质量控制体系有效运行的思考

目的:保证药品仪器质量体系持续有效运行,实现由经验性管理向规范化管理的转变。方法:依据国际、国家、军队质量控制标准,结合工作实际,建立质量管理体系,确定质量方针和目标,编写质量手册,明确各部门职责,规定各类活动的工作程序,实施内部审核和管理评审制度,完善保证检测结果准确的质量监督检查机制,制定全员培训计划,分析校准项目的测量结果不确定度,提供委托方溯源所需的全部信息;同时对检测设备、检测方法、环境监控、样品管理等环节均做出严格规定,实现对药品仪器检测工作质量的有效控制。结果:规范检测行为,及时发现问题,使质量体系不断改进、不断完善,不断提高。结论:只有认真贯彻执行各项质量控制文件,做好质量控制监督,坚持内部审核,才能使质量控制体系持续有效运行。

Continual operation of quality system for drugs and medical devices

Objective: To make quality system operate always effectively. Methods:According to the international, national and military standards in combination with practical work, we set up quality management system; fix quality policy and goal; compile quality manual; clear the duty of every department; stipulate the procedures of all kinds of activities; implement internal check and evaluation system; complete the supervision and examine mechanism; plan the training program;analyze the examine results;offer all the...