ISO 13485:2016 – Internal Auditor Training CourseISO 13485:2016 / Internal Auditor Training Course

ISO 13485:2016 - Internal Auditor Training Course
A highly interactive 2 days ISO 13485 internal auditor training course that enables delegates to interpret the requirements of the ISO 13485 medical devices standard from an auditing perspective, conduct effective internal audits and produce audit findings.

Duration : 2 Days

who should attend?

  • Executives and Senior Management
  • Design Engineering
  • R&D Managers/Engineers and Members of Design Review Teams
  • Regulatory Affairs/QA Managers and Management Representatives
  • Members of multi-discipline Design Teams
  • Sales and Marketing, Production, Shipping, MIS, Purchasing

objective

A detailed understanding of:

  • Medical devices, quality and auditing terminology
  • Auditing skills
  • Structure & intent of the medical devices standard ISO 13485 :2016
  • Planning, preparation and management of audits
  • Types of audit
  • Checklist development
  • Internal audit objectives
  • Conducting process audits
  • Internal audit scope and criteria
  • Reporting audit findings
  • The audit process
  • Verifying corrective action
  • Roles and responsibilities of the internal auditor
  • Interviewing skills

content

  • Complying with FDA and CE Marking requirements – the requirements of ISO 13485 and QSR
  • Principles of auditing, the audit cycle and audit objectives
  • Auditing skills and techniques:
    • Planning – use of checklists, resources and timing
    • Selection of audit teams and training
    • Interviewing and evaluation of information and findings
    • Observation – objective evidence
    • Evaluating the significance of nonconformities
    • Communicating and presenting audit reports
    • Corrective actions and effective follow-up programmes
    • Effective improvement – planning, monitoring and results
  • Sources of information and further development
how can we help you?

Contact us via email at info@edullence.com or submit a business inquiry online.

Thank you for an excellent course which was greatly enjoyed in all respects. It was a real “Crammer” but has undoubtedly fired my imagination as to what can be achieved.

Sue Haworth
Quality Manager, BNFL

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