1. Regulations on the Management of Medical Institutions: This regulation stipulates that medical institutions should strengthen quality management to ensure the safety and effectiveness of medical technology. Clinical laboratory is a very important department in medical institutions, and a perfect quality management system must be established.
2. Diagnostic test standard and quality control guide: This guide was issued by the National Health and Wellness Committee, and made detailed provisions on the equipment, environment, personnel and operation flow of clinical laboratories, aiming at improving the level and quality of diagnostic tests.
3. Medical Laboratory Management Specification: This specification was promulgated by China Food and Drug Administration, which stipulated the requirements of medical laboratories in terms of capital construction, equipment procurement, internal management and personnel training, so as to ensure the quality and safety of medical laboratories.
4. Other relevant documents, such as Regulations on the Management of Medical Devices, Work Standards for Clinical Laboratories, and Measures for the Management of Adverse Events of Medical Devices, have provided corresponding norms and guidance for the management system of clinical laboratories.