Course Content
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COURSE CONTENTS
- Understanding the requirements of ISO 13485:2016, ISO 19011:2018 and ISO/IEC 17021-1:2015 Standards
- 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)
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