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Quality Management

We have been accredited according to DIN EN ISO 15189 since 2004 and expanded our accreditation to DIN EN ISO/IEC 17025 in 2006. The laboratory operates in accordance with the guidelines of the German Medical Association (RiliBÄK) and the principles of Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) .

Since the mid-1990s, we have been operating as a central laboratory for clinical trials (GCP) in phases I to IV. In addition, we carry out quality control tests in the context of the manufacture of active ingredients in accordance with GMP .

In addition, we regularly participate in external quality assurance programs to ensure the accuracy and reliability of our results. These accreditations demonstrate our high level of performance in terms of the accuracy and precision of our analytical work, as well as our extensive experience in quality assurance and quality management.

All measurements are subject to unavoidable deviations from the true value, even under optimal conditions. To minimize these measurement uncertainties, we perform calibrations, internal quality controls, and participate in interlaboratory tests, among other measures. These measures help to reduce the residual risk of diagnostic errors and ensure the precision and reliability of our results.

Below, we provide you with a selection of certificates for selected interlaboratory tests as well as our accreditation certificates and attestations, which you can conveniently download.

Certificates

GMP-Certificate
BMVA Audit Certificate

Accreditation certificates

DIN EN ISO 15189-2024
DIN EN ISO 15189-2024 (annex)
DIN EN ISO IEC 17025-2018
DIN EN ISO IEC 17025-2018 (sub-sector food)
DIN EN ISO IEC 17025-2018 (sub-sector water)
DIN EN ISO IEC 17025-2018 (sub-sector hygiene)

Procedure lists in the flexible accreditation area

Procedure list (medical laboratory)
Procedure list (sub-area food)
Process list (sub-area drinking water)
Procedure list (sub-area hygiene)

Interlaboratory test certificates

Allergology - equipment 2015
Amino Acid Analysis
Bone metabolism (urine)
Clinical chemical analytes - equipment 2015
Erythrocyte Sedimentation Rate
Faecal Diagnostic - equipment 2021
Hepatitis HIV - equipment 2015
Hormones I - equipment 2015
Hormones II - equipment 2015
Hormones – Adrenal Gland/Pituitary
Interferon Gamma Release Assay
Parasite microscopy (stool)
Serum proteins
Trace elements in serum plasma
Tumor markers - equipment 2015
Urine chemistry qualitative
Urine chemistry quantitative equipment 2015