When fewer than one laboratory in a hundred can prove its competence to an international standard, the proof itself becomes the product.
Dr. Emeka Patrick Chukwuka · Physician-haematologist · Founder, EEHLSS | ALAFIAAI · ~8 min read
Educational commentary on industry and policy. Figures are drawn from the public sources listed at the end; nothing here is legal, regulatory or financial advice.
Every haematologist in Nigeria knows this story. A full blood count returns a platelet count that simply does not match the patient sitting in front of you. You repeat the test elsewhere and get a different result. The patient pays twice, clinical decisions are delayed by a day, and trust in the laboratory system erodes. When you multiply this across millions of tests, it becomes clear why many Nigerians still fly abroad for investigations that a well-run local laboratory could perform.
Accreditation provides the formal solution to that problem. Over the last two years, it has also quietly become a commercial differentiator. In this post, I explain why this is happening, what the actual costs are, and where the opportunities lie for laboratory owners, investors, and those developing laboratory technology.
The scarcity is the story
ISO 15189 is the international standard for quality and competence in medical laboratories. It covers the entire process, from receiving samples and verifying methods to assessing staff competence, measurement uncertainty, and how results are reported. When a laboratory is accredited, it means an independent body has assessed its work against this standard and confirmed its competence for a specific scope of tests.
| 5,000+ | <30 | <1% |
|---|---|---|
| clinical laboratories estimated in Nigeria | hold ISO 15189 accreditation (2026 review) | accredited share: a market signal, not just a quality gap |
A 2026 review in Frontiers in Health Services by Basil and colleagues estimated that fewer than 30 of Nigeria’s more than 5,000 clinical laboratories hold ISO 15189 accreditation. In 2021, the head of the Nigeria National Accreditation Service (NiNAS) put that figure at fewer than ten. The number is rising, but it is starting from a very low base.
The momentum in 2026 is real. In February, the Medical Laboratory Science Council of Nigeria (MLSCN) presented ISO 15189:2022 certificates to 11 laboratories, including public, private, military and research facilities. By September, it presented six more: five new accreditations and one re-accreditation. The Registrar noted that none of those six were government-owned and urged public laboratories to pursue accreditation. In July, a private laboratory in Lagos announced its re-accreditation to ISO 15189:2022, having first been accredited in 2013.
In a market where almost nobody can prove competence, the few who can are no longer competing on price alone.
Why the rules of competition are changing
Accreditation is shifting from a “nice to have” to a primary reason why clients choose a laboratory. Four forces are driving this change.
1. The standard has reset. The global transition from ISO 15189:2012 to the 2022 edition finished in December 2025. This new edition moves towards a more risk-based, patient-centred approach and brings point-of-care testing requirements into the main standard. Laboratories accredited under the new edition meet the current benchmark. Everyone else is now further behind than they were.
2. Clinicians and institutions are choosing based on evidence. Referring doctors, hospital partners, research sponsors and corporate clients are increasingly asking a simple question: can you show me your quality system? In multi-centre research and clinical trials, laboratories are commonly expected to demonstrate documented competence and external quality assessment performance. Accreditation answers that question in one document.
3. Africa has built the on-ramp. The WHO AFRO Stepwise Laboratory Improvement Process Towards Accreditation (SLIPTA), through its training partner programme SLMTA, offers laboratories a star-rated path instead of an all-or-nothing leap. The African Society for Laboratory Medicine (ASLM) reports that fewer than 1% of African medical laboratories were accredited before 2010. By 2020, the number of accredited laboratories had risen from 382 (2013) to 668, and by 2024, 674 laboratories in 28 countries had achieved SLIPTA certification. In Lagos State, a 2022–2023 mentorship programme took 60% of participating laboratories to three-star SLIPTA status.
4. Diagnostic trust has a price tag. Nigerian regulators often link poor laboratory quality to the rise of health tourism. In 2023, the MLSCN Registrar cited a reported figure of around US$2 billion a year spent by Nigerians seeking diagnosis abroad. While that number is unverified and should be treated with caution, the trend is clear: every patient who trusts a local result represents revenue that stays in the country.
What accreditation actually buys a laboratory
| Advantage | How it shows up |
|---|---|
| Trust and referrals | Clinicians can point to an independent assessment, not a brochure. |
| Partnerships | Research groups, trial sponsors and teaching hospitals have an easier path to due diligence. |
| Operational discipline | Documented processes, internal audits and corrective actions reduce repeats, rework and complaints. |
| Data you can defend | Traceable results, EQA records and audit trails become assets when negotiating contracts. |
| Portability | ISO 15189 is recognised internationally, which matters to groups eyeing the GCC or other African markets. |
The honest truth is that accreditation does not automatically raise your prices or win you contracts. It is a licence to compete for better work, not a guarantee. Laboratories that treat it as a certificate on the wall, rather than a management system, rarely see the commercial upside.
The cost side, without the gloss
Accreditation in Nigeria is difficult, and every laboratory manager understands why. The 2026 review lists the specific challenges: the cost of assessment and annual surveillance, staff shortages caused by migration, unreliable electricity, reagent stock-outs due to import dependence, and overlapping regulatory mandates. During a 2025 assessor-training workshop in Accra, an African accreditation official estimated that travel can account for up to 60% of total accreditation costs. This is exactly why building a local pool of assessors matters.
For a private laboratory, the practical question isn’t “can we afford accreditation?” but rather “which tests, in which order, and with what evidence?” I find it more manageable to start with a narrow scope—perhaps the full blood count, coagulation screen, and a few high-volume chemistry tests. This approach keeps the first assessment under control and helps build a track record.
Where digital quality systems fit
Much of the work required for ISO 15189 comes down to evidence management: tracking who performed a task, which reagent lot was used, the specific calibrated analyser involved, the QC results, and the exact steps taken when an error occurred. While paper systems can manage this, they are slow to audit and prone to failure.
This is why the 2026 review recommends laboratory information systems and electronic quality management systems as part of Nigeria’s accreditation strategy. A well-designed system keeps QC charts, document control, competency records, non-conformities and turnaround-time indicators in one place. This ensures the evidence an assessor asks for exists by default, instead of being scrambled together the week before a visit.
That is the problem we are addressing with MedLabAI-LIS: making audit-ready data a natural by-product of daily work. Our tools are research and decision-support prototypes, and no software replaces the people running a quality system. However, good software can make maintaining that quality system much cheaper.
A practical starting sequence
- Be honest about your baseline. Run a SLIPTA-style gap assessment against ISO 15189:2022 and score yourself without any kindness.
- Start with a narrow scope. Focus on high-volume tests where your external quality assessment results are already strong.
- Fix the power and supply basics. No quality system survives repeated analyser shutdowns or reagent gaps.
- Digitise your evidence. QC, document control, training records and incidents must be searchable, dated and traceable.
- Train your internal auditors. Your own staff should be able to spot issues before an assessor arrives.
- Let the data tell the story. Once you have accreditation, share your turnaround times and EQA performance with your referrers; this is where the commercial value actually shows up.
The bottom line
For much of the last decade, Nigerian laboratories have competed on location, price, and personal relationships. These factors still matter. But as accredited laboratories become more visible—through regulatory ceremonies, hospital partnerships, and patients who know what to ask for—the gap between “we say we are good” and “we have been assessed as competent” will widen. The laboratories that close that gap early will set the standard by which everyone else is measured. In a market this under-served, that is not just good medicine. It is good strategy.
References
- Basil B, Okoro NI, Mba IN, Myke-Mbata BK. Translating laboratory quality management system into practice: strategic opportunities and challenges for ISO 15189:2022 implementation in Nigeria’s healthcare system. Front Health Serv. 2026. doi:10.3389/frhs.2026.1850576
- News Agency of Nigeria. 11 laboratories secure global accreditation for reliable diagnostics. 17 Feb 2026. nannews.ng
- News Agency of Nigeria. MLSCN urges public laboratories to seek international accreditation. 9 Sep 2026. nannews.ng
- BusinessDay. EL-Lab secures re-accreditation on technical competence in laboratory testing. 27 Jul 2026. businessday.ng
- Nigerian Tribune. Only seven out of 5,349 medical labs in Nigeria meet international standard. 23 Jul 2021. tribuneonlineng.com
- African Society for Laboratory Medicine. Strengthening laboratory quality systems across Africa (LabVoice Issue 02). 10 Feb 2026. aslm.org
- EU-Africa Chamber. Africa’s growing pool of lab assessors. 2025. eu-africa-chamber.org
- News Agency of Nigeria. Health tourism: Laboratory Council to save $2bn on foreign diagnosis annually – Registrar. 11 Nov 2023. nannews.ng
- ILAC. ISO 15189:2022 for medical labs published. ilac.org
- Yao K, Luman ET, et al. A comprehensive review of the SLMTA literature part 2: Measuring success. Afr J Lab Med. PMC5637800
© 2026 EEHLSS | ALAFIAAI · Research & decision-support only · eehlss.io
Leave a Reply