Medical Devices - Quality Management Systems Auditor/Lead Auditor Training Course (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.

IRCA Certified Course (A18190)


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 transition and Auditor Refresher 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).

How will I benefit?

  • Identify the aims and benefits of an ISO 13485:2016 audit
  • Interpret ISO 13485:2016 requirements for audit application
  • Plan, conduct and follow-up auditing activities that add real value
  • Grasp the application of risk-based thinking, leadership and process management
  • Access the latest auditor techniques and identify appropriate use
  • Build stakeholder confidence by managing processes in line with the latest requirements
  • Understand the arrangements for BSI certification

What's included?

  • Training course notes
  • Lunch & refreshments
  • Loan copy of the standard (to be returned after the course)
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