ISO 13485:2016 Lead Auditor Course – Online & Self-Paced
✅ 100% Online & Self-Paced ISO 13485 Lead Auditor Training
✅ Start Immediately – No Booking Required
✅ Exemplar Global Recognised Training Provider
✅ Covers ISO 13485:2016 & ISO 19011:2026
✅ First, Second & Third-Party Audit Training
✅ Practical Audit Templates, Checklists & Resources Included
✅ Internationally Recognised Certificate
✅ No Prior Auditing Experience Required
About the ISO 13485 Lead Auditor Training Course
The ISO 13485 Lead Auditor Training Course provides the practical knowledge and auditing skills required to plan, conduct, report and follow up first, second and third-party audits of Medical Device Quality Management Systems (MD-QMS) against ISO 13485:2016. The course also covers auditing principles and guidance in accordance with ISO 19011.
Participants develop practical skills in audit planning, gathering and evaluating objective evidence, identifying audit findings, preparing audit reports and leading audit teams. The course is designed for professionals working with medical device quality management systems who want to develop their competence as ISO 13485 auditors and lead auditors.
Some of the ISO 13485 Audit Templates & Practical Resources Includedin this course:
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Explanation of ISO 13485 and workshops
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ISO 13485 audit checklist
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ISO 13485 documentation requirements
- ISO 14971:2019 Overview of structure and contents
- Clean room technologies and validation
- Biological evaluation of medical devices
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Process approach guide
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Risk management guide
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Risk-based thinking guide
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Sample audit plan
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Sample audit report
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Auditor meeting guide
Duration
Complete the course module by module at your own pace. The course is equivalent to 48 hours (six days full-time study)
Qualifications
- Exemplar Global – TL Management Systems Lead Auditors
- Exemplar Global – AU Auditing Management Systems – ISO 19011:2026
- Exemplar Global – QMS MD Quality Management Systems Medical Devices – ISO 13485:2016
Prerequisite
No prior experience in auditing and management systems is required.
Assessment
At the end of every module, you will take a short multiple-choice quiz which assesses your knowledge and understanding gained throughout the training. The quizzes are based on the topic that you have completed. Once you complete and submit the quiz, the scores are marked instantly by LMS TRG. The quizzes consist of questions with single answer and multiple answers. You can do the practice quiz as many times as you like until you pass.
Final Exam
Similar to the end-of-module quiz, the final quiz is shaped based on questions of single or multiple answers. To obtain your qualification, you will be required to pass the final exam. The final quiz questions are based on all the course modules. The score is marked instantly by LMS TRG. You can redo the final exam if you fail.
Course Structure
100% Online & Self-Paced ISO 13485 Lead Auditor Training
The course includes 17 comprehensive topics, with a knowledge quiz at the end of each topic to support learning and assess your understanding.
Topics:
- Introduction to ISO 13485 Lead Auditor Training
- Management Systems Fundamentals
- High-Level Structure (HLS) and ISO Management Systems
- ISO 13485:2016 Medical Device Quality Management Systems (MD-QMS)
- ISO 13485 Audit Fundamentals and Principles
- Management Systems Audit Cycle
- Audit Sampling and Objective Evidence
- Auditor Roles, Responsibilities and Competence
- ISO 13485 Audit Planning and Preparation
- Conducting an ISO 13485 Management System Audit
- Auditor Principles, Professional Behaviour and Ethics
- Leading Audit Teams, Team Management and Managing Audit Challenges
- Reading, Understanding and Evaluating Audit Evidence
- Identifying Audit Findings and Nonconformities
- Preparing ISO 13485 Audit Reports
- ISO 13485 Lead Auditor Practical Case Study
- Final ISO 13485 Lead Auditor Examination
Exemplar Global recognized certificate (formerly RABQSA).
Standards in this Course
ISO 19011:2026, ISO 13485:2016
Who Should Attend ISO 13485 Lead Auditor Training?
- Quality Managers and Quality Assurance professionals in the medical device industry
- Internal, supplier and external auditors
- Professionals seeking to develop ISO 13485 Lead Auditor competencies
- Regulatory Affairs and Compliance professionals
- Medical Device Quality Management System Managers and Coordinators
- ISO 13485 consultants
- Supplier Quality Engineers and Supplier Auditors
- Professionals responsible for ISO 13485 certification and compliance
- Individuals involved in first, second or third-party medical device QMS audits
Learning outcomes
- Understand the requirements of ISO 13485:2016
- Understand auditing principles and guidance applicable to management systems audits
- Plan and prepare first, second and third-party ISO 13485 audits
- Develop effective audit plans and checklists
- Gather and evaluate objective audit evidence
- Conduct audits of Medical Device Quality Management Systems
- Identify and report audit findings and nonconformities
- Lead and manage an audit team
- Conduct effective opening and closing meetings
- Prepare clear and effective audit reports
- Follow up audit findings and corrective actions
- Apply professional communication and auditor behaviours throughout an audit
Frequently Asked Questions
What is ISO 13485 Lead Auditor Training?
ISO 13485 Lead Auditor Training develops the knowledge and practical auditing skills required to plan, conduct, report and lead audits of Medical Device Quality Management Systems (MD-QMS) against ISO 13485:2016. It covers first, second and third-party auditing and the responsibilities of an audit team leader.
What does an ISO 13485 Lead Auditor do?
An ISO 13485 Lead Auditor plans and manages audits of Medical Device Quality Management Systems, coordinates audit teams, evaluates objective evidence, identifies audit findings and nonconformities, conducts opening and closing meetings, and prepares audit reports.
Who should complete an ISO 13485 Lead Auditor Course?
The course is suitable for quality managers, QA professionals, medical device professionals, regulatory affairs and compliance personnel, supplier quality professionals, internal auditors, consultants, management systems professionals and individuals seeking to develop ISO 13485 auditing and lead auditor skills.
What is the difference between an ISO 13485 Internal Auditor and Lead Auditor?
Internal Auditor training primarily focuses on conducting audits within an organisation. ISO 13485 Lead Auditor Training develops broader competencies for planning, managing and leading first, second and third-party management system audits, including managing audit teams and communicating audit results.
What types of audits can ISO 13485 Lead Auditor Training prepare me for?
The training develops skills applicable to first-party internal audits, second-party supplier audits and third-party management system audits. Additional competence, experience or certification requirements may apply depending on the organisation, certification body or auditing role.
Do I need previous ISO 13485 or auditing experience to enrol?
No prior auditing experience is required. The course builds knowledge of Medical Device Quality Management Systems and auditing principles before progressing to audit planning, conducting audits, evaluating evidence, reporting findings and leading audit activities.
What skills will I develop during ISO 13485 Lead Auditor Training?
You will develop practical skills in audit planning and preparation, audit sampling, gathering and evaluating objective evidence, interviewing, identifying nonconformities, reporting audit findings, conducting opening and closing meetings, managing audit teams and following up audit outcomes.
Is ISO 19011 relevant to ISO 13485 Lead Auditor Training?
Yes. ISO 19011 provides guidance on auditing management systems, including audit principles, managing audit programmes, conducting audits and auditor competence. These principles support the systematic approach used when auditing an ISO 13485 Medical Device Quality Management System.
How is ISO 14971 relevant to ISO 13485 and medical device auditing?
ISO 14971 provides a framework for risk management of medical devices. Understanding the relationship between risk management and ISO 13485 helps auditors evaluate how risk-based requirements and processes are addressed within a Medical Device Quality Management System.
Can ISO 13485 Lead Auditor Training help me become an external or third-party auditor?
The course develops important knowledge and lead auditor competencies relevant to external and third-party auditing. Certification bodies and other organisations may have additional requirements relating to industry experience, auditor qualifications, witnessed audits and demonstrated competence.
What is the role of a Lead Auditor when managing an ISO 13485 audit team?
The Lead Auditor coordinates the audit from planning through completion. Responsibilities may include allocating audit activities, communicating with the auditee, supporting the audit team, reviewing findings, resolving audit issues, conducting meetings and ensuring the audit report accurately reflects the audit conclusions.
Why is ISO 13485 Lead Auditor Training important for medical device professionals?
Effective auditing helps organisations evaluate whether their Medical Device Quality Management System is properly implemented and maintained. Lead Auditor Training develops the skills needed to assess conformity, identify weaknesses and support the effectiveness and continual improvement of the management system.
Testimonials
"First, I am thankful for this training as it increased my knowledge and expertise in my field of work. It gave me the opportunity to be more efficient as Auditor, thus provided more methods to be applied in my specialization. There are times that I have no access to the internet, but because of the study materials provided, I can still review offline . Moreover, the educators were utmost in support and approachable, making me feel secure in gaining knowledge. Lastly, I am hoping to have another opportunity for education from your training courses. Appreciate everything from you. Thank you very Much LMS TRG.“
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- Edmer
"Highly recommend courses from LMS TRG. Excellent course material with easy to understand templates and worksheets. The course contains very practical real world knowledge of audits without the added fluff. It is a goto training organisation for anyone who wants certification with maximum ease and professionalism. No time wastage on useless course material or unnecessary work. As a working professional it was easy for me to complete the course along side with work and gave me the insights needed to improve my work and helped me in upskilling. Great admin support with very quick response time. Will definitely come back for another course."
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- Preet
"An excellent, self-paced course with value for money. The presentations and courseware provided valuable tools for understanding and successfully completing the course."
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- Neil
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About LMS TRG
Based in Melbourne, Australia, LMS TRG provides practical ISO management systems training and compliance solutions to individuals and organisations worldwide. Our self-paced online courses are designed to help you build real-world auditing skills and gain internationally recognised qualifications.
We specialise in ISO management systems training, auditing and compliance, helping professionals and organisations implement, maintain and improve their management systems with confidence.
As an Exemplar Global Recognised Training Provider, LMS TRG delivers training that meets internationally recognised quality standards. We also work closely with our Certification Body partners to deliver auditor training, ensuring our courses reflect current industry practices and real-world auditing
