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This online training is designed specifically for those who are new to ISO 13485, those in need of a bit of a refresher, or those scheduled to attend our Internal / Lead Auditor training courses.
Facilitated by experts working in the Quality Management, for many years, this is an excellent opportunity to listen and ask all the questions you may have in relation to the standard or your upcoming IRCA Approved Internal / Lead Auditor training.
By the end of the webinar, participants will be able to:
• Explain what Quality Management System (QMS) means in relation to ISO 13485:2016
• Describe the Process Approach and the Plan-Do-Check-Act Cycle advocated by ISO 13485.
• Explain Risk-based thinking and relate to ISO:14971
• Understand the ISO 13485:2016 requirements in relation to:
– Quality Management Systems.
– Management Responsibilities.
– Resource Management.
– Product Realisation.
– Measurement, analysis and improvements.