The Course

This I-RAB Certified Auditor training course is based on the ISO 13485 QMS standard, to provide international recognition for auditors who conduct information security management system audits.

This course is intended to provide participants with a basic understanding of the ISO 13485:2016 requirements and how to interpret them, as well as the benefits of implementing a medical device quality management system.

Participants will be able to understand the various modules of a QMS during this training course, including QMS policy, procedures, performance measurements, management commitment, internal audit, management review, and continuous improvement.

Certification 

This course includes a two-hour written test.

Using the I-RAB methods of continuous assessment and evaluation, participants must demonstrate that they have met the learning and enabling objectives.

Who should attend?

• The ISO 13485 Lead Auditor training course is geared towards:
• Auditors who want to perform and manage ISO 13485 audits
• Technical experts who want to prepare for ISO 13485 and MDD audit
• Managers who want to specialize in the ISO 13485 and MDD audit process
• Persons responsible for maintaining compliance with ISO 13485 and MDD requirements in an organization
• Expert advisors in anti-bribery management

Prerequisites

You should have a good knowledge of ISO 13485:2016 and the basic principles of a QMS.

If not, we recommend that you attend the I-RAB ISO 13485:2016 Basic Training.