Based on the knowledge of quality assurance concepts, the students know the basics of quality and risk management, industry-relevant QM systems and tools in quality management; they know the basic implementation process of QMS and can understand the necessary control tasks at the respective system levels. Based on their knowledge of the basics and implementation of QMS, including risk management, they are able to design appropriate QM concepts for professional practice and to evaluate their effectiveness. In addition, they master the methods of modern process management, i.e. they can describe, measure, modulate and evaluate relevant processes. Finally, the students can handle automation and information technology for the work context of biomedical science as well as questions of laboratory organization in order to ensure a high-quality, effective and efficient work.

Modules of semester 1-5

• Quality, quality assurance, quality development and quality management, risk and risk management as part of quality and process management
• Quality as a process in the organization, quality policy
• Models, approaches and methods of quality, risk and process management, fundamentals of project management
• Tools and implementation of QMS
• Normative foundations of QM in health care, certification and accreditation in the medical laboratory
• Measurement of quality, effectiveness of quality management
• Planning, design, control and optimization of (part) processes in the laboratory including laboratory organization in the medical laboratory, regulatory procedures, quality and process controlling, workflow concepts
• Business basics for laboratory organization
• Automation and information technology for biomedical analysis, automation concepts, digitization in the process of biomedical analysis
• Communication, information and archiving systems in medicine / healthcare (KIS, LIS, PACS, Middleware)
• Telemedicine and e-health applications (e.g. telemicroscopy, ELGA)
• Standards and interfaces (HL7, DICOM, xDT, XML)

Ertl-Wagner B. et al. (2013), Qualitätsmanagement und Zertifizierung, Springer;
Klusen N. et al. (2011), Qualitätsmanagement im Gesundheitswesen, Normos;
Rebscher H. & Kaufmann S. (2011), Qualitätsmanagement in Gesundheitssystemen, medhochzwei;
Schuhmann H. (2010), Grundlagen der Qualitätssicherung und Qualitätsmanagement im Gesundheitswesen, Grin Verlag;
Books, journals and websites according to the current state of knowledge in the respective fields.

Lectures, exercises, group discussions, reflections

Module examination