Certifications

CLIA

CLIA

Committed to the highest standards of Quality & Safety

At GenoSUR, we are committed to providing the highest standards of quality testing in our state-of-the-art laboratory in Miami, Florida. We offer exceptional services to healthcare professionals, researchers, and patients. Our team of experienced scientists provides the depth of expertise to meet all your testing needs regardless of project complexity.

GenoSUR is a high complexity CLIA laboratory and is licensed in the state of Florida.

The Clinical Laboratory Improvement Amendments (CLIA) program ensures quality laboratory testing that is accurate, reliable, and timely. CLIA labs are subject to inspections and are overseen by federal regulatory agencies including the FDA, the Centers for Medicare & Medicaid Services (CMS), and the Centers for Disease Control & Prevention (CDC). In the U.S., any testing that yields results to determine patient treatment or eligibility to a clinical trial must be conducted in a CLIA laboratory.

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Grupo

ISO 13485:2016

World-Class quality management systems

GenoSUR is focused on maintaining world-class quality management systems (QMS) and has achieved the International Organization for Standards (ISO) 13485:2016 for its Quality Management Systems. This certification reflects our risk-based approach to design, development, and production and is evidence of our commitment to consistently meet customer expectations and regulatory requirements.

Achieving ISO 13485:2016 also demonstrates our commitment to products and services of the highest standards for quality, performance, consistency, and reliability.

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ISO 9001:2015

ISO 9001:2015

Quality is our guiding principle

GenoSUR has also met the requirements of the International Organization for Standards (ISO) 9001:2015, an achievement that translates to improved efficiency and cost savings for customers. Achieving ISO 9001:20015 demonstrates our ability to consistently provide products and services that meet customer and regulatory requirements and aims to enhance customer satisfaction through an effective system.

Acquiring this certification exemplifies that quality is our guiding principle and assures customers that we are a qualified and trusted partner.

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COLA

COLA

Efficiency, compliance, and positive impact on patient care

GenoSUR is committed to quality and patient care. That’s why the company has maintained accreditation in a wide range of programs. GenoSUR’s clinical lab in Miami, Florida is COLA-certified.

COLA, Inc. is an independent nonprofit education and accreditation organization that helps clinical laboratories stay in compliance with federal CLIA (Clinical Laboratory Improvement Amendments) and state regulatory requirements. Having a COLA certification means that a lab is also recognized by the Joint Commission, a U.S.-based nonprofit that accredits domestic and international healthcare organizations and programs.

COLA accreditation is for core lab specialties such as chemistry, immunology, microbiology, and others.

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