Patient-safe results through competent people, validated methods, and controlled processes. The global standard trusted by clinical laboratories in 100+ countries.
Improved result reliability and reduced errors across all examination phases
Stronger trust in laboratory results and faster corrective action when needed
Compliance with international standards and regulatory requirements
ILAC-recognized accreditation for tenders, insurers, and referral networks
Medical laboratories performing examination of human specimens require competence demonstration and patient-focused quality systems.
Clinical laboratories within hospital systems, from single-site to multi-campus networks requiring coordinated quality systems.
Commercial laboratories providing testing services to healthcare providers, including specialty and high-volume reference testing.
Focused disciplines including microbiology, hematology, clinical chemistry, immunology, histopathology, and molecular diagnostics.
POCT management programs within healthcare facilities, often combining ISO 15189 with ISO 22870 requirements.
Laboratory systems spanning multiple locations requiring consistent quality management and competence demonstration.
Laboratories in regions where ISO 15189 is increasingly required by purchasers, ministries, or accreditation programs.
Comprehensive requirements for quality and competence across the complete examination process.
Test requesting procedures, patient identification and preparation, specimen collection, handling, transportation, and reception. Includes request review, patient preparation instructions, phlebotomy procedures, specimen integrity, and chain of custody requirements.
Analytical methods, validation and verification procedures, metrological traceability, measurement uncertainty assessment where clinically relevant. Includes equipment management, reagent control, calibration procedures, and environmental conditions.
Result review and authorization, interpretation and reporting, critical value management, result release and communication. Includes turnaround time monitoring, report format requirements, and communication with healthcare providers.
Risk-based approach to quality management, patient confidentiality, informed consent considerations, ethical review processes, and conflict of interest management throughout laboratory operations.
Competence assessment and authorization procedures, continuing education requirements, supervision structures, and performance monitoring. Includes qualification requirements for different roles and competence maintenance programs.
Internal quality control programs, external quality assessment participation, proficiency testing enrollment, and alternative assessment where PT is unavailable. Includes performance monitoring and corrective action procedures.
Our proven six-phase approach takes laboratories from initial gap assessment to accreditation readiness in 16–24 weeks.
Comprehensive scope definition, accreditation body selection, readiness scorecard, and detailed project planning with resource allocation and milestone mapping.
Quality manual development, process mapping, document control system, risk register creation, and KPI framework establishment for ongoing performance monitoring.
Method validation and verification, metrological traceability establishment, QC/EQA program design, uncertainty estimation, and equipment lifecycle management.
Competence matrices, training programs, authorization procedures, biosafety protocols, and environmental control systems for optimal laboratory operations.
Record-keeping systems, nonconformity and CAPA procedures, internal audit program implementation, and management review processes with performance data.
Application package completion, site preparation, witness simulations, mock assessment execution, and corrective action implementation before AB assessment.
Understanding when to use ISO 15189 compared to related laboratory and quality standards.
| Aspect | ISO 15189 | ISO/IEC 17025 | ISO 9001 |
|---|---|---|---|
| Primary Focus | Medical laboratory competence | Testing/calibration competence | Quality management systems |
| Patient Focus | ✓ Patient-centered | ✗ Customer-focused | ✗ Customer-focused |
| Clinical Interface | ✓ Clinical consultation | ✗ Limited clinical context | ✗ No clinical requirements |
| Medical Ethics | ✓ Ethical requirements | ✗ Not addressed | ✗ Not addressed |
| Pre/Post Analysis | ✓ Complete pathway | ✗ Testing phase only | ✗ Process-generic |
| Recognition | ILAC medical laboratory ABs | ILAC testing/calibration ABs | IAF quality system CBs |
| Best For | Clinical/medical laboratories | Industrial testing labs | Quality system baseline |
Professional development pathway from foundation awareness to lead assessor competence for medical laboratory personnel.
Overview of ISO 15189:2022 requirements, laboratory roles, risk management, and process approach for medical laboratory quality systems.
ISO 19011-aligned internal auditing skills, sampling strategies, nonconformity writing, root cause analysis, and laboratory-specific audit trails.
QMS development, risk management, KPI design, document systems, validation/verification approaches, uncertainty estimation, and EQA/QC program design.
Advanced skills for senior internal auditors or assessor candidates. Assessment planning, team leadership, witness activities, reporting, and close-out procedures.
Training available in multiple formats: public virtual classes, private on-site delivery, and blended programs with templates and coaching.
View Full Training ScheduleProfessional implementation services scaled to laboratory size and scope complexity.
All packages include gap analysis, documentation, training, and assessment preparation. Target timeline: 16–24 weeks to accreditation body assessment scheduling.
Get a personalized readiness score and implementation roadmap for your medical laboratory.