The Aurum Institute’s Biomedical Research Laboratory (BRL) in Tembisa has become the first laboratory within Aurum to receive accreditation from the South African National Accreditation System (SANAS) under the ISO 15189:2022 standard — the internationally recognised benchmark for quality and competence in medical laboratories.
In practical terms, this means the laboratory has been independently assessed and shown to consistently produce accurate and reliable results. It gives research partners, funders and regulators confidence that the laboratory’s systems, equipment and processes meet internationally recognised standards.
The accreditation follows almost a year of work to strengthen the laboratory’s quality management system. The team reviewed procedures, introduced new quality controls, completed internal audits and developed around 60 policies and standard operating procedures before undergoing an external SANAS assessment.
“It was a big shift from our existing systems,” said Aurum Quality Manager Malebo Mahlalela. “It meant reviewing how we work across the laboratory, strengthening our documentation and making sure every process met the required standard.”
The BRL supports TB research at Aurum and serves as a referral laboratory for research sites in Rustenburg, Pretoria and Klerksdorp. The accreditation strengthens the laboratory’s ability to support clinical trials and research partnerships that require accredited laboratory testing.
Laboratory Manager Lindelwa Nkangane said the accreditation is recognition of the team’s work.
“For a laboratory of our size, this is an important achievement. It shows that the quality of our work meets the same standards expected of established accredited laboratories.”
The achievement comes after a challenging period for the research sector, with many organisations affected by funding uncertainty. Despite this, the team continued working towards accreditation while supporting ongoing research.
Aurum’s Managing Director for Clinical Research, Tanya Nielson, said the accreditation reflects the organisation’s commitment to quality.
“This recognises the dedication of our laboratory team and strengthens our ability to support high-quality research. It also provides a strong foundation as we continue to grow our laboratory capacity.”
Aurum plans to build on this work by strengthening quality systems across its other laboratories.