ISO 13485:2016 Medical Devices - Quality Management System

ISO 13485:2016 Internal Auditor Course

This course aims to provide learning opportunities to acquire the knowledge of the requirements behind the ISO 13485:2016 standard to facilitate establishing a Quality Management System for medical devices to meet this standard, customer, and applicable regulatory requirements.


  • Understand ISO 13485:2016 QMS regulatory requirements
  • Understand how to plan and conduct an internal audit based on the ISO 13485:2016 requirements


Who should attend:

  • Implementers of ISO 13485:2016
  • Management Representatives
  • Quality Managers


Course Structure:

✓ Introduction to ISO 13485:2016
✓ Understanding the new high-level structure (HLS) system requirements of ISO 13485:2016
✓ Understanding the concept and scope of the general Quality Management System and its relation to the standard
✓ Understand the concept and process of internal audit, management review, and improvement


Course Details:

  • Time: 9:30 am - 5:30 pm
  • Venue: CIS Training Room
  • Fee*: S$1,100 (excl 8% GST)
    • Day 1: $700 (excl 8% GST)
    • Day 2: $400 (excl 8% GST)

(Note: A discount of 10% awaits if you signed up for more than 3 participants)
*Inclusive of Summarized Notes & Certificate of Attendance

For more information:

Available Schedule