What is the difference between GLP and ISO?

The key difference between GLP (Good Laboratory Practice) and ISO standards lies in their purpose, scope, and regulatory application. GLP is a legally recognized framework that governs how non-clinical laboratory studies are conducted, ensuring that data generated for regulatory submissions (such as safety or toxicology studies) are reliable, traceable, and reproducible. It is typically enforced by government agencies such as the EMA, FDA, or OECD member states.

In contrast, ISO (International Organization for Standardization) standards — such as ISO 9001 for quality management or ISO 17025 for testing laboratories — are voluntary certifications that demonstrate an organization’s commitment to consistent quality processes and technical competence. While ISO focuses on the overall management system and customer satisfaction, GLP emphasizes the integrity of scientific data and strict adherence to study protocols. Many laboratories operate under both frameworks: ISO ensures operational excellence, while GLP guarantees regulatory credibility. In short, ISO certifies how you manage quality, and GLP validates how you produce scientifically defensible results.