CAP 15189 is a process management approach to running your laboratory. It is a CAP program that provides accreditation to ISO 15189, an international quality standard for medical laboratories.

“This program helps laboratories sustain the progress they’ve made in their Lean and Six Sigma Projects” Caroline Maurer CAP 15189 Director

CAP 15189 builds on the gold standard technical requirements of the CAP Laboratory Accreditation Program. However, it makes additional requirements of the quality management system, including the following:

• Demonstrated understanding of processes and their interactions (Process mapping)
• Designated quality manager
• Periodic review of the quality management system (Management review)
• Quality manual summarizing the quality management system
• Expansion of quality policy into quality objectives and corresponding metrics
• Review of service agreements
• Evaluation of referral laboratories and suppliers
• Internal audits
• PT for all tests
• Demonstrated continuous process improvement

CAP 15189 is available to US-based medical laboratories. Laboratories applying to CAP 15189 must be CAP accredited by the CAP’s Laboratory Accreditation Program.

ISO 15189 accreditation is voluntary in the United States.

CAP 15189 will help your organization:

• Sustain the progress you’ve made in your Lean and Six Sigma projects
• Improve patient care
• Mitigate risk
• Optimize performance
• Provide validation of an integrated quality management system throughout all parts of your organization that interact with the medical laboratory

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