ISO 13485:2016 QMS Auditor/Lead Auditor Training Course

COURSE CONTENTS  0/18

• 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)