Research On The Quality Management Maturity Evaluation System Of The In Vitro Diagnostic Reagent Manufacturing Industry In My Country

With the intensification of market competition,and the country's legal system is perfect,in vitro diagnostic reagents manufacturing small and medium-sized enterprises to improve their quality management level,must be objective identify itself advantages and disadvantages of quality management,quality management and to find a suitable for itself development direction.Therefore,how to objectively and effectively evaluate the overall quality management of an IVD reagent manufacturing enterprise and the level of various indicators are the main problems discussed in this paper.According to the basic principle of quality management maturity model and quality evaluation,a quality management maturity evaluation system for domestic small and medium-sized IVD reagent manufacturing enterprises was established.In this paper,from the connotation of quality management,based on the existing several quality management maturity model research summary and Outlines the build a maturity assessment system need the principle and way of thinking,summarized the principle of reusing and evaluate ideas to build the framework of quality management maturity model and steps.Using the summary model modeling principle,according to the characteristics of the IVD reagent manufacturing enterprises in China will be the quality management maturity is divided into five levels,from five big aspects to enterprise quality management work.By establishing evaluation group,to quality management maturity assessment team training,and then issued relevant questionnaire has been designed,by the team members to fill out after recycling questionnaire and data sorting,using the fuzzy comprehensive evaluation method in fuzzy evaluation,the enterprise quality management level of maturity in the office,and then analysis the evaluation results,giving eligible enterprises to improve their quality management maturity level by factor analysis.In the process of establishing the model,the analytic hierarchy process is used to assign the weight of the evaluation index.By comparing the study of several analysis methods,choose the sequence relations of fuzzy evaluation in the process of empowerment,primary and secondary indexes using the fuzzy comprehensive analysis method of comprehensive analysis to get the evaluation results.Finally,the thesis will also set up the evaluation system used on a small and medium-sized enterprise has carried on the empirical analysis,through the investigation and analysis,this paper sums up the degree of the enterprise quality management level and improve the quality of the enterprise management maturity is given Suggestions for improvement.