ISO 13485:2016 Medical Device Quality Management System Auditor Refresher Training Course

Are you an existing auditor with knowledge of ISO 13485 wishing to update your audit programme in line with ISO 13485:2016? This course will refresh your auditing techniques, allowing you to prepare to audit against requirements.

With a transition period of 3 years, it’s important to get up to speed so you can ensure your organization is ready to comply with new requirements. Through audit scenarios, you’ll identify opportunities for improvement and build on your reporting skills.  


Who should attend?

Anyone involved in auditing an ISO 13485:2016 QMS, including Quality Managers, Consultants and Internal/Lead Auditors.

What will I learn?

You will learn about:

  • Auditing techniques to refresh your skills
  • Audit principles, practices and terminology
  • Changes to the requirements and their impact from an auditing perspective
  • Developing an internal audit schedule and planHow these changes may impact your current QMS.

How will I benefit?

  • Make a smooth transition to ISO 13485:2016
  • Refresh your auditing techniques
  • Conduct effective audits against the requirements of ISO 13485:2016
  • Update your knowledge of audit principles, practices and terminology
  • Gain further confidence and recognition in your role as auditorParticipate in audit workshop scenarios to apply the skills you’ve learnt.

What is included?

This training course is HRDF approved under the SBL scheme.

On completion, you will be awarded an internationally recognized BSI Training Academy certificate.