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    CQI and IRCA Medical Devices – QMS Auditor/Lead Auditor (ISO 13485:2016)

    CQI and IRCA Medical Devices – QMS Auditor/Lead Auditor (ISO 13485:2016)

    Level Lead auditor Duration 5 days
    Available to book: Public classroom

    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.

    What are the 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.
    • On completion of this training, participants 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
      • 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.

      • Refreshments
      • Lunch 
      • Training course notes
      • Pen
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