Total Quality Management Of Hereditary Deafness Biochip Project

The thesis used the theory of project quality management, combining with the characteristics of biochip project quality management, has set up the total quality management system, baseing on medical device quality management. By analyzing the hereditary deafness biochip quality management system, the thesis has already improved the quality management system, from management responsibility, resource management, product realization aspect, specific include:(1) Clearly-defined project management responsibilities.(2) Reasonable distribution of project resources, including human resources, infrastructure and work environment in three aspects.(3) Control of the whole product realization process, containing customer-related processes, design and development, logistics procurement, production and services in four areas.Trough monitoring and measuring the improved quality management system, as well as comparing the quality of data collected before and after improvement, it showed that the first-generation product of the hereditary deafness biochip project has gained higher degree of market acceptance and the second-generation product has efficiently completed technical research and production transformation. This strongly proved that the improved total quality management system was able to run effectively.