About the course:

Embark on a journey to enhance medical device quality management with our comprehensive ISO 13485:2016 Lead Auditor Course. Approved by Exemplar Global, this program is meticulously designed to equip professionals with the essential knowledge and skills needed to lead effective audits of Quality Management Systems (QMS) based on ISO 13485:2016 standards.

Course Accreditation:

Our course is proudly Approved by Exemplar Global, ensuring its quality and adherence to international standards. Upon completion, participants will not only gain a comprehensive understanding of ISO 13485:2016 but also receive exclusive benefits, including a Graduate Certificate and eligibility to apply for Exemplar Global Certified Lead Auditor status.

Course Aim:

The Exemplar Global Approved ISO 13485:2016 QMS Lead Auditor Course aims to empower professionals to lead and conduct impactful quality management system audits. Participants will develop a profound understanding of ISO 13485 principles, audit methodologies, and the competencies essential for successful QMS leadership.

Benefits of Attending:

  • Comprehensive Understanding: Gain in-depth insights into ISO 13485:2016 requirements and quality management best practices.
  • Global Connectivity: Access the Exemplar Global Portal to connect with industry peers, attend live webinars, and access exclusive resources.
  • Graduate Certificate: Achieve a Graduate Certificate from Exemplar Global, enhancing your professional credentials.
  • Path to Certification: Eligibility to apply for Exemplar Global Certified Lead Auditor status within 10 years of course completion.
  • Enhanced Skills: Elevate your auditing skills and capabilities to drive effective risk management.
  • Lead Your Audit Team: Lead impactful audits of Quality Management Systems, ensuring compliance and fostering product quality and safety.
  • Continuous Improvement: Drive ongoing enhancements in quality management practices, enabling proactive identification and mitigation of quality risks.
  • Career Advancement: Propel your career in the medical device industry with recognized expertise and certification.

Who Should Attend?

This course is tailored for professionals involved in planning, implementing, maintaining, supervising, or auditing Quality Management Systems based on ISO 13485 standards. Whether you’re a seasoned quality management professional or new to the field, this training will equip you to make a positive impact on medical device quality and safety.

Course Content:

  • Overview of ISO 13485:2016 standard
  • Understanding the purpose and scope of quality management in the medical device industry
  • Principles of quality management according to ISO 13485
  • Key terminology and definitions in quality management
  • Understanding the quality management framework
  • Context establishment and identification of regulatory requirements
  • Risk management in the medical device industry
  • Quality planning and risk-based decision making
  • Design and development controls for medical devices
  • Supplier management and control of external processes
  • Production and service provision controls
  • Validation and verification of processes
  • Monitoring and measurement of product and process performance
  • Control of nonconforming products and corrective actions
  • Internal audit program management
  • Planning and conducting quality management system audits
  • Audit techniques and methods
  • Reporting and documenting audit findings
  • Follow-up and corrective actions in quality management auditing

Our Facilities:

E-Learning / Self-Study Mode: Access the course materials and resources online at your convenience, allowing you to study at your own pace and schedule.

Premium Study Materials: Benefit from curated study materials designed to facilitate comprehensive learning and understanding of ISO 13485:2016 requirements.

Assessment and Certification: Test your knowledge with an online exam and receive a globally recognized certificate upon successful completion.

Enrol Today

Seize the opportunity to master ISO 13485:2016 and become a leader in driving medical device quality and safety through effective quality management. Secure your spot in our upcoming course and embark on a transformative learning journey that will redefine your career trajectory in the medical device industry.