Dedication to Quality
Helping You Meet Your ISO Requirements
ISO 13485:2016, EN ISO 13485:2016 and MDSAP
Randox Laboratories Ltd operates a Quality Management System which complies with the requirements of ISO 13485:2016 and EN ISO 13485:2016. We have also obtained MDSAP certification. These accreditations are for the following scope:
The design, development, manufacture, service and distribution of in-vitro diagnostic medical devices, in-vitro diagnostic test kits, in-vitro diagnostic reagents, calibrators and controls and in-vitro diagnostic analysers used in diagnosis and management of cancer, diagnosis of immune status, disease status and autoimmune status, and the identification of drugs of abuse, cardiac markers, protein metabolism, endocrine disorders, blood analytes, blood components, blood gases, coagulation, transmissible agents, sexually transmissible agents, fertility and for immunological typing and therapeutic drug monitoring.
Randox International Quality Assessment Scheme (RIQAS) is accredited in accordance with International Standard ISO/IEC 17043:2010. Details of the schemes accredited, are provided in the RIQAS Brochure.