CAP Laboratory Accreditation
CAP accreditation from the College of American Pathologists is held by laboratories in 60 countries and rests on peer inspections against discipline checklists that are updated every year with input from 25+ scientific committees. KombiMED GmbH, the official distributor of CAP PT/EQA programs for most countries in Central Asia and the Caucasus region, prepares laboratories for it, starting with at least 6 months of CAP proficiency testing, which laboratories outside the US and Canada need before they can apply.
What laboratory accreditation means
Laboratory accreditation is a process in which an independent body certifies that a laboratory meets defined quality standards. It ensures that a lab’s methods, equipment and personnel deliver accurate and reliable results.
The CAP has shaped these standards since the 1960s by developing checklists and creating an accreditation program with inspections that still form the foundation for outstanding patient care today.
Proficiency testing (PT)/EQA requirement before accreditation
To demonstrate their readiness and commitment to a comprehensive quality program, laboratories outside the US and Canada must participate in a CAP Proficiency Testing / External Quality Assessment (PT/EQA) program for at least 6 months before they become eligible for CAP accreditation.
6-month minimum
Continuous proficiency testing (PT)/EQA participation before eligibility.
Recognized in 60 countries
An internationally respected accreditation standard.
21 checklists
Discipline-specific requirements guide every inspection.
2-year cycle
Re-accreditation keeps quality standards current.
Why do laboratories choose the CAP?
Laboratories choose the CAP for a number of reasons:
- depth: it accredits laboratory medicine disciplines and anatomic/molecular pathology only, across the pre-analytical, analytical and post-analytical phases;
- one standard across the globe: no room for diverging interpretations and therefore full comparability with other top-quality labs around the globe;
- increased international business opportunities for specialized labs;
- eligibility for clinical-trial work under GCP / GCLP;
- and inspection by working laboratory peers rather than contractors.
Depth
The CAP accredits laboratory medicine disciplines and anatomic/molecular pathology only, across the pre-analytical, analytical and post-analytical phases.
One standard across the globe
No room for diverging interpretations and therefore full comparability with other top-quality labs around the globe.
International business opportunities
Specialized laboratories gain referral work, cross-border contracts and partners who need a quality credential they already know.
Clinical-trial eligibility
CAP accreditation makes a laboratory eligible for clinical-trial work under GCP / GCLP.
Inspection by working peers
Trained, practicing laboratory professionals (not contractors) inspect your lab using checklists tailored to your test menu.
Annually updated checklists
Checklists are reviewed every year with input from 25+ scientific committees to reflect the latest techniques, standards and best practices.
The CAP peer-inspection approach
What makes a CAP inspection different: it is carried out by fellow laboratory professionals, tailored to your disciplines and grounded in everyday practice.
A collaborative approach
Inspections are a peer-to-peer exchange between laboratory professionals: a constructive dialogue, not a one-way audit.
Discipline-specific expertise
Inspectors are practising specialists in your field, so requirements are assessed by people who understand your day-to-day work.
Hands-on, practice-driven
The review is grounded in real laboratory practice and examines how methods, equipment and staff actually perform at the bench.
A thorough, structured inspection
Discipline-specific checklists guide a complete, documented review across the pre-analytical, analytical and post-analytical phases.
What CAP accreditation delivers for your laboratory
CAP accreditation is more than a certificate on the wall. It is a strategic investment that raises quality, builds trust and opens concrete business opportunities. Here is what your laboratory gains.
Prove your quality beyond doubt
Accreditation turns "we are good" into independently verified proof. Standardized, documented processes reduce errors and give clinicians, patients and partners hard evidence they can trust.
Unlock new markets
CAP is recognized in 60 countries and is the reference standard for US and international healthcare. Accreditation opens doors to referrals, cross-border business and tenders that require a globally accepted mark of quality.
Become clinical-trial eligible
Pharmaceutical sponsors and CROs require laboratories with internationally accepted quality systems. CAP accreditation makes your lab eligible for lucrative clinical-trial and central-lab work.
Win on quality, not only on price
A CAP mark differentiates you from competitors and lets you compete on excellence. It is a decisive argument in negotiations, tenders and partnership discussions.
Build a culture of continuous improvement
Annually updated checklists and recurring peer inspections keep your team learning, aligned to best practice and improving year after year, not just compliant once.
Grow revenue and reputation
Higher trust attracts higher-value work: complex testing, long-term contracts and premium partners. Quality becomes a growth engine, not just a cost.
Turn CAP accreditation into a clinical-trial business
Clinical trials demand the highest, internationally recognized quality standards. CAP accreditation positions your laboratory as a trusted, high-end partner for pharmaceutical sponsors and contract research organizations (CROs) and opens a high-value, recurring revenue stream alongside your routine diagnostics.
Partner with top pharmaceutical manufacturers
Global pharma companies and CROs place central-lab and biomarker work only with laboratories they can trust. A CAP mark puts your lab on their shortlist.
Position as a high-end laboratory
CAP accreditation signals the top tier of laboratory medicine and instantly elevates how sponsors, regulators and referring labs perceive your organization.
Meet data-integrity and regulatory expectations
CAP requirements align with the rigorous documentation, traceability and quality-control standards that clinical-trial and regulatory work (including GCP/GCLP and FDA-driven studies) demand.
Extend and diversify your business
Clinical-trial testing adds a high-value, recurring revenue stream alongside routine diagnostics. It reduces dependence on any single market and smooths demand.
The accreditation process
Technical evaluation
Review of the laboratory’s quality management system and documentation.
On-site assessment
An on-site inspection verifies the quality and competence of methods, equipment and personnel.
Regular audits
Recurring audits ensure continued compliance and ongoing improvement throughout the accreditation cycle.
Discipline-specific checklists
CAP checklists cover the entire laboratory spectrum, from management to the bench, and form a common basis across teams. They are full of proven practices and drive learning and quality improvement.
Does accreditation fix internal QC by itself?
No. In the 2025 Great Global QC Survey by Westgard QC, 29 % of ISO 15189 laboratories and 44 % of US CLIA laboratories were out of control every day or several times a day, and more than 15 % of the ISO laboratories regularly overrode failed QC runs. An accreditation sets the framework; how control limits are chosen and how failures are handled is still up to the laboratory, and it is exactly what inspectors look at.
- • Control limits from your own mean and SD, not the manufacturer's range
- • Troubleshooting before a failed control is repeated
- • A documented override log with reasons
- • Measurement uncertainty for every quantitative test
Our readiness assessment includes these points. More background: internal QC rules, limits and survey results, what ISO 15189 assessors check first and ISO 15189, CAP or CLIA: does accreditation improve QC? · Source: Westgard QC, 2025 Great Global QC Survey: ISO and CLIA labs
Every PT/EQA round is a chance to learn
A CAP PT/EQA case is examined like a patient sample and then compared with the intended result and the peer group. In anatomic pathology, cytopathology and molecular pathology the CAP adds educational and competency programs. Participate and claim CME credit for pathologists and CE credit for laboratory staff.
More: how CAP EQA trains the laboratory team · EQA in histopathology and IHC
Frequently asked questions
The most common questions laboratories ask before starting their CAP accreditation journey.
What does CAP accreditation mean?
The CAP’s accreditation programs for laboratories of all lab disciplines rely on the CAP’s own extremely detailed quality norms, developed by its expert membership over more than 60 years. The Laboratory Accreditation Program (CAP LAP) is built on discipline-specific checklists, inspects the whole pre-analytical, analytical and post-analytical process and runs in a two-year cycle, with a self-inspection in the interim year.
Who can apply for CAP accreditation?
Any medical or clinical laboratory (hospital-based, independent/reference, physician office, academic, public health, veterinary or clinical-trial laboratories) can pursue CAP accreditation, regardless of size or country. Laboratories outside the US and Canada first complete at least 6 months of CAP proficiency testing; accredited laboratories already work in 60 countries.
Do we need proficiency testing (PT) before accreditation?
Yes. Laboratories outside the US and Canada must participate in a CAP Proficiency Testing (PT) / External Quality Assessment (EQA) program for at least 6 months before they become eligible for CAP accreditation. It demonstrates readiness and a genuine commitment to quality.
What does a CAP inspection actually involve?
A peer inspection carried out by practising laboratory professionals, using the general checklists plus the discipline checklists (21 by discipline) that match your exact test menu. It reviews the pre-analytical, analytical and post-analytical phases: how your methods, equipment and staff really perform at the bench. It is a constructive, educational review, not a one-way audit.
How long does it take to become accredited?
Timelines vary with the size of the lab and how mature your quality management system already is. Together with the mandatory 6-month proficiency testing (PT) period, most laboratories plan for several months of preparation. Our readiness assessment helps you see exactly where you stand and what is still needed.
How is accreditation maintained over time?
CAP accreditation runs on a recurring cycle. After the initial on-site assessment, regular audits and re-inspections ensure continued compliance and ongoing improvement. They keep your quality system current with checklists updated every year with input from 25+ scientific committees. Proficiency testing continues throughout the cycle, so performance is measured between inspections as well.
Is CAP accreditation recognized internationally?
Yes. CAP accreditation is a globally recognized gold standard, held by laboratories in 60 countries and referenced by healthcare systems, regulators and pharmaceutical partners. The CAP proficiency testing programme, the largest worldwide, has more than 23,000 participating laboratories in 100+ participating countries, so results are comparable across borders.
How does KombiMED support our laboratory?
As the official distributor of CAP PT/EQA programs for most countries in Central Asia and the Caucasus region, KombiMED GmbH guides you end to end: from a structured readiness assessment (7 topics, 41 questions) and proficiency testing (PT) enrolment to equipment from 68+ brands, consumables and preparation for the inspection, so you reach accreditation with confidence.
Can pathologists and laboratory staff earn CME or CE credit through CAP programs?
Yes. The CAP’s educational programs in anatomic pathology and cytopathology (for example the Performance Improvement Program in Surgical Pathology, Nongynecologic Cytopathology Education, PAP Education and digital slide programs) carry CME credit for pathologists and, for many, CE credit for laboratory staff. Every PT/EQA round becomes a training case. Whether the credit counts toward a national licence is decided by each country’s licensing body.
Does CAP or ISO 15189 accreditation automatically improve internal QC?
Not by itself. In the 2025 Great Global QC Survey (Westgard QC), 29 % of ISO 15189 laboratories and 44 % of CLIA laboratories were out of control every day. Accreditation defines the framework; the laboratory still has to set sensible control limits, troubleshoot before repeating controls and document overrides. These are the points inspectors check.
Download the CAP brochures
The official CAP International Accreditation brochure (Phase 2), available in German and Russian.
Start your CAP accreditation journey
Complete the CAP Accreditation Questionnaire and receive a structured readiness summary as a downloadable PDF, or talk directly with a KombiMED CAP specialist about your laboratory’s path to accreditation.
No vendor obligations · Structured readiness PDF · Support from the official CAP PT/EQA distributor