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ISO 13485 Lead Auditor Course

  1. Language


  2. Duration

    30 hours

  3. CPE


  4. Course type

    Online self-paced + live online workshop

  1. Course benefits:

    • Improve your knowledge of auditing techniques
    • Learn how to lead audit teams
    • Add new skills to your resume and expand your business

    This ISO 13485 Lead Auditor training is accredited by ASIC and allows you to become a certification auditor for ISO 13485. The course was created to help you start working for certification bodies or expand your consulting

    After passing the exam, you will receive an ISO 13485 Lead Auditor certificate, accredited by ASIC, which proves your ability to perform certification audits and lead audit teams.

    The ISO 13485 Lead Auditor course is divided into three parts:

    1. A video library: includes lessons and practical information about the standard and how to prepare for the ISO 13485 audit, lead the audit team, perform the audit and prepare the final audit report
    2. An interactive workshop: helps you practice the concepts necessary for auditing the standard guided by an Advisera top expert
    3. ISO 13485 Lead Auditor certification exam: upon successful completion of the exam, you will get a certificate and a badge for your LinkedIn profile to highlight your qualifications

    Who should attend:

    • Novice consultants/auditors seeking to acquire new expertise and perform medical device QMS certification audits
    • Experienced consultants/auditors needing proof of their competence as ISO 13485 lead auditor
    • Quality managers that need to prepare for a medical device QMS audit


    • There are no prerequisites to attend the ISO 13485 Lead Auditor course.

Online course

Please expect an email from titled "Please register for your exam." This email will usually arrive within one business day of purchase.

Your time slot for the exam will be open right after your complete the system check. You will be able to enter the session the moment you click on the link from the email titled "You are now ready to take your exam" as seen here.

Please contact us at if you need our help.

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Course Instructors

ISO 13485 Lead Auditor Course - Advisera

Kristina Zvonar Brkic

ISO 13485 Expert

Kristina Zvonar Brkic is an experienced consultant, auditor, assessor, and trainer for ISO 13485 and EU MDR. She runs a thriving ISO 13485 consulting practice and helps companies and consultants to build their businesses. In her career, she also worked as an ISO 9001 and ISO 22716 consultant and lead auditor, and auditor and assessor for MDD.

ISO 13485 Lead Auditor Course - Advisera

Carlos Pereira da Cruz

ISO Consultant, Trainer, and Auditor

Carlos Pereira da Cruz has more than 30 years of experience working as a consultant, trainer, and auditor with ISO 9001 and ISO 14001. He is a university teacher and author of several books on strategic management, ISO 9001, and ISO 14001.

ISO 13485 Lead Auditor Course - Advisera

Garry Cornell

ISO Consultant, Trainer, and Auditor

Garry Cornell has more than 25 years of global experience as a senior manager, certification auditor, and consultant, helping a wide range of businesses in their implementations of ISO 14001, ISO 45001, and ISO 50001. He has developed various courses and is the author of several books on auditing techniques and ISO 14001. He is a member of the Institute of Environmental Management and Assessment.

Why Advisera ISO 13485 Lead Auditor Course?

ISO 13485 Lead Auditor Course - Advisera

Free unlimited access to the entire course

ISO 13485 Lead Auditor Course - Advisera

Globally recognized accreditation by ASIC

ISO 13485 Lead Auditor Course - Advisera

Expert support from Advisera's top experts

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