[Certification and quality management of a complex university cardiac center according to law EN ISO 9001: 2000].

Quality management systems can improve quality in health care units. The introduction of a quality management system according to ISO 9001: 2000 in a university department of cardiovascular surgery is described. First a thorough analysis of all processes of patient treatment and clinical research was obtained. Multiple interfaces had to be defined to different departments as well as to administration units. All necessary resources were evaluated and optimised. Customer satisfaction was evaluated by surveys of patients and collaborating physicians. Quality rounds including physicians, nurses and technicians were instituted. Based on these preparatory works all processes including their responsibilities and necessary resources were redefined and described in the quality manual. After 18 months' of certification of our quality management system according to ISO 9001: 2000 was recommended by an independent, accredited organisation. In summary, certification of a university department of cardiovascular surgery according to ISO 9001: 2000 is possible and may represent the first step towards total quality management. In complex health care units the certification of individual departments may help to generate a consciousness for quality on the road to total quality management.