卫生综合实验室一体化质量管理体系的建立和运行  

Establishment and Operation of Integrated Quality Management System in Health Laboratory

作　　者：戴金凤[1] 王民生[2] 

机构地区：[1]南京医科大学公共卫生学院,江苏南京210029 [2]江苏省疾病预防控制中心,江苏南京210009

出　　处：《中国卫生质量管理》2013年第3期85-88,共4页Chinese Health Quality Management

基　　金：江苏省教育厅重点项目(NY22225001);江苏省优势学科(苏政办发[2011]6号)经费资助

摘　　要：卫生综合实验室承担着多个领域的卫生分析和毒理学安全性评价任务,其质量管理必须同时满足多个准则要求。通过比较《检测和校准实验室能力的通用要求》(ISO/IEC 17025)、经合组织良好实验室规范(OECD GLP)、《实验室资质认定评审准则》和《食品检验机构资质认定评审准则》等之间的差异,探讨卫生综合实验室一体化质量管理体系的构建及运行方法。Health laboratory bears health and toxicology safety evaluation tasks from several areas, and its quality management needs to meet the multiple requirements of guidelines. Through comparison among general requirements for Competence of Testing and Calibration Laboratories （ ISO/IEC 17025 ）, Organization for Economic Co - operation and Development （OECD） - Good Laboratory Practice （GLP） , the Assessment Criteria for Laboratory Accreditation, and the Assessment Criteria for Food Inspection Agency, the establishment and operation of integrated quality management system in heahh laboratory was discussed.

关 键 词：卫生综合实验室 一体化 质量管理体系 建立 运行 

分 类 号：R197.3[医药卫生—卫生事业管理]