High Quality and Continuous Improvement.

Our analyses have stood for quality and reliability for many years. Since 2009 we have been accredited according to the international standards DIN EN ISO 15189 "Medical laboratories - special requirements for quality and competence" and DIN EN ISO/IEC 17025 "General requirements for the competence of testing and calibration laboratories" and have successfully maintained these accreditations since then. In addition, MLL Dx 2021 received the "Laboratory Accreditation Program" certificate by the College of American Pathologists.

Our QM system

  • State-of-the-art premises and technical equipment

  • Extensive training and further education of our personnel

  • Exclusive use of suitable analytical methods (validation/verification)

  • Detailed documentation of all laboratory processes

  • Successful participation in external quality assurance programmes (profeciency tests)

  • Use of internal quality controls

  • Monitoring of analytical equipment (maintenance, calibration, qualification)

  • Implementation of internal audits for self-control

  • Continuous improvement of our processes

Interlaboratory tests

Our methods are accredited to the highest standards. As part of our quality assurance procedures, we regularly participate in ring tests for our methods from the following providers:


MLL has been accredited according to DIN EN ISO 15189 and DIN EN ISO/IEC 17025 since 2009 and strictly adheres to the guidelines of the German Medical Association (BÄK) Guidelines on Quality Assurance. Since 2021, MLL Dx has also been accredited by the College of American Pathologists (CAP) and always works according to these quality standards.


Accreditation Certificate DIN EN ISO 15189:2014

MLL has been accredited for medical laboratory diagnostics according to DIN EN ISO 15189:2014 since 2009 and always works according to these high quality standards.


Accreditation Certificate DIN EN ISO/IEC 17025:201

MLL has been accredited in accordance with DIN EN ISO/IEC 17025 for testing laboratories since 2009 and carries out tests in the field of healthcare (medical laboratory tests as part of clinical studies).


College of American Pathologists

MLL Dx GmbH has been accredited by the College of American Pathologists in 2021 and always works according to these quality standards.


Certificates round robin tests

UK NEQAS Immunophenotyping

MLL successfully participates in the "Flow Cytometry Programs" for PNH.


UK NEQAS Molecular genetics

MLL successfully participates in the "Molecular Haemato-oncology programs" for various analyses and methods.


CAP proficiency testing program

MLL Dx successfully participates in the CAP proficiency testing program for various analyses and methods.


Certificate ERIC IGHV

MLL meets the highest ERIC (European Research Initiative on CLL) standards for immunoglobulin (IG) mutation detection and interpretation.


Certificate of the MDS Center of Excellence

MLL has been recognized as a Center of Excellence in the diagnosis and treatment of the myelodysplastic syndromes.


Environmental management

We are aware of our special responsibility for the environment and are committed to protecting it. For us it is a matter of course to use natural resources as sparingly as possible and to strive for continuous improvement of our processes to protect the environment. We comply with legal requirements.

Our environmental management system according to ISO 14001 has been officially confirmed by the accredited certification body DEKRA.

Certificate "Enviromental management system ISO 14001"

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Your contact person

»We stand for high quality and sustainability, as we are aware of our responsibility for the patient and for the environment.«

Dr. rer. nat. Christine Käppel

Head of Quality Management