Quality Management

We are the heart and center of coordination of the quality management system at the RKI.

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 for continuous evaluation and improvement of the effectiveness and efficiency of the QM system at the RKI.

The basis of our QMS is the standard DIN EN ISO 9001 ("Quality management systems - Requirements"), as well as the standards DIN EN ISO 15189 ("Medical laboratories - Requirements for quality and competence") and DIN EN ISO/IEC 17025 ("General requirements for the competence of testing and calibration laboratories") in the laboratory areas. The RKI is also accredited as a proficiency testing provider according to the standard DIN EN ISO/IEC 17043 ("Conformity assessment - General requirements for proficiency testing").

The 19 accredited laboratories of the RKI are spread over four locations and include, among others, national reference centers, consiliary laboratories and central service facilities (e.g. such as genome sequencing and center for culture medium).

The following laboratories are accredited:

• FG 11, NRZ for Salmonella and other bacterial enteritis pathogens and CL for Listeria, ML*/PL**-13113-01-01
• FG 12, NRZ for measles, mumps, rubella, ML/PL-13113-01-01
• FG 13, NRZ for staphylococci and enterococci, ML/PL-13113-01-01
• FG 14, culture media center, PL-13113-01-01
• FG 14, WG-2 listing procedures and test methods, PL-13113-01-01
• FG 15, CL for noroviruses and CL for rotaviruses, ML/PL-13113-01-01
• FG 15, NRZ for poliomyelitis and enteroviruses, ML/PL-13113-01-01
• FG 16, KL for cryptococcosis and rare systemic mycoses, ML/PL-13113-01-01
• FG 17, NRZ for influenza virus and CL for respiratory syncytial virus (RSV), parainfluenza virus (PIV), and human metapneumovirus (HMPV), ML/PL-13113-01-01
• FG 18, HIV and other retroviruses, ML/PL-13113-01-01
• FG 22, Epidemiological central laboratory, ML/PL-13113-01-02
• ZBS 1, CL for poxviruses, special laboratory for highly pathogenic viral agents ML/PL-13113-01-03
• ZBS 2, CL for Bacillus anthracis, CL for Francisella tularensis, CL for Yersinia pestis and CL for human-pathogenic Vibrions, ML/PL/EP-13113-01-03
• ZBS 3, CL for neurotoxin-producing clostridia (botulism, tetanus), ML/PL-13113-01-03
• MF 1, Genome Center of Excellence, 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/IEC 17043)

Since 2018, the RKI also bears the combined DAkkS/ILAC symbols. These serve as identification marks worldwide and are used to visualize the uniform standards. They are a sign of national and international recognition of competent performance in all ILAC member states.

With a high level of participation from all accredited areas and associated bodies in the RKI, the changeover to the revised DIN EN ISO/IEC 17025 standard was successfully completed. In addition, all accredited areas of the RKI were reaccredited in 2020.

The QM of the RKI participates on a national level in committee work such as the working group of quality management representatives from accredited laboratories in the public sector, and in the revision of DIN EN ISO 15189 in the DIN standard-committee for medicine "QM in medical laboratories". Furthermore, MF 5 also participates on an international level in ISO/TC 212/WG 1 (Quality and competence in the medical laboratory) as well as in ISO/CASCO/WG 57 (Revision of ISO/IEC 17043).

In addition, with the transformation of MF 5, the scope of some of our familiar tasks was increased to include, among others, the following topics:

• Support of research studies regarding quality assurance requirements regarding method selection, preparation/planning, execution, follow-up/evaluation, publication and sustainable data management.
• Quality in digitization (eScience).
• Integrated Management System (IMS - One Quality).

Further information can be found in our publications.

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