Question 1

What is ISO 15189 certification?

Accepted Answer

ISO 15189 certification is a quality standard that verifies a laboratory or organization meets specific regulatory and operational requirements. For CROs, holding ISO 15189 certification demonstrates that their facilities, procedures, and staff comply with industry-recognized benchmarks for data integrity, safety, and scientific rigor required by regulatory agencies.

Question 2

Why is ISO 15189 certification important for CROs?

Accepted Answer

ISO 15189 certification is important because regulatory agencies often require data from ISO 15189-compliant facilities for drug approval submissions. Working with a ISO 15189-certified CRO reduces the risk of regulatory rejection, ensures study data meets quality standards, and gives sponsors confidence that the CRO's processes have been independently verified against established benchmarks.

Question 3

How do I verify a CRO's ISO 15189 certification status?

Accepted Answer

Request a copy of the CRO's current ISO 15189 certificate and check its validity dates. Cross-reference with the issuing body's public registry when available. During your qualification audit, review inspection reports, corrective action history, and any conditions placed on the certification. Ask for documentation of ongoing compliance activities such as internal audits and proficiency testing.

ISO 15189 Certified CROs

Covance Genomics Lab (LabCorp)