ISO 13485 - Internal Auditor Training - Quality Management Systems for Medical Devices

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.

Contact SGS now for more information on SGS ISO 13485 Internal Auditor Training.

Medical Devices ServicesBrochureMedical Devices Services brochureFind the most reliable route to the market (PDF 175KB) ...

IVD Medical DevicesWhite PaperIVD Medical Devices White PaperAbout EC DIRECTIVE 98/79/EC-IVD Medical Devices

Electro-Medical DevicesBrochureComplete Global Solutions for Electro-Medical DevicesGet your product to market faster. We know the way. ...

Now Viewing

All 3 resources

• 

  Medical Devices Services

  published 02/28/12

  PDF

• 

  IVD Medical Devices

  published 05/24/12

  Video

• 

  Electro-Medical Devices

  published 12/07/12

  PDF