Glossary

ISO 17025

What is ISO 17025?

ISO/IEC 17025 is the international standard that specifies the general requirements for the competence of testing and calibration laboratories. It outlines the necessary criteria for laboratories to demonstrate their ability to produce valid and reliable test and calibration results. The standard encompasses both management and technical requirements, ensuring that laboratories operate consistently and effectively, thereby enhancing the quality of their outputs. ISO/IEC 17025 is crucial for laboratories seeking accreditation, as it establishes a framework for quality management and technical competence in various sectors, including environmental, medical, and industrial testing.

What are the benefits of ISO 17025 in pharma?

ISO/IEC 17025 provides several key benefits for pharmaceutical laboratories:

  • Compliance Assurance: ISO 17025 accreditation helps pharmaceutical labs ensure they remain compliant with regulatory requirements and legislation. It evidences adherence to safety requirements, satisfying authorities and customers.
  • Reputation and Credibility Boost: As an internationally recognized standard, ISO 17025 accreditation boosts a lab’s reputation and demonstrates the reliability of its testing, measurement, and calibration to stakeholders. This global acceptance facilitates international trade.
  • Performance Guideline: ISO 17025 provides guidelines that ensure continued competency and data quality. Clients can trust the accuracy and reliability of results produced by an ISO 17025 accredited lab.
  • Increased Business: ISO 17025 accreditation gives labs a competitive advantage and opens opportunities internationally. Clients are assured of a reliable, properly conducted process.