PR 369 ISO 13485:2016 Auditor/Lead Auditor Training Course

Yes, this is a CQI-IRCA Certified Lead Auditor programme under Course ID 17584. The course is designed to build and verify your competence to audit a complete Medical Device Quality Management System, known as QMS, against ISO 13485:2016. It also includes formal assessment requirements aligned with Auditor and Lead Auditor expectations.

This course is intended for professionals who need to audit a complete Medical Device Quality Management System against the requirements of ISO 13485:2016. It is particularly suitable for learners involved in second-party audits, such as customer or supplier audits, and third-party audits, including certification-focused audit activities. It is also suitable for those preparing to work in these audit environments. As this is a five-day intensive training programme with practical audit activities and a final examination, it is best suited to learners who are ready for a more advanced and demanding level of auditor training.

Yes, before registering for this course, you should already be familiar with the requirements of ISO 13485:2016, or you should have completed ISO 13485 QMS Fundamentals training beforehand. This background knowledge is required because it provides the essential foundation needed for Auditor and Lead Auditor training. It also helps ensure that you can fully engage with the full audit lifecycle activities covered during the course, including planning, conducting audits, reporting audit results, and following up on audit outcomes.

This course is the right level if your goal is to develop the competence to perform and lead audits of a complete Medical Device QMS, rather than simply understand the standard requirements. The course is structured around the full audit lifecycle, including planning, conducting, reporting, and follow-up. If you are new to ISO 13485:2016, then a Fundamentals course would be the best starting point before progressing to Lead Auditor training.

The delivery format for your course will be confirmed at the time of registration. If your cohort is delivered virtually, the training will take place on the Zoom platform, and you will receive the relevant joining instructions, access details, and platform guidance in advance. To participate effectively, you will need a stable internet connection and a laptop, desktop, iPad, or other tablet device that supports the required platform, together with working audio and an active web camera.

The course is practical and skills-focused, not just theory-based. It includes consultant-facilitated activities and follows a structured audit approach aligned with the ISO 19011 audit lifecycle. There is also strong emphasis on audit tools, audit techniques, auditor behaviours, and the responsibilities expected of a Lead Auditor.

Yes, learners complete a facilitated audit covering the full audit lifecycle. During this practical audit work, learners apply audit planning, evidence gathering, findings development, and reporting methods in practice. Competence is developed and verified through structured course activities and applied audit work.

Yes, the course includes a final written Medical Device QMS Lead Auditor examination. The exam forms part of the formal assessment requirements for successful course completion. Successful completion of both the course and examination supports achievement of the programme outcome in line with CQI-IRCA requirements.

After completing the course, you will be able to plan, conduct, report, and follow up audits of a complete Medical Device QMS against ISO 13485:2016. You will also be able to apply the ISO 19011 audit lifecycle across different medical device QMS audit scenarios in a structured and professional manner. In addition, you will be able to deliver evidence-based audit findings and conclusions that support QMS effectiveness, conformity, product safety, and product effectiveness.

This Lead Auditor course focuses on auditing a complete Medical Device QMS through a structured, facilitated audit approach. It places strong emphasis on consistent interpretation of ISO 13485:2016 requirements, together with the evaluation of process effectiveness, regulatory expectations, and product safety and effectiveness. The course also provides practical development of auditor tools, techniques, behaviours, and the leadership capability expected of professional Lead Auditors.

An ISO 13485 Internal Auditor course focuses on auditing an organization’s own medical device quality management system and is typically focused on the organization’s product or process, while an ISO 13485 Lead Auditor course develops the advanced skills needed to lead audit teams, plan and conduct management system audits, manage audit activities, evaluate findings, and report audit results against all the ISO 13485:2016 requirements.

An ISO 13485 Lead Auditor course provides practical knowledge of audit principles, planning, preparation, execution, evidence collection, interviewing, documenting nonconformities, reporting, and follow-up. It helps participants develop the audit and social skills required to lead systematic and effective audits of medical device quality management systems.

An ISO 13485:2016 Lead Auditor course typically covers an overview of the structure and requirements of ISO 13485:2016, and more fully the audit principles, audit program management, audit planning including risks/opportunities, audit team management, audit meetings, collecting and evaluating objective evidence, identifying and documenting nonconformities, audit communication, audit reporting, corrective actions, and audit follow-up activities.

Yes. The ISO 13485 Lead Auditor course is suitable for professionals involved in auditing or managing medical device quality management systems, including internal auditors, quality professionals, regulatory and compliance personnel, consultants, and professionals working with medical device manufacturers, suppliers, importers/distributors, authorized representatives and service organizations.

Completing an ISO 13485 Lead Auditor course can strengthen your qualifications for roles involving quality management system auditing, supplier audits, internal audits, regulatory compliance, quality assurance, and medical device quality management. The training can also support professionals who want to develop their capabilities in leading ISO 13485 and regulatory affairs audits.