Die Verankerung von bereichsspezifischen QM-Systemen im Gesundheitswesen in deutschen und europäischen Rechtstexten und anzuwendenden QM-Normtexten

Abstract

This article presents the first results from an ongoing QM research project. The research question is:“What influence does the legal anchoring of QM systems have on the organizations on five different areas of healthcare“. Legal and normative texts pertaining to QM were systematically selected and analyzed according to predefined rules. The results show that not only area-specific QM standards are required in the legal texts, but also QM methods across systems such as the responsibility of the organizational management, training, corrective and preventive management and auditing. The QM standards are tailored to the legal requirements and take over the focus of the legal texts. Process-oriented QM methods that are aimed at the organizational goal are supplemented in the normative texts regulating QM. Not in all examined areas the primary focus of the regulations is on the planning of processes, in some cases also the way in which processes are carried out is considered within the legal texts. In addition, there are production sections in the examined areas that are not required to implement a binding QM system.