Medical device quality management system is a comprehensive and systematic management mode, which aims to ensure that the production, use and supervision process of medical devices comply with relevant laws and regulations and quality requirements.
The system is based on the ISO13485 standard, which reflects the specificity and importance of the medical device industry. The core of the medical device quality management system is the quality policy and objectives, enterprises need to establish a clear quality policy, and develop quantifiable quality objectives to ensure the effective operation of the entire management system and continuous improvement.
System documents include quality manuals, program documents, operating instructions and records, which provide clear guidance and basis for production, quality management and business activities.
Management responsibilities in the quality management system include customer focus, management commitment, quality policy, planning, responsibility authority and communication, and management review. Resource management covers the requirements for human resources, infrastructure, and working environment to ensure that the enterprise has the various resources needed to produce qualified medical devices.
In terms of product realization, the quality management system sets out clear requirements for design and development, procurement, production and service provision, and control of monitoring and measuring devices to ensure that the quality of products meets the required standards.
Features of medical device quality management system:
1. Strong regulatory orientation: medical device quality management system is constructed on the basis of the ISO13485 standard, which puts special emphasis on meeting the requirements of national and regional medical device regulations. Enterprises not only need to follow the general principles of quality management, but also need to pay attention to and comply with the special provisions of laws and regulations.
2. Risk management as the core: ISO13485: 2016 version strengthens the position of risk management in the entire quality management system, requiring companies to implement systematic and structured risk analysis and management in the design, production and service process.
3. Traceability and verifiability: The medical device quality management system emphasizes the completeness and traceability of records to ensure that the history of each batch of products can be traced, which facilitates the investigation and resolution of quality issues, and also facilitates compliance review by regulatory agencies.