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ISO 15189 — Medical Laboratory Accreditation Consulting
ISO 15189 is the international standard for quality and competence in medical laboratories. In the US, accreditation pathways include ANAB, A2LA, and CAP 15189.
Important Regulatory Disclosure
ISO 15189 accreditation is not recognized by the FDA as equivalent to CLIA certification under 42 CFR Part 493. US laboratories must maintain CLIA certification independently. Exceleor’s consulting scope addresses ISO 15189 accreditation readiness only.
What Exceleor Will Offer
ISO 15189 Gap Assessment
ISO 15189 Implementation Consulting
ISO 15189 Internal Auditor Training
Status
Developing this offering. Accepting inquiries now.
Ready to Achieve ISO Certification?
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Free initial consultation
Custom implementation roadmap
Transparent pricing
Guaranteed audit success