• Journal of the Korean Society of Radiology
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• v.18 no.5
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• pp.463-471
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• 2024

Through this study, the purpose of this study is to harmonize the quality assurance system of diagnostic radiation generator inspection bodies with current international standards, standardize the diversity of inspection bodies, provide consistent inspection services to medical institutions, and improve review efficiency of regulatory agencies. We compared and reviewed the quality assurance systems of all domestic diagnostic radiation generator and defense facility inspection bodies. For international harmonization, we reviewed international and domestic and international standards, including ISO/IEC 17020, and added and reflected the requirements of regulatory agencies. The quality assurance systems of all inspection bodies included all required items in compliance with ISO/IEC 17020, but some of the quality procedures showed differences. Standards were drawn up through expert meetings for items where differences were compared and analyzed, and rules for safety management of diagnostic radiation generators and amendments to these regulations were proposed. The results of this study are expected to improve the operational efficiency of inspection bodies and the work efficiency of regulatory agencies for inspection bodies, and international harmonization in accordance with international standards such as ISO/IEC 17020 should be continuously maintained.