Quality Training

ISO 13485: Foundation

Objectives

It is essential that personnel involved in the development, implementation and auditing of medical device quality management systems understand the ISO 13485 requirements.
This course will evaluate and focus on the requirements of the ISO 13485 against your own organisation’s services and products. The course is available online and is a 1-day course.

Content includes

At the end of the training you will be able to:

• Understand the purpose of a quality management system and the 7 principles of quality management
• Process approach and process management
• How to conduct a Gap analysis to address outstanding requirements
• Risk-based thinking and applicable regulatory requirements
• How existing and other regulatory changes (MDR) may impact your current QMS
• Revised terms, new terms and changed terms in the 2016 ISO 13485 Standard Requirements related to documentation
• Impact of changes from an auditing perspective and How to professionally liaise with external auditors.
• The ISO 13485:2016 requirements in relation to:
  • Quality Management Systems
  • Management Responsibilities.
  • Resource Management
  • Product Realisation.
  • Measurement, analysis and improvements

  Who should attend

  Quality personnel

Management and Supervisors

Any responsible personnel involved in the design, development, implementation and auditing of medical device quality management systems

Upcoming dates:

No training dates available at the moment.