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Duration: 90 Days

Fees: 200 US$

Course duration is the Learning Management System (LMS) access available to the student. However, the student can complete the course early or whenever within 90 days and appear for the exam as per the individual learning goals.

Eligibility criteria:

Must have completed & passed Exam of ISO 13485:2003 Lead Auditor Training Course of 40 Hours. Please email us a copy of your ISO 13485:2003 Lead Auditor Certificate in order for us to verify your eligibility prior to enrolling for the course.

Course material:

  • PowerPoint Presentations
  • Reference material
  • Articles
  • Case Studies
  • Case Reference Material
  • Management System Documentation Templates
  • Videos

Assessment method:

  • Assignments
  • Examination

Career Prospects:

  • Manager
  • MD-QMS Lead Auditor
  • Subcontractor Lead Auditor


Certified Lead Auditor Conversion/Transition Course ISO 13485:2016

Lead Auditor Conversion/Transition Course - ISO 13485: 2016:

  • Credential Global’s Lead Auditor Transition/Conversion Training and Certification is intended to train experienced Lead Auditors with the knowledge needed to assess and report on the conformance and effective implementation of the Medical Devices Quality Management System Standard.
  • Receive state of the art training & qualify for Credentials Global’s ISO 13485:2016 Lead Auditor Certification. By achieving a Credentials Global Lead Auditor Transition /Conversion Certificate, you will be able to demonstrate that you have the practical knowledge and professional capabilities to conduct First, Second and Third Party Medical Devices Quality Management Systems audits.
  • On course completion, appear for the exam and qualify for Credentials Global’s ISO 13485:2016 Lead Auditor Certification.
  • This course is open to professionals that seek to spearhead audits conforming to the ISO 13485:2016 standard, in self/customer/client organizations.

Key outcomes:

  • Awareness of the intent and value of an ISO 13845:2016 audit
  • Understand how the ISO 13485:2016 standard relates to other standards and global regulations
  • Apply the concepts of the ISO 13485:2016 framework to the context of an audit, organization, industry
  • Understand theoretical concepts as well as best practices relevant to a QMS audit for medical devices
  • Develop competency to manage an ISO 13485:2016 audit from start to finish.

Course Chapters:

  • Chapter 1 Introduction to Course
  • Chapter 2 Introduction to Standard & Quality Related Concepts
  • Chapter 3 Terms & Definitions
  • Chapter 4 Process Mapping
  • Chapter 5 High Level Structure
  • Chapter 6 Requirements of Standard Part I
  • Chapter 7 Requirements of Standard Part II
  • Chapter 8 Requirements of Standard Part III
  • Chapter 9 Understanding the terms and Definitions of Auditing
  • Chapter 10 Guidelines for Auditing Management System.