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ePaper created 2017-03-14, 10:25:37 | version 1.49.03
HEALTH 1 QUALITY MANAGEMENT SYSTEMS IN PRE-CLINICAL RESEARCH INSTITUTIONS M arco M e t zg e r, T h o r s te n B e rg mann Optimizing work and process quality The Translational Center “Regenerative Therapies for Oncol- ogy and Musculosceletal Diseases” (TZKME) is committed to covering the entire value chain in the ield of regenera- tive treatments – from the development to the approval of (biologized) medical products and cell-based transplants. To offer the highest possible quality, the necessary infrastructure based on a quality management system (QM system) is cur- rently being established at the Translational Center. QM systems are becoming increasingly important in today’s corporate world, with the aim of improving work and pro- cess quality within companies as well as maintaining and continuously improving the quality of products and services. Depending on individual systems and standards, QM systems comprise different things: They focus on standardizing and optimizing work processes and structures, establishing stan- dards for products and services and ensuring meticulous doc- umentation. One important goal is to maintain and increase customer satisfaction. But the focus is on not only customers, but also employees. QM systems are designed to enhance employees’ motivation, ensure their continuous professional development and improve the organization and equipment of their working space. role as increased production output made the implementation of certain product quality standards ever more necessary. In general, QM systems comprise the following three ields: Quality planning (deining quality objectives, planning processes and checks); quality scheme (assessing quality stan- dards and identifying appropriate measures if necessary); and quality improvement (optimizing structures and processes). In 1979, Great Britain introduced the irst European Standard for QM systems, the British Standard 5750, which later served as the basis for the DIN EN ISO 9000 and its successor ver- sions. Today, the current DIN EN ISO 9001 (version 2015) [1] is the standard commonly used worldwide in the implementa- tion of QM systems and is applied by most organizations. In some ields, such as the health care sector, the automotive or the pharmaceutical industry, a QM system based on interna- tional norms is even a statutory requirement. Mapping of value chains The chairs of Tissue Engineering and Regenerative Medicine (TERM) and of Functional Materials in Medicine and Dentistry (FMZ) are both located in the TZKME and run a joint pre- clinical study unit. Their common goal is to cover the entire value chain of regenerative treatments. Quality management pursuant to international standards Some rudimentary forms of QM systems have a long tradition, going back to the provisions and checks carried out by the guilds in the Middle Ages. With the start of the industrial rev- olution, these systems started to play an extremely important This, however, requires the establishment of solid infra- structures that enable eficient, ongoing interdisciplinary cooperation in the ields of research, development, pre-clinical and clinical trials and approval. To this end, the QM system currently in place is to be adapted in line with DIN EN ISO 9001:2015 and certiied in the course of 2017. 6 2