ISO 13485:2016 - Medical Devices Quality Management Systems - Internal Auditor Training Course

This intensive training aims to provide delegates with the skills required to conduct internal audits, using interactive training by medical device lead auditors experienced in ISO 13485 and Notified Body audits.

On training completion you will be able to:

• Understand the requirements of ISO 13485:2016, and the quality system requirements of Directives 93/42/EEC and 98/79/EC
• Know how to conduct internal quality system audits
• Understand the role of internal audits in the maintenance and improvement of management systems
• Plan and prepare for an internal audit
• Learn to gather evidence by observation, questioning and sampling
• Write factual reports on the compliance of the management system against the audit standards
• Participate in the corrective action process

The training comprises presentations, workshops and interactive role-play exercises with medical device lead auditors experienced in ISO 13485 and Notified Body audits.

Contact SGS now for more information on SGS ISO 13485 Internal Auditor Training.