Research Of PS Company Medical Device Quality Management System Construction Project Management

With the rapid growth of economic and the increasing internationalization of the market in China, how to better use QMS (Quality Management System) in the medical device industry which already operated under internationalization to enhance the quality level of products, thereby raising the quality of management level and core competitiveness of enterprises, that is a important topic for the administers, With the introduction of international IS013485:2003 Medical Device QMS, how to make it a smooth landing in local medical device manufacturing industry, and how to construct, implement this system to achieve the suitability, adequacy and validity is a good subject worthy of study.This article will apply the theory of project management to the construction of Medical Device QMS in PS Company. It also point out the problems in current QMS ISO9001 in PS Company and analyze the necessity of Medical Device QMS construction in PS Company, at the same time the final goal is established for this construction project. Then build the project plan based on the task decomposition, the sort of work tasks and the estimated time required to construct the Medical Device QMS in PS Company. This article also discusses the project plan, progress checking and adjustment to the effective control of project schedule. Meanwhile this paper also provide a detailed analysis of identification in the business process, document preparation system, training and commissioning, internal audit and management review during the construction of Medical Device QMS project. Finally, the paper discusses the acceptance of this construction project and summarizes the experience of this project. Results of this article can be used for the reference of ISO13485:2003 Medical Device QMS construction in the medical device industry.