A validated Quality Management System for a research lab

Quality disciplines have been widely used for decades in industrial and business fields. It is only in recent times, however, that Quality management and approaches have received proper attention in life science (including basic research), overcoming the prejudice that they are an impediment to creativity. The perception and dissemination of an innovative and simplified way of planning and organizing research activity, inspired by Quality and Project Management (PM) principles, was the aim of the present work. Hence, the main output of the project is the model of a management system for a laboratory for scientific research. To create this Quality model it was necessary to translate the methods and skills related to Quality in industry and apply them in research. We have generated a Quality Management System (QMS) for a pilot laboratory that deals with the housing and handling of marine organisms. The MarLab laboratory has been certified with ISO 9001:2008 in June 2014 and April 28, 2015 it received and passed the surveillance audit. Based on our quality management system, we have created a modular software, Help4Lab, to manage Quality, safety, environment and documents in a research laboratory. Help4Lab contains a section "Processes" that helps the management of all documentation (management procedures, guidelines, operating instructions and forms) inherent to processes identified in the research laboratory (primary processes: Research, Student training and Science Communication; and secondary processes: management processes, quality management system, etc.). A second section (Suppliers List and Ratings, Warehouse, etc.) supports the "material handling". Furthermore, the section "management tools" helps planning maintenance and calibration of instruments. The QMS model and the management software Help4Lab related to it could be a new tool for improving and simplifying the organization of research laboratories. Such a system could also ensure the reliability of the results of research laboratories, increasing the prestige of the laboratory.