本文關(guān)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(xué)》2015年碩士論文　論文類型：學(xué)位論文

  更多相關(guān)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(jì)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(yù)防理念的新產(chǎn)品項目質(zhì)量管理,更是被先進(jìn)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(yīng)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(jìn)一步成長。本課題選取國內(nèi)醫(yī)療器械領(lǐng)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(jìn)而以項目質(zhì)量管理理論為基礎(chǔ),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(guān)項目管理流程,對項目各個階段的主要質(zhì)量管理活動進(jìn)行了剖析和深入研究,闡述了相應(yīng)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(yīng)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(yīng)完成的任務(wù)和實施方式,并對本項目結(jié)果進(jìn)行效果確認(rèn),最終總結(jié)出標(biāo)準(zhǔn)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(yīng)用有所指導(dǎo),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(xué)位授予單位】：東北大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2015
【分類號】：F426.4;F273.2

【參考文獻(xiàn)】

相關(guān)期刊論文 前10條

1 吳春其;;應(yīng)用8D方法解決問題的實踐要點[J];標(biāo)準(zhǔn)科學(xué);2012年03期

2 劉尊亮;;全數(shù)字超聲診斷系統(tǒng)關(guān)鍵技術(shù)淺析[J];中國衛(wèi)生產(chǎn)業(yè);2012年01期

3 李曦;;論新產(chǎn)品研發(fā)項目中的質(zhì)量管理活動[J];項目管理技術(shù);2011年05期

4 高敬業(yè);;質(zhì)量管理中的QFD法[J];企業(yè)改革與管理;2010年09期

5 葉慶菊;楊淑芳;王瓊;;生產(chǎn)件批準(zhǔn)過程在汽車供應(yīng)鏈的應(yīng)用[J];專用汽車;2010年09期

6 汪長飚;;8D方法在汽車零部件供應(yīng)商質(zhì)量改進(jìn)中的實踐[J];改革與開放;2009年12期

7 陳崇進(jìn);;淺談項目質(zhì)量管理在新產(chǎn)品開發(fā)中的應(yīng)用[J];法制與經(jīng)濟(jì)(中旬刊);2009年11期

8 陳力;;淺析8D質(zhì)量改進(jìn)方法及管理[J];柴油機設(shè)計與制造;2009年01期

9 周軍;;新版ISO13485標(biāo)準(zhǔn)剖析[J];醫(yī)療保健器具;2007年05期

10 于金偉;;FMEA與控制計劃在過程控制中的應(yīng)用[J];世界標(biāo)準(zhǔn)化與質(zhì)量管理;2006年09期

相關(guān)碩士學(xué)位論文 前2條

1 林文溪;基于新產(chǎn)品開發(fā)流程的產(chǎn)品開發(fā)項目的質(zhì)量管理研究[D];上海交通大學(xué);2012年

2 蔡菁華;CS公司進(jìn)入美國超聲診斷儀器市場戰(zhàn)略研究[D];華南理工大學(xué);2012年

，

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