ISO 15189 sets requirements for quality and competence in medical laboratories, with patient care at its center. Our compliance certification is an independent audit of your laboratory against ISO 15189:2022, with a USGSR Certificate of Compliance.
This is a compliance certification issued by US Global Standards Registrars. It is not medical laboratory accreditation and does not replace regulatory licensing (for example, CLIA certification in the United States). Where accreditation is required, it must be granted by an accreditation body, for example USIAS.
Key Requirements We Audit
| Clause | Topic |
|---|---|
| 4 | Impartiality, confidentiality, patient-related requirements |
| 5 | Structure, governance, risk management |
| 6 | Personnel, facilities, equipment, traceability, reagents |
| 7 | Pre-examination, examination, post-examination processes |
| 8 | Management system |
| Annex A | Point-of-care testing |
The Certification Process
- Application: share your scope, sites and headcount; we confirm the route and audit time.
- Proposal and agreement: written proposal and certification agreement.
- Stage 1 audit: documentation and readiness review.
- Stage 2 audit: on-site evaluation of implementation and effectiveness.
- Certification decision: made by a competent reviewer who was not on the audit.
- Surveillance and recertification: annual surveillance, recertification every three years.
FAQs
Is ISO 15189 compliance certification the same as accreditation?
No. Accreditation is granted by an accreditation body for a defined scope of examinations.
Does it replace CLIA in the US?
No. CLIA certification is a federal regulatory requirement.
Request a Quote
Tell us your scope, sites and headcount; we’ll confirm the route and audit days in writing. Request a Quote