本文關鍵詞：NEU公司HD24醫(yī)療產(chǎn)品開發(fā)項目質(zhì)量管理研究　出處：《東北大學》2015年碩士論文　論文類型：學位論文

  更多相關文章： 醫(yī)療器械 超聲診斷系統(tǒng) 新產(chǎn)品開發(fā) 項目質(zhì)量管理

【摘要】：在經(jīng)濟高速發(fā)展的今天,保證優(yōu)良的產(chǎn)品質(zhì)量有助于獲取更大的社會及企業(yè)效益已為廣大有識之士所接受。在以安全、有效為基本要求的醫(yī)療器械產(chǎn)業(yè),基于事前預防理念的新產(chǎn)品項目質(zhì)量管理,更是被先進企業(yè)視作核心競爭力之一,成為在日趨激烈的競爭中,謀求生存及發(fā)展的基本戰(zhàn)略。但同時應看到,在我國眾多,特別是中小規(guī)模醫(yī)療企業(yè)中,仍普遍存在,或項目先期質(zhì)量意識淡薄,或質(zhì)量管理、改善手段相對欠缺的問題,極大限制了企業(yè)的進一步成長。本課題選取國內(nèi)醫(yī)療器械領先企業(yè)NEU公司的HD24彩色超聲診斷系統(tǒng)新產(chǎn)品開發(fā)項目作為研究主體,以超聲診斷系統(tǒng)及新產(chǎn)品開發(fā)的基本知識,適用于醫(yī)療器械企業(yè)的主流質(zhì)量管理體系介紹為切入點,進而以項目質(zhì)量管理理論為基礎,結(jié)合NEU公司現(xiàn)行質(zhì)量管理體系及新產(chǎn)品開發(fā)相關項目管理流程,對項目各個階段的主要質(zhì)量管理活動進行了剖析和深入研究,闡述了相應活動的內(nèi)容,包括FMEA、PPAP在內(nèi)的質(zhì)量方法及工具的使用案例,項目過程中原材料供應商的管理方案,明確了項目各階段質(zhì)量計劃、保證及控制應完成的任務和實施方式,并對本項目結(jié)果進行效果確認,最終總結(jié)出標準化的內(nèi)容,期望對中小規(guī)模醫(yī)療器械企業(yè)超聲診斷系統(tǒng)新產(chǎn)品開發(fā)項目實際應用有所指導,可對其提高項目質(zhì)量管理水平有所幫助。同時希望對其他醫(yī)療診斷產(chǎn)品,乃至其他行業(yè)的新產(chǎn)品開發(fā)項目質(zhì)量管理過程,也可提供一定的借鑒意義和實踐價值。
[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.

【學位授予單位】：東北大學
【學位級別】：碩士
【學位授予年份】：2015
【分類號】：F426.4;F273.2

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