ISO 13485 Internal Auditor Practitioner Qualification

Level Practitioner Duration 4 days

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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.

How will you benefit?

Gain the knowledge you need to find ways to increase efficiency and cost savings in your organization
Learn how to develop safe and effective medical devices
Understand how to conduct an effective audit based on process identification, sampling, and questioning
Achieve formal recognition of your knowledge and ability to directly apply your skills in your organization
Continue advancing your career progression and get access to a wider range of higher-level and more advanced specialized qualifications
Enter a global community of qualified professionals to share experiences and practical advice to use in your everyday life

Which qualification will I achieve?

On successful completion of your qualification, you’ll receive a BSI Mark of Trust that can be shared within your organization and across your network of contacts.

ISO 13485 Internal Auditor Practitioner qualification includes:

ISO 13485:2016 Clause by Clause (2 days classroom – in-person or virtual)
- Gain an appreciation for the origins of ISO 13485
- Understand the use of ISO 13485 as the basis for a Quality Management System for Medical Device organisations
- Gain awareness of the key differences to the ISO 9001:2015 standard
- Understand the process approach concept of the standard and the Plan-Do-Check-Act (PDCA) framework
- Learn the overall structure of ISO 13485:2016
- Recognize the key clauses of the ISO 13485:2016 standard
ISO 13485:2016 Internal Auditor (2 days classroom – in-person or virtual)
- Understand the structure and scope of ISO 13485:2016 and how it applies to the organization seeking regulatory compliance
- Identify the key principles of auditing and auditor responsibilities
- Plan an internal audit
- Conduct an effective audit based on process identification, sampling, and questioning
- Determine if corrective action has been effectively implemented
Each module is followed by a mandatory online multiple-choice examination. Delegates must pass the examination to be awarded the qualification.
- Medical device quality professionals with knowledge of quality management systems and ISO 13485:2016
- Individuals interested in conducting first-party or second-party audits
- Management representatives
- Internal auditors
- Consultants
We are:
- A full scope Notified Body
- A full scope UK Approved Body
- A national Standards Body
- An accredited ISO 13485 Certification Body
- A recognized Auditing Organization under the Medical Device Single Audit Program
- A globally recognized Certification Body

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