Quality & Accreditation

Oxford Immunotec is accredited by UKAS for the operation of Oxford Diagnostic Laboratories. UKAS audit to this standard on an annual basis.

In addition, Oxford Diagnostic Laboratories operate under Oxford Immunotec's Quality Management System (QMS) which is based on the following International Standards: ISO 13485:2003, ISO 9001:2008, the Canadian Medical Device Regulations (CMDR) and the Quality System Regulations (QSR) of the USA. 

The use of Quality management principles in our employment and training procedures have ensured that highly qualified and competent staff are involved in all aspects of the business.  All Oxford Immunotec staff are committed to the quality of product and to the service that we offer to our customers.

Documented procedures have allowed the company to operate more effectively and consistently and to identify and troubleshoot any issues.  Oxford Immunotec are focused on our customers and many of the processes in the QMS are geared towards ensuring that we can provide customer satisfaction and even exceed their expectations by listening to their needs.


Description of different standards:

ISO 17025:2005 (General requirements for the competence of testing and calibration laboratories): Oxford Immunotec is accredited by UKAS for the operation of Oxford Diagnostic Laboratories. UKAS audit to this standard on an annual basis.


ISO 13485:2003 (Medical devices – Quality management systems – Requirements for regulatory purposes): OI has been certified for this standard by Underwriters laboratories since 2004. A surveillance audit is carried out annually with a full audit carried out triennially.

ISO 9001:2008 (Quality management systems – Requirements): OI were certified for ISO 9001:2000 in 2004 and were upgraded to the 2008 version by Underwriters laboratories in 2010. A surveillance audit is carried out annually with a full audit carried out triennially.