What You Will Gain
The course provides the principles and practices of effective internal audits in accordance with the ISO 13485:2016 and refers to ISO 19011:2018, “Guidelines for Quality and Environmental Management Systems Auditing.” Delegates gain auditing skills through a balance of formal classroom tutorials, practical group workshops, and open discussions.
Day 2 of the course will concentrate on auditing practice using a case study specifically developed for medical device approvals.
• Understand the requirements of ISO 13485:2016
• Internal, external and third party auditing
• The essential steps and techniques required for Quality Management System auditing, from planning through audit and follow up.
• Write factual reports on the compliance of the management system against the management standard and function immediately as a member of a Management Systems audit team
• Demonstrate compliance with regulatory and legal requirements
• Ensure the establishment of quality management system practices that consistently yield safe and effective medical devices
• Assist in the effective management of risk
• Where appropriate, improve processes and efficiencies.