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ISO 13485:2016 – Operational management of the quality system

This course provides a practical interpretation of ISO 13485 requirements applied to the daily management of the Quality System.

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 practical interpretation of ISO 13485 requirements applied to the daily management of the Quality System. It focuses on process integration, functional responsibilities, and maintaining compliance over time, with particular attention to audits and inspections.

Key Points

  • ISO 13485 operational quality system management

  • Process integration and functional responsibilities

  • Maintaining compliance over time

  • Audits and inspections focus

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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