Quality assessment according to DIN EN ISO 9001:2000.: Certification in a university ENT department

Background. In 2003, our department inaugurated a quality management system. The certification according to DIN EN ISO 9001:2000 as required by the hospital management was achieved in August 2005. The aims were optimization of internal operating schedules and standardization of procedures according to logistic interfaces with external structures. Methods. Since 2000, the implementation of an internal quality management system is required by German law and threatened by penalty in case of non-implementation. Beside a basic audit and optimization of all organizational procedures, all core processes were determined and the approvals checked. These aims involve both the quality of operational procedures, in and outpatient treatment, research, study and teaching and aspects of service such as quickness of scheduling and forwarding of reports as well as economic aspects and efficiency. The department of quality management, whose main tasks are the professional guidance and the training of the quality management representatives, plays an important role. Results. Realization of the new regulations and restructuring resulted in an increase in effectiveness and an improvement in operational procedures. In particular, patients and staff have benefited from the reorganized and modified sequence of operations. Conclusion. Implementation of a quality management system in different hospital departments is recommended.