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Tripolt, NJ.
Konzeption der Implementierung eines Qualitätsmanagementsystems nach DIN EN ISO 9001 für klinische Studien an einer klinischen Abteilung.
[ Diplomarbeit/Master Thesis ] Medizinische Universität Graz; 2009. pp.70. [OPEN ACCESS]
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Authors Med Uni Graz:: Tripolt Norbert
Advisor:: Yazdani-Biuki Babak
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Abstract:: Introduction: The demand for the best possible quality in patient care as well as in the development of new drugs have led to a stronger discussion about the implementation of quality management systems in these areas. Although quality management systems in service organisations and in industry are already standard, the implementation of comprehensive systems (e.g. ISO) in health care have gained attention in the past few years. Purpose: The purpose of this paper is to present a concept for the implementation of a quality management system according to DIN EN ISO 9001 for clinical research. Method: After defining the basic terms, all requirements for implementation according to DIN EN ISO 9001 are presented. An explanation of the fundamental concepts as well as a short introduction to the ISO 9000 Standards then follow. The different forms of clinical trials are then described as well as the legal and ethical-moral principles. After a short description of the already existing quality management plans, the individual requirements for implementation of a quality management program for clinical studies in a clinical department are addressed in detail. Special attention is paid to adherence to the ISO-9001 guidelines. As a conclusion, the advantages and disadvantages of implementing a quality management system are discussed. Conclusion: The implementation of a quality management system according to DIN EN ISO 9001 for clinical research at a clinical department will at first be associated with a considerable amount of work; individual groups and professions will need to learn to rethink. Ultimately the positive effect on work flow and structure will outweigh the disadvantages and make the realisation of a quality management system according to ISO 9001 for clinical research in a clinical setting quite commendable.