Medical Devices - Quality Management Systems Auditor/Lead Auditor Training Course (ISO 13485:2003)(IRCA Registration No.: A17579)

This course teaches the principles and practices of effective quality management systems and process audits in accordance with ISO 13485 and ISO 19011, “Guidelines for Quality and/or Environmental Management Systems Auditing.” Experienced instructors guide students through the entire audit process, from managing an audit programme to reporting on audit results. Participants will gain necessary auditing skills through a balance of formal classroom tutorials, practical role-playing, group workshops, and open forum discussions.


Who is it for?

  • 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 course teaches auditing principles using ISO 13485, therefore a knowledge of ISO 13485 and its application within a Medical Device organization is strongly recommended together with internal audit experience.

You will be able to

  • 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-party

Benefits

  • 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's included?

  • You will gain 40 CPD hours on completing the course
  • Lunch
  • Refreshments
  • Course notes
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