Accreditation vs Certification vs Licensure for Medical Laboratories

Laboratory staff use the words accreditation, certification and licensure as if they were interchangeable. They are not. Each answers a different question: are you allowed to operate, does your management system follow a standard, and can you prove your results are valid? This guide explains the difference in plain terms, shows where SLIPTA, CAP and JCI fit, and helps you decide which one your laboratory needs and when.

What is the difference between accreditation, certification and licensure?

Licensure gives you legal permission to operate, certification confirms your management system follows a standard, and accreditation confirms your laboratory is competent to produce valid results. They build on each other rather than replace each other.

• Accreditation is formal recognition, by an authoritative body, that a laboratory is competent to carry out specific examinations against a standard such as ISO 15189. In Africa this is done by national or regional accreditation bodies such as KENAS in Kenya and SADCAS in Southern Africa, which are signatories to the ILAC mutual recognition arrangement.
• Certification is confirmation by a certification body that an organisation’s management system conforms to a standard such as ISO 9001. It checks that processes are defined, followed and improved. It does not assess whether your test results are technically correct.
• Licensure (or registration) is legal permission from a regulator to practise or to run a facility. In Kenya, the Kenya Medical Laboratory Technicians and Technologists Board (KMLTTB) licenses laboratory practitioners and regulates medical laboratories.

How do accreditation, certification and licensure compare?

The quickest way to see the difference is to compare who grants each one, what is assessed and what it proves to patients, clinicians and funders.

What is the difference between ISO 15189 and ISO 9001?

ISO 15189 is a standard for the quality and competence of medical laboratories and leads to accreditation; ISO 9001 is a generic quality management standard for any organisation and leads to certification. A laboratory can be ISO 9001 certified and still produce wrong results, because ISO 9001 does not examine analytical performance.

ISO 15189:2022 covers the requirements you would expect in a management system (document control, nonconformities, corrective action, internal audit, management review, risk management) and adds laboratory-specific technical requirements. These include personnel competence assessment, equipment calibration and metrological traceability, verification and validation of examination methods, measurement uncertainty, internal quality control, external quality assessment, and pre- and post-examination processes. The 2022 edition also absorbed point-of-care testing requirements that were previously in ISO 22870.

Some hospitals hold ISO 9001 certification for the whole organisation while the laboratory pursues ISO 15189 accreditation. That is a sensible combination. What is not sensible is presenting an ISO 9001 certificate as proof that laboratory results are accurate. Note also that ISO 15189:2012 accreditation is no longer recognised under the ILAC arrangement after the transition to the 2022 edition ended in December 2025, so check that any accreditation you rely on is to the current edition.

Where do SLIPTA stars, CAP and JCI fit?

SLIPTA is a stepwise improvement and recognition programme, not accreditation; CAP is an accreditation programme for laboratories; JCI accredits whole healthcare organisations, including their laboratory services.

• SLIPTA (Stepwise Laboratory Quality Improvement Process Towards Accreditation), coordinated by ASLM, uses a checklist based on ISO 15189 that certified auditors score to award 0 to 5 stars. A star rating is valid for two years. It shows how close a laboratory is to accreditation readiness, which is why many public and donor-supported laboratories in Africa use it as a stepping stone. The current SLIPTA checklist (V3, 2023) is a useful free self-assessment tool.
• CAP (College of American Pathologists) accreditation uses detailed checklists and peer inspections every two years. Some laboratories in Africa, particularly those supporting clinical trials or international networks, hold CAP accreditation instead of, or alongside, ISO 15189.
• JCI (Joint Commission International) accredits hospitals and other healthcare organisations. A JCI-accredited hospital’s laboratory is assessed as part of the hospital, not against a laboratory-specific competence standard in the same depth as ISO 15189.

Is a course certificate the same as professional certification?

No. A certificate of completion shows that you attended and completed a course; a professional certification shows that an independent body has assessed you against defined criteria, usually by examination, and that you maintain it over time.

There are three different things people call “certified”:

1. Licence to practise. Issued by your regulator (KMLTTB in Kenya). Without it you cannot legally practise. It is not optional.
2. Professional or personnel certification. Awarded by a certification body after assessment, often an examination, with requirements to maintain it. Bodies that certify persons may themselves be accredited to ISO/IEC 17024. Examples include specialist registrations and recognised auditor certifications.
3. Certificate of completion or attendance. Issued by a training provider at the end of a course. It is evidence of learning and can support CPD records, but it is not a licence and not a professional certification.

To be clear about our own courses: Elmenta Consulting issues a certificate of completion only. Completing the ISO 15189:2022 Lead Implementer course gives you the knowledge to lead implementation, but it does not make you a certified lead auditor or accredit your laboratory. Only an accreditation body such as KENAS can accredit a laboratory.

How do CPD points relate to licensure in Kenya?

To renew the annual practice licence, KMLTTB requires laboratory practitioners to attain at least 50 CPD points in the previous year and to show evidence such as certificates and attendance lists.

This is a licensure requirement, not an accreditation one, but the two meet in practice. ISO 15189 expects the laboratory to keep records of each person’s training and competence, and the same evidence often supports both CPD claims and accreditation assessments. Whether a particular course earns CPD points, and how many, is decided by KMLTTB, so check the current KMLTTB renewal requirements rather than relying on any provider’s claims.

Which one does my laboratory need, and when?

Every laboratory needs licensure first; accreditation to ISO 15189 is the target for any laboratory that wants to prove the reliability of its results; ISO 9001 certification is optional and rarely the right first goal for a medical laboratory.

1. Licensure, from day one. Make sure the facility and every practitioner hold current licences and that CPD records are up to date.
2. Build the quality management system. Put in place the 12 quality system essentials: documents and records, occurrence management, internal audit, equipment, process control and the rest. Our guide to building a laboratory quality management system walks through them.
3. Measure progress. Use the SLIPTA checklist for a self-assessment, or apply for a SLIPTA audit if your laboratory is eligible.
4. Audit yourselves. Train internal auditors and run a full internal audit and management review against ISO 15189:2022 before you apply.
5. Apply for accreditation. Choose your scope, apply to KENAS, SADCAS or your national accreditation body, and prepare for assessment. See the ISO 15189 accreditation process roadmap for the phases.

Pursue accreditation earlier if a regulator, funder, insurer, research sponsor or referral network asks for it. Consider ISO 9001 only if your wider organisation is already certified and wants a single management system across departments.

How can training help your team prepare?

Accreditation depends on people who understand the standard and can turn it into daily practice, so the most useful training matches each role in the journey.

• Quality managers and laboratory managers who will lead implementation: ISO 15189:2022 Lead Implementer (3 days).
• Laboratories starting from a weak or informal system: Establishing and Maintaining a Laboratory QMS (5 days), built around the 12 quality system essentials.
• Staff who will audit your own system before the accreditation body does: ISO 15189:2022 Internal Audit Training (3 days).
• Teams that want ongoing support between courses: Elmenta Lab Pro mentorship, with the first month free for quarterly course participants.

Courses run every quarter in person in Nairobi and live online on Zoom, and any course can be delivered in-house for your laboratory team. Each issues a certificate of completion.