Classroom 2 Days
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Description
The training has been designed to give you the necessary skills to perform internal audits on an organisation’s Quality Management Systems (QMS) for Medical Devices to the requirements of ISO 13485:2016 and to contribute to their continual improvement .
The training comprises presentations, workshops and interactive role-play exercises with medical device lead auditors experienced in ISO 13485 and Notified Body audits.
Objectives
- Understand the requirements of ISO 13485:2016, and the quality system requirements of Directives 93/42/EEC and 98/79/EC
- Know how to conduct internal quality system audits
- Understand the role of internal audits in the maintenance and improvement of management systems
- Plan and prepare for an internal audit
- Learn to gather evidence by observation, questioning and sampling
- Write factual reports on the compliance of the management system against the audit standards
- Participate in the corrective action process
Audience
The ISO 13485 Internal Auditor Course includes the in-depth interpretation of ISO 13485 requirements, auditing skills and case studies to ensure thorough implementation of ISO 13485 and audit skills within the organization.
Classroom 2 Days
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