Short answer: The ISO 15189 accreditation process takes a medical laboratory from a gap assessment through building and running a quality management system, internal audit and management review, to an application and on-site assessment by an accreditation body such as KENAS or SADCAS. Most laboratories need 12 to 18 months, depending on their starting point.
- Accreditation is granted by an accreditation body, not by a training provider or consultant.
- Since the ILAC transition ended in December 2025, new and renewed accreditation is to ISO 15189:2022.
- Assessors want evidence that the system runs every day, not just documents that describe it.
- SLIPTA stars are a useful stepping stone, but a star rating is not accreditation.
What does ISO 15189:2022 accreditation actually mean?
ISO 15189 accreditation is formal recognition by an independent accreditation body that a medical laboratory is competent to perform specific examinations and operates a quality management system that meets ISO 15189:2022. It applies to a defined scope of tests, not to the laboratory as a whole by default.
The scope matters. A laboratory may be accredited for haematology and clinical chemistry examinations while its microbiology section works towards a later extension. Clients, clinicians and funders can check exactly which examinations are covered on the accreditation body’s certificate and schedule.
In Kenya, the national accreditation body is the Kenya Accreditation Service (KENAS), which accredits medical laboratories to ISO 15189 across disciplines including clinical chemistry, haematology, blood transfusion, microbiology, histopathology, immunology and genetics. Laboratories in Southern Africa commonly work with SADCAS. Check which arrangements your chosen body is a signatory to, because that recognition is what makes an accredited result trusted across borders.
Accreditation is different from certification and from licensure. If your team mixes these up, read our guide to accreditation vs certification vs licensure for medical laboratories.
What changed with the move from ISO 15189:2012 to 2022?
ISO 15189:2022 was published on 6 December 2022, and ILAC set a three-year transition period, so accreditation to the 2012 edition is no longer recognised under the ILAC arrangement after December 2025.
Most accreditation bodies used 31 December 2025 as the cut-off, and some set slightly earlier dates. Any laboratory starting the process now should build directly against the 2022 edition. The main differences you will notice are:
- A stronger emphasis on risk management and on the patient, with requirements on impartiality and confidentiality placed up front.
- A restructured standard: general requirements, structural and governance requirements, resource requirements, process requirements and management system requirements.
- Point-of-care testing requirements, previously in ISO 22870, now incorporated into ISO 15189 itself.
- Less prescription about documents and more focus on demonstrable outcomes.
The ILAC announcement on ISO 15189:2022 sets out the transition arrangements.
What are the steps in the ISO 15189 accreditation process?
The ISO 15189 accreditation process has nine practical steps: gap assessment, QMS design, implementation and training, method verification and quality control, internal audit and management review, application, assessment, closure of nonconformities, and ongoing surveillance.
- Readiness and gap assessment. Your own team compares current practice against every requirement of ISO 15189:2022 and records the gaps. Use the standard itself or the SLIPTA checklist as a structured tool. Be honest: a generous gap assessment only moves the problems to the assessment day.
- QMS design. Define the scope of accreditation, quality policy and objectives, organisational structure, responsibilities and the documented procedures you need. Write procedures that describe what you actually do, then improve the practice where it falls short.
- Implementation and training. Put the procedures to work. Train staff, assess and record their competence, start document control, equipment records, occurrence logs and complaint handling. Allow at least three to six months of records before you apply, so assessors can see the system running.
- Verification, validation and quality control. Verify the performance of each examination procedure in your scope (or validate it where needed), evaluate measurement uncertainty, confirm reference intervals, and run internal quality control with defined rules such as Westgard multirules. Enrol in external quality assessment (proficiency testing) for every examination you can.
- Internal audit and management review. Trained internal auditors audit the whole system, including witnessing examinations. Raise nonconformities, carry out root cause analysis and corrective action, then hold a formal management review that looks at audit findings, EQA performance, complaints, risks and quality indicators.
- Application to the accreditation body. Submit the application, proposed scope, quality documents and fees. KENAS, SADCAS and other bodies each have their own forms, timelines and fee structures, so check their current requirements before you start.
- Assessment. The body reviews your documents and then sends a team (a lead assessor plus technical assessors for each discipline) to assess on site. Some bodies offer an optional pre-assessment visit.
- Nonconformity closure. Almost every laboratory receives findings. You submit evidence of root cause analysis and effective corrective action within the period the body sets. The accreditation decision follows.
- Surveillance and reassessment. Accredited laboratories receive periodic surveillance assessments and a full reassessment at the end of each accreditation cycle. Extensions to scope are handled through the same body.
How long does ISO 15189 accreditation take?
Most medical laboratories take 12 to 18 months from gap assessment to accreditation decision, but the real figure varies with your starting point, staffing, test menu and the accreditation body’s scheduling.
A laboratory that already has SOPs, EQA enrolment and a working quality officer can move faster. A laboratory starting from scratch, or one with high staff turnover, should plan for the longer end. The table below shows a typical pattern.
| Phase | Typical duration | Main outputs |
|---|---|---|
| Gap assessment and planning | 1 to 2 months | Gap report, scope, action plan, named quality manager |
| QMS design and documentation | 2 to 4 months | Quality policy, objectives, procedures, forms, document control |
| Implementation and training | 3 to 6 months | Training and competency records, QC and EQA records, occurrence logs |
| Verification, validation and QC review | Runs in parallel, 2 to 4 months | Verification reports, measurement uncertainty, reference interval review |
| Internal audit and management review | 1 to 2 months | Audit reports, corrective actions, management review minutes |
| Application, assessment and closure | 2 to 4 months or more | Assessment report, closed nonconformities, accreditation decision |
Treat these as planning ranges, not promises. Waiting times for assessment depend on the accreditation body’s calendar and the number of disciplines in your scope.
Is SLIPTA the same as ISO 15189 accreditation?
No. SLIPTA (Stepwise Laboratory Quality Improvement Process Towards Accreditation) gives a laboratory a rating of 0 to 5 stars against a checklist based on ISO 15189, but a star rating is not accreditation and is valid for two years.
SLIPTA is run under the African Society for Laboratory Medicine (ASLM), which publishes the current checklist (SLIPTA Checklist V3, 2023). Certified auditors score the laboratory, and the result shows where it stands on the path to accreditation. The related SLMTA programme (Strengthening Laboratory Management Toward Accreditation) has been used in Kenya with Ministry of Health and CDC support.
For many public and faith-based laboratories, SLIPTA is the most realistic route: work up the star levels, close the gaps the checklist reveals, then apply for full ISO 15189 accreditation once the system is stable. Use the checklist as a free, structured self-assessment tool even if you are not being formally audited.
Why do laboratories struggle to get accredited?
Laboratories usually struggle because their documents do not reflect what staff actually do, not because they lack procedures.
The patterns that cause most delays are predictable:
- Copied documentation. SOPs borrowed from another laboratory describe equipment, workflows or roles that do not exist. Assessors spot this quickly by asking staff to talk them through a task.
- One person carrying the system. When only the quality manager understands the QMS, it collapses during leave or after a resignation.
- Training without competency assessment. Attendance lists are not evidence that someone can perform an examination correctly.
- Weak corrective action. Nonconformities closed with “staff retrained” and no root cause analysis tend to recur, and assessors check for recurrence.
- Thin records. Applying too early, with only a few weeks of QC, EQA and maintenance records, leaves nothing to assess.
- Ignoring the pre- and post-examination phases. Most laboratory errors arise outside the analyser, in sample collection, labelling, transport and reporting.
- No real management review. A meeting that does not use data or produce decisions does not meet the requirement.
A good test of readiness: the assessment day should feel like a normal working day. If staff need to prepare special records for it, the system is not yet embedded.
Who in the laboratory needs which training?
Accreditation needs a trained quality lead, a pool of trained internal auditors, and bench staff who understand the procedures they follow, so training should be matched to each role.
| Role | What they need to be able to do | Relevant course |
|---|---|---|
| Quality manager, laboratory manager | Plan and lead implementation against ISO 15189:2022 | ISO 15189:2022 Lead Implementer |
| Internal auditors (senior scientists, section heads) | Plan and run internal audits, write findings, follow up corrective action | ISO 15189:2022 Internal Audit Training |
| Quality officers, supervisors | Build and maintain the 12 quality system essentials day to day | Establishing and Maintaining a Laboratory QMS |
| Quality and safety leads, section heads | Run risk assessments, FMEA, root cause analysis and CAPA | Risk Management in the Clinical Laboratory |
Internal auditors should not audit their own work, so most laboratories train at least two or three people. For a step-by-step view of the system itself, see our guide on how to build a laboratory quality management system.
How can Elmenta training support your accreditation plan?
Elmenta Consulting provides the training and mentorship your own team needs to run the accreditation process; the work of implementation and the accreditation decision stay with your laboratory and the accreditation body.
Courses run every quarter, in person in Nairobi (consecutive days, 08:00 to 16:00 EAT) and live online on Zoom (Monday, Wednesday and Friday, 18:00 to 20:00 EAT). Facilitators include ISO 15189 lead auditors and quality managers with CAP accreditation experience. Quarterly courses include the first month of Elmenta Lab Pro mentorship free, which is useful when you start writing procedures and need someone to ask. Every course can also be delivered in-house for your whole team, and participants receive a certificate of completion. Check the training calendar for the next cohort.
Leading your laboratory towards ISO 15189:2022? The 3-day Lead Implementer course walks your quality lead through every clause and every step of the process described above, so you can plan with confidence.
Frequently asked questions
How much does ISO 15189 accreditation cost in Kenya?
Costs depend on your scope, number of disciplines, assessor days and the accreditation body's current fee schedule, plus your own internal costs for EQA schemes, calibration, training and staff time. KENAS publishes its fees and application requirements, so request the current schedule directly before you budget. Internal costs are often larger than assessment fees, so plan for both.
Can a small laboratory get ISO 15189 accredited?
Yes. ISO 15189 does not set a minimum size. A small laboratory can apply for a narrow scope, such as a few core haematology and chemistry examinations, and extend later. The challenge is staffing: you still need a quality lead, independent internal audits and documented competency for every person, so small teams often share or rotate roles carefully.
Do we need a consultant to get ISO 15189 accreditation?
No. Many laboratories reach accreditation with their own staff, provided the quality lead and internal auditors are properly trained and management gives them time and authority. External help can speed things up, but the accreditation body assesses whether your own people understand and run the system, so building internal capability is essential either way.
What happens if the assessment finds nonconformities?
Findings are normal. The accreditation body gives you a set period to submit evidence of root cause analysis and effective corrective action for each nonconformity. Once the evidence is accepted, the accreditation decision is made. Serious or unresolved findings can delay the decision or exclude specific examinations from the scope until they are fixed.
Does ISO 15189 accreditation cover point-of-care testing?
It can. ISO 15189:2022 incorporates the point-of-care testing requirements that were previously in ISO 22870, so POCT under the laboratory's governance can be included in the scope. You will need oversight, training and competency records, QC and EQA for those devices, just as for examinations performed in the main laboratory.
