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
Benefits
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
