Medical device quality management system for: quality management system, quality management organization, personnel training, procurement control, production quality control, storage and transportation control.
1, quality management system
Establish a medical device quality management system including organizational structure, procedures, processes and resources to ensure quality control of medical device design, production, storage, use and disposal.
2, quality management organization
Establishing a department or organization specifically responsible for quality management, clarifying its responsibilities and authority, and ensuring its independence and authority. The department shall be responsible for supervising the operation of the quality management system and implementing various quality management activities.
3, personnel training
The personnel engaged in medical device-related work quality management training to ensure that they understand and follow the relevant laws, regulations and standards. The training should include the basic knowledge of medical devices, the operation process of the quality management system, duties and responsibilities.
4, procurement control
Develop and implement procurement control procedures to ensure that the purchased medical devices meet the specified requirements. During the procurement process, suppliers should be evaluated and selected to ensure that the purchased medical devices are traceable.
5, production quality control
Develop and implement quality control procedures in the production process to ensure that the production process of medical devices meet the specified requirements. In the production process, product quality should be inspected and tested to ensure that product quality meets the expected requirements.
6, storage and transportation control
Develop and implement storage and transportation control procedures to ensure that medical devices are not damaged or contaminated during storage and transportation. The inventory should be checked regularly to ensure that the storage environment of medical devices meets the specified requirements. During transportation, it should ensure that the packaging of medical devices is intact and clearly labeled.