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COLA’s Status and Responsibilities as an ISO 15189 Accreditation Body
COLA is authorized to evaluate laboratories based on the requirements of the ISO 15189 standard. Any laboratory that wants to earn ISO 15189 accreditation must purchase the most recent version of the standard.
Our ISO 15189 Program team includes assessors and support staff with at least six years of laboratory experience. All assessors receive in-depth, ongoing training to ensure accurate and consistent assessments.
COLA’s Responsibilities as an Accreditation Body
• Impartiality Policy – View Policy
• Confidentiality Policy – View Policy
COLA upholds the principles of impartiality and confidentiality in all accreditation activities, ensuring that decisions are made objectively and with integrity.
Funding and Fees for the ISO 15189 Accreditation Program
COLA charges fees for participation in the ISO 15189 Accreditation Program. These fees cover the application process, initial assessments, surveillance assessments, reapproval assessments, any extraordinary assessments and associated travel costs.
Additional Services and Products Offered by COLA
In addition to ISO 15189 accreditation, COLA provides a variety of services to support clinical laboratories, including:
• CLIA-Equivalent Accreditation Program
• Third-Party Review Services for the FDA
• Educational Products and Services
International Recognition
COLA is proud to be an Associate Member of the Inter-American Accreditation Cooperation (IAAC), reflecting our commitment to maintaining internationally recognized accreditation practices.
COLA’s ISO 15189 Accreditation Process:
Accreditation Scheme – View Document
As an accreditation body, COLA fully complies with all requirements of ISO 17011 Standard. This ensures that our ISO 15189 Accreditation Program operates with impartiality, confidentiality and a commitment to the highest standards of quality.
Application of ISO 15189:2022 Requirements
COLA’s ISO 15189 Assessors apply a patient-focused and risk-based approach. Each assessment emphasizes how laboratory operations affect patient care, quality and safety.
Rights and Responsibilities of Laboratories
Laboratories accredited under ISO 15189 must ensure that patients’ well-being, safety, and rights are the primary considerations in all laboratory activities.
Accredited laboratories also have the right to:
• Lodge complaints against COLA
• Appeal decisions made by COLA’s ISO Accreditation Board
Complaints and Appeals
• Complaint Process – View Document
• Appeals Process – View Document
COLA provides transparent and fair procedures for laboratories or individuals to submit complaints or appeals related to accreditation decisions, investigations or sanctions.
Use of the COLA Accreditation Symbol and Certificate
• Policy on Use of Accreditation Symbol and Claims of Accreditation – View Policy
This policy defines the proper and authorized use of COLA’s accreditation symbol and certificate by accredited laboratories.