ISO/IEC 17025:2017 Lead Auditor Training

Master the skills to plan, lead, and report on ISO/IEC 17025 laboratory management system audits. Self-paced online training with real-world video demonstrations and comprehensive audit resources.

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About This Course

Duration: 40 hours

ISO/IEC 17025 is the internationally recognized standard for testing and calibration laboratories. Accreditation to this standard demonstrates technical competence and generates confidence in test and calibration results. Skilled lead auditors are essential to verify that laboratory management systems meet these rigorous requirements.

This online Lead Auditor training prepares you to fulfill that critical role. You will learn how to interpret ISO/IEC 17025:2017 requirements, plan and lead audits, evaluate technical and management system elements, and manage audit teams. Through a structured curriculum combining theoretical knowledge with practical video demonstrations, you will develop the competence to conduct first-party, second-party, and third-party laboratory audits.

The course is delivered entirely online and is self-paced, allowing you to progress through the material according to your own schedule. Upon successful completion, you will receive a certificate documenting your training as an ISO/IEC 17025 Lead Auditor.

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What Makes an Effective Lab Lead Auditor

An effective lead auditor understands both management system requirements and technical laboratory operations. A competent ISO/IEC 17025 lead auditor must be able to:

  • Interpret ISO/IEC 17025 requirements including management requirements and technical requirements for testing/calibration
  • Plan and prepare audits by coordinating with the auditee, assigning auditors, and developing checklists
  • Evaluate competence of personnel and assess the validity of test and calibration methods
  • Assess measurement traceability and uncertainty and verify equipment calibration programs
  • Apply risk-based thinking to laboratory processes and identify areas for improvement
  • Lead audit teams and communicate findings effectively to laboratory management

This course develops these capabilities through structured lessons, video demonstrations of actual audit situations, and practical resources you can apply immediately.

Course Content

The training is organized into nine focused sessions that build your knowledge progressively. Sessions include:

  • Audio-visual lectures:  Each session includes narrated presentations that explain concepts clearly.
  • Video demonstrations:  Real-world videos showing opening meetings, audit interviews, and closing meetings.
  • Session assessments:  Each session concludes with a quiz to confirm understanding before progressing.

Session 1:  Awareness of ISO/IEC 17025:2017

An introduction to the ISO/IEC 17025 standard – its purpose, scope, and importance for testing and calibration laboratories. Understand what accreditation means and why it matters.

What you'll learn:  The role of ISO/IEC 17025 in demonstrating laboratory competence and supporting global acceptance of results.

Session 2:  ISO 17025:2017 Lab Accreditation Process

Examination of the steps necessary to implement an ISO/IEC 17025 Laboratory Management System and achieve accreditation. Learn about the application process, assessment stages, and ongoing surveillance.

What you'll learn:  The pathway to laboratory accreditation and the auditor's role in that process.

Session 3:  Requirements of ISO/IEC 17025:2017 Laboratory Management System

A comprehensive clause-by-clause review of the standard. You will examine both management requirements (organization, QMS, document control, improvement) and technical requirements (personnel, methods, equipment, traceability, reporting).

What you'll learn:  Detailed understanding of all ISO/IEC 17025 requirements and how to evaluate conformity during an audit.

Session 4:  Documented Information for ISO/IEC 17025:2017

A focused examination of documented information requirements specific to laboratories. Learn the practical differences between management system documents and technical records.

What you'll learn:  How to audit document control systems in a laboratory environment and verify proper documentation practices.

Session 5:  Risk-Based Approach in ISO/IEC 17025:2017

ISO/IEC 17025:2017 emphasizes risk-based thinking and preventive action. This session explains how laboratories identify risks to impartiality, validity of results, and operational stability - and how auditors evaluate these controls.

What you'll learn:  How to assess a laboratory's risk management processes and identify gaps in risk-based thinking.

Session 6:  ISO/IEC 17025:2017 Audit Process

This session introduces the complete audit cycle based on ISO 19011:2018 guidelines. Includes a video demonstration of an auditor conducting an opening meeting in a laboratory setting.

What you'll learn:  How to plan audits, conduct opening meetings, and manage the audit process from start to finish.

Session 7:  Audit Terms, Definitions & Roles and Responsibilities

Clear understanding of audit terminology is essential for professional communication. This session defines key terms and explains the distinct roles within an audit team.

What you'll learn:  Professional audit vocabulary and the responsibilities of each audit team role.

Session 8:  Performing an Audit based on ISO/IEC 17025:2017

Practical demonstration of audit execution through video examples. Observe effective questioning techniques in a laboratory context and learn how to gather objective evidence. Includes a sample LMS manual for document review practice.

What you'll learn:  Practical techniques for conducting audit interviews in laboratories and evaluating technical documentation.

Session 9:  Nonconformity and Corrective Action

Identifying a nonconformity is only the first step. Learn how to classify findings appropriately, write clear nonconformity statements, and evaluate the adequacy of proposed corrective actions. Includes a video demonstration of a closing meeting.

What you'll learn:  How to classify findings, write effective nonconformity statements, and conduct professional closing meetings.

Course Materials

The course provides comprehensive resources that support learning and serve as valuable references:

  • Handouts:  100+ pages of downloadable PDF materials covering all nine sessions.
  • Sample LMS manual:  A practical example of a laboratory management system manual for document review practice.
  • Audit checklist:  400+ audit questions organized by ISO/IEC 17025 clause and laboratory department.
  • Video demonstrations:  Real-world videos of opening meetings, audit interviews, and closing meetings in laboratory settings.

Who Should Take This Course

This training is designed for individuals who need to lead or participate in laboratory management system audits. Typical participants include:

  • Staff appointed to lead ISO/IEC 17025 audits, manage audit teams, or oversee the laboratory's audit program
  • Laboratory directors, quality managers, and management representatives responsible for maintaining accreditation
  • Individuals preparing for third-party auditor roles with accreditation bodies
  • Consultants and compliance executives who advise laboratories on ISO/IEC 17025 implementation and accreditation

The course is also suitable for anyone intending to perform audits conforming to ISO/IEC 17025 requirements.

Examination

The training program includes nine session exams and a comprehensive final examination. The assessments are in multiple-choice format, without time constraint, and open book. To pass, you need a score of 60% or higher. If you do not pass on your first attempt, you may retake any exam at no additional charge.

Certificate of Completion

Graduates receive a Certificate of Completion bearing the Exemplar Global accreditation mark. This certificate documents successful completion of ISO/IEC 17025 Lead Auditor training and the final examination.

Certificate ISO/IEC 17025:2017 Lead Auditor Training

Certificates are issued in digital format upon passing the final examination. You may download, add to LinkedIn, and print your certificate directly from your course dashboard.

What's Included

Complete course access including dashboard login, downloadable handouts, and certificate.

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Self-paced learning – complete the 40 hours of content on your schedule.

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Instructor access and technical support whenever you need assistance.

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30-Day Money-Back Guarantee – enroll risk-free.

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Instant access after enrollment with 3 months to complete.

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Learn on any device – Windows, Mac, iOS, or Android.

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Average Rating: 4.4 (304 ratings)

Reviewer Rating 5 Stars

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Jonas Schmidt

Canada
Reviewer Rating 4 Stars15 June 2025

I appreciated the emphasis on impartiality and PDCA application in lab settings. The modules were concise and clear, though I’d have liked more interactive simulations ...

Isabella Russo

Canada
Reviewer Rating 4 Stars30 May 2025

The factual breakdown of the standard’s structure was very helpful—I now understand where uncertainty, records, and PDCA fit. A couple of lessons could use slower ...

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Frequently Asked Questions

How long do I have access to the course materials?

Once enrolled, you have 3 months access to the course content (can be extended upon request). During this time you can complete the training at your own pace and return to review materials whenever you need to refresh your knowledge.

Course access ends upon successfully completing the final exam.

What's the difference between ISO 17025 Auditor and Lead Auditor training?

Auditor training prepares you to participate in internal audits as a team member, covering audit fundamentals and techniques.

Lead Auditor training covers additional competencies required to plan audits, lead audit teams, manage audit programs, and communicate findings to management.

Lead Auditor certification is typically required for third-party auditors and those managing internal audit programs.

Does this course include real audit video examples?

Yes. This course includes video tutorials with real-time examples of ISO/IEC 17025 audits, including demonstrations of opening meetings, audit interviews, and closing meetings. This is one of the first e-learning courses to include such practical video content.

Can I use the audit checklists in my own laboratory?

Yes. The 400+ question audit checklist provided with the course is designed to be a practical tool that you can customize and use for internal audits within your laboratory or for client assessments.

What are the prerequisites for this course?

Knowledge of quality management systems and the PDCA cycle is helpful. A diploma or bachelor's degree and some laboratory experience are advantageous but not mandatory. Ability to understand English is required.

Can I try this course before buying it?

While we don't have a sample version available, you can try the entire course without risk! Your purchase includes our comprehensive 30-Day Money-Back Guarantee.

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