Lead Auditor: ISO 13485:2016

This course teaches the key principles and practices of effective quality management system audits in accordance with ISO 13485:2016 and ISO 19011, “Guidelines for auditing management systems”. Experienced instructors guide students through the entire audit process, from managing an audit programme to reporting on audit results. Participants will gain the knowledge and skills to plan, conduct, report and follow up a QMS audit that establishes conformity and enhances overall organizational performance.

As a prerequisite, this course requires knowledge of both ISO 9001:2015 and ISO 13485:2016. If you need to improve your knowledge in either of these subjects, we recommend the ISO 9001:2015 Requirements training course and the Introduction to ISO 13485:2016 training course.

This course is certified by the International Register of Certificated Auditors (IRCA).


Who should attend?

  • Medical device quality professionals interested in conducting first-party, second-party, and/or third-party audits
  • Management representatives
  • Quality directors, managers, and engineers
  • Consultants
  • Regulatory Affairs Managers
  • Internal and external Auditors
  • Anyone involved in implementing and/or auditing quality management systems for medical devices

Learning objectives

On completion of this training, participants will be able to:

  • Interpret the requirements of ISO 13485:2016 in the context of an audit
  • Describe the purpose of a quality management system and explain the 8 principles of quality management
  • Explain the role of an auditor to plan, conduct, report and follow up a quality management system audit in accordance with ISO 19011
  • Plan, conduct, report and follow-up on a QMS audit in accordance with ISO 19011 and by interpreting ISO 13485:2016
  • Manage the duties of a lead auditor in their organization or for a third-party

Course Benefits

  • Benefit from effective ISO 13485:2016 audits and compliance
  • Maintain and improve quality standards with regular audits
  • Be confident that your organisation can rely on ISO certified lead auditors 
  • Increase credibility and competitive advantage
  • Motivate employees and build your customer base
  • Meet training requirements for IRCA certification

Next Steps

  • Introduction to: CE Marking training course - Gain an introduction to the Medical Device Directives and understand their background and key features. On completion of this course, you'll be able to make informed decisions on meeting the requirements of medical device directives, identify the steps required to reduce the risks in the regulatory process and bring products to the EU market much quicker
  • Medical Devices Risk Management: ISO 14971 training course - Our ISO 14971 risk management training is an essential element for all medical device manufacturers. You will learn how to identify, evaluate and control risks associated with medical devices throughout the product lifecycle, helping you implement a risk management framework to achieve ongoing compliance.