ISO 13485:2016 Internal Auditor

Course Content:

• Introduction & Course Objectives
• 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
• Q&A
• Conclude & Follow Up Process

On the course completion participants will have the following;

• 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

This ISO 13485:2016 Internal Auditor training programme may be beneficial to those responsible for audit program for ISO 13485:2016, for those who perform the audit, for Quality Assurance managers, ISO Project Managers, ISO Project Team Members and for Managers & Supervisors interested in deeper understanding of ISO 13485:2016 and its practical application.