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This training is designed to give you the relevant skills and knowledge to carry out audits of quality management systems (QMS) for medical devices.

Medical device

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:

  • Understand the requirements of ISO 13485:2016, and the quality system requirements of the Medical Device Regulation
  • Understand the role of internal audit in the maintenance and improvement of management systems
  • Possess in-depth knowledge of the ISO 13485:2016 audit and certification process
  • Have the skills and knowledge needed to plan and conduct third party audits against the requirements of the ISO 13485:2016 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 13485:2016 before attending this training.

Contact your SGS expert now to learn more about the benefits of ISO 13485 Lead Auditor Training.