Introduction
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.
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. This online training is designed specifically for those who are new to ISO 13485 or are scheduled to attend our IRCA Approved Internal / Lead Auditor training courses.
Cancellations
Places cancelled within 10 working days of commencement must be paid in full. Substitutions may be made at any time at no additional charge.
Course Objectives:
The 1-day course on ISO 13485:2016 is highly interactive with many team exercises and discussion. At the end of the training, you will be able to explain:
• 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.