Randox Laboratories Ltd operates a Quality Management System which complies with the requirements ofISO 13485:2016andEN ISO 13485:2016. We have also obtainedMDSAPcertification. 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.
Randox Clinical Laboratory Services (RCLS) are ISO 17025 accredited laboratory labs – ID 9329
Randox Testing Services (RTS) are ISO 17025 accredited laboratory labs – ID 4348