[Quality management systems are compulsory: clinics have the choice. Comparison of the systems DIN EN ISO 9000 ff, KTQ and EFQM]. / Qualitätsmanagementsysteme sind Pflichtprogramm: die Kliniken haben die Wahl. Ein Vergleich der QM-Systeme DIN EN ISO 9000 ff, KTQ® und EFQM.

According to §§135-137 SGB V (German Civil Code), German hospitals are required to introduce and develop an institutional quality management (QM) system. They are, however, currently not obliged to undergo a certification. The prime responsibility to introduce a QM system lies with the top management. The aim is to continuously monitor and improve the quality of the processes and practices in the hospital. QM systems are one of the major constituents which influence the prosperity of an enterprise. Hospitals are able to improve the quality of their processes without significantly increasing the costs. The Excellence Barometer® Health Care (ExBa) of the Fraunhofer Institute has shown that deficits are usually not identified in the professional competence of the medical personnel but rather in respect to leadership abilities, communication and motivation. The introduction of QM in a hospital requires an in-depth familiarity with the various QM systems to select an appropriate model for the own institution. The systems most commonly in use in German hospitals are DIN EN ISO ff, EFQM and KTQ®. The article illustrates and compares the layout, requirements and assessment criteria of the various systems.

[(No) Fear of audits? Control is good, trust is better. Audits as a core element of quality management]. / (K)eine Angst vor Audits? Kontrolle ist gut, Vertrauen ist besser. Audits als zentrales Qualitätsmanagementelement richtig anwenden.

Quality management (QM) cannot be successfully implemented and performed without audits. The PDCA (Plan-Do-Check-Act) cycle is the core component of QM systems. In this cycle an audit represents the crucial step "check". Audits verify whether the performed actions and their results conform to the requirements. It is especially important to verify whether the principles of QM are omnipresent and fully implemented in a department or institution. The announcement of an audit may cause mixed feelings or even anxiety among the personnel to be audited. Without previous information and training the audit may be perceived as an act of control and intrusion into departmental affairs. The colleagues often fear sanctions if lapses are found or consider the audit to be a cross-examination. However, an audit is rather meant to be a helpful aid and a chance to continuously improve the departmental QM system by means of a constructive communication among colleagues. In the year 2009 the European Commission published guidelines for the performance of clinical audits in medical radiology, including diagnostic radiology, nuclear medicine and radiation therapy (Council Directive 97 / 43 / EURATOM). The aim is an optimal protection of the individual from the hazards of ionizing radiation and the directive expects radiological departments to perform clinical audits in accordance with national procedures.