ISO 13485:2016 Internal Auditor

Medical Devices Monitor ImageISO 13485:2016 Internal Auditor
Two Days

You need this course if ...

  • You want to understand the best practices to conduct an effective internal quality management system (QMS) audit in accordance with the requirements of ISO 13485:2016 and ISO 19011:2011
  • You want to add value to your organization and improve the effectiveness of the QMS

You will learn …

  • An overview of the ISO 13485 requirements 
  • The role management systems and internal audits play in helping business manage their risks
  • The roles and responsibilities of an Internal Auditor
  • How to plan your audits and how to develop effective checklists
  • How to carry out your effective audits using LRQA’s 6 Stage Approach
  • To gather objective evidence through observation, interviewing and sampling of documents
  • To evaluate audit findings and determine conformity, nonconformity and effectiveness
  • To prepare value adding reports and findings accurately
  • What corrective action is and who is responsible for taking action
  • How to follow up and verify the effectiveness of corrective action taken
  • How to address common internal audit weaknesses within the medical device industry

You will need …

Your future development

  • ISO 13485:2016 Implementation
  • ISO 13485:2016 Lead Auditor
  • Tutored Audits (coached live audit at your company)
  • Refer to LRQA’s Business Improvement courses

Course length

  • Two days

Contact us to learn more about ISO 13485:2016 training

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