ISO 17511 is officially titled:
“In vitro diagnostic medical devices — Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples”
This standard outlines the requirements and procedures that IVD manufacturers and clinical laboratories must follow to ensure that:
It applies to qualitative and quantitative measurements, particularly in clinical chemistry, immunology, hematology, and molecular diagnostics.
Inconsistent or untraceable results across different labs or devices can lead to:
ISO 17511 addresses these concerns by providing a structured method for ensuring that all measured values—whether for cholesterol, glucose, hormones, or infectious markers—are traceable to a reliable reference system.
Implementing ISO 17511 in your laboratory or IVD manufacturing process offers multiple scientific, operational, and compliance-related benefits:
Ensure that results are linked to national or international reference materials and procedures.
Enable result comparability between instruments, manufacturers, and labs.
Follow globally accepted processes for assigning values to calibrators and control materials.
Provide reliable results that clinicians can trust for diagnosis and treatment.
Build traceability into your quality assurance programs.
When implemented with GMC’s consulting expertise, ISO 17511 strengthens your organization’s market position and regulatory readiness:
Align with requirements from EU IVDR, US FDA, WHO, and other global health bodies.
Enhance compliance with broader quality and competency standards.
Build credibility with clinicians, regulators, and patients.
Avoid delays in IVD certification or laboratory accreditation.
Ensure measurement systems are traceable, validated, and stable.
Meet harmonized international requirements for IVD devices and clinical labs.
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