Bioanalytical quality assurance: a Tesla with a trafficator?

Jones AB | Bioanalysis, 16(09), 365–367, (2024) Keywords: • bioanalysis • GCLP • GLP• good clinical laboratory practice • good laboratory practice • quality assurance • quality management This paper describes some opportunities to evolve further toward modern, risk-based, bioanalytical quality assurance. My intent is not to cast aspersions on bioanalytical quality or bioanalysis, we can be proud of the advances in quality and technology over the past 50 years. However, the persistence of mental models formed during the 20th Century imposes constraints on today's quality and compliance in the bioanalytical laboratory. One of these is the expectation that quality...