Accreditation by the College of American Pathologists (CAP) is the most widely recognised quality credential in laboratory medicine: 8,400+ laboratories in 60 countries hold it, inspected against 21 discipline checklists that are revised every year. It is also a long project with a fixed entry condition: at least 6 months of CAP proficiency testing for laboratories outside the US and Canada. This page sets out what it involves and where a laboratory in Central Asia or the Caucasus starts.
As published by the College of American Pathologists, 2026.
Founded; accreditation outside the US since 1979
Accredited laboratories in 60 countries on six continents
Discipline-specific checklists, revised every year
Peer inspectors for inspections outside the US
A laboratory outside the United States and Canada has to take part in a CAP proficiency testing / EQA programme for at least 6 months before it can apply. The requirement is deliberate: it shows the laboratory can sustain a quality programme before anyone inspects it. Only then do the 3 steps of the accreditation follow: technical evaluation, on-site inspection and recurring audits.
In practice this means the accreditation project begins with ordering the right PT programmes for the test menu, which is where we come in. KombiMED is the official distributor of CAP PT/EQA programmes for most countries in Central Asia and the Caucasus region.
After the 6-month proficiency testing period, CAP accreditation runs in 3 steps: a technical evaluation of the quality management system and its documentation, an on-site inspection by practising laboratory professionals matched to the laboratory's disciplines, and recurring audits that confirm compliance holds. Outside the US, inspections are carried out by a pool of 400+ peer inspectors.
Review of the quality management system and its documentation against the checklists that apply to the laboratory's test menu.
A team of practising laboratory professionals, chosen to match the laboratory's disciplines, inspects methods, equipment and staff on site.
Accreditation is a cycle, not a certificate: a self-inspection in the interim year and a peer re-inspection every two years confirm that compliance holds.
From the first PT round to re-accreditation
The CAP accreditation path for a laboratory outside the US and Canada
Source: College of American Pathologists, entry condition (brochure 2026) and two-year cycle with interim self-inspection (historical timeline).
3 general checklists (fundamentals, laboratory director assessment and laboratory general) apply to every laboratory. On top come the discipline checklists, 21 in total and revised every year, that match what the laboratory actually does, so staff prepare only for requirements that are relevant to them:
Anatomic pathology · Chemistry and toxicology · Biochemical genetics · Cytogenetics · Cytopathology · Flow cytometry · Haematology and coagulation · Histocompatibility · Immunology · Limited service laboratory · Microbiology · Molecular pathology · Point-of-care testing · Transfusion medicine · Urinalysis, plus separate programmes for biorepositories, forensic drug testing and reproductive laboratories.
Each requirement comes with guidance on how to meet it: examples of compliance evidence, notes, and references to guidelines from bodies such as CLSI, WHO and OSHA. New and revised items are marked, so an annual update does not mean rereading everything.
Laboratories choose the CAP for a number of reasons:
The CAP accredits laboratory medicine disciplines and anatomic and molecular pathology and nothing else. Its inspections follow the whole process, pre-analytical, analytical and post-analytical, at a level of technical detail that general accreditation schemes rarely reach.
The same checklist applies in every country, so there is no room for diverging interpretations. A CAP-accredited laboratory in Almaty meets the same requirements as one in Chicago, and its results are comparable with other top-quality laboratories.
For specialised laboratories the CAP mark opens referral work, cross-border contracts and partners who need a quality credential they already know.
Pharmaceutical sponsors and CROs need laboratories whose data meet GCP / GCLP expectations. CAP accreditation opens central-lab and clinical-trial work, a recurring revenue stream alongside routine diagnostics.
Inspectors are working laboratory professionals, not contractors. The inspection is a technical exchange as much as an audit, and laboratories routinely report learning from it.
The free CAP readiness assessment: 7 topics, 41 questions, a summary report.
Every CAP PT / EQA round is also a training case: the laboratory examines it like a patient sample, then compares its answer with the intended result and the peer group. In anatomic pathology, cytopathology and molecular pathology the CAP adds educational and competency programmes for which pathologists can claim CME credit and laboratory staff CE credit, for example:
Every EQA round is a chance to learn
One round of a CAP PT / EQA or educational programme, seen from the laboratory
Whether CME or CE credit counts toward a national licence or recertification is decided by each country’s licensing body, so check which credits it recognises. Which educational programmes fit your disciplines is part of our advice when we plan the PT / EQA order. More on EQA as a learning tool: External quality assessment in histopathology and IHC.
Before investing in PT programmes and documentation, it helps to know how far the laboratory is from the CAP's requirements. The KombiMED readiness assessment covers 7 topics in 41 questions and produces a summary report. KombiMED GmbH, the official distributor of CAP PT/EQA programmes for most countries in Central Asia and the Caucasus region, then advises which proficiency testing programmes to order first for the test menu.
One part of that preparation is worth doing first: a review of the laboratory's own QC plan. Accreditation alone does not make QC good. In the 2025 Great Global QC Survey, 29 % of ISO 15189 laboratories and 44 % of CLIA laboratories were out of control every day. Inspectors look at how QC is designed and how failures are handled, so check before the self-inspection:
More in ISO 15189, CAP or CLIA: does accreditation improve QC?, in the EQC guide on internal QC rules and limits and on what assessors check first.
Start the CAP readiness assessment Talk to us
Which PT programmes a laboratory needs under ISO 15189:2022.
CAP next to RIQAS, INSTAND, QCMD, NordiQC and others, and how to combine them.
CAP PT / EQA programmes through their official distributor for the region.
