Medical Devices-Quality Management Systems Auditor/Lead Auditor Course (ISO 13485 & EN ISO 13485)-IRCA Certified Course (A17579)

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.

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

Do you already have a good knowledge of ISO 13485:2016?

If not, we highly recommend you take our ISO 13485:2016 Clause by Clause training course first as there are particular requirements you need to understand before you can be an auditor.

"We are proud to have the standard. It gives us enormous credibility with our potential customer base and with that credibility we give them confidence."

What will I learn?

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

  • Gain the skills to plan, conduct, report and follow up an audit in accordance with ISO 19011
  • Identify the purpose and benefits of an ISO 13485:2016 QMS
  • Explain the role of an auditor to plan, conduct, report and follow up an audit in accordance with ISO 19011 (and ISO 17021 where appropriate).

What are the benefits?

  • Benefit from effective ISO 13485 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 through CPD and build your customer base.






What is included?

  • Refreshments
  • Lunch 
  • Training course notes
  • Pen