Conduct a gap analysis of a laboratory's quality management system against ISO 15189:2022 clause requirements.
Healthcare & Pharmaceutical Management
ISO 15189 Accreditation for Medical Laboratory Quality Management
Prepare a medical laboratory for ISO 15189 accreditation, from gap analysis and method validation through quality control, competency assessment and the assessor visit.
🗓️Duration5 training days
📚Content4 modules · 8 sessions
🎓On completionAccredited attendance certificate
About the programme
Course Overview
Laboratories preparing for ISO 15189 accreditation often underestimate how much of the standard concerns management processes rather than bench technique, and assessors routinely find gaps in document control, competency records and measurement uncertainty statements even where analytical quality is strong. This course walks laboratory managers and quality officers through the 2022 revision of the standard end to end, mapping requirements to the pre-examination, examination and post-examination phases of the total testing process. Participants learn to run a structured gap analysis against the standard's clauses, build a quality manual and procedure set that will withstand assessor scrutiny, and design internal quality control schemes using Westgard multirule logic alongside external quality assessment participation. Sessions on method validation and verification teach how to calculate measurement uncertainty and establish traceability of calibration to reference standards. The course closes with practical technique for planning internal audits, managing non-conformances and corrective actions, and running a management review that satisfies accreditation body expectations. Exercises use realistic laboratory scenarios so participants leave with templates and a self-assessment they can apply immediately.
Expected Learning Outcomes
Define rejection criteria for pre-examination samples and document them within a quality manual.
Validate or verify an examination method and calculate its measurement uncertainty budget.
Design an internal quality control scheme applying Westgard multirule logic to a specific test menu.
Establish calibration traceability for laboratory equipment to appropriate reference standards.
Plan and conduct an internal audit that produces defensible non-conformance and corrective action records.
Prepare a management review agenda and evidence pack that meets accreditation body expectations.
Who Should Attend
Laboratory quality managers preparing for initial or renewal ISO 15189 accreditation
Medical laboratory scientists responsible for method validation and quality control
Pathology directors overseeing multi-department laboratory accreditation programmes
Internal auditors assigned to laboratory quality management system reviews
Point-of-care testing coordinators extending accreditation scope to satellite sites
Regulatory affairs staff coordinating accreditation body submissions and assessor visits
Course Modules
Select any module to see its sessions and points.
01ISO 15189:2022 Framework and Accreditation Process
2 sessions · 8 points
Session 1Standard Structure and Scope Definition
- Map the management and technical requirement clauses of ISO 15189:2022 to laboratory functions.
- Define an accreditation scope statement that accurately reflects the tests a laboratory intends to offer.
- Distinguish requirements specific to point-of-care testing from core laboratory clauses.
- Compare ISO 15189 requirements with related standards such as ISO/IEC 17025 where dual scope applies.
Session 2Gap Analysis and Accreditation Application
- Run a structured gap analysis scoring current practice against each clause of the standard.
- Prioritise remediation actions by risk to patient results and assessor visibility.
- Prepare the formal application package and supporting evidence for an accreditation body.
- Plan a realistic timeline from gap analysis through document approval to the assessment visit.
02Pre-Examination, Examination and Post-Examination Process Control
2 sessions · 8 points
Session 1Sample Collection, Transport and Rejection Criteria
- Document sample collection, labelling and transport requirements for each specimen type handled.
- Define objective rejection criteria for haemolysis, clotting, mislabelling and transport time breaches.
- Design a specimen tracking process that maintains chain of custody from collection to disposal.
- Audit turnaround time from collection to result release against defined post-examination targets.
Session 2Method Validation, Verification and Measurement Uncertainty
- Distinguish when a method requires full validation versus verification against manufacturer claims.
- Design a validation protocol covering accuracy, precision, linearity and reportable range.
- Calculate a measurement uncertainty budget and express it correctly in patient-facing reports.
- Document method performance records in a format an assessor can trace end to end.
03Quality Control, Proficiency Testing and Equipment Management
2 sessions · 8 points
Session 1Internal Quality Control and Westgard Rules
- Configure an internal quality control scheme with appropriate control materials and run frequency.
- Apply Westgard multirule logic to distinguish random error from systematic shift or trend.
- Investigate and document a quality control failure before releasing affected patient results.
- Review quality control performance trends monthly to detect gradual analytical drift.
Session 2External Quality Assessment and Calibration Traceability
- Enrol test menus in appropriate external quality assessment or proficiency testing schemes.
- Investigate an unsatisfactory proficiency testing result and document the corrective action taken.
- Establish and record calibration traceability of equipment to national or international reference standards.
- Schedule preventive maintenance and calibration verification to prevent equipment-related non-conformances.
04Personnel Competency, Audits and Continual Improvement
2 sessions · 8 points
Session 1Competency Assessment and Document Control
- Design a competency assessment scheme covering direct observation, blind samples and record review.
- Maintain training and competency records that demonstrate ongoing staff capability to an assessor.
- Control document versions so only current, approved procedures are in use at each workstation.
- Plan competency reassessment intervals for new starters, returning staff and new methods introduced.
Session 2Internal Audit, Non-Conformance and Management Review
- Plan an internal audit schedule that covers every clause and department within the accreditation cycle.
- Classify and document non-conformances with root cause analysis and effectiveness checks on corrective action.
- Prepare a management review pack summarising audit results, complaints, risk and quality objectives.
- Track continual improvement actions between audit cycles to prevent recurring findings at reassessment.
What the participant receives
4 course modules
A structured syllabus
8 training sessions
across 5 days
32 detailed points
Applied, detailed content
Accredited attendance certificate
On completing the programme
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