摘要
目的探讨ISO 9001:2000标准在临床实验室管理中的应用价值。方法以顾客为关注焦点、领导作用、全员参与、过程控制、管理的系统方法、持续改进、基于事实的决策方法及与供方互利的关系为原则,建立和运行临床实验室ISO 9001:2000质量管理体系。结果根据ISO 9001:2000标准,确定了符合实验室自身特点的质量方针和目标;有效识别实验室的主要工作环节,明确了过程控制与管理的系统方法;建立了《质量手册》、程序文件和支持性文件组成的三级文件体系。结论该体系对于规范临床实验室与国际标准化管理接轨,促进服务自觉化、决策科学化、工作规范化及改进制度化,保证检验医学事业可持续发展,均具有十分重要的意义。
Objective To explore the application value of ISO 9001;2000 standards in clinical laboratory management. Methods Regarding customer as the focus, taking the leading role, participating in wholly, process control, management approach system, continual improvement,decision on the basis of the fact and with supplier＇s mutual beneficial relation as principle,to set up and operate the quality management system in clinical laboratory, Results According to the ISO9001：2000 standard, the quality policy and ob}ective which suits with laboratoryrs own characteristic were determined, the groundwork link in the laboratory was discerned effectively and the systems approach about process controls and management was defined. 3-levels file system was set up,which consisted of the quality manual, procedure file and supporting file. Conclusion This system plays a very important role in standardizing the clinical laboratory and integrating with international standardization, promoting to serve consciously, making policy decision scientifically, working standardization and improvement of institutionalization, and ensuring the laboratory medical science has sustainable development.
出处
《重庆医学》
CAS
CSCD
2006年第1期6-7,9,共3页
Chongqing medicine
关键词
临床实验室
国际标准
质量保证
clinical laboratory, international standards, quality assurance
