Quality Management System
The laboratory for Molecular Diagnostics at the Center of Nephrology and Metabolic Disorders in Weißwasser, specialised in metabolic and kidney diseases, offers its service to physicians, clinicians, genetic counsellors and other laboratories. Our top priority is to provide a constantly high quality level. In order to preserve and improve the quality, we established a quality management system (QMS) in 2007. The laboratory is accredited pursuant to DIN EN ISO 15189:2014 by Deutsche Akkreditierungsstelle (DAkkS). Additionally, the Center of Nephrology and Metabolic Disorders is certified according to ISO DIN EN 9001:2015. As implementation of the quality management system, documented procedures, operating instructions and forms are established.
Our quality policy includes particularly the following aspects:
The analyses are performed according to the current state of science and technology. Here, great attention is paid to the specificity, stability, precision and accuracy of the analytical methods. The quality of applied methods is guaranteed by regular internal and external controls. In order to ensure the quality of diagnostic offers, the laboratory participates in suitable proficiency testing programs issued by DGKL (German Society for Clinical Chemistry and Laboratory Medicine) and EMQN (The European Molecular Genetics Quality Network).
In clinic a reliable and rapid completion is essential. Requests have to be processed in defined turnaround times. This is achieved by optimisation of the workflow and regular monitoring of the sample turnaround times.
Qualification of the personnel is the important point to ensure quality of the laboratory. Basis for this is a qualified permanent staff. All employees of the laboratory have appropriate qualifications and undergo regular internal and external advanced trainings. For new staff there is an initial training on all instruments/methods.
The work in our laboratory is focused on highest quality requirements in molecular diagnostics. Our aim is to establish a close cooperation with our partners (physicians, clinicians, laboratories, genetic counsellors etc.). This aim is achieved by practical measures such as prompt response to all request via telephone, fax or e-mail. Also evaluation of complaints is conducted regularly.
Certificates can be downloaded here.