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ISO 13485:2016 Lead Auditor Training Course

ISO 13485:2016 Lead Auditor Training Course

Level Lead auditor Duration 5 days
Available to book: Instructor led training £3995 + VAT View dates and book now

From managing an audit programme to reporting on results, this lead auditor training course teaches you everything needed to conduct a quality management system (QMS) audit. 

Led by experienced instructors over five days, the training is suited to quality managers, directors, engineers or consultants. It will help you fully identify the benefits of a QMS and explain the role of the auditor.

On completing this stage of your learning journey, you will be able to apply risk-based thinking, leadership and process management and understand the arrangements for BSI certification. 

How will I benefit?

  • Identify the aims and benefits of an ISO 13485:2016 audit
  • Plan, conduct and follow up on auditing activities
  • Build stakeholder confidence by understanding the latest requirements
  • Gain 40 CPD points on completion of the course
  • On completion of this training, participants will be able to:

    • Gain the skills to plan, conduct, report and follow up an audit in accordance with ISO 19011
    • Identify the purpose and benefits of an ISO 13485:2016 QMS
    • Explain the role of an auditor in planning, conducting, reporting and following up an audit in accordance with ISO 19011 (and ISO 17021 where appropriate)
    • Medical device quality professionals interested in conducting first-party, second-party, and/or third-party audits
    • Management representatives
    • Quality directors, managers, and engineers
    • Consultants
  • The residential and non-residential courses both include: 

    • You will gain 40 CPD points on completing the course
    • Course notes

    The residential option also includes 4 nights accommodation and evening meals from the first day of the course.

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