Course Overview

The ISO/IEC 17025: Testing and Calibration Laboratories Lead Auditor course provides participants with the knowledge and skills required to audit the quality management systems of testing and calibration laboratories. This standard is crucial for laboratories seeking accreditation and aiming to ensure that their testing, sampling, and calibration services are reliable and meet the international quality and competence requirements.

With the recent updates to ISO/IEC 17025 (in alignment with ISO 9001), this course includes the latest changes and advancements in the laboratory and accreditation processes, covering technology, technical requirements, and IT developments. Participants will learn the audit process, as well as how to assess the effectiveness and compliance of laboratory operations, ensuring that the laboratory consistently delivers accurate and reliable results.

Who is ISO/IEC 17025 for?

ISO/IEC 17025 is designed for:

• Testing Laboratories: Any laboratory performing testing, including those in industries like pharmaceuticals, food safety, environmental testing, and more.
• Calibration Laboratories: Laboratories involved in calibration, ensuring measurement instruments are accurate and precise.
• Universities and Research Centres: Institutions performing testing or calibration as part of their research work.
• Governments and Regulatory Bodies: Organizations that perform regulatory testing or inspection.
• Inspection and Certification Bodies: Bodies performing conformity assessments that require testing or calibration services.

It is also relevant to any organization, government agency, or laboratory aiming for accreditation or looking to improve their testing and calibration services.

Why Has ISO/IEC 17025 Been Revised?

The ISO/IEC 17025 revision, which was published in 2017, updated the previous 2005 version to keep pace with changing market conditions, technology advancements, and evolving international requirements. The key updates in this revision include:

• Technical Changes: The new version includes revised technical requirements, ensuring that laboratories are using the most up-to-date methods and techniques.
• Updated Vocabulary: To better reflect modern practices and language in laboratory management and operations.
• Advances in IT Techniques: Incorporating newer technologies that impact laboratory practices and improve efficiency and precision.
• Alignment with ISO 9001: The revision aligns ISO/IEC 17025 with the structure and principles of ISO 9001:2015 to improve integration with broader quality management systems.

Course Benefits

• Global Recognition: Gain internationally recognized certification in ISO/IEC 17025 auditing, improving your credibility and career prospects.
• Increased Competence: Develop the ability to conduct effective audits in testing and calibration laboratories, ensuring they meet accreditation standards.
• Practical Auditing Skills: Learn to assess compliance, identify gaps, and recommend corrective actions in laboratory systems and operations.
• Stay Current with Industry Standards: Stay up-to-date with the most recent changes to ISO/IEC 17025, including updates related to technology and IT.
• Improved Laboratory Operations: Help laboratories improve their operations, ensuring they deliver accurate, reliable, and competent results.

Learning Outcomes

By completing this course, participants will be able to:

• Understand the core principles of ISO/IEC 17025 and its applicability to testing and calibration laboratories.
• Learn the updated requirements of the ISO/IEC 17025:2017 revision and how to apply them in audits.
• Conduct audits to assess a laboratory’s compliance with ISO/IEC 17025, identifying areas for improvement.
• Lead audit teams effectively and provide valuable feedback on corrective actions.
• Evaluate laboratory equipment, methods, and staff competence in line with ISO/IEC 17025 standards.
• Support laboratories in achieving and maintaining ISO/IEC 17025 accreditation.

Course Content Overview

1. Introduction to ISO/IEC 17025
   • Understanding ISO/IEC 17025 and its importance in ensuring accuracy and reliability in testing and calibration.
   • Overview of the structure and key clauses of the standard.
2. ISO/IEC 17025 Requirements
   • Detailed examination of the technical and management requirements for testing and calibration laboratories.
   • Key areas: competence of personnel, equipment calibration, testing methods, and environmental conditions.
3. ISO/IEC 17025:2017 Changes
   • Review of the revisions in the new version of the standard.
   • Changes related to the alignment with ISO 9001, IT developments, and technical requirements.
4. Planning the Audit
   • Techniques for creating an audit plan tailored to ISO/IEC 17025.
   • Preparing audit criteria, scope, and objectives.
5. Conducting the Audit
   • Gathering objective evidence and evaluating laboratory processes.
   • Evaluating personnel competence, equipment calibration, and testing procedures.
   • Managing the audit team and ensuring an effective audit process.
6. Reporting and Non-Conformities
   • Identifying non-conformities and areas of improvement.
   • Reporting audit findings in a clear and actionable manner.
   • Formulating corrective actions and supporting laboratories in implementing improvements.
7. Achieving Accreditation
   • Understanding the process of achieving ISO/IEC 17025 accreditation.
   • Steps for maintaining ongoing compliance and quality assurance.
8. Case Studies and Practical Exercises
   • Real-world scenarios and role-playing exercises to practice auditing techniques.
   • Learning how to assess a laboratory's competency and compliance with ISO/IEC 17025.

Career Pathways

• Laboratory Auditor: Conduct audits of testing and calibration laboratories, ensuring compliance with ISO/IEC 17025.
• Quality Manager: Oversee quality assurance in laboratories, ensuring processes and procedures align with ISO/IEC 17025 standards.
• Laboratory Consultant: Provide consultancy services to laboratories seeking ISO/IEC 17025 accreditation or looking to improve their processes.
• Accreditation Manager: Manage the accreditation process and maintain ISO/IEC 17025 certification for testing and calibration laboratories.

Why Choose Us?

• Experienced Trainers: Learn from experts with real-world experience in laboratory auditing and quality management.
• Comprehensive Curriculum: Receive detailed course materials covering every aspect of ISO/IEC 17025 and auditing.
• Global Certification: Obtain an internationally recognized certification that can advance your career.
• Interactive Learning: Participate in practical exercises and case studies, helping you to apply your knowledge in real-world scenarios.
• Ongoing Support: Receive post-course assistance to help you apply your new skills in your professional work.

Ensure your laboratory operations meet international standards—enroll in the ISO/IEC 17025 Lead Auditor course today and take your career to the next level.