title: Quality assurance in military medical research and medical radiation accident management.
abstract: The provision of quality radiation-related medical diagnostic and therapeutic treatments cannot occur without the presence of robust quality assurance and standardization programs. Medical laboratory services are essential in patient treatment and must be able to meet the needs of all patients and the clinical personnel responsible for the medical care of these patients. Clinical personnel involved in patient care must embody the quality assurance process in daily work to ensure program sustainability. In conformance with the German Federal Government's concept for modern departmental research, the international standard ISO 9001, one of the relevant standards of the International Organization for Standardization (ISO), is applied in quality assurance in military medical research. By its holistic approach, this internationally accepted standard provides an excellent basis for establishing a modern quality management system in line with international standards. Furthermore, this standard can serve as a sound basis for the further development of an already established quality management system when additional standards shall apply, as for instance in reference laboratories or medical laboratories. Besides quality assurance, a military medical facility must manage additional risk events in the context of early recognition/detection of health risks of military personnel on deployment in order to be able to take appropriate preventive and protective measures; for instance, with medical radiation accident management. The international standard ISO 31000:2009 can serve as a guideline for establishing risk management. Clear organizational structures and defined work processes are required when individual laboratory units seek accreditation according to specific laboratory standards. Furthermore, international efforts to develop health laboratory standards must be reinforced that support sustainable quality assurance, as in the exchange and comparison of test results within the scope of external quality assurance, but also in the exchange of special diagnosis data among international research networks. In summary, the acknowledged standard for a quality management system to ensure quality assurance is the very generic standard ISO 9001.Health Phys. 103(2):221-225; 2012.
authors.affiliation: Bundeswehr Institute of Radiobiology, University of Ulm, Munich, Germany. markhotz@bundeswehr.org
authors.forename: Mark E
authors.initials: ME
authors.lastname: Hotz
authors.forename: Viktor
authors.initials: V
authors.lastname: Meineke
mesh_terms: D035843:Biomedical Research / Q000592:standards*; D004635:Emergency Medicine / Q000592:standards*; D007390:International Agencies / Q000592:standards; D007753:Laboratories; D008887:Military Medicine / Q000592:standards*; D011786:Quality Control; D018788:Radioactive Hazard Release; D012015:Reference Standards