Enterprises should be based on regulatory requirements, risk management requirements, product technical requirements, product characteristics, production scale, process characteristics, quality management capabilities and other practical, to determine the product to achieve the whole process, in particular, the verification of the procurement and production process of verification, validation, monitoring, measurement, inspection, testing processes and requirements.
Enterprises shall, with respect to the purchased items, intermediate and finished products and their related processes, after the completion of the design and development of medical devices, especially after the completion of the design conversion, output incoming inspection procedures, process inspection procedures and finished product inspection procedures and other systematic and comprehensive quality control documents, which are used to guide the realization of the whole process of the product, in particular, the purchasing and production process of quality control and finished product release work, to ensure that The use of purchases in line with the requirements of the flow of intermediate products in line with the requirements of the release of finished products in line with the requirements.