Quality management system of a university cardiac surgery department according to DIN EN ISO 9001 : 2000.

Background: A quality management system (QMS) will improve quality in health care units. This report describes the introduction of a QMS according to ISO 9001:2000 in a university cardiovascular surgery department.

Methods: First, a thorough analysis of all processes of patient treatment and clinical research was obtained. Multiple interfaces were defined to different departments as well as to administration units. We evaluated and optimized all necessary resources, evaluating customer satisfaction using patients' and referring physicians' surveys. We started quality rounds including surgeons, nurses and technicians. Based on this preparation, we redefined and explained all processes including their responsibilities and necessary resources in the quality manual.

Results: After a process of 18 months, an independent, accredited organization recommended that our QMS be given certification according to ISO 9001:2000.

Conclusions: Certification of a university cardiovascular surgery department according to ISO 9001:2000 is possible, and may represent the first step towards total quality management (TQM). In complex health care units, certification of separate departments may help generate a consciousness of quality on the way to TQM.