ISO 13485 Training: Introduction (1 Day Course).

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.

With LRQA, you can access a wide range of courses to help you further your career and bring improvements to the management systems in your organization. With many learning styles to choose from, our training courses can help you develop and reach your next level. Find out more about Ascend Training Courses from LRQA. 

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

One day.

Contact us to learn more about ISO 13485 training.