Experiences in transitioning a testing laboratoryto the new ISO/IEC 17025:2017 standard

Area of Science:

• Laboratory quality management
• Accreditation standards
• Radiation safety

Background:

• The international standard ISO/IEC 17025 has undergone revisions, with the latest edition (2017) introducing a new structure, harmonized terminology, and risk-based thinking.
• Accreditation to ISO/IEC 17025 is crucial for demonstrating laboratory competence and ensuring the reliability of measurement results.

Purpose of the Study:

• To disseminate the experience of the IAEA Radiation Safety Technical Services Laboratory in transitioning to and achieving re-accreditation under ISO/IEC 17025:2017.
• To outline the key stages and methodologies involved in the transition process.
• To highlight lessons learned regarding operational resilience and business continuity.

Main Methods:

• Conducting a gap analysis of the existing quality system against ISO/IEC 17025:2017 requirements.
• Updating quality documentation, including policies and procedures.
• Developing and implementing training and communication plans for laboratory personnel.
• Monitoring system changes through internal audits and management reviews.
• Participating in proficiency testing schemes to validate performance.

Main Results:

• Successful transition and re-accreditation to ISO/IEC 17025:2017.
• Implementation of risk-based thinking within the laboratory's quality management system.
• Enhanced operational resilience and a strengthened business continuity management system.
• Improved laboratory personnel understanding and adherence to the revised standard.

Conclusions:

• The transition to ISO/IEC 17025:2017 requires a systematic approach encompassing gap analysis, documentation updates, personnel training, and continuous monitoring.
• Adopting a risk-based approach and focusing on business continuity are essential for maintaining laboratory operations during disruptions.
• The experience provides a valuable framework for other laboratories seeking to meet the updated international quality standard.