Benefits and approaches of a quality management system in biomedical research laboratories

Abstract

Quality in biomedical research is a much-discussed topic among experts, research institutes, and funding organizations. Quality issues are frequently reported in the scientific and general press (e.g., stability of study results after test retake – “replication crisis”). Quality management systems are a globally accepted and established tool to guide and manage quality and to address quality problems. However, the notion of quality management is often met with resistance among researchers: low resources, too much regulation, restriction of research, and unnecessary bureaucracy are counter-arguments. The idea of implementing a quality management system for research laboratories is nothing new worldwide. There are various approaches by scientists and organizations to establish a quality management system in research laboratories and to develop a value-added system for themselves. Their expectations are an optimization of the research processes as well as an increase in effectiveness and efficiency. This report summarizes publications concerning quality measures and management in biomedical research and explains the background and advantages of quality management systems in organizations, laboratories, and research. A currently ongoing project of the Robert Koch Institute is presented as an outlook. The article is based on a literature review in English and German. In addition, internationally and nationally applicable and relevant guidelines were considered.