ISO 15189:2012 – MEDICAL LABORATORIES – REQUIREMENTS FOR QUALITY AND COMPETENCE & INTERNAL AUDITING

Course Content

Total Training Hours: 14 hours

  • DAY ONE: Interpretation and Application of ISO 15189:2012 Requirements  The course includes a high level of interactivity during training on: 0/28

    • Lecture1.1
      Scope / Normative References / Terms and Definitions
    • Lecture1.2
      Management Requirements
    • Lecture1.3
      – Organization & Management Responsibility
    • Lecture1.4
      – Quality Management System
    • Lecture1.5
      – Document Control
    • Lecture1.6
      – Service Agreements
    • Lecture1.7
      – Examination By Referral
    • Lecture1.8
      – Laboratories
    • Lecture1.9
      – External Services and Supplies
    • Lecture1.10
      – Advisory Services
    • Lecture1.11
      – Resolution of Complaints
    • Lecture1.12
      – Identification and Control of Non-conformities
    • Lecture1.13
      – Corrective Action
    • Lecture1.14
      – Preventive Action
    • Lecture1.15
      – Control of Records
    • Lecture1.16
      – Evaluation and Audits
    • Lecture1.17
      – Management Review
    • Lecture1.18
      Technical Requirements
    • Lecture1.19
      – Personnel
    • Lecture1.20
      – Accommodation and Environmental Conditions
    • Lecture1.21
      – Laboratory Equipment, Reagents and Consumables
    • Lecture1.22
      – Pre-examination Processes
    • Lecture1.23
      – Examination Processes
    • Lecture1.24
      – Reporting of Results
    • Lecture1.25
      – Laboratory Information Management
    • Lecture1.26
      – Release of Results
    • Lecture1.27
      – Post-examination Processes
    • Lecture1.28
      Class-room Exercises, Assignments & Discussion

  • DAY TWO: ISO 19011:2018 Guidelines For Auditing  0/13

    • Lecture2.1
      Terms & Definition: Audit, Audit Objective, Audit Scope, Audit Criteria, Audit Evidence, Audit Findings & Audit Conclusion
    • Lecture2.2
      Seven Principles of Auditing
    • Lecture2.3
      Audit Plan vs Audit Programme
    • Lecture2.4
      Management of An Audit Programme
    • Lecture2.5
      Six Steps In Performing An Audit
    • Lecture2.6
      Prepare Audit Plan and Audit Check Sheet
    • Lecture2.7
      Execution of Audit By Applying 6A Auditing Approach
    • Lecture2.8
      Documenting Non-conformity / Non-compliance, Corrective Action & Follow up Verification Audit
    • Lecture2.9
      Brief Outlines Of Internal Quality Audit Procedure
    • Lecture2.10
      Human Aspect of Auditing
    • Lecture2.11
      Preparatory Work for External Audit
    • Lecture2.12
      Group Assignment & Presentation
    • Lecture2.13
      Question & Answer / General Discussion
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