The Quality Management System at the European Tritium Handling Experimental Laboratory

The main limitations of conventional Quality Assurance (QA) are discussed with reference to the operational phase of a radiochemical research laboratory. The paper suggests a broader approach utilising a Quality Management System (QMS) which focuses on the operational efficiency of a R&D organisation in terms of reliability, reproducibility, cost effectiveness and safety. The management's role is presented with particular reference to the best fit of managerial style to the organisation's mission, culture, personnel and surrounding environment. QMS policies and QA criteria are suggested for ETHEL to replace conventional QA requirements. Finally, guidelines for designing the ETHEL organisational structure are discussed.