Quality assessment according to DIN EN ISO 9001:2000. Certification in a nuclear medicine department

In the year 2002 our department started to inaugurate a quality management system. The certification according to DIN EN ISO 9001:2000 as required by the hospital management was achieved in August 2004. The aim was the optimisation of internal operating schedules and the standardisation of procedures according to logistic interfaces with external structures. Since 2000 the implementation of an internal quality management system is required by German law (SGB V paragraph 135) and threatened by penalty in case of non-implementation (SGB V paragraph 137). Beside a basic audit and optimisation of all organisational procedures all core processes of our department were determined and the approvals were checked. These aims concern i.e. both the quality of our diagnostics of nuclear medicine and of the in vitro laboratory and the aspects of service such as quickness of scheduling and forwarding of reports and economic and efficient aspects of our work. An important role plays the department of ''quality management'', whose main tasks are the professional guidance and the training of the quality management representatives. The realisation of the new regulations and the restructuring resulted in an increase of effectiveness and in an improvement of operational procedures in our department. Especially the patients and the staff granted from the reorganised and modified sequence of operations. Implementation of a quality management system takes some efforts but the positive aspects for the structure and the flow of work are predominant so that the inauguration of a quality management system in the different departments of a hospital are recommendable. (orig.)