ISO 15189:2022 – MEDICAL LABORATORIES – REQUIREMENTS FOR QUALITY AND COMPETENCE & INTERNAL AUDITING
To equip the participants with the basic knowledge and skills to interpret and to apply the requirements for enhancing Quality & Competence in Medical Laboratories.
Curriculum
- 2 Sections
- 41 Lessons
- 14 Hours
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- DAY ONE: Interpretation and Application of ISO 15189:2022 RequirementsThe course includes a high level of interactivity during training on:28
- 2.1Scope / Normative References / Terms and Definitions
- 2.2Management Requirements
- 2.3– Organization & Management Responsibility
- 2.4– Quality Management System
- 2.5– Document Control
- 2.6– Service Agreements
- 2.7– Examination By Referral
- 2.8– Laboratories
- 2.9– External Services and Supplies
- 2.10– Advisory Services
- 2.11– Resolution of Complaints
- 2.12– Identification and Control of Non-conformities
- 2.13– Corrective Action
- 2.14– Preventive Action
- 2.15– Control of Records
- 2.16– Evaluation and Audits
- 2.17– Management Review
- 2.18Technical Requirements
- 2.19– Personnel
- 2.20– Accommodation and Environmental Conditions
- 2.21– Laboratory Equipment, Reagents and Consumables
- 2.22– Pre-examination Processes
- 2.23– Examination Processes
- 2.24– Reporting of Results
- 2.25– Laboratory Information Management
- 2.26– Release of Results
- 2.27– Post-examination Processes
- 2.28Class-room Exercises, Assignments & Discussion
- DAY TWO: ISO 19011:2018 Guidelines For Auditing13
- 3.1Terms & Definition: Audit, Audit Objective, Audit Scope, Audit Criteria, Audit Evidence, Audit Findings & Audit Conclusion
- 3.2Seven Principles of Auditing
- 3.3Audit Plan vs Audit Programme
- 3.4Management of An Audit Programme
- 3.5Six Steps In Performing An Audit
- 3.6Prepare Audit Plan and Audit Check Sheet
- 3.7Execution of Audit By Applying 6A Auditing Approach
- 3.8Documenting Non-conformity / Non-compliance, Corrective Action & Follow up Verification Audit
- 3.9Brief Outlines Of Internal Quality Audit Procedure
- 3.10Human Aspect of Auditing
- 3.11Preparatory Work for External Audit
- 3.12Group Assignment & Presentation
- 3.13Question & Answer / General Discussion
Management Requirements
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