ISO 13485:2016 Internal Auditor

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  ISO 13485 Internal Auditor

  2 Days

You need this course if ...

  • you want to understand the best practices to conduct an effective internal QMS audit in accordance with the requirements of EN ISO 13485:2016 and ISO 19011:2011
  • you want to add value to your organisation 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 businesses manage their risks
  • the roles and responsibilities of an Internal Auditor
  • how to plan your audits and how to develop the effective checklists
  • how to carry out 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 report findings accurately, adding value to the business
  • what is corrective action and who is responsible for implementation
  • 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 …

  • to have successfully completed the ISO 13485:2016 Appreciation and Interpretation course

Your future development

  • ISO 13485:2016 Implementation
  • Tutored Audits (coached live audit at your company)
  • See our business improvement courses

Course length

  • Two days

Dates and Venues