ISO 13485 Internal Auditor Training

Why should you attend?

ISO 13485 Internal Auditor is a two-days training course which focuses on the concepts of medical devices and MDQMS management, and provides an overall explanation of ISO 13485 requirements for a medical devices quality management system (MDQMS). In this training course, you will be acquainted with the various aspects of a MDQMS based on ISO 13485, such as the role of top management, identify the steps for defining, planning, organizing and scheduling necessary activities, requirements for performance evaluation, and the importance of continual improvement.

After completing this course, you can sit for the exam. If you successfully pass the exam, you can have Exemplar approved Internal Auditor Certificate. This certificate demonstrates that you have a general knowledge of ISO 13485 requirements for a MDQMS and enables you to be part of MDQMS implementation projects.

Who should attend?

People involved in the auditing, maintaining, or supervising of an MDQMS should join this ISO 13485 internal auditor training course. This course is specially designed for the following:

  • MDQMS internal auditors
  • MDQMS managers and officers
  • MDQMS professionals and consultants
  • Top management
  • Anyone interested in the MDQ management system
  • Auditors seeking to perform and lead medical devices management system (MDQMS) internal audits

Learning objectives

  • After completion of this Online course for ISO 13485 lead auditor training, the users will be able to:

    • Familiarize yourself with ISO 13485:2016 requirements in detail.
    • Know about the resource requirements and process requirements.
    • Understand the documentation required by ISO 13485:2016.
    • Understand documentation and list of procedures to be maintained, and to check them as lead auditor.
    • Get the knowledge of internal auditing and use of audit checklist.
    • Know about the types of auditing and questioning techniques.
    • Familiarize yourself with principles & implementation of ISO 13485:2016 lead audit programs in detail.
    • Get the ready-to-use audit checklist with clause-wise questions to perform an effective audit.

Educational approach

  • Lecture sessions are illustrated with practical questions and examples
  • Practical exercises include examples and discussions
  • Practice tests are similar to the Certificate Exam



Course Agenda 

    • Day-1

      • Session 1 : Overview of ISO 13485.
      • Session 2 : Requirements of ISO 13485 Medical Devices Quality Management System.
      • Session 3 : Documented Information for ISO 13485 Implementation.
      • Session 4 : ISO 13485 Internal Audit Process.
      • Session 5 : ISO 13485 Audit Records.
      • Session 6:  Objectives & Plan.
    • Day-2
    • Detail overview of ISO 13485 requirements — Clauses 7 to 10

Exemplar Global and CPD Certified Course                      Exemplar Global Lead Auditor - Competitive Edge Performance Solutions       

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Megademi is approved training partner by Exemplar Global for ISO Courses.

Exemplar Global has been accredited for Management System Auditor courses and personnel accreditation. Formerly known as RABQSA, Exemplar Global has over 30 years of expertise building certification programs for the conformity community. RABQSA was established in 2004 from the merger of the personnel certification activities of the U.S Registrar Accreditation Board (RAB) with the Australia-based Quality Society of Australasia (QSA).