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College of American Pathologists

CAP accreditation

Accreditation by the College of American Pathologists is the most widely recognised quality credential in laboratory medicine. It is also a long project with a fixed entry condition. This page sets out what the accreditation involves, what it demands, and where a laboratory in Central Asia or the Caucasus starts.

The CAP in figures

As published by the College of American Pathologists, 2026.

1946

Founded; accreditation outside the US since 1979

8,400+

Accredited laboratories in 60 countries on six continents

21

Discipline-specific checklists, revised every year

400+

Peer inspectors for inspections outside the US

The entry condition: six months of CAP proficiency testing

A laboratory outside the United States and Canada has to take part in a CAP proficiency testing / EQA programme for at least six months before it can apply. The requirement is deliberate: it shows the laboratory can sustain a quality programme before anyone inspects it.

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 CAP distributor for Central Asia and the Caucasus.

How the accreditation runs

1

Technical evaluation

Review of the quality management system and its documentation against the checklists that apply to the laboratory's test menu.

2

On-site inspection

A team of practising laboratory professionals, chosen to match the laboratory's disciplines, inspects methods, equipment and staff on site.

3

Recurring audits

Accreditation is a cycle, not a certificate: regular audits confirm that compliance holds and improvement continues.

What the checklists cover

Three general checklists — fundamentals, laboratory director assessment and laboratory general — apply to everyone. On top come the discipline checklists 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.

Why laboratories choose the CAP

Depth over breadth

The CAP accredits laboratory medicine 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.

One standard worldwide

The same requirements apply in every country. A CAP-accredited laboratory in Almaty meets the same checklist as one in Chicago — which is exactly what international partners want to know.

Clinical-trial eligibility

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.

Inspected by peers

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.

Where to start

Before investing in PT programmes and documentation, it helps to know how far the laboratory is from the CAP's requirements. The readiness assessment covers seven topics in 41 questions and produces a summary report.

Start the CAP readiness assessment Talk to us

Further reading in the KombiMED blog


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