Quality management serves as an important instrument for lasting effectiveness and efficiency in the context of realizing processes of varying forms.
New technological developments and guidelines strengthen the awareness for quality, competency and transparency in the performance of various tasks and document the perception of the private sector as a provider of quality-assured products and services. Through the social responsibility of PharmGenomics GmbH the quality policy is based on “Guidance on social responsibility” (DIN ISO 26000:2011).
Considering the demands on genetic diagnostic laboratories and in-vitro-diagnostics manufacturers, the PharmGenomics GmbH established a quality management system based on good professional practice and according to international standards (i.e. DIN EN ISO 9001:2008, DIN EN ISO 13485:2010, DIN EN ISO 15189:2007 und DIN EN ISO/IEC 17025:2005), directives (i.e. 98/79/EG, Directives of the genetic diagnostic commission and the German Federal Medical Council) and guidelines (i.e. S2-guideline human genetic diagnostics). The QM-system relies on the eight fundamental quality management principles: customer orientation, leadership, inclusion of the employees, process approach, system-oriented management approach, continuous improvement, factual approach to decision making and mutually beneficial supplier relationships. The current Quality Management Handbook is available on request.
External quality evaluations measures, so called round robin tests, complement the quality management of PharmGenomics GmbH as further verification control. Round robin tests are used to review the applicability/efficiency of methods and test-systems and to determine the competency of the diagnostic laboratory.
We strictly follow the guidelines of the German Federal Medical Council for the quality assurance of medical laboratory tests (RiLiBÄK).Quality management representative: Dipl.-Biol. Wolfdieter Braun.