Laboratory, Testing & Calibration
ISO/IEC 17025 Laboratory Competence
Apply competence, impartiality and consistent laboratory operation.
Upcoming: Jeddah
Laboratory, Testing & Calibration
ISO 15189 Medical Laboratory Management
Apply competence and quality requirements for medical laboratory services.
Advanced5 daysEnglish or ArabicISO Systems
Course overview
ISO 15189 specifies requirements for quality and competence in medical laboratories. Accreditation to it gives clinicians and patients confidence that results are accurate, timely and clinically useful.
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This course explains the 2022 edition clause by clause, with examples from clinical chemistry, haematology and microbiology, and shows quality managers and assessors how to audit the pre-examination, examination and post-examination processes.
Key takeaways
- 01Interpret ISO 15189:2022 requirements, including risk management and patient focus
- 02Assess method verification, measurement uncertainty and internal quality control
- 03Audit pre-examination, examination and post-examination processes
- 04Plan and lead first-, second- and third-party audits using ISO 19011
- 05Report findings that drive real corrective action
Course outline
- Day 1
Medical laboratory quality and ISO 15189
- Structure of ISO 15189:2022
- Impartiality, confidentiality and patient focus
- Personnel competence and facilities
- Day 2
Laboratory processes
- Sample collection and transport
- Method verification, validation and uncertainty
- Quality control, EQA and reporting of results
- Day 3
Audit principles and planning
- ISO 19011 audit principles
- Certification audits under ISO/IEC 17021-1
- Audit programme, scope and plan
- Day 4
Conducting the audit
- Opening meeting and process-based interviews
- Sampling and gathering objective evidence
- Writing clear nonconformity statements
- Day 5
Reporting and follow-up
- Audit conclusions and closing meeting
- Report writing and certification recommendation
- Corrective-action follow-up and surveillance
- Examination
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Frequently asked questions
Is this course relevant to CBAHI or JCI?
Yes. ISO 15189 aligns closely with laboratory chapters of national and international healthcare accreditation programmes.
How is the course assessed?
Through continuous assessment of workshop exercises and a written examination on the final day.
How do I choose the right course?
Compare your professional goals, experience and preferred format, or ask an adviser to help.
Are courses available online?
Yes. Live virtual and in-house options are available depending on the programme.
Will I receive a certificate?
Certificate requirements depend on the programme and awarding organisation.
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