药品检验机构质量管理体系运行中的改进措施探究

Improvement Measures for Implementation of Quality Management System in Drug Control Institutes

目的:探究药品检验机构质量管理体系运行实施持续改进的有效措施。方法:通过分析质量管理体系运行中面临的现实困难和问题,提出相应的改进方法和措施。结果:领导重视和全员参与,开展宣贯培训,注重人力资源优化,提高日常监督、内部审核及管理评审等各项质量活动的有效性,提升质量管理体系的信息化管理水平,是质量管理体系有效的持续改进措施。结论:应持续完善质量管理体系的改进措施,保持管理体系的充分性和有效性,不断提高药品检验机构的管理水平和检验检测能力。

Objective:To explore effective measures to improve the implementation of quality management system(QMS)in drug control institutes.Methods:By analyzing the practical difficulties and problems in implementing the QMS,improvement methods and measures are proposed.Results:Effective measures for improving implementation of QMS include attention from top management and involvement of the whole staff,carrying out publicity efforts and training,paying attention to the optimization of human resources,improving the effectiveness of routine supervision,internal audit,management review and other quality activities,and enhancing the information system of QMS.Conclusion:It is necessary to continuously improve the QMS to maintain its adequacy and effectiveness,and improve the management level and testing capabilities of drug control institutes.