ISO 13485 Internal Auditor Training

Complete our Internal Auditor ISO 13485 Training Course to guarantee the highest quality standards and remove barriers to market for medical devices in your business. Gain the necessary auditing skills to confidently guide your organization towards ISO 13485 accreditation – an essential standard for all medical device manufacturers.

ISO 13485 outlines quality management system requirements for design, development, production and servicing of medical devices and related services. Get to grips with the entire internal auditing process, learn to plan audits, report on results and lead on follow up action


Who should attend?

  • Medical device quality professionals with knowledge of quality management systems and ISO 13485
  • Individuals interested in conducting first-party or second-party audits
  • Management representatives
  • Internal auditors
  • Managers
  • Consultants

This training course is HRDF approved under the SBL scheme

What will I learn?

  • Explain the structure and scope of ISO 13485 management system standard and how it applies to the organization aiming for regulatory compliance worldwide
  • Identify the principles of auditing and auditor responsibilities
  • Plan an internal audit
  • Conduct informal opening and closing meetings
  • Conduct an audit based on process identification, sampling and questioning
  • Provide verbal and written feedback
  • Document concise nonconformities
  • Effectively report on an audit
  • Follow-up on corrective actions

How will I benefit?

  • Be better able to continue compliance with ISO 13485
  • Maintain and improve a global benchmark in quality standards 
  • Be confident that your organization can rely on ISO certified internal auditors
  • Motivate colleagues through CPD and build customer confidence.

What does the fee cover?

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