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What does ISO 15189 accreditation mean, and why does it matter?

Learn what ISO 15189 accreditation means and why it matters for the quality, reliability and competence of medical laboratory testing.

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Written by Hana

ISO 15189 is the international standard for medical laboratories – the same class of accreditation a hospital pathology laboratory holds.

In Australia, Microba's laboratory is accredited to that standard by NATA, which is a signatory of the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA) ensuring this certification is recognised globally including UKAS (United Kingdom).

Accreditation is an independent assessment of how a laboratory operates: its competence, quality management and the consistency of its processes. It is worth understanding what it does and does not mean. Accreditation covers how the testing is performed. It is not a regulatory endorsement of any particular health claim, and it is not the same thing as a product approval.

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