛勤努力和奋斗，通过了百余次的各类培训及考核，与临床科室进行了各种形式的沟通50余次，对各类检测系统进行了严格的性能验证或校准确认，不同检测系统对同一检验项目的比对测试累计逾千次，获得各类设备、通用测量仪器的校准、鉴定、检定证书近百份，为达到