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ISO 13485 Lead Auditor Practitioner Qualification

ISO 13485 Lead Auditor Practitioner Qualification

Level Practitioner Duration 5.5 days
Available to book: Virtual instructor led training Book now
BSI Qualifications Guide

Download the qualifications guide (PDF) for more information.

This first step on your auditor qualification journey is designed for senior management, regulatory affairs or quality managers, internal and external auditors with a need to understand the full requirements of the ISO 13485:2016 Quality Management System (QMS) standard. You’ll learn everything you need to become a Lead Auditor Practitioner, including how to manage an audit programme, how to apply risk-based thinking, and how to show leadership. 

Expert BSI trainers will guide you on your learning journey and show you how to identify the aims and benefits of an ISO 13485:2016 QMS audit. You’ll also learn how to monitor supply chains to achieve continuous improvement, and how to develop safe and effective medical devices. 

How will you benefit?

  • In-depth understanding of how the ISO 13485:2016 interacts with the ISO 9001:2015  
  • Discover ways to increase efficiency and cost savings via quality management 
  • Learn how to build stakeholder confidence by understanding the up-to-date requirements 
  • Gain formal recognition of your knowledge and learn how to directly apply your skills in your organization 
  • Contribute to your career progression and unlock access to a wider range of higher-level and more advanced specialized qualifications 
  • Engage with a global community of fellow 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 Lead 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 Lead Auditor (5 Days classroom – in-person or virtual) 

    • Gain the skills to plan, conduct, report and follow up an audit in accordance with ISO 19011 
    • Identify the purpose and benefits of an ISO 13485:2016 QMS 
    • Explain the role of an auditor in planning, conducting, reporting and following up an audit in accordance with ISO 19011 (and ISO 17021 where appropriate)     

    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 interested in conducting first-party, second-party, and/or third-party audits 
    • Management representatives 
    • Quality directors, managers, and engineers 
    • Consultants 
  • ISO-13485-Lead-Auditor-Professional-mark-of-trust-logo-En-GB-0820.jpg

    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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