ISO 13485 – Quality Management Systems For Medical Devices – Internal Auditor Training
The training has been designed to give you the necessary skills to perform internal audits on an organization’s Quality Management Systems (QMS) for Medical Devices to the requirements of to ISO 13485:2003 and to contribute to their continual improvement. This intensive training aims to provide delegates with the skills required to conduct internal audits, using interactive training by medical device lead auditors experienced in ISO 13485 and Notified Body audits.
On training completion you will be able to:
- Understand the requirements of ISO 13485:2003, 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 audit 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
The training comprises presentations, workshops and interactive role-play exercises with medical device lead auditors experienced in ISO 13485 and Notified Body audits.
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