ISO 13485 Internal Auditor Training

Introduction to the ISO 13485 Internal Auditor Course

The ISO 13485 Internal Auditor Course equips participants with the skills and knowledge to conduct internal (first-party) audits of a medical-device quality management system in adherence to ISO 13485 within their own organisation, and to help prepare it for external certification. Delivered by seasoned experts in quality management and auditing through EAS, IAS's sister organisation, the course integrates interactive activities, case studies, and practical examples, and leads to a course-completion certificate.

Course Content

The curriculum combines ISO 13485 requirements with the internal-audit discipline of ISO 19011:

• The structure of ISO 13485 and its alignment with medical-device regulatory requirements.
• Quality management system and documentation, including the medical device file (Clause 4).
• Management responsibility and resource management (Clauses 5–6).
• Product realization — design and development controls, purchasing, production and service provision, cleanliness and sterile-device requirements, identification and traceability, and validation of processes (Clause 7).
• Risk management applied across the QMS, aligned with ISO 14971.
• Measurement, analysis and improvement — complaint handling, reporting to regulatory authorities, internal audit, control of nonconforming product, and corrective and preventive action (CAPA) (Clause 8).
• The internal audit process per ISO 19011 — planning, conducting, evidence, nonconformities, reporting, and follow-up.

Benefits of ISO 13485 Internal Auditor Training

Delivery Formats for ISO 13485 Internal Auditor Training

Assessment and Certification

Upon completing the course, participants take an examination provided by IAS, requiring a minimum passing score of 70% to receive the ISO 13485 Internal Auditor course-completion certificate. To learn more, contact IAS.