ISO 13485:2016  Internal Auditor Training

Course Content:

• Introduction to ISO 13485
• Eight Quality Management Principles
• The Process Approach
• ISO 13485 Quality Management System for Medical Devices
• ISO 13485:2016
• QMS / Internal Auditing
• Principles of Auditing
• Internal Audit Program
• Audit Team & Auditor Competence
• Audit Planning
• Audit Evidence & Questioning Techniques
• Audit Reporting & Follow Up

Overview Outcomes

• An overall understanding of ISO 13485:2016, including the relevant elements and clauses
• The knowledge of how to interpret these requirements
• An understanding of the process approach and how it relates to internal auditing.
• Knowledge of the theory and practice of internal auditing
• Understanding of audit planning and assessing auditor competence