摘要
目的探讨在血站建立和运行符合实验室认可标准《检测和校准实验室能力的通用要求》(ISO/ IEC17025)的质量管理体系程序。方法通过制定详细的认可计划,建立组织架构和配备必要的资源,进行全员培训,识别过程和编写质量管理体系文件,建立质量管理体系,并试运行。结果建立和运行了实验室认可质量管理体系,并获得中国实验室国家认可委员会颁发的认可证书。结论在血站建立和运行实验室认可质量管理体系是完全可行和必要的,可确保血液质量和安全。
Objective To discuss the procedure of establishing and implementing quality management system that accorded with laboratory accreditation standard ＂General Requirements for Competence of Testing and Calibration Laboratories＂ （ISO/ IEC17025） in station. Methods It is necessary that drawing up particular plan, building organization structure, equipping essential resource, training all staff, identifying process, compiling quality management system document. The aim is to establish and implement quality management system and trial run. Results Quality management system had been established and imple- mented, and it had been award accreditation certificate by China National Accreditation Board for Laboratories. Conclusion It is feasible and necessary that establishing and implementing quality management system in blood station, It can insure blood quality and safety.
出处
《中国卫生质量管理》
2007年第5期15-17,共3页
Chinese Health Quality Management
