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RefLab’s has a Quality Management System (QMS) compliant with DS/EN ISO 13485:2016 (which builds on DS/EN ISO 9001:2015) and DS/EN ISO/IEC 17025:2017. View ISO 17025 and 13485 related documents at the bottom of the page.

Our QMS is managed using D4InfoNet, an DS/ISO 9001:2015 and DS/EN ISO/IEC 27001:2023 certified quality management system. Through means of our QMS and by listening to our customers, auditors and employees, RefLab is committed to being:

  • A credible and quality conscious company in everything we do
  • Customer-centric and flexible without lowering our quality standards
  • Trustworthy and scientifically founded
  • Always updated on the latest requirements, standards, and recommendations applicable for our business
  • A culture of continuous improvement driven by employees owning and promoting RefLab’s quality policy

ISO 17025 accreditation

The allergen-induced basophil histamine release assay (a-BHRA) and the serum-induced basophil histamine release assay (s-BHRA) are accredited by DANAK according to DS/EN ISO/IEC 17025:2017.

DANAK is a part of the ILAC Mutual Recognition Arrangement (MRA) inspection, that has been established and evaluated in the three recognized regional cooperation bodies of ILAC: APLAC, EA and IAAC. Each signatory to the ILAC MRA recognizes the accreditation and results of an inspection body accredited by another signatory, as it were one of its owns accredited inspections bodies.

View ISO 17025 related documents

ISO 13485 certification

For the scope of development, manufacturing and sales of products for clinical diagnostics, RefLab is certified in accordance with DS/EN ISO 13485:2016 and hence entitled to market CE labelled in vitro diagnostic products in compliance with the Directive 98/79/EC (IVDD). Effective May 26th 2022, RefLab’s products are furthermore marketed in compliance with Regulation (EU) 2017/746 (IVDR).

View ISO 13485 related documents

Instructions for use