| In recent years,with the continuous enhancement of national health awareness,consumers’ quality requirements for medical device products have also been improved.In particular,in 2019,novel coronavirus pneumonia was rampant,and the national quality supervision of medical device products became increasingly strict.Medical device enterprises are facing huge development opportunities,but also facing the challenges of market competition and price pressure.In order to seek development in the fierce market competition,enterprises must reduce the cost to obtain profits on the premise of ensuring product quality.Therefore,how to improve the quality and cost management level has become an urgent problem to be solved by every medical device enterprise.By using literature research method,case study method,quantitative research method,questionnaire survey method and other research methods,according to the current situation of quality cost management of BK company,with IS09000,ISO13485,medical device laws and regulations as reference,from the aspects of quality cost management awareness,system,system,process,accounting and other aspects.Find out the four main problems existing in the quality cost management of BK company: weak awareness of quality cost management,formalization of quality cost management system,imperfect quality cost management system,inaccurate collection and accounting of quality cost data,and analyze the causes of the problems.Based on this,the DMAIC model is used to improve the quality cost management system of BK company.Define the scope and objectives of improvement;Summarize the quality and cost data of BK Company during the measurement stage;Analysis stage to find out the causes of the problems;Improvement stage in view of the existing problems put forward the specific improvement countermeasures: increase the cost of prevention,improve the quality cost management training assessment mechanism,strengthen supplier quality management,improve the quality cost management system,adjust the quality cost management organization and responsibilities,make full use of financial management software to collect data,refine quality cost subjects and responsibility,etc.;The control phase by comparing the changes in the indicators,To evaluate the improvement effect of BK Company and put forward suggestions for subsequent work,In order to determine the improved quality management system to adapt to the development of the company.With the proposal of the concept of high-quality development,it is urgent to promote the transformation and upgrading of medical device enterprises.This thesis provides certain reference for the high-quality development of medical device enterprises and has certain social value.At the same time,the improvement of the quality management system of BK company can provide guidance for the development of the quality management work of the company in the later stage,and further improve the economic benefits of the company,which has a certain economic value. |