Quality management according to DIN EN ISO 9001 at a university eye hospital and department of ophthalmology

Background. Quality assurance is an integral part of modern microsurgical ophthalmology. Health care laws also mandate overall quality management. Materials and methods. In recent years we have standardized the preexisting features of quality management according DIN EN ISO 9001 and have integrated previously missing features. Results. Establishing quality management according to ISO 9001 is possible even at a university eye hospital and department of ophthalmology. Certification according to ISO 9001 specifications was granted in April 1999. The major difficulty was in translating industrial norms to the context of an eye hospital. It was also difficult to overcome skepticism towards quality-assurance measures that lie beyond ophthalmological quality control. Conclusion. It is useful and feasible to establish a quality management system at German university eye hospitals and departments of ophthalmology. Certification according to ISO 9001 is one possibility to make a quality management system transparent and evaluable both inside and outside the hospital.