Register for ISO 13485 Standard Internal Auditing

This course provides fundamental knowledge of the concept of auditing, its scope, and procedures, as well as the skills and qualifications to function as an internal auditor in accordance with the ISO 13485:2016 standard within your own organization. The training is conducted in two parts. The intermediate assignment involves conducting an audit exercise in your own organization. Basic knowledge of the ISO 13485:2016 standard is required to participate in the training. The training includes small-group discussions and interactive exercises using various tools.

Topics - Training Day 1

• Introductions and training objectives
• Basic concepts and procedures of quality and auditing
• ISO standard concepts and documentation requirements
• Internal audit process and requirements
• Planning, executing, and reporting internal audits
• Review of example cases
• Instructions for the intermediate assignment (audit exercise)

Topics - Training Day 2

• Review of intermediate assignments
• Observations, nonconformities, and evidence in internal audits
• Special characteristics of auditing subcontractors
• EU legislation (MDR 2017/745 and IVDR 2017/746) requirements for the quality management system
• Review of example cases
• Internal audit and quality management tools