自2011年1月1日《医疗器械生产质量管理规范(试行)》和2014年6月1日《医

疗器械监督管理条例(修订草案)》实施以来,对医疗器械的监管从注册、创新评审、

生产、流通经营实现了全方面覆盖。医疗器械GMP已逐步进入全面执行过程,在推动

医疗器械质量管理体系实质进步的同时,也给医疗器械生产企业带来巨大挑战和难得机

遇,整个欧亿·体育（中国）有限公司特别是中小生产企业面临着重新整合发展的压力和动力。

A医疗器械公司作为一家民营的中小型医疗器械生产企业,面对医疗器械质量管理

体系更高更全面的要求,结合自身生产质量管理实施过程中存在的问题,必须对质量管

理体系进行战略性思考,防止各种质量问题的产生,使产品更具竞争力,以此推动企业

的快速向前发展。

本文在对A医疗器械公司质量管理体系存在的问题及其原因进行分析的基础上,

运用全面质量管理理论、结合最新法规的要求和A医疗器械公司目前的实际情况,基

于PDCA循环从质量管理体系文件、设计开发过程、设计转移过程和供应商质量管理

四个方面提出了相应的工作计划和具体措施,并讨论了质量管理体系改进的效果。本文

的研究结果对保证医疗器械的生产质量管理具有现实意义和价值,对国内其他中小型医

疗器械的质量管理体系改进也具有一定的借鉴意义。

关键词:GMP;质量管理;医疗器械

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华东理工大学硕士学位论文

Research of A Medical Device Company Quality Management

System Improvement

Abstract

Since the Chinese Medical Device Quality Management Regulations (trial version) has

been implemented on January 1,2011 and Regulation on the Supervision and Management of

Medical Device (revised draft) was effective on June 1,2014,all the aspects of the

supervision and management of medical devices have been covered, including reregistration,

innovation review, production and distribution. Medical device GMP has entered a stage of

full implementation, the medical device industry especially for the small and medium size

manufacturing enterprises are facing to the pressure and driving force of the development of

integration.

A medical device company is a private small and medium production enterprise, facing

to the higher and more comprehensive requirements of quality management system,

considering the existing problems of the implementation, A medical device company should

strategic thinking the questions of quality system improvement to prevent the quality

problems and make products more competitive, to propelling the company developed rapidly.

Based on the currently existing quality problems and the analysis of root causes,

combining with the theory of total quality management, new regulations and actual situations

of A medical device company, this article addressed a detailed improvement plan and

concrete measures from four aspects of quality management system documents, design and

development, design transfer and supplier quality management through PDCA cycles. The

results of this article has practical value to ensure the product quality of medical device

manufacturing,and has provide a reference to quality management system improvement for

other domestic small and medium medical device enterprises.

Keywords: GMP, Quality management, Medical device.