针对医院参加各种质量管理体系认证或标准评审过程中,如何有效实施医疗器械管理迎检的现实问题,探讨通过建立不以满足某一特定质量认证或评审标准为目的的整合型医疗器械质量安全标准化管理体系,实现各种质量管理方法与工具的快速导入,提高医院医疗器械管理认证或评审的效率.并详细论述了该体系构建的基础、特征和由7个步骤组成的改进路线图.%In this paper, an integrated standardized management system for medical device quality and safety was proposed to enhance the efficiency of the preparing working for hospital to implement quality management authentication or standards accreditation. This system is not to meet a certain quality standard certification or accreditation standards for hospital and through this system. All kinds of quality management methods and tools can be quickly induced to enhance the management efficiency of medical device in hospital. The integrated standardized management system is based on the American the Malcolm Baldrige National Quality Award of health care criteria for performance excellence and driven by quality and benefit. The roadmap for building the integrated quality management system included seven steps.
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