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ISO 13485 Internal Auditor Training Course – 2 days

ISO 13485 Internal Auditor Training Course – 2 days

This two-day course is intended for medical device quality professionals aiming to build on their knowledge of ISO 13485:2016 and evaluate the effectiveness of the quality management system in their organisation. Learn the practices of effective quality management systems process audits in accordance with the ISO 13485:2016 and ISO 19011:2018.

COURSE OBJECTIVES
  • To explain the structure and scope of ISO 13485:2016 and how it applies to the organisation seeking regulatory compliance
  • To identify the key principles of auditing and auditor responsibilities
  • To plan an internal audit
  • Conduct an effective audit based on process identification, sampling and questioning
  • Determine if corrective action has been effectively implemented.
TARGET AUDIENCE
  • Medical device quality professionals with knowledge of quality management systems and ISO 13485:2016
  • Individuals interested in conducting first-party or second-party audits
  • Management representatives
  • Internal auditors
  • Consultants
COURSE BENEFITS 
  • Maintain compliance with ISO 13485:2016
  • Improve in quality standards
  • Build confidence within your organisation with competent auditors
  • Motivate colleagues and ensure effective regulatory internal processes