ISO 13485:2016 / EN 13485:2012 – Internal Auditor Training

ISO 13485:2016 / EN 13485:2012 is the internationally recognized standard for quality management systems in the medical equipment industry. With this training you will understand the ISO 13485:2016 / EN 13485:2012 standard and how to perform internal audits based on ISO 19011 and prepare your audit management system.

Why choose ISO 13485:2016 / EN 13485:2012 internal auditor training from SGS?

Our course can help you:

• Gain an overview of the ISO 13485:2016 / EN 13485:2012 standard
• Learn how conduct audits
• Plan and prepare internal audits
• Write factual reports on the compliance of the management system against the audit standards

ISO 13485:2016 / EN 13485:2012 internal auditor training from the SGS Academy, one of Brazil’s leading training providers

Our three-day (24 hour) training covers:

• An overview of ISO 13485:2016 / EN 13485:2012 requirements
• Structure, concepts, and documentation requirements
• Introduction to the history and development of quality management systems
• Quality assurance
• Basic concepts and definitions
• Introduction to NBR 19011
• Types of audit
• Steps and conducting internal audits and supplier audits
• Audit reports
• Closure

The certificates will only be issued to participants who attend at least 80% of the training and achieve a pass mark of 70% in the final examination.

To find out more about the ISO 13485:2016 / EN 13485:2012 internal auditor training, please contact us today.