ISO13485:2016 Foundation

About Training

Belgium, Brussels Crown Plaza
2 days
1100 €

What is an ISO 13485 Foundation Course?

A highly interactive ISO 13485 foundation training course that is designed to give delegates a sound knowledge of the requirements of ISO 13485 and the fundamentals of a medical device management system.

Other levels of the course plan (Lead Implementer, Auditer) are available on request. Just ask us.

Who should attend?

  • People new to ISO looking to gain the knowledge of the clauses of ISO 13485
  • Those who already work as an auditor, but need a refresher
  • Those looking to attend an auditing course, but do not have the necessary prior knowledge
  • ISO 13485 specifically requires that staff are trained and competent, this course satisfies this requirement.

What will you learn?

A detailed understanding of:

  • Differences & similarities between ISO13485:2016 & ISO9001:2015
  • Management system principles 
  • Management system structures 
  • Quality terminology relating to medical devices
  • Interpreting the requirements of the ISO 13485: 2016 Standard
  • The Process Approach
  • Continual Improvement




50.8553653, 4.3605573

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