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This training is designed to give you the relevant skills and knowledge to carry out audits of Quality Management Systems for Medical Devices (QMS).

People in a glass meeting room

The principles of ISO 13485 set out an explicit management system so that you can audit, examine and continually improve systems for a QMS.

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
  • Understand the role of internal audit in the maintenance and improvement of management systems
  • Possess in-depth knowledge of the ISO 13485:2003 audit and certification process
  • Have the skills and knowledge needed to plan and conduct third party audits against the requirements of the ISO 13485:2003 and report the compliance of the management systems against the standard requirements so that any corrective action can be undertaken.

Please note: Participants should have some prior knowledge of ISO 13485:2003 before attending this training.

Contact your SGS Expert now for more benefits of SGS ISO 13485 Lead Auditor Training.