ISO 13485:2016 QMS Auditor/Lead Auditor Training Course

Establish the link between ISO 13485:2016 Clauses and key processes or functional departments

Application of “Plan, Do, Check, Act (PDCA) Cycle”, “Process Approach” and Risk-based Thinking Approach

Brief Introduction and Application of ISO 14971:2019 In Establishing ISO 13485:2016 Medical Devices-QMS

Assess the capability of the measuring equipment to achieve the desired degree of accuracy.

Interpretation of Process Validation (Installation Qualification (IQ) / Operational Qualification (OQ) / Performance Qualification (PQ)

Terms & Definition: Audit, Audit Objective, Audit Scope, Audit Criteria, Audit Evidence, Audit Findings & Audit Conclusion

 Seven Principles of Auditing and Their Application (Ref: ISO 19011:2018)

Audit Plan vs Audit Program / Management of an Audit Program (Ref: ISO 19011:2018)

Six Essential Steps in Performing an Audit (Ref: ISO 19011:2018)

Responsibilities and Authorities of Auditor and Lead Auditor

Prepare Audit Program, Audit Plan, Audit Checklist and Corrective Action Form

Execution of Audit by applying The Six Key Points of Audit Methodology (Ref: ISO 19011:2018)

Documenting Non-conformity / Non-compliance, Corrective Action & Follow up Verification Audit

Analysis and Presentation of Audit Findings and Audit Conclusion

Necessary attributes or desired professional behaviours of an auditor

How to deal with classic problems during an audit?

Desk-top audit session (Case study with role play)