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 a ISO/IEC 17043:2010 UKAS accredited proficiency testing provider No. 0010. Details of the schemes accredited, are provided in the RIQAS Brochure

ISO/IEC 17025:2017

Randox Clinical Laboratory Services (RCLS) is an ISO/IEC 17025:2017 UKAS accredited Testing Laboratory No. 9329, whose accreditation is limited to those actives detailed within the UKAS Schedule of accreditation.

ISO/IEC 15189:2012

Randox Clinical Laboratory Services (RCLS) is an ISO/IEC 15189:2012 UKAS accredited Medical Laboratory No. 9329, whose accreditation is limited to those actives detailed within the UKAS Schedule of accreditation.

ISO/IEC 17025:2017

Randox Testing Services (RTS) is an ISO:IEC 17025 UKAS accredited testing laboratory No.4348

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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 15189:2012

ISO/IEC 17025:2017

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