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Institute of Bio Research Auditing and Training in Southern Africa (Pty) Ltd

Accredited by: SANAS

The Institute of Bio Research Auditing and Training in Southern Africa (Pty) Ltd is a South African certification body accredited by the South African National Accreditation System (SANAS). They specialize in certifying organizations in the medical devices sector, specifically for ISO 13485:2016 (Medical Devices Quality Management Systems). Their accreditation covers various technical areas, including non-active medical devices and in vitro diagnostic medical devices.

https://www.ibratsa.co.za

222 Corobay Avenue, Waterkloof Glen, Pretoria, 0010

Certification Scopes (2)

ISO 9001

Medical Laboratory

South African National Accreditation System

South Africa

The Institute of Bio Research Auditing and Training in Southern Africa (Pty) Ltd certifies organizations in the pharmaceuticals and transport, storage, and communication sectors under the ISO 9001:2015 standard, which focuses on quality management systems. This certification ensures that these organizations meet international quality requirements, enhancing their operational efficiency and customer satisfaction.

Manufacture of basic pharmaceutical products and pharmaceutical preparations
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ISO 13485

Medical Laboratory

South African National Accreditation System

South Africa

The Institute of Bio Research Auditing and Training in Southern Africa (Pty) Ltd certifies organizations under ISO 13485:2016, focusing on Medical Devices Quality Management Systems. Their accreditation covers a range of sectors including non-active medical devices, in vitro diagnostic medical devices, and associated services such as maintenance and decontamination.

Manufacture of basic pharmaceutical products and pharmaceutical preparations
View Source