ISO 15189:2022 Medical Laboratories Lead Auditor
The PIMS ISO 15189:2022 Medical Laboratories Lead Auditor course develops professional competence in evaluating medical laboratory quality and competence systems against ISO 15189:2022 requirements.The programm...
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Program Overview
The PIMS ISO 15189:2022 Medical Laboratories Lead Auditor course develops professional competence in evaluating medical laboratory quality and competence systems against ISO 15189:2022 requirements.
The programme covers laboratory resources, personnel competence, pre-examination, examination and post-examination processes, impartiality, confidentiality, audit planning, evidence gathering and continual improvement.
What You'll Learn
- 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
Empowering professionals with knowledge, practical understanding and stronger workplace skills.
PIMSWho Should Attend?
This PIMS Medical Laboratories Lead Auditor course is suitable for Medical Laboratory Managers, Technical Supervisors, Laboratory Quality Professionals, Internal and External Auditors, Compliance Personnel and Laboratory Consultants.
Key Benefits
After completing the programme, learners should be better prepared 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
Assessment & Evaluation
- 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).
Start Your Professional Learning Journey.
Contact PIMS for information about ISO 15189:2022 Medical Laboratories Lead Auditor, training schedules and enrollment.
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