South Africa

LIS Software for South African Labs — SANAS & ISO 15189

For independent pathology practices working to ISO 15189 under SANAS — with the records an assessment asks for and pricing in rand.

What SANAS accreditation means in South Africa

South Africa is the one market on this list where accreditation is explicitly voluntary — which changes what it is for. It is a competitive signal to referrers and funders rather than a licence to open the doors.

The Accreditation for Conformity Assessment, Calibration and Good Laboratory Practice Act 19 of 2006 establishes SANAS as a juristic person and recognises it as the only accreditation body in the Republic.

In SamLab: Report templates that stay consistent across every printer, operator and branch, so what an assessor reviews is what a referrer receives.

SANAS grants formal recognition to medical laboratories against ISO 15189, and separately to testing and calibration laboratories against ISO/IEC 17025.

In SamLab: IQC with Levey-Jennings charting, kit and batch recorded beside the method, and barcoded specimen traceability end to end.

An accredited laboratory earns the right to display the SANAS symbol on patient request forms and on results, which makes the accreditation visible to referring clinicians at the point they choose a laboratory.

In SamLab: Configurable report letterheads and footers, so the symbol and practice details sit on every report without being redrawn per template.

Accreditation in South Africa is a voluntary process rather than a precondition of operating, so the commercial case for it rests on referrer confidence and funder requirements instead of on compliance alone.

In SamLab: Turnaround-time visibility and a result revision history, the two operational records a referrer actually judges a laboratory on.

Source: South African Government — Accreditation Act 19 of 2006 · checked 2026-08-08. Accreditation is granted to the laboratory, not to its software — what SamLab provides is the records an assessor asks to see.

Runs when the internet doesn’t

Registration, billing, result entry and reports work with the connection down and sync when it returns. Prices are shown in your own currency.

Questions from South Africa laboratories

Is accreditation compulsory for a South African laboratory?

No. SANAS accreditation is a voluntary process in South Africa, unlike some jurisdictions where it is a licensing precondition. That is precisely why the records matter commercially: a practice pursuing accreditation is doing it to win referrer and funder confidence, so the evidence has to be produced consistently rather than assembled the week before an assessment.

Does SamLab make us ISO 15189 compliant?

It cannot, and any vendor saying otherwise is selling you something that does not exist. SANAS accredits the laboratory against ISO 15189 — its personnel, procedures, equipment and records. SamLab supplies a specific and useful part of that evidence: traceable barcoded specimens, IQC with Levey-Jennings, an audit log, a result revision history where verified results lock, and reports that carry method, units and reference ranges every time.

Can we be billed in rand?

Yes. South African rand is a supported billing currency, so a practice in Johannesburg or Cape Town sees R rather than a dollar figure plus a foreign-transaction fee. SamLab is sold internationally as a yearly subscription with no separate maintenance contract.

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