Quality Assurance is defined as “all those planned and systematic actions necessary to provide adequate confidence that a structure, system, component or procedure will perform satisfactorily and comply with agreed standards.” Holders must ensure that appropriate quality assurance programmes are implemented.
Criteria for Acceptability of Equipment
Council Directive 97/43/EURATOM on health protection of individuals against the dangers from ionizing radiation in relation to medical exposure stipulates that the EU Member States' competent authorities shall adopt specific criteria of acceptability for equipment in order to indicate when appropriate remedial action is necessary, including, if appropriate, taking the equipment out of service. In order to facilitate the implementation of this requirement in the EU Member States, in 1997 the Commission published Radiation Protection 91: Criteria for acceptability of radiological (including radiotherapy) and nuclear medicine installations (RP㻛). This publication specified minimum criteria for acceptability and has been used to this effect in legislation, codes of practice and by individual professionals throughout the member states and elsewhere in the world.
The Commission reviewed this document and has published a draft (RP 162) for public consultation prior to 30 June 2010. Further details on the consultation process are here. The Criteria for Acceptability of Equipment Committee, established to advise the Department of Health on suitability of equipment and representative of the relevant stautory bodies and expertise in Ireland, submitted a coordinated Response to the Consultation Process in June 2010, available here.
Draft publication Radiation Protection𧆢: Radiation Criteria for Acceptability of Medical Radiological Equipment Used in Diagnostic Radiology, Nuclear Medicine and Radiotherapy.