ISO 13485:2016 QMS Auditor/Lead Auditor Training Course

Course Content

Total Training Hours: 5 days

    • Lecture1.1
      Understanding the requirements of ISO 13485:2016, ISO 19011:2018 and ISO/IEC 17021-1:2015 Standards
    • Lecture1.2
      Establish the link between ISO 13485:2016 Clauses and key processes or functional departments
    • Lecture1.3
      Application of “Plan, Do, Check, Act (PDCA) Cycle”, “Process Approach” and Risk-based Thinking Approach
    • Lecture1.4
      Brief Introduction and Application of ISO 14971:2019 In Establishing ISO 13485:2016 Medical Devices-QMS
    • Lecture1.5
      Assess the capability of the measuring equipment to achieve the desired degree of accuracy.
    • Lecture1.6
      Interpretation of Process Validation (Installation Qualification (IQ) / Operational Qualification (OQ) / Performance Qualification (PQ)
    • Lecture1.7
      Terms & Definition: Audit, Audit Objective, Audit Scope, Audit Criteria, Audit Evidence, Audit Findings & Audit Conclusion
    • Lecture1.8
       Seven Principles of Auditing and Their Application (Ref: ISO 19011:2018)
    • Lecture1.9
      Audit Plan vs Audit Program / Management of an Audit Program (Ref: ISO 19011:2018)
    • Lecture1.10
      Six Essential Steps in Performing an Audit (Ref: ISO 19011:2018)
    • Lecture1.11
      Responsibilities and Authorities of Auditor and Lead Auditor
    • Lecture1.12
      Prepare Audit Program, Audit Plan, Audit Checklist and Corrective Action Form
    • Lecture1.13
      Execution of Audit by applying The Six Key Points of Audit Methodology (Ref: ISO 19011:2018)
    • Lecture1.14
      Documenting Non-conformity / Non-compliance, Corrective Action & Follow up Verification Audit
    • Lecture1.15
      Analysis and Presentation of Audit Findings and Audit Conclusion
    • Lecture1.16
      Necessary attributes or desired professional behaviours of an auditor
    • Lecture1.17
      How to deal with classic problems during an audit?
    • Lecture1.18
      Desk-top audit session (Case study with role play)