Internal audits for auditors in the medical device industry according to ISO 13485

• You will learn to successfully carry out the mandatory audits in the medical device industry.
• As an internal auditor for medical devices, you make a contribution to process improvement through effective audits.
• You can guarantee the required product safety of your medical devices through internal audits.
• You will get to know communication techniques for successful audits.

• Legal and standard parameters (ISO 13485:2016, characteristics of the standards concerning audit requirements, EU regulations)
• Conducting audits as per ISO 19011:2018
• Significance of internal audits
• Requirements of the internal auditors
• Overview of the various audit types
• Frequency of internal audits
• Planning audits
• Preparing audits in a practice-oriented manner
  • Which areas will be audited?
  • Audit questions
  • Audit process
  • Audit documentation

• Performing the audit (incl. initial and wrap-up meeting)
• Communication in the audit team and audited parties
• Follow-up and evaluation of audit results
• Corrective action determination and tracking
• Case studies and, if applicable, role playing

• Manufacturer and operator of medical devices
• Managers and specialists from the medical device industry who want to work as auditors
• Internal auditors who want to expand their knowledge
• Senior staff from quality management
• Quality management representative
• Product manager, project manager, employee quality affairs and regulatory affairs

• The seminar deals with internationally valid standards and is also suitable for implementation abroad.
• This seminar is part of the modular training for the I. and II. Party Process Auditor Medical Devices.

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