[Benefits and approaches of a quality management system in biomedical research laboratories]. / Vorteile und Ansätze eines Qualitätsmanagementsystems in biomedizinischen Forschungslaboratorien.

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.

[Quality assurance in medical laboratories-an indispensability with benefits and risks]. / Qualitätssicherung in medizinischen Laboratorien ­ Eine Unentbehrlichkeit mit Nutzen und Risiken.

The importance of quality assurance (QA) and quality management (QM) in medical laboratories has been a topic in many political and public discussions, especially since the beginning of the SARS-CoV­2 pandemic. Uniform standards are required in order to create comparability not only among medical laboratories in Germany, but also across national borders. There are two leading systems in Germany: The Guideline of the German Medical Association (Rili-BÄK) and accreditation according to DIN EN ISO 15189.This article is intended to raise awareness of quality in medical laboratories to ensure patient safety through competent diagnostics on the patient. A literature search was carried out, including legal texts, standards, and further QM documents and publications. Furthermore, empirical values from representatives of various institutions are considered.A comprehensive QM system significantly supports work in medical laboratory diagnostics. Maintaining trust in the efficiency of medical laboratories and the facilities that support them is of great importance for the best possible care for the population. The additional effort associated with accreditation is justified with regard to patient safety but should not experience any additional bureaucracy.