iso13485 system refers to the medical device quality management system standard, which aims to provide a set of management system standards for medical device manufacturers and suppliers to ensure the quality and safety of their products.
The standard was developed by the International Organization for Standardization (ISO), and after years of development, it has now become one of the quality management system standards widely adopted by the medical device industry worldwide.The core requirements of the ISO13485 system include the establishment, implementation, maintenance, and improvement of the quality management system, as well as the medical device product design, production, inspection, packaging, The core requirements of the ISO13485 system include the establishment, implementation, maintenance and improvement of the quality management system, as well as the quality management and risk control in the whole process of medical device product design, production, inspection, packaging, storage and transportation.
It requires medical device enterprises to establish a set of documented quality management system to ensure that the quality of the products meets the requirements of relevant regulations and standards, and requires enterprises to take effective measures to continuously monitor and improve the safety of the products. The establishment and implementation of ISO13485 system can improve the quality management level of medical device enterprises, enhance the quality and safety of products, enhance the market competitiveness of enterprises, and help enterprises to obtain recognition and certification in the international market.
ISO 13485 system requirements
1, management responsibility: to ensure that the top management of the importance of quality management has a clear understanding of the quality of the target to provide and support.
2, resource management: rational allocation and management of manpower, equipment, facilities and funds to meet the requirements of quality management.
3, design and: to ensure that the design and process of medical devices, standardized, controllable, in line with relevant regulations and technical standards.
4, risk management: determine and assess the risk of medical devices, and take appropriate measures to control and manage.
5, supplier management: establish procedures for supplier evaluation and selection, and establish cooperative relationships with suppliers to ensure that their products and services meet the requirements.
6, production process control: to ensure that the production process, standardized and controllable to the stability and consistency of product quality.