Introduction to ISO 13485.

This introductory course provides an overview of ISO 13485:2016 and gives delegates an understanding of the intent and the requirements for ISO 13485:2016 quality management systems (QMS) for manufacturers of medical devices.

• Individuals, of any level, involved with an ISO 13485:2016 management system who needs an overview of the intent and requirements of the standard
• Those involved with ISO 13485:2016 who need to create a single Quality Management System.

• Scope and application of the new standard
• The differences between ISO 13485:2003 and ISO 13485:2016
• Essential definitions and terminology
• Key requirements of ISO 13485:2016 and how they relate to each other to form a robust, effective system
• The relationship between the standard and the risk management standard ISO 14971.

No previous training or knowledge is required to attend this course.

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

• ISO 13485 Internal auditor
• ISO 13485 Implementation
• ISO 14971 Risk implementation.

One day.