1, medical device quality management documents refers to the guidance and standardization of medical device quality and safety management of the document, the main provisions and constraints of various types of medical device enterprises in accordance with the relevant national laws, regulations and standards, how to organize and implement the management of quality and safety of the methods and procedures.
2, medical device quality management documents are documents that enterprises should comply with to ensure that the products provided to meet the requirements of the market, society and medical insurance.
Two, content
1, product access qualification: according to the enterprise qualification, production environment, technical equipment, management system and other factors, to confirm whether it meets the conditions for product access.
2, quality management system: to establish the quality management system applicable to the management of medical devices, covering the person in charge of quality, quality management department, quality inspection department, quality management records.
3, quality management technical documents: the preparation of various quality management technical documents including production disassembly, operation, maintenance, reliability, technical inspection, etc., to ensure that the enterprise in the operation process to achieve the highest quality standards.
4, quality control: installation and use of the process to ensure that the system of medical devices is safe and effective, the quality of the relevant laws, regulations and standards to meet the requirements, and set up a medical device maintenance and inspection system to strengthen the supervision of the quality and safety of the equipment.
5, quality management review: Regularly convene quality management review meeting to grasp the level of enterprise quality management, and make corresponding improvement measures, so as to realize the improvement of quality management.
Three, implementation
1, product access: according to the requirements of the enterprise quality management system, regular product access control to ensure product compliance.
2, quality assurance measures: the establishment of internal quality inspection system in the factory to facilitate the checking of quality, to ensure that the product can provide customers with services to ensure quality.
3, quality traceability: the establishment of a quality traceability system to facilitate the management to quickly find the existence of quality problems in the product, and timely disposal.
4, quality management review: Regularly carry out quality management review, and take timely modification of unqualified products in order to realize quality improvement.