dc.description.abstract | With the continuous development of industries in modern society, we find that the barriers between industries are becoming increasingly blurred. Cross-industry business investment has been heard from time to time and even achieved considerable success, such as the increasing profitability the electronics manufacturing industry has gotten through the vertical integration, joining the upper and lower stages of the manufacturing process; Brands, such as Xiaomi has stepped into the field of smart appliances and software giant Microsoft has launched competition in the field of hardware in the name of their expected PC. However, in the face of medical products with strict qualification requirements, it is rare to get involved in cross-business. This study aims to explore the problems and practical solutions for EMS (Electronic Manufacturing Service) cross-medical products in the context of actual cases.
P company is one of the large enterprises that will step into the production of medical equipment, and currently has already had ISO 9001 quality management system (a voluntary-based quality management system established by the international standards organization). Considering many factors such as cost and time, it is neither economical nor time-consuming to completely push down and re-establish the medical equipment quality system. Therefore, the quality management system, based on the existing quality system to meet the requirements of ISO 13485 (medical device quality management system that requires mandatory certification according to national regulations) and FDA 21 CFR 820 (Foot and Drug Administration, 21 CFR 820, the medical equipment quality system regulation), is undoubtedly the best choice for P company.
In this paper, the concepts, theories and different requirements of ISO 9001, ISO 13485 and 21 CFR 820 are expounded systematically, and the theoretical framework for strategy formulation and implementation as well as project management is studied and sorted out. By comparing and analyzing the framework, focus, and document system of them, we have summarized the entry points and problems to be solved for establishing a medical device quality management systmen based on the original one. Then using the principles and methods of strategy formulation, combined with the actual situation of P company; adopting the method of project management to evaluate and communicate the strategy implementation plan; formulating the strategy implementation framework and the relative supporting plans; resource budget and allocation, and the performance of functions and activities to the establishment of the completed medical device quality system and obtaining corresponding qualification certificate and audits, this paper will be completed.
Through the research examples in this paper, it is of great reference value for enterprises in similar situations to analyze the differences between different systems and formulate correct implementation strategies, so as to eventually establish a medical device quality management system that meets regulatory requirements in a shorter period of time and at a lower cost, thereby improving and promoting the medical device quality management concept and even business structure optimization. | en_US |