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.

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