發(fā)布時間：2018-04-25 03:01

  本文選題：質量管理 + 質量控制計劃�。� 參考：《華南理工大學》2014年碩士論文

【摘要】：隨著世界經濟、科技的發(fā)展，人類在滿足日益增長的物質和精神需求的同時，越來越關注自身的健康，越來越多的資源投向了醫(yī)療服務行業(yè)。近幾十年來人類發(fā)現(xiàn)僅依靠藥物無法應對各種疾病的研究、診斷、預防、監(jiān)護、治療以及替代人體組織、支持或者維持生命，于是醫(yī)療器械開始出現(xiàn)并迅速發(fā)展。從無到有、不斷改進，醫(yī)療器械有著與其他產品不一樣的產品特性要求-安全、有效。這也就意味著醫(yī)療器械質量管理的重點在產品的設計開發(fā)階段。在醫(yī)療器械產品的設計開發(fā)階段做好質量管理，對今后產品的制造、上市、銷售、使用和回收過程起著決定性的作用，能夠提高企業(yè)的經濟效益，能夠預知、控制產品在制造、銷售、使用過程的風險，減少對病人造成的傷害。 Y醫(yī)療科技公司成立于1996年，有優(yōu)秀的產品設計開發(fā)和質量管理的團隊，在十幾年的運營中積累了一些設計開發(fā)和和質量管理的經驗，擁有十幾項發(fā)明專利和實用外型專利，該企業(yè)是國內同行業(yè)的龍頭企業(yè)，參與制定多項的國家標準。 本文將采用案例研究的方式，以Y公司X產品設計開發(fā)項目的質量管理為研究對象，介紹PDCA、質量控制計劃、風險管理、過程確認、質量功能展開、失效模式分析等改進的措施和工具，描述X醫(yī)療器械產品在設計開發(fā)階段質量管理的現(xiàn)狀和過程，，通過總結X產品設計開發(fā)的質量管理存在的問題和分析，對產品設計開發(fā)的質量管理提出改進措施和對改進前后進行效果對比。 本文對X產品設計開發(fā)質量管理存在問題的分析和提出改進措施，對于Y公司設計開發(fā)、質量管理能力的提高和持續(xù)改進有重要意義，也為醫(yī)療器械行業(yè)其它公司新產品的設計開發(fā)質量管理提供參考和借鑒。
[Abstract]:With the development of the world economy and science and technology, human beings pay more and more attention to their health while meeting the increasing material and spiritual needs, and more and more resources are directed to the medical service industry. In recent decades, human beings have found that drugs alone can not cope with the research, diagnosis, prevention, monitoring, treatment and replacement of human tissues, support or life support, so medical devices began to appear and develop rapidly. From scratch, continuous improvement, medical devices have different product characteristics from other products-safe, effective. This also means that the focus of medical device quality management in the product design and development phase. In the stage of design and development of medical device products, quality management plays a decisive role in the manufacture, marketing, sale, use and recovery of future products. It can improve the economic benefits of enterprises, predict and control the products in manufacture. Sales, use of the process of risk, reduce the damage caused to patients. Y medical science and technology company was founded in 1996, has excellent product design and development and quality management team, has accumulated some design development and quality management experience in the operation of more than ten years, has more than ten invention patents and practical external patents, The enterprise is the leading enterprise in the same industry, participating in the formulation of a number of national standards. This paper will adopt the method of case study, take the quality management of X product design and development project of Y Company as the research object, introduce PDCA, quality control plan, risk management, process confirmation, quality function development, This paper describes the current situation and process of quality management in the design and development phase of X medical device products, and summarizes the existing problems and analysis of quality management in the design and development of X products by means of improved measures and tools such as failure mode analysis. Improve the quality management of product design and development and compare the effect before and after improvement. This paper analyzes the problems existing in the quality management of X product design and development and puts forward the improvement measures, which is of great significance to the design and development of Y Company, the improvement of quality management ability and the continuous improvement. Also for other companies in the medical device industry new product design and development quality management to provide reference and reference.
【學位授予單位】：華南理工大學
【學位級別】：碩士
【學位授予年份】：2014
【分類號】：F273.2;F426.4

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