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ISO 13485 Quality Systems Audit – Methodology and operational practice according to ISO 13485

This course provides a structured and practical overview of the internal audit process for medical device quality systems, in accordance with ISO 13485 and ISO 19011.

This course belongs to the “Quality System & Process Excellence” line.

Contact our team if you would like a complete training package covering all related topics, or to request a tailored solution.

Abstract

This course provides a structured and practical overview of the internal audit process for medical device quality systems, in accordance with ISO 13485 and ISO 19011. It focuses on the preparation, execution, and management of internal audits, with emphasis on evidence collection, non-conformities, and follow-up actions.

Key Points

  • ISO 13485 internal audit process

  • Preparation, execution, and management

  • Evidence collection and non-conformities

  • Follow-up actions

Structure

8-hour course.

Live streaming or on-site at your company, based on your needs.

Would you like to host this course at your company?

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