Training
ISO 13485:2016
ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
From an internal auditor perspective, you will learn about the scope, use, and clauses of ISO 13485. Get to know the basics of auditing, the different types of auditing, the techniques for interviewing and assessing processes, and how to prepare and perform an internal audit including the communication of the results in a report.
Who should attend
If you are in Senior management, Quality Assurance Managers, Internal auditors, and anyone involved in the implementation and maintenance of Quality Management Systems in the Medical Device Industry.
Registration
We offer open enrolment, on-location, and train-the-trainer formats. Please contact us to schedule in-house training, which is also recommended for training multiple colleagues or teams at the same time.