NEU公司HD24医疗产品开发项目质量管理研究

发布时间：2018-01-02 02:33

本文关键词：NEU公司HD24医疗产品开发项目质量管理研究　出处：《东北大学》2015年硕士论文　论文类型：学位论文

【摘要】：在经济高速发展的今天,保证优良的产品质量有助于获取更大的社会及企业效益已为广大有识之士所接受。在以安全、有效为基本要求的医疗器械产业,基于事前预防理念的新产品项目质量管理,更是被先进企业视作核心竞争力之一,成为在日趋激烈的竞争中,谋求生存及发展的基本战略。但同时应看到,在我国众多,特别是中小规模医疗企业中,仍普遍存在,或项目先期质量意识淡薄,或质量管理、改善手段相对欠缺的问题,极大限制了企业的进一步成长。本课题选取国内医疗器械领先企业NEU公司的HD24彩色超声诊断系统新产品开发项目作为研究主体,以超声诊断系统及新产品开发的基本知识,适用于医疗器械企业的主流质量管理体系介绍为切入点,进而以项目质量管理理论为基础,结合NEU公司现行质量管理体系及新产品开发相关项目管理流程,对项目各个阶段的主要质量管理活动进行了剖析和深入研究,阐述了相应活动的内容,包括FMEA、PPAP在内的质量方法及工具的使用案例,项目过程中原材料供应商的管理方案,明确了项目各阶段质量计划、保证及控制应完成的任务和实施方式,并对本项目结果进行效果确认,最终总结出标准化的内容,期望对中小规模医疗器械企业超声诊断系统新产品开发项目实际应用有所指导,可对其提高项目质量管理水平有所帮助。同时希望对其他医疗诊断产品,乃至其他行业的新产品开发项目质量管理过程,也可提供一定的借鉴意义和实践价值。
[Abstract]:In today's rapid economic development, ensure social and business efficiency and excellent product quality helps to obtain more has been widely accepted. A person with breadth of vision in a safe, effective for the basic requirements of medical equipment industry, the concept of prevention of new product project quality management based on, is regarded as one of the core competitiveness of advanced enterprises. As in the increasingly fierce competition, to seek survival and development of the basic strategy. But should also be seen in many Chinese, especially small and medium-sized medical enterprises, still exists, the advanced quality consciousness or weak project, or quality management, improve the means of the relative lack of problems, which greatly limits the further growth of enterprises this paper takes the domestic medical equipment. The leading enterprise NEU company's new product development project HD24 color ultrasonic diagnostic system as the research subject, the ultrasonic diagnosis system and new product development The basic knowledge, the mainstream of the quality management system is applicable to the medical instruments enterprises as the starting point, and then to the project quality management theory, combined with NEU's current quality management system and the development of new products related to the project management process, the main quality management activities of each stage of the project are analyzed and studied, the corresponding activities the content, including FMEA, PPAP, quality methods and tools use case management project of raw materials suppliers, the quality assurance and the various stages of the project plan, should complete the task control and implementation methods, and the project results confirm the effect, finally summarizes the standardization of content expectations new products of medical ultrasonic diagnostic system of small and medium-sized enterprise development project application guide can help to improve the quality management level of the project. It also hopes to provide some reference and practical value for other medical diagnosis products, and even the quality management process of new product development projects in other industries.

【学位授予单位】：东北大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：F426.4;F273.2

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