BRIEF INFORMATION

This two-day intensive training course enables participants to gain the knowledge and skills necessary for planning and conducting internal audits of Quality Management System (QMS) for compliance with the requirements of ISO 13485 and in accordance with the recommendations of ISO 19011. Participants should know standard requirements or prior to participating in this course attend the training course “Development and Implementation of the QMS based on ISO 13485”

 TARGET AUDIENCE

  • Personnel and specialists of the companies responsible for internal audits of QMS

THE PROGRAM OF THE TRAINING COURSE

  • Introduction
  • Terms and definitions
  • Auditor skills and qualification
  • Development and implementation of the Internal Audit Program on the Management System
  • Auxiliary internal audit tools
  • Preparation for audit
  • Audit
  • Follow-up activities
  • 8 assignments, knowledge testing
  • Written exam on ISO 13485 and ISO 19011