Leadership: Claudia Kurreck
Deputy leadership: Janine Drucker

Employees: Dr. Annika Nerlich, Uwe Schäfer

Our team is responsible for the coordination, training and auditing of all 16 accredited laboratories of the RKI. We integrate the necessary interfaces to ensure that quality management is not only anchored in theory, but is actively implemented and continuously developed.

The Quality Management Coordination Unit (KS QM) is currently preparing for the assessment of our accredited laboratories by the German Accreditation Body (DAkkS) in November 2024. The focus is on the changeover to the revised DIN standards DIN EN ISO 15189 and DIN EN ISO/IEC 17043. Accreditation means that the quality of the laboratory work and the competence of its employees are externally assessed according to international standards, thereby strengthening the public's trust in the RKI's laboratory diagnostics. Procedures and processes at the RKI are constantly optimized and a continuous improvement process is maintained. KS QM primarily supports the laboratories in working in an even more standardized manner.

Our QM system is based on the seven fundamental QM principles: Customer orientation, leadership, involvement of people, process-oriented approach, improvement, fact-based decision-making and relationship management. The spectrum of tasks ranges from A for accreditation of laboratories according to international standards to Z for satisfaction analyses to continuously evaluate and improve the effectiveness and efficiency of the QM system at the RKI.

Our QM system is based on the DIN EN ISO 15189 and DIN EN ISO/IEC 17025 standards in the laboratory areas. The RKI is also accredited as a proficiency testing provider in accordance with the DIN EN ISO/IEC 17043 standard.

The accredited laboratories of the RKI are spread over three locations and include National Reference Centers (NRC), Consultative Laboratories (CL) and central service facilities (such as the Genome Competence Center and the Culture Media Center).

The following laboratories are accredited:

• FG 11, NRZ for salmonella and other bacterial enteritis pathogens, ML-13113-01-00/PL-13113-01-01
• FG 12, NRZ for measles, mumps, rubella, ML-13113-01-00
• FG 13, NRZ for staphylococci and enterococci, ML-13113-01-00
• FG 14, Culture medium center, PL-13113-01-01
• FG 14, AG2 Listing procedures and test methods, PL-13113-01-01
• FG 15, CL for noroviruses and CL for rotaviruses, ML-13113-01-00/PL-13113-01-01
• FG15, NRZ for poliomyelitis and enteroviruses, ML-13113-01-00
• FG16, CL for cryptococcosis and rare systemic mycoses, ML-13113-01-00/PL-13113-01-01
• FG17, NRZ for influenza viruses and CL for respiratory syncytial viruses (RSV), parainfluenza viruses (PIV) and human metapneumoviruses (HMPV), ML-13113-01-00/PL-13113-01-01
• FG 18, HIV study laboratory, ML-13113-01-00/PL-13113-01-01 (Change of scope to CL for gonococci, valid from 2025)
• FG 22, Central Epidemiology Laboratory, (Accreditation paused due to restructuring)
• ZBS 1, CL for smallpox viruses, special laboratory for highly pathogenic viral pathogens, ML-13113-01-00/PL-13113-01-03
• ZBS 2, CL for Bacillus anthracis, CL for Francisella tularensis, CL for Yersinia pestis and CL for human pathogenic vibrios, ML-13113-01-00 / PL-13113-01-03 / EP-13113-01-00
• ZBS 2-PT, Highly pathogenic microbial pathogens, EP-13113-01-00
• ZBS 3, CL for neurotoxin-producing clostridia (botulism, tetanus), ML-13113-01-00/PL-13113-01-03
• MF 1, Genome Competence Center, PL-13113-01-04

ML = Medical laboratory (accreditation according to DIN EN ISO 15189)
PL = Testing laboratory (accreditation according to DIN EN ISO/IEC 17025)
EP = Proficiency testing provider (accreditation according to DIN EN ISO 17043)

The RKI uses the combined ILAC-DAkkS symbol. These serve worldwide as an identification mark and are used to visualize the uniform standards. They are a sign of national and international recognition of competent services in all ILAC member states.

The RKI is currently in the process of implementing the revised standards DIN EN ISO 15189 and DIN EN ISO/IEC 17043 with a high level of involvement of all accredited areas and the associated interfaces. Further information can be found in our publications.