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[ISO 15189修订及特定健康检查医学实验室认可概述]

[Outline of the revision of ISO 15189 and accreditation of medical laboratory for specified health checkup].

作者信息

Kubono Katsuo

机构信息

The Japan Accreditation Board for Conformity Assessment, Accreditation Center, Shinagawa, Tokyo.

出版信息

Rinsho Byori. 2007 Nov;55(11):1029-36.

Abstract

GOAL which accredited medical laboratory aims at is to continue "offering useful laboratory's service for patient medicine and treatment or the health of the nation". The medical laboratory, administers a quality management system, is competent technically and offers laboratory's service to satisfy the needs of all patients and clinicians taking responsibility for the medical testing and treatment. International standard ISO 15189 is a tool to embody thought of its basic quality and scientific grounds about the test result, and it was published in 2003. A revision for one part was considered to be it, and it was published afterwards for ISO 15189: 2,007 in this April. On the other hand, Ministry of Health, Labour and Welfare announced that all insurance members from 40 years old to 74 years old must have a checkup by the specified health checkup that paid its attention to visceral fat type obesity from April, 2008. And, in a standard health checkup program, it is shown that it strengthens the quality assurance management of laboratory carrying out medical testing. ISO 15189 which prescribed quality and competence of medical laboratory is an excellent standard, and it is hoped that it can offer high quality medical testing data with using quality management system. Here, I explain both outline of revised ISO 15189 and accreditation of the medical laboratory for specified health checkup using with this standard.

摘要

认可的医学实验室的目标是持续“为患者医疗、治疗或国民健康提供有用的实验室服务”。医学实验室实施质量管理体系,具备技术能力,并提供实验室服务以满足所有患者以及负责医学检测和治疗的临床医生的需求。国际标准ISO 15189是体现其关于检测结果的基本质量和科学依据思想的工具,该标准于2003年发布。之后对其中一部分进行了修订,并于今年4月发布了ISO 15189:2007。另一方面,厚生劳动省宣布,从2008年4月起,所有40岁至74岁的保险成员必须通过关注内脏脂肪型肥胖的特定健康检查进行体检。而且,在标准健康检查项目中,表明加强了开展医学检测的实验室的质量保证管理。规定医学实验室质量和能力的ISO 15189是一项优秀标准,希望能通过质量管理体系提供高质量的医学检测数据。在此,并使用本标准解释修订后的ISO 15189的概要以及特定健康检查的医学实验室认可情况。

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