Course Description

ISO 13485:2016 specifies the requirements for a quality management system, in which an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

UTAP grant supported, able to claim up to 50% of course fee.

Course Content

  • General concepts and principles of auditing
  • Understand the requirements of ISO 13485:2016, and the quality system requirements of Directives 93/42/EEC and 98/79/EC
  • Identify the principles of auditing and auditor responsibilities
  • Conduct informal opening and closing meetings
  • Plan and prepare for an internal audit
  • Performing the audit (How to conduct a mock audit based on compiled checklist?)
  • Document concise nonconformities
  • Write factual reports on the compliance of the management system against the audit standards
  • Participate in the corrective action process

Target Audience

This course is specially designed for:

  • Anyone tasked with development of a QMS or conversion from ISO 13485:2003
  • Management representatives
  • Implementation team members
  • Auditors (Internal or External /Supply Chain)
  • Quality Managers
  • Regulatory Affairs personnel


At the end of this course, participants will be able to:

  • Increase access to more markets worldwide with certification
  • Outline how to review and improve processes across an organization
  • Increase efficiency, cut costs and monitor supply chain performance
  • Demonstrate that you produce safer and more effective medical devices
  • Meet regulatory requirements and customer expectations

Course Information

Mode: Virtual Class

Course Duration: 16 hrs [2 days]

Course Fee: S$550

Enquire Now