ISO 13485 Lead Auditor Training (IRCA)

Be the lead in quality management for medical devices with our Lead Auditor ISO 13485 Training Course. Guide your organization towards quality management excellence and ISO 13485 accreditation and remove barriers to market for medical devices, gaining competitive advantage.

Work with qualified trainers over the next five days to consolidate your knowledge of ISO 13485 and ISO 19011:2002. Understand the entire audit process at lead level, from planning to managing and reporting on results and learn through tutorials and practical exercises to become a recognized auditing professional for ISO 13485.

You will take away the leadership and specialist auditing skills to help others understand and implement effective quality management systems in medical device manufacturing.

Who should attend?

  • Medical device quality professionals interested in conducting first-party, second-party, and/or third-party audits
  • Management representatives
  • Quality directors, managers, and engineers
  • Consultants

This training course is HRDF approved under the SBL scheme.

What will I learn?

  • Interpret the requirements of ISO 13485 in the context of an audit
  • Describe the purpose of a quality management system and explain the 8 principles of quality management
  • Explain the role of an auditor to plan, conduct, report and follow up a quality management system audit in accordance with ISO 19011
  • Plan, conduct, report and follow-up on a QMS audit in accordance with ISO 19011 and by interpreting ISO 13485
  • Manage the duties of a lead auditor in their organization or for a third-part

How will I benefit?

  • Benefit from effective ISO 13485 audits and compliance
  • Maintain and improve quality standards with regular audits
  • Be confident that your organisation can rely on ISO certified lead auditors 
  • Increase credibility and competitive advantage
  • Motivate employees through CPD and build your customer base

What does the fee cover?

  • Training course notes
  • Lunch
  • Refreshments
  • Loan copy of the standard (to be returned after the course)
  • Professional certificate (only if candidates passed the exams)
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