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ISO 13485 Internal Auditor Practitioner Qualification

ISO 13485 Internal Auditor Practitioner Qualification

Level Practitioner Duration 2.5 days
Available to book: Virtual instructor led training Request a quote
BSI Qualifications Guide

Download the qualifications guide (PDF) for more information.

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 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 across within your organization and across your network of contacts.  

  • ISO 13485 Internal Auditor Practitioner qualification includes:  


    ISO 13485:2016 Requirements

    • Gain an appreciation for the origins of ISO13485 
    • Understand the use of ISO13485 as the basis for a Quality Management System for Medical Device organisations  
    • Gain awareness of the key differences to the ISO9001:2015 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 
  • ISO-13485-Internal-Auditor-Professional-mark-of-trust-logo-En-GB-0820.png

    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.  

    Find out more here

  • ISO-13485-Internal-Auditor-Certified-Professional-mark-of-trust-logo-En-GB-0820.png

    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.  

    Find out more here

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