Our Commitment to Quality

At Examen, our dedication to quality is central to everything we do. Our robust quality framework ensures that all our tests and services meet the highest international standards, providing confidence to both our partner clinics and to you as a patient.

ISO Certification & Accreditation

We hold two distinct certifications that work together to guarantee the quality of our entire testing service.

ISO accreditations

ISO 15189 – Accredited for laboratory service delivery

This accreditation applies specifically to the delivery of our medical laboratory services (including the testing process itself). ISO 15189 is an internationally recognised standard that verifies the technical competence, integrity, and impartiality of our laboratory.

What this means:

  • Expert team: The technical competence and integrity of our laboratory team who handle your sample is assured.
  • Accurate results: Stringent quality control measures and external comparisons are used to continuously verify the accuracy and reliability of the produced test results.

ISO 13485 – Certified for test design and safety

This internationally recognised standard is for quality management systems in the medical device industry (including in vitro diagnostic, or IVD, tests). This certification applies to the design, development, and manufacture of our DNA-based assays (the Exact® and Extend® tests).

What this means:

  • Safe & reliable tests: The test and all of its components have been designed and manufactured with rigorous risk management and quality controls.
  • Guaranteed best practices: We follow best practices throughout the entirety of the test’s life cycle, ensuring the quality of the test itself never wavers.

Accreditations by Test

(Tables below best viewed in landscape)

Exact Tests
(Total SDF damage)
ExactExactFocusExactPrepExactSSR
MeasuresTotal SDF damage (single and double strand breaks)
Used forSperm concentrations above 5M/mlSperm concentrations below 5M/mlPrepared ejaculate samples (e.g. prepared for ICSI, Zymot, DG, nMx, etc.)Surgically retrieved sperm samples
CE Mark StatusSelf-certified as a general IVD in accordance with EU IVDD 98/79/ECCurrently omitted from intended use
ISO 15189 Accreditation StatusAccredited (Laboratory no: 25925)Currently outside the scope of ExamenLab’s ISO 15189 accreditation
Accreditation and Application Details for Exact Sperm DNA Fragmentation (SDF) Tests: This table outlines the intended use, CE Mark status, and ISO 15189 accreditation scope for the suite of Exact SDF tests, which measure Total SDF damage (single and double strand breaks) in sperm.
Extend Tests
(Double-Strand SDF damage)
ExtendExtendFocusExtendPrep
MeasuresDouble-strand DNA breaks (dsDB) damage
Used forSperm concentrations above 5M/mlSperm concentrations below 5M/mlPrepared ejaculate samples (e.g. prepared for ICSI, Zymot, DG, nMx, etc.)
CE Mark StatusSelf-certified as a general IVD in accordance with EU IVDD 98/79/ECCurrently omitted from intended use
ISO 15189 Accreditation StatusAccredited (Laboratory no: 25925)Currently outside the scope of ExamenLab’s ISO 15189 accreditation
Accreditation and Application Details for Extend Sperm DNA Fragmentation (SDF) Tests: This table details the intended use, CE Mark status, and ISO 15189 accreditation scope for the suite of Extend SDF tests, which specifically measure Double-Strand DNA Breaks (dsDB) damage in sperm.
Semen Analysis
MeasuresAssess sperm concentration, motility, and morphology
Used for– Assisting fertility diagnosis
– Assessing male reproductive health and guiding choice of ART procedure
– Monitoring response to treatments
ISO 15189 Accreditation StatusAccredited (Laboratory no: 25925)
Accreditation Status and Applications of Standard Semen Analysis: This table summarises the primary uses and ISO 15189 accreditation status for Semen Analysis, a test used to assess sperm numbers, motility, and morphology in fertility and male reproductive health diagnosis.
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