High Quality and Continuous Improvement.
Our analyses have stood for quality and reliability for many years. In close cooperation with MLL MVZ, we have met the requirements of the international standards DIN EN ISO/IEC 17025 "General requirements for the competence of testing and calibration laboratories" and DIN EN ISO 15189 "Medical laboratories - Special requirements for quality and competence" since 2009. In addition, MLL Dx has been accredited according to DIN EN ISO/IEC 17025 since 2019 and by the College of American Pathologists (CAP) according to the "Laboratory Accreditation Program" since 2021.
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 (proficiency 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
- Continuous assessment of risks in all laboratory processes and establishment of appropriate measures for risk elimination and reduction
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:
Certificates
MLL has been accredited according to DIN EN ISO/IEC 17025 since 2009 and strictly adheres to the guidelines of the German Medical Association (BÄK) Guidelines on Quality Assurance. Also since 2009, MLL MVZ has been accredited according to DIN EN ISO 15189. MLL Dx also received DIN EN ISO/IEC 17025 accreditation in 2019 and College of American Pathologists (CAP) accreditation in 2021. All in vitro diagnostic medical devices manufactured internally at MLL fulfil the requirements of Art. 5 (5) of the EU Regulation on in vitro diagnostic medical devices (EU) 2017/746 (Declaration of Conformity according to IVDR).
Accreditations
Accreditation Certificate DIN EN ISO/IEC 17025
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).
DownloadAccreditation Certificate DIN EN ISO 15189
The MLL MVZ 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.
DownloadCollege 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.
DownloadAccreditation Certificate DIN EN ISO/IEC 17025
MLL Dx GmbH has been accredited according to DIN EN ISO/IEC 17025 for testing laboratories since 2019 and carries out tests in the field of healthcare (medical laboratory tests within the scope of clinical studies).
DownloadCurrent list of all examination procedures within the (flexible) scope of accreditation
DownloadCertificates round robin tests
UK NEQAS Immunophenotyping
MLL successfully participates in the "Flow Cytometry Programs" for PNH.
DownloadUK NEQAS Molecular genetics
MLL successfully participates in the "Molecular Haemato-oncology programs" for various analyses and methods.
DownloadCAP proficiency testing program
MLL Dx successfully participates in the CAP proficiency testing program for various analyses and methods.
DownloadCertificate ERIC IGHV
MLL meets the highest ERIC (European Research Initiative on CLL) standards for immunoglobulin (IG) mutation detection and interpretation.
DownloadCertificate of the MDS Center of Excellence
MLL has been recognized as a Center of Excellence in the diagnosis and treatment of the myelodysplastic syndromes.
DownloadEnvironmental 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