Although the ISO 15189:2022 and US Clinical Laboratory Improvement Amendments (CLIA) can be comparable regarding laboratory conditions to perform human testing, they are not the same. The specific regulations for medical laboratories to comply with CLIA are found in the FDA 42 CFR Part 493. Certification to the ISO 15189:2022 does not meet the FDA 42 CFR Part 493 requirements and cannot replace a CLIA certification in the US market.