Research On Quality Management Strategy For New Product Introduction Process Of QS Company

The medical device industry is growing faster than ever before,driven by technology,policy,and human expectations for health.New technologies are pushing new products into the market,bringing better treatment to patients and business opportunities to companies.In this context,how to smoothly and quickly provide new products to the market has become an urgent issue that enterprises must pay attention to.QS Group has a long history and is a benchmark enterprise in the global orthopaedic industry.QS’s problems are typical in the industry.This thesis reviews the development of medical device industry.Then starting from the actual situation of QS company,focusing on quality management strategy of new product introduction process,by carefully analyzing the current situation of new product introduction,taking the regulatory requirements under consideration,points out the comprehensive quality planning,process development and management,risk management and project hand-over issues,and apply the thought of total quality management.The corresponding improvement plan and implementation measures have been formulated.In the aspect of risk management,an innovative working mode of process failure mode and effect analysis is proposed,which is a beneficial attempt to improve the effect of risk management.This thesis analyzes and expounds the guarantee work of the implementation of the improvement plan from the perspective of promoting the top-down change,emphasizes the importance of management engagement on the implementation of the change,and introduces the process improvement model of QS company.It also introduces the mechanism of QS company in encouraging all employees to participate in the change,collecting employees’ opinions extensively,continuously innovating and improving the process.Finally,the effect of implementation is summarized.