Home Resources Quality
Quality Guranteed Fast Delivery ad for support

Commitment to Quality

Randox are committed to quality at every stage of the production process from research and development to customer support, this commitment has been recognized through official accreditation to both national and international standards including UKAS and ISO.

Accreditation to international standards ensures confidence in the quality and consistency of the products and services provided by Randox and demonstrates compliance to internationally agreed standards.

ISO 13485:2003

ISO 13485:2003 The International Organisation for Standardization (ISO) is the largest developer and publisher of international standards in the world. In 2003 Randox were accredited with ISO 13485:2003 approval.

ISO 13485:2003 highlights the requirements for a quality management system where an organisation needs to prove its ability to provide medical devices and other related services that consistently meet regulatory requirements.

ISO 13485:2003 relates to the design/development, manufacture, service and distribution of in vitro diagnostic medical devices, in vitro diagnostic test kits, in vitro diagnostic reagents and in vitro diagnostic analyzers.


UKAS 2005 The United Kingdom Accreditation Service (UKAS) is the only national accreditation body recognised by the government to assess, against internationally agreed standards.

In 2002 the systems and procedures within Randox Laboratories Ltd were accredited with UKAS approval to ISO/IEC Guide 43-1:1997 "Proficiency testing by interlaboratory comparisons Part 1: Development and operation of proficiency testing schemes through assessment against ILAC-G13:2007 - Guidelines for the Requirements for the Competence of Providers of Proficiency Testing Schemes".

Queen’s Award for Enterprise

Queens Award In 2007 Randox received the Queen’s Award for Enterprise. This was Randox’s fifth Queens Award with previous awards for Export Achievement received in 1990, 1993, 1997 and the Queen’s Award for Enterprise received in 2001.

The Queens Award is a highly prestigious and coveted prize that recognizes the outstanding achievements Randox have made in innovation, international trade and sustainable development.

The award is testimony to the hard work and dedication of Randox in the global diagnostics market.

CE Mark

CE Many of our products are CE certified and carry the CE mark. CE marking on a product is evidence the product complies with the requirements set out by the In Vitro Diagnostic Medical Devices Directive 98/79/EC. CE marking is essential for products to be placed on the market and sold in the European Union (EU) it also ensures the free movement of product within the EFTA and EU.