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Dedication to Quality

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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.

ISO/IEC 17043:2010

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.

ISO/IEC 17025:2017

Randox Clinical Laboratory Services (RCLS) are ISO 17025 accredited laboratory labs – ID 9329

ISO/IEC 17025:2017

Randox Testing Services (RTS) are ISO 17025 accredited laboratory labs – ID 4348

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Product availability may vary from country to country. Some products may be for Research Use Only. For more information on product application and availability, please contact your local Randox Representative.

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Dedication to Quality

–

Helping You Meet Your ISO Requirements

ISO 13485:2016, EN ISO 13485:2016 and MDSAP

ISO/IEC 17043:2010

ISO/IEC 17025:2017

ISO/IEC 17025:2017

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