Perform the ISO 15189:2022 Assessment using eAuditor
ISO 15189:2022 is an international standard that specifies the requirements for quality and competence in medical laboratories. It is designed to help clinical laboratories implement robust quality management systems (QMS) and ensure accurate, reliable, and timely patient test results. It replaces the previous 2012 version and aligns more closely with ISO 17025 and ISO 9001, focusing on risk management, patient safety, and continual improvement.
Performing the ISO 15189:2022 Assessment using eAuditor enables medical laboratories to systematically evaluate their quality management systems (QMS) and technical competence in alignment with the latest version of the standard. Through the use of eAuditor’s digital platform, laboratories can conduct comprehensive audits covering all phases of the laboratory workflow—pre-analytical, analytical, and post-analytical—while digitally capturing findings, assigning corrective actions, and generating audit-ready reports for accreditation readiness and continuous improvement.
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Planning the ISO 15189:2022 Assessment in eAuditor
1.1 Define the Audit Scope and Purpose
- Assessment Objectives:
- Evaluate conformance with ISO 15189:2022
- Identify gaps in laboratory practices and QMS
- Prepare for accreditation or re-accreditation
- Strengthen patient safety and risk mitigation
- Scope:
- Entire laboratory system or specific departments (e.g., Hematology, Microbiology)
- Full audit or focused internal audits (e.g., equipment calibration, staff training)
1.2 Gather Pre-Audit Documentation
Review essential documentation:
- Organizational charts and governance structure
- Quality manual and documented procedures
- Staff competency records and licenses
- Equipment calibration and maintenance logs
- Test method validation records
- Sample collection and handling procedures
- Internal and external quality control (IQC & EQC) data
- Incident reports, corrective action logs, and audit findings
1.3 Prepare a Digital eAuditor Checklist for ISO 15189:2022
Structure the checklist based on the standard’s main sections:
- General and structural requirements
- Resource and personnel requirements
- Pre-analytical, analytical, and post-analytical processes
- Risk management and continual improvement
- Documentation and QMS performance
Checklist features:
- Predefined responses (Compliant / Partial / Non-Compliant)
- Fields for detailed observations and notes
- Evidence attachments: SOPs, photos, calibration certificates
- Corrective action assignment (who, when, what)
- Sign-off and timestamp capabilities
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Executing the ISO 15189:2022 Assessment Using eAuditor
2.1 Assess Each Section of the Standard in Detail
- General & Structural Requirements
- Is the lab legally identifiable with clear accountability lines?
- Are impartiality and confidentiality policies enforced?
- Are ethical practices and data integrity maintained?
- Resource Requirements
- Are all personnel competent, trained, and licensed where applicable?
- Is there a system for ongoing training, evaluation, and requalification?
- Is the infrastructure (lighting, ventilation, space) appropriate for the services?
- Are IT systems validated, secure, and supported by backup protocols?
- Pre-Analytical Phase
- Are procedures for patient preparation, specimen collection, and labeling in place?
- Are sample transport, storage, and rejection criteria clearly defined?
- Is sample traceability ensured from collection to analysis?
- Analytical Phase
- Are validated, up-to-date test methods in use?
- Have quality control measures (IQC/EQC) been documented and reviewed routinely?
- Are reagents stored per manufacturer specs and monitored for expiry?
- Is equipment calibration verified and traceable to standards?
- Post-Analytical Phase
- Are results reviewed, validated, and reported in a timely manner?
- Have critical results been managed with urgency and documented communication?
- Are report formats clear, interpretable, and accessible?
- Risk Management & Continual Improvement
- Are risk assessments conducted for key lab activities?
- Have corrective/preventive actions been recorded and tracked for effectiveness?
- Are internal audits, incident investigations, and client feedback incorporated into management reviews?
- Management System and Documentation
- Is there a QMS that aligns with ISO 15189:2022?
- Are documents version-controlled, accessible, and regularly reviewed?
- Are KPIs (e.g., turnaround time, QC failures) monitored and acted upon?
2.2 Use eAuditor to Document and Validate Findings
- Use mobile devices or desktops to conduct audits on-site or remotely
- Attach digital evidence (SOPs, photos, signatures, certificates) in real time
- Capture comments, identify root causes, and tag locations or equipment
- Enable automatic scoring and rating based on compliance criteria
2.3 Assign and Track Corrective Actions
- Create tasks for each finding within the eAuditor app
- Assign roles, deadlines, and follow-up verification steps
- Monitor progress via the Actions dashboard
- Document resolution and evidence for closure
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Post-Audit Actions and Reporting
3.1 Generate the Assessment Report
eAuditor auto-generates a detailed audit report:
- Breakdown by ISO 15189 clause or section
- Compliance scores, audit notes, and embedded attachments
- Open and close actions with the responsible persons and due dates
- Report export options: PDF, Excel, or shareable cloud link
3.2 Close the Loop on Nonconformities
- Monitor action completion status
- Attach documentation (e.g., revised SOPs, re-training records)
- Use follow-up audits to confirm compliance restoration
- Integrate audit data into management reviews and QMS updates
3.3 Analyze Trends with eAuditor Analytics
- Identify recurring issues across lab units or over time
- Track key performance indicators (e.g., audit scores, action closures)
- Use graphs and visualizations for accreditation reports or internal dashboards
- Highlight patterns in compliance, risk, and improvement initiatives
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Key Elements to Include in Your ISO 15189:2022 Checklist in eAuditor
- Patient safety and ethics procedures
- Staff competency tracking and revalidation
- Sample handling SOPs and test turnaround compliance
- Calibration logs and QC documentation
- Complaint handling and incident management
- Risk registers and mitigation plans
- Document control logs and review schedules
- Management review meeting records and outcomes
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Benefits of Using eAuditor for ISO 15189:2022 Assessments
- Digitized, standardized assessments with clause-based checklists
- Mobile access for audits across departments or remote lab sites
- Real-time evidence capture, including photos, comments, and files
- Seamless action tracking for nonconformities and improvements
- Professional reporting for stakeholders, regulators, or accreditation bodies
- Insightful analytics to visualize performance and compliance trends
- Secure storage and traceability of audit history and actions
Summary
Conducting an ISO 15189:2022 Assessment using eAuditor equips clinical laboratories with a robust, efficient, and transparent system to evaluate and document their quality and competence. From digital checklists and real-time action tracking to automated reports and analytics, eAuditor helps ensure your laboratory is prepared for accreditation, driven by data, and committed to continuous improvement in patient-centered diagnostic services.