Quality standards and guidelines for test validation for infectious diseases in veterinary laboratories

Area of Science:

• Veterinary Diagnostics
• Laboratory Quality Management
• Animal Health Surveillance

Background:

• The World Organisation for Animal Health Manual outlines veterinary laboratory governance and quality management.
• Current standards are based on ISO/IEC 17025:2005, requiring an update for modern diagnostic needs.

Purpose of the Study:

• To provide an updated overview of standards and regulatory bodies for veterinary laboratory accreditation.
• To highlight key considerations for designing and maintaining quality management systems (QMS) based on ISO/IEC 17025:2017.
• To emphasize the importance of test validation, verification, and measurement uncertainty in QMS.

Main Methods:

• Review and update of relevant international standards and regulatory frameworks for laboratory accreditation.
• Analysis of ISO/IEC 17025:2017 requirements for testing and calibration laboratories.
• Discussion of critical QMS components including test validation, measurement uncertainty, and quality control.

Main Results:

• ISO/IEC 17025:2017 provides updated requirements for laboratory competence and QMS.
• Effective QMS design encompasses staff, structure, processes, and procedures.
• Accreditation necessitates independent assessment, validated tests, proficient staff, and ongoing quality control.

Conclusions:

• Accreditation ensures technically valid diagnostic results through standardized processes and peer review.
• A robust QMS, aligned with ISO/IEC 17025:2017, is crucial for meeting diverse stakeholder needs in animal health.
• Implementing updated standards enhances laboratory competency and reliability for animal health decision-making.