| In vitro diagnostic reagent sector is high-tech industries, but because of in vitro diagnostics industry in the country has just begun the early stages of development, relevant policies and backward development of the industry is not standardized, the authorities lack of supervision, the development of in vitro diagnostic reagent sector in the country has not been a very smooth, With all of the in vitro diagnostic reagent industry profit of understanding more and more emerging country in vitro diagnostics company set up, which makes in vitro diagnostic reagent industry more competitive, management, more and more confusion and even some manufacturers to produce quality substandard products on the market, which seriously endanger the physical health of people in public health.It is in this situation, the State Food and Drug Administration in 2007 issued a series of in vitro diagnostic reagents for the confusion in the industry policy to regulate all behavior in vitro diagnostic reagent manufacturers, factories act to regulate and standardize the market effect. These policies include "in vitro diagnostic reagent production Rules (Trial)", "in vitro diagnostic reagents for Registration", "in vitro diagnostic reagents for the evaluation criteria (Trial)" and, combined with "Medical Device Registration" and other early stage has been enactment of national legislation to regulate in vitro diagnostic reagents manufacturer management.Beijing JZTK Biotechnology Co., Ltd. It is in the context of this policy set up. Private capital investment is a high-tech enterprise, the company's main products are bio-chip technology used in products in the United States developed a new technology developed by U.S. scientists new products vitro diagnostic reagents. Founded purpose is to introduce the success of this project in China, not only for the company to create profits, but also in order to enable the advanced products to market in time for the benefit of the general public.Production in vitro diagnostic reagents, only rely on advanced technologies and products are also not enough, a company or project of Cheng Gong also need external and internal factor, Management is one very important major factors, particularly Quality management. In vitro diagnostic reagents manufacturer's management have him different from other general corporate characteristics, the general in vitro diagnostic reagent manufacturers have based on ISO9001:2000 and ISO 13485:2003 and national regulations for in vitro diagnostic reagents to establish their own quality management system of enterprises. JZTK biochip project is no exception. This study is around JZTK biochip project quality management system process of the establishment. Firstly, the basic quality management have been described, mainly ISO9001:2000; then on the medical device industry-specific quality management standards have been described, mainly ISO 13485:2003; focus on quality management JZTK biochip methods used do systematic introduction, the main brains storm method. Then, on JZTK biochip project in the absence of a quality management system, project quality management when the situation was analyzed, the main project is to find the problems and causes, through in-depth analysis of each issue to find the cause of the problem, as After the implementation of quality management of the project provides a specific target.JZTK biochip according to the problems the project, combined with ISO9001: 2000 and SIO13485:2003, taking into account the line "in vitro diagnostic reagents manufacturing Rules (Trial)" and other state laws and regulations, JZTK biochip project quality management system well-planned start, drawing the project plan Gantt chart; and projects targeted towards problems Make all management systems, these system include document, plant, protection, measure, personnel, production, quality management, R&D, sale, authentication and other aspects; take a variety of flexible methods of management, to human management; in the rational allocation of project implementation staff, and staff training and rigorous assessment; strict control time, every step is completed as planned; efforts to reduce costs, give full play to the enthusiasm, there are problems brainstorming; makes the contradictions in the project are resolved.In the project hardware, JZTK biochip project in strict accordance with relevant state regulations, established a 10 clean room, equipped with the necessary production equipment and testing equipment; established the Treasury and the dangerous goods warehouse, and the establishment of a complete management system. project implementation strictly control the production process, inspection process, procurement processes, eliminate the problem in the process, not so the results come out, think of way to end the problem occurs.Meanwhile, in the project implementation process, also applied in other advanced quality control methods, such as brainstorming to solve the chip can't timely arrival, instead of chips with a slide problems; causal diagram, the stability of the product failed to resolve problem; Pareto solve the issue of substandard quality; plot, identified the enzyme concentration and the link between product quality. The application of quality management methods, but also for the smooth progress of the project has provided a guarantee for the project and sometimes save a lot of time, or to save a lot of the cost of the project, the project's success for the future laid a good foundation.Finally, according to ISO9001:2000 and SIO13485:2003, and "in vitro diagnostic reagent production Rules (Trial)", through targeted solutions JZTK biochip project issues, preparation of documents and systems, and improved operating system; also applications such as brainstorming with the quality of management. Beijing JZTK Biotechnology Co., Ltd. has established a company for its quality management system, also established a working environment for their company's management team and technical team, which is the company's greatest achievement. Reference to other companies to establish quality management system, consider the personal experience of the establishment of quality management system, can be concluded, the implementation of an enterprise management system is necessary, an in vitro diagnostic reagent manufacturers, the implementation of ISO13485:2003 quality management system to the role of quality management is huge, the State Food and Drug Administration's "Rules for the Implementation of production in vitro diagnostic reagents (Trial)" to improve the in vitro diagnostic reagent industry, management level, in vitro diagnostic reagents for improving the quality of products has a very important role in.JZTK on the quality of microarray project management-related research, not only on JZTK biochip project itself has a very important role, but also on the quality management system in the application of in vitro diagnostics industry, has added a valuable experience points, on the other in vitro diagnostic reagent industry, manufacturers and want to get into in vitro diagnostics industry, investors also have some reference. |
PDF Full Text Request