Structure of Quality Management

The structure and the tasks of the blood transfusion institutions – in particular such institutions that are connected with a university - have changed due to the new medical challenges of the last few years.
Such changes occurred in the cellular and gene therapy sector and the multifaceted patient laboratory diagnostics sector. Above all, new approaches to molecular biology techniques have to be mentioned in this respect.

The complex structure of these institutions requires the processes in all areas to be closely integrated. All areas and departments of the institutes are involved in a strong quality assurance and quality management system and are subject to the same quality criteria as the pharmaceutical sectors.

Our blood transfusion service has one harmonised quality management system that is uniform and mandatory for all institutions. This system sets quality guidelines and contains clear rules for all processes. Level 1 quality management (QM) documents include the quality management manual and the process instructions, which are general measures that are adopted and valid for all institutes. The Level 1 documents are released by the responsible general managing directors. The processes in each department are more specified in the Standard Operating Procedures (SOP, Level 2), which are released by the responsible department managers or heads, the different institutes or the responsible qualified persons.

QM documents are established within an electronic document management system (DMS) and are approved by an electronic signature. The electronic tracking system of a document within a workflow allows for the instant, location-independent availability of documents in the circle of the author and the responsible persons (i.e., approvers). Using this structure, the administrative effort is not too time consuming, and the approval of documents can be done without delay. The QM documents can be searched using defined categories, parameters or keywords and are available for the employees without delay. All versions are immediately and completely traceable on short notice.

Our Quality Management System comprises four areas: quality control and assurance, drug safety, and drug licensing. This structure ensures that all important medical exercises and pharmaceutical processes are controlled and assessed within a given system. The system is based on a central quality management that cooperates permanently, interactively and intensively with all 17 institutes and their local quality managers.

Our Quality Management System was certified according to DIN ISO EN 9001:2000 for the first time in 2001. In the context of mergers and centralisations, the system was extended to the other institutes that are also required to undergo a certification process. All of our laboratories are accredited according to DIN EN ISO 15189:2007. The QM System was adjusted in the year 2005 to the DIN ISO EN 13485:2003. A certification to this standard was achieved in 2006. The ISO 13485 is necessary for the development, manufacture and marketing of medical devices. At present, two CE-product groups are produced and used by our laboratories, including seven diagnostic kits: virus PCR kits in Frankfurt and HLA Class I and II kits in Ulm.