<p>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.</p><p><strong>Eligibility criteria:</strong></p><ul><li>Knowledge of ISO 13485 -Medical Device-Quality Management System</li></ul><p><strong>Course material:</strong></p><ul><li>PowerPoint Presentations</li><li>Reference material</li><li>Articles</li><li>Case Studies</li><li>Case Reference Material</li><li>Management System Documentation Templates</li><li>Videos</li></ul><p><strong>Assessment method:</strong></p><ul><li>Assignments</li><li>Examination</li></ul><p><strong>Career Prospects:</strong></p><ul><li>QMS Internal Auditor</li><li>Audit Team Member</li></ul>
Certified Internal Auditor - ISO 13485 Medical Device - Quality Management System
Internal Auditor - ISO 13485:2016
- As an ISO 13485 Internal Auditor you will be able to help your organization optimize its processes to produce the safest and most reliable medical devices. You will have the power to make a positive change by minimizing chances of defects, failures and inconsistencies in the system; by enhancing the Medical Devices Quality Management System (MD-QMS) of your organization. By achieving conformity with the ISO 13485 standards, manufacturers can achieve increased business opportunities owing to their goodwill and credibility in the marketplace.
- In this course, you will learn how to launch and conduct an effective ISO 13485 audit, record & report findings and perform follow-up audits. As an internal auditor, you would need to ensure that the MD-QMS is maintained in the firm, to ensure continued compliance with the ISO 13485 standard.
- 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 completion of training, appear for the exam and qualify for Credentials Global’s ISO 13485 Internal Auditor certificate.
- This course is open to professionals performing or supervising internal audits for ISO 13485.
Key outcomes:
- Gain understanding of the ISO 13485 standard for MD-QMS
- Understand how the ISO 13485 framework is associated with other international standards and regulations
- Fully recognize the responsibilities of an Internal Auditor
- Appreciate how a successful ISO 13485 audit can contribute to ensuring patient safety and satisfaction
- Prepare for and handle a ISO 13485 internal audit, report findings, draft audit report, take remedial action, conduct follow up audit
- Ensure compliance with the ISO 13485 framework
Course Chapters:
Chapter 1 Introduction to Course
Chapter 2 Introduction to Standard & Quality Related Concepts
Chapter 3 Terms & Definition
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 Definition of Auditing
Chapter 10 Guidelines for Auditing Management Systems