ICTQual ISO/IEC 17025:2017(en) Testing and Calibration Laboratories Lead Auditor

Learning Outcomes for the Study Units:

Introduction to ISO/IEC 17025:2017 Standard

• Understand the structure, scope, and objectives of ISO/IEC 17025:2017.
• Explain the importance of laboratory accreditation in global quality assurance.
• Recognise the changes introduced in the 2017 version compared to earlier editions.
• Identify the key clauses and requirements of the standard.
• Develop awareness of how ISO/IEC 17025:2017 supports laboratory credibility and trust.
• Link laboratory standards to customer confidence and international recognition.

Principles of Quality Management Systems in Laboratories

• Apply quality management principles specific to laboratory environments.
• Recognise the relationship between quality management and laboratory performance.
• Implement policies and procedures to maintain consistency and reliability in results.
• Evaluate how continual improvement impacts laboratory effectiveness.
• Identify risks and opportunities that affect quality systems.
• Integrate QMS principles into routine laboratory activities.

Requirements for Competence of Personnel

• Define the knowledge, skills, and behaviour required for competent laboratory personnel.
• Assess competency frameworks for technical staff.
• Link personnel competence to laboratory reliability and accuracy.
• Develop systems for monitoring and evaluating staff competence.
• Understand the role of training and ongoing professional development.
• Apply best practices in ensuring impartiality and integrity of laboratory personnel.

Equipment and Measurement Traceability

• Explain the importance of calibration and maintenance of laboratory equipment.
• Understand measurement traceability and its role in reliable results.
• Implement procedures for equipment verification and validation.
• Recognise international standards for calibration and measurement traceability.
• Manage records and documentation related to equipment use.
• Apply preventive maintenance practices to reduce errors and downtime.

Testing and Calibration Procedures

• Identify requirements for valid and reliable testing and calibration methods.
• Evaluate laboratory procedures against ISO/IEC 17025:2017 requirements.
• Implement validation processes for testing and calibration methods.
• Ensure proper sampling techniques and environmental controls.
• Develop documentation and reporting practices for laboratory procedures.
• Apply technical judgment to resolve challenges in testing and calibration.

Quality Assurance Practices

• Recognise the importance of internal quality control in laboratory work.
• Apply quality assurance procedures to ensure accurate testing outcomes.
• Evaluate inter-laboratory comparisons and proficiency testing.
• Develop corrective and preventive actions for identified issues.
• Implement risk-based approaches in laboratory quality assurance.
• Monitor and improve performance through regular reviews and audits.

Audit Planning and Preparation

• Understand the principles of planning an audit in accordance with ISO/IEC 17025:2017.
• Define objectives, scope, and criteria for laboratory audits.
• Prepare audit checklists and relevant documentation.
• Identify key risks and focus areas during audit planning.
• Schedule audits effectively while minimising disruption to laboratory operations.
• Communicate audit plans with laboratory management and staff.

Conducting Audit Activities

• Apply audit techniques such as interviews, observation, and document review.
• Assess laboratory compliance with ISO/IEC 17025:2017 requirements.
• Identify nonconformities and gather supporting evidence.
• Demonstrate professional behaviour, impartiality, and integrity during audits.
• Report findings clearly and constructively to laboratory management.
• Recommend corrective actions and follow-up processes to ensure compliance.