ISO 13485:2016 Internal Auditor

Duration 2 days

Available to book: Virtual classroom View dates and book now

Make sure your medical devices make the grade as an ISO 13485 internal auditor.

Train with us and use your existing knowledge of medical devices quality management systems to help you organization maintain ISO 13485 compliance. Review what you know about the standard to broaden your understanding of ISO 13485 requirements.

Learn how to stay ahead of new industry developments and discover links between medical devices quality management and ISO 14971 medical device risk management.

And as an ISO 13485 internal auditor you can ensure your organization continually improves quality management.

This Online Course is available in English.

Please note: the price stated is excluding local taxes.

Auditor Qualifications

This course forms part of our Auditor Qualification programme. To find out more, please visit our training auditor qualifications page here.

Prerequisites

It is essential that you have knowledge and experience of the medical devices industry.

- Understand each stage and requirement of ISO 13485
- Know how to apply and assess quality management principles
- Plan, conduct and report on an ISO 13485 internal audit
- Get a basic understanding of ISO 14971 and its role
- Quality and regulatory affairs managers
- Those who want to carry out an ISO 13495 internal audit
- Those who want to improve ISO 13485 quality management
- Qualified ISO 13485 internal auditors within your business
- Identify and close performance gaps in quality management
- Ability to achieve and maintain ISO 13485 compliance
- Improve quality and customer confidence in standards

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