ISO 15189:2022 Medical Laboratories Lead Auditor
The ISO 15189:2022 Medical Laboratories Lead Auditor course offered by OXQUAL develops professional competence in auditing medical laboratory quality and competence systems against ISO 15189:2022 requirements. The programme covers personnel competence, laboratory processes, impar...
About this qualification
The ISO 15189:2022 Medical Laboratories Lead Auditor course offered by OXQUAL develops professional competence in auditing medical laboratory quality and competence systems against ISO 15189:2022 requirements. The programme covers personnel competence, laboratory processes, impartiality, confidentiality, audit planning and continual improvement.
Career-focused
Develop relevant skills and knowledge that can support your next professional step.
What you'll cover
Key topics covered in this OXQUAL programme include:
- ISO 15189:2022 Fundamentals
- Medical Laboratory Quality Principles
- Structural Requirements
- Resource Requirements
- Laboratory Process Requirements
- Personnel Competence
- Equipment and Reagent Management
- Pre-Examination Processes
- Examination Processes
- Post-Examination Processes
- Impartiality and Confidentiality
- ISO 19011 Audit Principles
- Audit Planning
- Medical Laboratory Audits
- Evidence Collection
- Non-Conformity Reporting
- Corrective Actions
- Continual Improvement
Who it's designed for
This OXQUAL programme is suitable for:
- Medical Laboratory Managers
- Technical Supervisors
- Laboratory Quality Professionals
- Internal and External Auditors
- Compliance Personnel
- Laboratory Consultants
What you'll gain
Successful completion of this OXQUAL programme can help learners to:
- Develop medical-laboratory auditing competence.
- Strengthen laboratory competence evaluation.
- Improve quality-process assessment.
- Develop audit planning and evidence-gathering skills.
- Improve non-conformity reporting.
- Support continual improvement of laboratory quality.
How this qualification is assessed
The assessment pattern for this OXQUAL programme is outlined below.
- Assessment Type: Written examination, audit simulation and project.
- Format: Multiple-choice questions, essay-style questions, applied audit scenarios and project submission.
- Total Questions: 100 theory questions plus 1 audit simulation and 1 project submission.
- Passing Score: 70%.
- Duration: 6–7 days (45–50 hours total).
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