ISO 13485:2016 Understanding & Internal Audit Training

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TERMINAL OBJECTIVES

By the end of the training, participants will be able to:

  1. Understand and interpret the ISO 13485:2016 requirements.
  2. Apply ISO 19011 principles in internal auditing processes.
  3. Conduct and report effective internal audits in compliance with ISO 13485:2016.
  4. Identify, classify, and grade audit findings to improve management systems and performance.
  5. Implement corrective and preventive action processes based on audit outcomes.

SESSION OBJECTIVES

At the end of the presentation participants should be able to do the following:

  1. Explain the purpose and scope of ISO 13485:2016.
  2. Interpret each clause of ISO 13485:2016.
  3. Apply audit principles based on ISO 19011.
  4. Conduct internal audits, including evidence gathering and staff interviews.
  5. Prepare reports and implement findings to enhance compliance and performance.

 

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