CAP 15189^SM Accreditation Program

The College of American Pathologists (CAP) CAP15189 is a quality management program that provides the following services:

• Readiness and advisory services through its QMAP program
• Online education courses on quality management systems through its Quality Management Education (QMEd) Resources
• Accreditation to ISO 15189, an international quality standard for medical laboratories

CAP 15189 will help you reduce risk, optimize performance, lower costs, and provide your customers with proof of an integrated quality management system throughout all parts of your organization that interact with the medical laboratory.

Program Benefits

Confidence

• The CAP's expertise of the ISO 15189 standards extends beyond the standard alone, through CAP pathologist participation in its creation and interpretation.
• CAP15189 relies on highly experienced assessors with practical knowledge of medical laboratory testing and ISO quality management systems auditing.

Competitive Advantage

• Elevate your prestige in the marketplace by leveraging your established partnership with CAP, the global leader in accreditation.
• Improve customer satisfaction and attract and retain business through confidence in your laboratory’s quality management processes.

Effective Resource Utilization

• Build on existing high-quality laboratory processes achieved through the CAP's Laboratory Accreditation Program (LAP).
• Align with proven quality framework models such as LEAN and Six Sigma to further optimize performance and operational efficiency gains.
• Watch a preview of the QMEd course on Root Cause Analysis.
• Access our Root Cause Analysis Poster (11" x 17") (PDF)
• Access our Mistake Proofing Poster (11" x 17") (PDF)
• Access our Quality Culture Poster (11" x 17") (PDF)
• Access Document Control Poster (17" x 22") (PDF)
• Access our Internal Auditing Poster (12" x 18") (PDF)

How Does CAP15189 Differ From the CAP Laboratory Accreditation Program?

CAP15189 and LAP are uniquely positioned to complement one another.

This balance leverages the assurance of accurate patient diagnosis achieved through technical requirements of LAP with the CAP15189's rigorous focus on sustainable quality management processes for all areas of an organization for which the laboratory interacts.

Eligibility Requirements

• Accreditation to ISO 15189 through the CAP is available to all US- and Canadian-based medical laboratories who are accredited by the CAP's LAP.
• ISO 15189 is voluntary in the United States.
• Accreditation to ISO 15189 through the CAP is available to international laboratories under certain conditions. Contact cap15189@cap.org for more information.
• Information about our international programs is available in the international laboratory section.

Case Examples

Discover how other pathologists and organizations benefit from the CAP 15189 program.

• ARUP Attains Hard-Earned ISO Accreditation (PDF)
• Henry Ford: Using ISO 15189 to Change Patient Care for the Better (PDF)
• ProMedica: Getting to the Root of the Problem (PDF)

CAP 15189 Frequently Asked Questions

Our ISO 15189 Frequently Asked Questions document provides more detailed information about the distinctions about the program.

Find a CAP15189 accredited laboratory.

Additional Resources

• Program Policies (PDF)
• Logo Guidelines (PDF)
• Risk Management Guide (PDF)
• Measurement Uncertainty Guide (PDF)
• MU Calculation Tool (Excel)

Purchase Standards

• IHS Standards Store