SAMM accreditation in Malaysia: what equipment records need to show

Standards Malaysia accredits medical labs to MS ISO 15189 with SC 2 layered on top. What that means for your equipment register, and an honest look at whether accreditation is worth it.

Last reviewed August 11, 2026

What SAMM is

The Department of Standards Malaysia operates SAMM — Skim Akreditasi Makmal Malaysia — the national laboratory accreditation scheme. It covers calibration and testing including medical testing, and assesses medical laboratories against MS ISO 15189, the Malaysian adoption of the international standard.

Reading ISO 15189 on its own is not quite enough preparation. Standards Malaysia publishes SC 2, “Specific Criteria for Accreditation in the Field of Medical Testing” — Issue 6, dated 25 July 2024 — which is explicitly supplementary to MS ISO 15189 and layers Malaysian requirements on top of it.

Accreditation here is voluntary, and we are not going to pretend otherwise. Standards Malaysia says so itself. No Malaysian law makes ISO 15189 accreditation a precondition for operating a medical laboratory. Anyone selling you software on the grounds that you must accredit or close is misrepresenting the position.

The honest picture

As at June 2024, Standards Malaysia listed 83 accredited medical testing laboratories— 29 government, 47 private, 7 in public institutes of higher learning. Against the size of Malaysia's diagnostic sector that is a small number, and it tells you something useful: accreditation in Malaysia is a deliberate differentiator, not the price of doing business.

Which reframes the question. The useful one is not “how do I get accredited” but “is accreditation going to win me work I do not currently get” — and if it is not, whether your equipment records are good enough for the reason they mattered before any standard existed.

What accreditation asks of your equipment records

MS ISO 15189 follows the international standard, so clause 6.4.7 governs: records for every item of equipment that influences examination results. Eleven record types, required where relevant — identity including software and firmware version; manufacturer, model and serial number; supplier contact; dates of receipt and entry into service; location; condition when received; the manufacturer's instructions; performance records confirming fitness for use; the maintenance programme and the maintenance actually performed; damage, malfunction, modification or repair; and current status.

The two that trip labs up are the same everywhere. A maintenance schedulewith no completion records proves intent and nothing else. And a status field that has gone stale — an instrument withdrawn months ago still reading “in use” — tells an assessor the register is not maintained and invites them to look harder at everything else.

Records are kept for the instrument's lifetime

Clause 6.4.7 does not only list record types; it also requires that they be retained and readily available for the equipment's lifespan, or longer where the laboratory's own retention policy says so. A register that starts when you bought the software, with nothing before it, is a gap you should expect to be asked about.

Deciding whether to pursue it

Reasons that hold up:

A corporate, insurer or hospital contract that requires it.
Cross-border recognition. Standards Malaysia's accreditation carries through ILAC mutual recognition, which matters if you handle referred work.
A genuine internal reason — a lab that wants the discipline, not the certificate.

Reasons that do not:

A belief that it is legally required. It is not.
A vendor implying your licence depends on it. In Malaysia it does not — though in Dubai, for what it is worth, it genuinely does.

Common questions

Is ISO 15189 accreditation compulsory for a medical laboratory in Malaysia?

No. The Department of Standards Malaysia states plainly that its accreditation schemes, including medical testing, are voluntary. Accreditation is not a legal precondition for operating a medical laboratory in Malaysia. That is not the same as light regulation — private healthcare facilities are separately licensed — but nobody is going to close your lab for not holding SAMM accreditation.

How many Malaysian medical labs are actually accredited?

As at June 2024, Standards Malaysia listed 83 accredited medical testing laboratories: 29 government, 47 private and 7 in public institutes of higher learning. That is a small number against the size of the sector, which tells you accreditation is a deliberate differentiator here rather than the cost of entry.

What is SC 2 and why does it matter?

SC 2, "Specific Criteria for Accreditation in the Field of Medical Testing", is Standards Malaysia's supplementary document to MS ISO 15189 — Issue 6 is dated 25 July 2024. It layers Malaysian-specific requirements on top of the international standard, so reading ISO 15189 alone is not sufficient preparation.

Is it worth pursuing accreditation if it is voluntary?

That is a commercial decision, not a compliance one. Accreditation is worth it where it wins work — corporate contracts, insurer panels, referral relationships and cross-border recognition through ILAC. If none of those apply to your lab, good equipment records are still worth keeping for the reason they existed before any standard did: instruments that are maintained and calibrated produce results you can defend.

Sources

Department of Standards Malaysia, SAMM scheme pages and accreditation statistics (as at June 2024) · SAMM SC 2, “Specific Criteria for Accreditation in the Field of Medical Testing”, Issue 6, 25 July 2024 · MS ISO 15189 / ISO 15189:2022 clause 6.4.7. Figures and document issues change; check the current versions before relying on them.