Quality Policy

RefLab’s has a Quality Management System (QMS) compliant with ISO 13485:2016 (which builds on ISO 9001:2015) and ISO 17025:2017. Our QMS is managed using D4InfoNet, an ISO 9001:2015 and ISO/IEC 27001:2017 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

RefLab’s Service Laboratory is accredited by DANAK in accordance with ISO 17025.

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.

ISO 13485 certification

For the scope of development, manufacturing and sales of products for clinical diagnostics, RefLab is certified in accordance with ISO 13485 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).

ISO 13485 certificate

Declaration of Conformity – IVDR Products

Free Sales Certificate – IVDR Products

Declaration of Conformity – IVDD Products

Free Sales Certificate – IVDD Products

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