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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.

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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.