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Duration: 180 Days

Fees: 280 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 180 days and appear for the exam as per the individual learning goals.

Eligibility criteria:

  • Knowledge of ISO 13485 - Medical Device-Quality Management System

Course material:

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

Assessment method:

  • Assignments
  • Examination

Career Prospects:

  • Quality Manager
  • QMS Lead Auditor
  • Subcontractor Lead Auditor
  • QA Lead
  • QA Head

In Medical devices industry.

Certified Lead Auditor - ISO 13485 Medical Device - Quality Management System


Lead Auditor - ISO 13485:2016

  • A course aimed at building your skills and competence to spearhead an Audit that gives professionals the exposure to auditing techniques, processes and practices; to competently lead a QMS audit for Medical devices, in line with the ISO 13485 standard. An effective ISO 13485 audit helps manufacturers improve their operations and produce medical devices that are safe and reliable.
  • The course structure equips you with the mandatory skills to successfully settle conflict, handle teams and conduct internal and external audits.
  • Empirical approach to coaching will include detailed training material, assignments, case studies and presentations to assist students in analysis and synthesis of body of knowledge and to develop required skills.
  • On course completion, sit for the exam and qualify for Credentials Global’s ISO 13485 Lead Auditor certification.
  • This course is open to all professionals, technical specialists, consultants, managers, leaders, quality heads who aim to ensure the highest level of patient safety; and seek to lead audits conforming with the ISO 13485 standard.

Key outcomes:

  • Awareness of the intent and value of an ISO 13845 audit
  • Understand how the ISO 13485 standard relates to other standards and global regulations
  • Apply the concepts of the ISO 13485 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 audit from start to finish.

Course Chapters:

  • Chapter 1 Introduction to Course
  • Chapter 2 High Level Structure
  • Chapter 3 Introduction to Standard & Related Terms and definition
  • Chapter 4 Process Mapping.
  • Chapter 5 Quality management system
  • Chapter 6 Management responsibility
  • Chapter 7 Resource management
  • Chapter 8 Product Realization I
  • Chapter 9 Product Realization II
  • Chapter 10 Product Realization III
  • Chapter 11 Product Realization IV
  • Chapter 12 Competence and Awareness and Organizational Communication
  • Chapter 13 Monitoring measurement and Data Analysis
  • Chapter 14 Performance Evaluation
  • Chapter 15 Improvement
  • Chapter 16 Guidelines For Auditing Management Systems
  • Chapter 17 Audit Excellence

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