Towards implementing a quality management system in an academic biomedical research laboratory

Abstract

A systemic quality problem plagues the biomedical research body. Laboratory management aims at optimizing existing resources, support and operation processes, as well as increasing confidence in the reproducibility of results, and is therefore directly linked to the quality of research results. A Quality Management System (QMS) is a structured, evidence-based approach to improve quality. This internship report highlights a roadmap towards implementing a QMS in an academic biomedical research laboratory, based on the international general standard ISO 9001:2015 and other laboratory-specific guidelines, like safety, waste and sustainability good practices. A quality manual with documentation templates- including Standard Operating Procedures (SOPs) and records- is drafted. Finally, similar approaches are presented, and the comprehensiveness of the QMS is portrayed through the Ishikawa ‘fishbone’ 7Ms diagram.