Measures for the Management of Radiological Health Technology Service Organizations

Legal analysis: In order to regulate the behavior of radiation hygiene technology services, and to strengthen the management of radiation hygiene technology service institutions, the State has formulated relevant regulations on the management of radiation hygiene technology service institutions.

Legal basis: "Measures for the Administration of Radiological Hygiene Technical Service Organizations"

Article 3 Organizations engaged in radiological hygiene technical services must obtain the Certificate of Qualification for Radiological Hygiene Technical Service Organizations issued by the Ministry of Health or the provincial health administrative department.

Article 4 The Ministry of Health is responsible for the supervision and management of the national radiation health technology service organizations. Local health administrative departments above the county level are responsible for the supervision and management of radiation hygiene technology service organizations within their jurisdiction.

Article 5 The establishment of radiological health technology service organizations shall follow the principle of rational allocation.

Article 6 The organization applying to engage in radiation hygiene technology services should have the following basic conditions: (a) legal personality or legal personality authorization qualification; (b) a fixed office space and the corresponding radiation hygiene technology services and working conditions; (c) can independently carry out the work of the corresponding technical services; (d) reasonable job setup, responsibilities are clearly defined; (e) have a comprehensive quality Management control system.

Article IX Radiological hygiene technical service organization's laboratory shall meet the following requirements: (1) The testing laboratory has good housekeeping, neat and orderly. Testing instruments are reasonably placed, easy to operate, and equipped with the necessary anti-pollution, fire prevention, anti-theft, control access and other safety equipment and related measures; (2) quality management system documents, and in strict accordance with the documents to carry out quality control work; (3) radioactive material testing sites, should be in line with the requirements of the relevant laws, regulations and standards of radiation health. There is the use of radioactive standard sources or standard substances to control the quality of testing measures. There are records of participation in inter-laboratory testing proficiency testing activities; (d) testing methods using national, industry or local regulations or standards. There should be details of testing methods, instrument operating procedures, sample management procedures and data processing rules and other operational guidance documents; (e) for the test samples to establish a unique identification system and status identification. Preparation of written procedures relating to sample collection, receipt, flow, preservation and safe disposal; (vi) radioactive samples should be stored separately from other samples, dedicated storage. Discarded radioactive samples and other radioactive waste shall be disposed of in accordance with relevant regulations. Handling of non-sealed radioisotopes in the laboratory should be ventilated, the ground, the laboratory table should facilitate the removal of radioactive contamination; (vii) the original records and test reports should be in accordance with their respective requirements, contain sufficient information, and in accordance with the relevant provisions of the writing, alteration, auditing, signing, distributing and preserving.