质量控制体系有效运行的思考

Continual operation of quality system for drugs and medical devices

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。

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 information and realize an effective control. Results：We improved the examination and found problems on time to improve the quality system. Conclusion：Only implementing the documents, doing quality supervision and insisting on internal monitoring can make the quality system operate effectively.