ISO 13485 Internal Auditor Course

  1. Language


  2. Duration

    16 hours

  3. CPE


  4. Course type

    Online self-paced

  1. Course benefits:

    • Understand the basics of ISO 13485
    • Improve your knowledge of auditing techniques
    • Add new skills to your resume

    This free ISO 13485 Internal Auditor course will teach you everything you need to know about ISO 13485 and how to perform an internal audit of your medical device Quality Management System (QMS). The course will help you get familiarized with all the key concepts of the medical device QMS and how to audit it, like planning of product realization, design and development, validation processes, identification and traceability, continual improvement, preparing the audit plan and audit checklist, etc.

    After passing the ISO 13485 Internal Auditor exam, you will receive a certificate, accredited by ASIC, which proves your expertise in the standard, as most organizations seek out certified individuals.

    This ISO 13485 Internal Auditor course is divided into two parts:

    1. A video library: includes lessons and practical information about the basics of the standard and how to perform internal audits
    2. 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:

    • Medical device quality managers
    • Persons responsible for conducting ISO 13485 internal audits
    • Compliance managers


    • There are no prerequisites to attend this ISO 13485 Internal 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.

Course Instructors

ISO 13485 Internal 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 an auditor and assessor for MDD.

ISO 13485 Internal 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.

Why Advisera ISO 13485 Internal Auditor Course?

ISO 13485 Internal Auditor Course - Advisera

Free unlimited access to the entire course

ISO 13485 Internal Auditor Course - Advisera

Globally recognized accreditation by ASIC

ISO 13485 Internal Auditor Course - Advisera

Expert support from Advisera's top experts

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