Quality Management System Improvement Strategy For X China Medical Device Company

Business on healthcare is always boom. Business in healthcare is always booming; Itsoutstanding growth catches everybody’s eyes; especially in the period of global economicrecession; the global total available market has been increased to416million at2011from187million at2001. With the reform and opening-up; Chinese healthcare also made greatstrides and keeping its rapid progress while human step into21st century. The forecast isChinese market will increased to25%from3%at2010in the global healthcare marketshare. To make the firm stand in the blooming market the enterprises of China will be more&more competitive; the establishment of effective MDQMS (Quality ManagementSystem for Medical Devices) will strengthen it.Company X is one global leader as the healthcare product provider in R&D;manufacturing; Sales&after-market service. It established the R&D and manufacturingCenter in China by acquisition&capital injection while its product has a leading salesgrowth in China than other countries and regions. But the MDQMS established base onrich experience from its European&American branches just can’t provide good support tothe development of the acquired company; its subsidiary in China for the culturaldifference. And on the other hands the local QMS of the subsid in China also didn’tconverge local native culture&the requirement of quality system standards and then madethe QMS is not a decoration or even fetter the development of Chinese Company. How toconverge China native culture to optimize current quality structure and then establisheffective MDQMS is the top priority task for the X Company.The QMS theory has almost one hundred years develop history. And there aredistinctive Quality management systems in Europe; America&Japan base on theirdifferent native culture. For instances; the TQM in Europe or America and the TQC inJapan. Both QMS has distinctive advantage and adapted for different culture enterprises.This thesis will converge the theory foundation&practice experiences of TQM&TQCwith the considering of native culture difference to give out the improve&optimizesolution for the QMS in Company X aiming at the current issue in the X. And base on thesolution to help establish effective QMS. The result is not only offering valuable reference to other multinational company in Chines healthcare market and also to Chinese localhealthcare product provider.