Randox Life Sciences are committed to quality at every stage of the production process from research and development to customer support, this commitment has been recognised 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 Life Sciences and demonstrates compliance to internationally agreed standards.
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 analysers.