Laboratory for Molecular Diagnostics
Center for Nephrology and Metabolic Disorders

Quality Management

Quality Management System

The laboratory for Molecular Diagnostics at the Center of Nephrology and Metabolic Disorders in Weißwasser, specialized for metabolic and kidney diseases, offers its service for physicians, genetic counsolors, and other laboratories. Its main priority is to provide a constant high quality level. Therefore in 2007, we implemented a quality management system (QMS) based on DIN EN ISO 15189:2014 and LAP Program of the College of American Pathologists (CAP).

Our QMS includes the following elements which summarise our quality policy principles:

The analysis is performed according to the current state of science and technology. Here, the great attention is pay to the specificity, stability, precision and accuracy of an analytical methods.

In clinical a reliable and rapid completion is essential, so the requests are being processed in the estimated turnaround times. This is achieved by optimization of the workflow and regulary monitoring of the sample turn around times. In urgent clincal cases, a shorter turn-around time may be accomplished.

Personnel is an important point to improve the quality of the laboratory. The basis for it, is long-term employment of qualified personnel. All employees of the laboratory have appriopriate qualifications and are trained by regular internal and external advanced trainings. For new personnel, there is an intial training on all instruments/methods.

The work in the laboratory is oriented towards the high quality requirements in molecular dignostics. Our aim is establishing a close cooperation with our partners (physicians, laboratories, genetic counsolors etc.). This aim is achieved by practical measures such as a prompt response to all request via telephone, fax or e-mail.

High quality analysis

The analysis is performed according to the current state of science and technology. Here, the great attention is pay to the specificity, stability, precision and accuracy of an analytical methods.

The laboratory for Molecular Diagnostics at the Center of Nephrology and Metabolic Disorders in Weißwasser, specialized for metabolic and kidney diseases, offers its service for physicians, genetic counsolors, and other laboratories. Its main priority is to provide a constant high quality level. Therefore in 2007, we implemented a quality management system (QMS) based on DIN EN ISO 15189:2014 and LAP Program of the College of American Pathologists (CAP).

Our QMS includes the following elements which summarise our quality policy principles:

The analysis is performed according to the current state of science and technology. Here, the great attention is pay to the specificity, stability, precision and accuracy of an analytical methods.

In clinical a reliable and rapid completion is essential, so the requests are being processed in the estimated turnaround times. This is achieved by optimization of the workflow and regulary monitoring of the sample turn around times. In urgent clincal cases, a shorter turn-around time may be accomplished.

Personnel is an important point to improve the quality of the laboratory. The basis for it, is long-term employment of qualified personnel. All employees of the laboratory have appriopriate qualifications and are trained by regular internal and external advanced trainings. For new personnel, there is an intial training on all instruments/methods.

The work in the laboratory is oriented towards the high quality requirements in molecular dignostics. Our aim is establishing a close cooperation with our partners (physicians, laboratories, genetic counsolors etc.). This aim is achieved by practical measures such as a prompt response to all request via telephone, fax or e-mail.

The laboratory participates in suitable proficiency testing programs issued by CAP (College of American Pathologists ), DGKL (German Society for Clinical Chemistry and Laboratory Medicine), and EMQN ( The European Molecular Genetics Quality Network ).

The laboratory for Molecular Diagnostics at the Center of Nephrology and Metabolic Disorders in Weißwasser is accredited by the College of American Pathologists (CAP) through their accreditation programm LAP and has CLIA (Clinical Laboratory Improvement Amendments) certification through CMS (Centers of Medicare and Medicaid Services). The laboratory is also accredited according to DIN EN ISO 15189:2014 by the german national accreditation body DAkkS. In addition to these procedure, the Center for Naphrology and Metabolic Disorders has also been certified with DIN EN ISO 9001:2008 certificate by the TÜV Rheinland-a global provider of technical, safety, and certification services.

Certificates are downloadable here.