← Policy & Regulation-Standards & approvals (all topics)

NABL/CAP accreditation

Policy & Regulation · Standards & approvals

What it is

Quality accreditation for diagnostic laboratories. NABL, under the Quality Council of India, certifies testing competence to ISO 15189; CAP, run by the US College of American Pathologists, is the stricter international standard used by reference and oncology labs

Both require documented processes, proficiency testing and periodic reassessment, and cover the lab rather than the organisation

Impact on industries

  • The main structural moat in a fragmented market - only ~3% of Indian labs are NABL-accredited, so accreditation separates chains from the standalone tail
  • Increasingly a commercial gate: insurers require it for empanelment and corporate health contracts mandate accredited reports, closing off unaccredited labs
  • CAP accreditation at a reference lab underpins entry into oncology, esoteric and clinical trial testing, the highest-margin work available
  • Cost and process discipline are hard for small labs, and accreditation is concentrated in the South and West, which hold ~58% of approved labs

Industries affected