The Medical Laboratory Quality Manage System Optimization Program Of Y Company

The Medical Laboratory was deemed as part of global pharmaceutical,biopharmaceutical,and medical device open-access capability and technology platform of Y Company,which is new established.Effective operation of medical laboratory quality management system is the key factor to continuously improve the quality of management and maintain the accuracy of the examination,as well as to improve the laboratory core competitiveness.But after the first year of implantation,the problems of the quality management system in many aspects were revealed,and there is big gaps compare to other similar laboratories,and some of the quality objectives were not archived,and these deficiencies must be optimized to improve the quality management system and to meet the needs of users continuously.With the continuous influx of foreign medical laboratories and the rapid development of other domestic medical laboratories,the future market competition is bound to be very serious,and only through continuou s improvement and effective operation of the quality management system can keep to improve the laboratory quality management level,and ensure that the laboratory get a favorable position in the fierce competition in future.The laboratory must learn from the international and domestic advanced quality management system theory and practice of the laboratory quality management system to optimize and improve the existing problems,and continuously improve the quality of laboratory management to ensure the timely,effective and accurate of the examination results,through high quality level service to gain the trust of users continuously.This paper examined the medical laboratory quality manage system of Y company firstly,then several deficiencies were concluded,which existed in organization and personnel management,document control management,pre-examination process / examination process / post-examination process management,facilities and environmental management,equipment,reagent and consumables management.After deeply and thoughtful research and analysis,the majority reasons were categorized as lack of management attention,lack of awareness of quality management,lack of effective control of the entire process of examination,lack of effective control of document management,lack of knowledge of facilities and equipment management.In order to solve above problems,the paper puts forward the optimization plan based on the theory of total quality management and the stand of ISO 15189 Medical Laboratories – Requirement for quality and competence.The results of the optimization will be evaluated by comparing the selected quality indicators before and after.Through the implementation of quality management system optimization program,it did improve the quality management level of the laboratory.The comparisons of the quality indicators before and after proved that the deficiency which was optimized was improved significantly.The effectiveness of the laboratory quality management system was optimized and the competitiveness was enhanced.