ISO 13485:2016 Implementation.

Learn how to design and implement an effective Quality Management System (QMS) based on ISO 13485:2016.

Applicable for those preparing for ISO 13485 certification or those looking to improve the effectiveness of their current management system.

• Individuals responsible for their organisation's ISO 13485 based Quality Management System
• System managers who may in the future be involved in managing an ISO 13485 based Quality Management System.

• To implement a QMS based on ISO 13485:2016
• To develop a quality policy and objectives
• The need for documenting systems, processes and typical methods
• Key features of risk assessment
• Importance and relevance of legislation
• Design requirements
• The significance of process and environmental controls (e.g. clean rooms, sterilisation, personnel controls)
• Plan and manage your internal quality auditing activities
• Eliminate the causes of problems through effective corrective action
• Develop an appropriate management review process and implement processes for improving the effectiveness of the system.

Knowledge of QMS fundamentals.

• 2.25 CPD hours
• Training course materials
• Lunch and refreshments for public attendees only
• Certificate of attendance.

ISO 13485:2016 Internal Auditor.

Two days.