A Research Of The Strategy Of Implementation Of QSR For Medical Device In P Company

With the rapidly revolution of the world economy and society,great changes have taken place in almost all industries.In the EMS industry,a very small number of oligopoly enterprises have mastered the vast majority of orders and profits.Then,for these relatively small-scale enterprises,differentiated competition is a good choice.P Company is one of them in the medical devices business.At present,it is ISO 13485 certificated.Considering the cost and time,it is neither economical nor time-consuming to completely overthrow and re-establish the new system.So,the only choice is to build the FDA medical system based on the current exist system.Firstly,systematically expounds the related concepts,theories and different requirements of the ISO medical system and the FDA regulations,studies and sorts out the relevant theoretical frameworks of strategy formulation and implementation,as well as project management.Through the comparative analysis of the framework of the two systems,the focus of attention,the document control system,and so on,the entry point and the problems to be solved to establish the FDA regulation system based on the current system are summarized,so as to clearly define the object of the study of the paper.Then,the implementation strategies applicable to the research objects are formulated at different levels,such as organization level,business level and function level,and then the strategies formulated are layered.It is divided into five different steps,combined with the use of project management methods,from the evaluation and communication of the strategy implementation plan,the development of the strategy implementation framework,the formulation of the strategy implementation support plan,the resource budget and allocation,and the execution.Through the research of this paper,it has obvious helped the company's internal decision-making and rapid response mechanism,the improvement of the quality consciousness of all employees and the systematic approach.And the way to establish a system based on current system at a lower cost in a shorter period of time,thereby improving and promoting the quality management concept even the optimization of business structure is of great reference significance.