Abstract
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.
Key words
Quality management - ISO 9001:2000 - Cardiac surgery
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MD Sven Beholz
Department of Cardiovascular Surgery, Charité Humboldt-University Berlin
Luisenstraße 65
10117 Berlin
Germany
Phone: ++49-30-450-522196
Fax: ++49-30-450-522921
Email: sven.beholz@charite.de
