Abstract
INTRODUCTION: Researchers are divided on quality management systems (QMS) in research laboratories-there are supporters and critics. Supporters use various quality management (QM) theories and emphasize advantages such as resource-saving added value. Critics, on the other hand, doubt their usefulness and feasibility. The aim of this study is to provide an objective assessment of the advantages and disadvantages of a QMS in research laboratories based on employee experiences. METHODS: The Robert Koch Institute and its cooperation partners introduced a QMS in pilot research laboratories or used existing systems. Employees were surveyed between 2023 and 2025 before and after the QMS implementation using specially developed questionnaires. RESULTS: The advantages of a QMS include improved documentation and reproducibility, optimized processes, increased quality awareness, and better collaboration. These are offset by disadvantages such as increased time and effort, the risk of overregulation, potential restrictions on creative freedom, difficult behavioral changes, limited influence on team culture, and the risk of "organizational blindness." Changes in employee knowledge, actions, and attitudes were already evident in the short term. The majority support QM measures after testing them and recommend them. DISCUSSION: Research laboratories require flexible QMS that respond to individual needs. Measures should be developed jointly within the team and implemented specifically where they increase efficiency. The commitment of all those involved and a balanced relationship between effort and benefit are crucial, as excessive regulation has a hindering effect.