- Search BSI
- Verify a Certificate
For those with some existing knowledge of the ISO 13485:2016, undertaking this first step on the auditor qualification pathway will boost your understanding and skills to help you fully grasp and comply with the standard as an Internal Auditor Practitioner. Guided by expert BSI trainers, you’ll learn how to write comprehensive audit reports in line with ISO 13485:2016 Quality Management System (QMS) and discover how the standard helps global alignment for Medical Device QMS.
Whether you’re a member of senior management, a regulatory affairs or quality manager, internal or external auditor, you can help everyone in your organization to fully understand the importance of the standard and how to identify the key differences from the ISO 9001:2015.
On successful completion of your qualification, you’ll receive a BSI Mark of Trust that can be shared across within your organization and across your network of contacts.
ISO 13485 Internal Auditor Practitioner qualification includes:
ISO 13485:2016 Requirements
ISO 13485:2016 Internal Auditor (2 days classroom – in-person or virtual)
Each module is followed by a mandatory online multiple-choice examination. Delegates must pass the examination to be awarded the qualification.
We are:
After completing your Practitioner level qualification, why not undertake the next step and become an ISO 13485 Internal Auditor Professional qualification holder. Professional level takes you beyond conformity audits and develops your ability to audit improvement initiatives.
The focus of this advanced qualification is to expand upon process improvement approaches that can help strengthen and improve your organization’s quality management system.
The final step on the Auditor qualification pathway provides the opportunity to get your Professional Auditor qualification certified. Demonstrating that you have applied everything that you have learned in practice and in your work.
Reach out and see how we can help guide you on your path to sustainable operational success.