ISO 15189 Mastery The Complete Guide to Accreditation Excellence
You’re under pressure. Your lab faces increasing scrutiny, rising compliance demands, and the constant fear of audit failure. One missed clause, one overlooked procedure, and your entire accreditation timeline collapses. You’re not alone. Many lab directors, quality managers, and technical leads are stuck in reactive mode, rushing to fix gaps instead of building a sustainable system that wins confidence-and trust. The difference between struggling and succeeding isn’t effort. It’s clarity. The labs that pass smoothly, earn global recognition, and win funding don’t do so by accident. They follow a precise, proven blueprint for ISO 15189 compliance. And now, that blueprint is inside ISO 15189 Mastery The Complete Guide to Accreditation Excellence. This course transforms uncertainty into confidence. It’s the only program designed to take you from overwhelmed to audit-ready in under 90 days, with a fully documented quality management system, staff trained to ISO standards, and a board-ready accreditation roadmap. No guesswork. No wasted effort. Just structured, step-by-step guidance built on real-world implementation. Dr. Alicia Mwangi, a clinical laboratory manager in Nairobi, used this framework to achieve full accreditation for her 35-person lab on the first attempt-after years of failed internal audits. “We had external consultants charge us thousands, yet still miss critical gaps. This course laid it all out so clearly. We closed 28 non-conformities in six weeks and passed our final assessment with zero major findings.” Accreditation is no longer a risk. It’s your competitive advantage. Funders trust accredited labs. Regulators defer to them. Patients depend on them. When your lab holds ISO 15189 certification, you’re not just compliant. You’re recognised. Here’s how this course is structured to help you get there.Course Format & Delivery Details You need clarity, not complexity. That’s why ISO 15189 Mastery is designed for real professionals with real responsibilities. No rigid schedules. No outdated material. Just immediate, on-demand access to a self-paced, hands-on mastery path that works around your calendar-and your lab’s workflow. Key Features & Assurance
- Self-paced, on-demand access: Begin anytime. Progress at your own speed. No fixed deadlines or mandatory live sessions.
- Immediate online access: Enroll once and start immediately. Materials are available the moment you complete registration.
- Lifetime access: Revisit the content whenever you need-during audits, staff training, or future re-accreditation cycles. All future updates are included at no extra cost.
- Mobile-friendly, 24/7 global access: Learn from your lab, office, or home. The platform works seamlessly on smartphones, tablets, and desktops-anytime, anywhere.
- Typical completion in 8–12 weeks: Most learners implement core requirements within 60 days, with full readiness achieved by 90 days. Many report early results-such as identifying critical gaps-within the first week.
- Direct instructor support: You are not alone. Ask questions through integrated guidance channels and receive expert feedback from ISO 15189 practitioners with decades of accreditation experience.
- Certificate of Completion issued by The Art of Service: Upon finishing the course, you’ll earn a globally recognised certificate that validates your mastery of ISO 15189 requirements. This isn’t a participation badge. It’s proof of applied competence used by labs in 67 countries to strengthen credibility with regulators, partners, and funders.
- No hidden fees: The price you see is the price you pay. There are no renewals, upgrade traps, or surprise charges.
- Secure payment via Visa, Mastercard, PayPal: Enroll with complete financial flexibility and peace of mind.
- 30-day satisfaction guarantee: Try the course risk-free. If you find it doesn’t meet your expectations, request a full refund-no questions asked. Your success is guaranteed, or you get your money back.
- Post-enrolment process: After registration, you’ll receive a confirmation email. Your access details and onboarding instructions will be sent separately once your materials are fully prepared-ensuring you receive everything in the correct sequence for maximum learning impact.
Worried this won’t work for your lab? This program has been used by hospital labs, private diagnostic centres, research facilities, and public health networks across Africa, Asia, and Europe. It works even if your lab has never pursued accreditation before. It works even if you’ve failed a previous audit. It works even if you’re the only person managing quality. Because this isn’t theory. It’s battle-tested. Every module is refined from actual lab implementations, corrective action reports, and successful accreditation dossiers. If your lab performs testing-no matter the size or scope-this course fits. You’re protected at every level. Financial risk is eliminated. Time investment is minimised. Results are maximised. You’re not buying content. You’re gaining a strategic advantage with documentation, confidence, and a path to lab excellence.
Extensive and Detailed Course Curriculum
Module 1: Foundations of ISO 15189 and Accreditation Strategy - Introduction to ISO 15189 and its role in medical laboratory excellence
- Differences between ISO 15189 and other ISO standards (e.g. ISO 9001, ISO 17025)
- Understanding the global recognition and benefits of ISO 15189 accreditation
- Key stakeholders in the accreditation process: regulators, funders, patients, and staff
- Strategic planning: defining your lab’s readiness timeline and goals
- Assessing current compliance gaps using the pre-assessment checklist
- Building a business case for accreditation to secure leadership buy-in
- Creating a project charter with milestones, roles, and accountability
- Understanding the role of national accreditation bodies and their expectations
- Mapping accreditation to improved patient outcomes and operational efficiency
Module 2: Leadership and Organizational Structure for Compliance - Defining the laboratory’s governance model under ISO 15189
- Assigning clear roles: Technical Manager, Quality Manager, Competent Person
- Developing an organogram aligned with ISO 15189 requirements
- Establishing a management structure with delegation of authority
- Ensuring impartiality and independence in testing operations
- Managing conflicts of interest in laboratory decision-making
- Ensuring sufficient staffing and workload balance
- Linking leadership accountability to quality objectives
- Developing a lab mission, vision, and quality policy statement
- Communicating the quality policy to all staff members
Module 3: Document Control and the Quality Management System (QMS) - Overview of a compliant Quality Management System (QMS)
- Designing a document hierarchy: manual, procedures, work instructions, forms
- Creating a master document list with version control
- Implementing a document approval and review process
- Controlling external documents (e.g. manufacturer guidelines, regulatory updates)
- Establishing document retention and archiving policies
- Ensuring document accessibility and security
- Managing electronic document control systems
- Conducting internal audits of document control processes
- Correcting common document control deficiencies found in audits
Module 4: Risk Management and Opportunity Analysis - Understanding risk-based thinking in ISO 15189
- Conducting formal risk assessments for pre-analytical, analytical, and post-analytical phases
- Selecting and applying risk assessment tools: FMEA, SWOT, fishbone diagrams
- Documenting risk registers with impact, likelihood, and mitigation plans
- Linking risk control to Standard Operating Procedures (SOPs)
- Integrating risk reviews into management meetings
- Monitoring effectiveness of risk controls over time
- Identifying opportunities for improvement alongside risk mitigation
- Using risk data to prioritise quality objectives
- Reporting risk outcomes to senior management and accreditation bodies
Module 5: Personnel Competence and Training Programme - Defining roles and required competencies for each position
- Developing job descriptions aligned with ISO 15189 responsibilities
- Creating a training needs analysis for technical and support staff
- Designing an annual training schedule with traceable outcomes
- Implementing initial and ongoing competence assessments
- Documenting training records with dates, formats, and evaluations
- Using direct observation, written tests, and performance reviews
- Managing staff qualifications and certifications (e.g. licences, special tests)
- Handling staff performance issues and retraining plans
- Ensuring temporary and agency staff meet competence requirements
Module 6: Facility and Environmental Conditions - Designing laboratory layout for workflow and safety
- Controlling temperature, humidity, ventilation, and lighting
- Designating clean, pre-analytical, analytical, and hazardous zones
- Ensuring proper storage conditions for reagents and specimens
- Managing biohazard and waste handling areas
- Providing emergency exits, eye wash stations, and safety showers
- Ensuring accessibility for staff with disabilities
- Controlling access to restricted areas with logbooks or electronic systems
- Implementing security measures to protect patient data and specimens
- Conducting regular facility inspections and corrective actions
Module 7: Equipment Management and Calibration - Creating a master equipment inventory with specifications
- Establishing equipment commissioning and acceptance testing
- Scheduling preventive maintenance based on manufacturer and risk criteria
- Tracking maintenance with logs and service records
- Calibrating equipment according to traceable standards
- Implementing calibration labels with expiry dates
- Handling out-of-calibration events and patient result impact assessment
- Controlling software updates and version releases
- Managing equipment downtime and backup plans
- Disposing of equipment with data security and environmental compliance
Module 8: Pre-Analytical Phase: Sample Collection and Handling - Developing specimen collection SOPs by test type
- Training phlebotomists and ward staff on correct techniques
- Validating collection containers and anticoagulants
- Labelling specimens with patient identifiers and collection time
- Training on patient preparation (fasting, medication effects)
- Ensuring proper chain of custody for forensic and legal samples
- Managing home and satellite collection sites
- Setting acceptable and unacceptable sample criteria
- Documenting specimen rejection reasons and trends
- Establishing transport conditions: time, temperature, agitation
Module 9: Analytical Phase: Test Method Validation and Verification - Differentiating between method validation and verification
- Conducting precision, accuracy, linearity, and reportable range studies
- Establishing sensitivity, specificity, and limit of detection
- Verifying manufacturer claims for commercial kits
- Implementing measurement uncertainty calculations
- Setting decision thresholds and clinical cut-offs
- Handling modified or in-house developed tests
- Documenting validation reports with raw data and conclusions
- Managing inter-laboratory comparisons and proficiency testing
- Updating validation after major equipment or reagent changes
Module 10: Post-Analytical Phase: Reporting and Result Release - Designing result reports to meet ISO 15189 and clinical needs
- Ensuring report clarity, units, reference intervals, and interpretive comments
- Validating electronic result transmission (LIS, EMR, portals)
- Setting result authorisation workflows and responsible personnel
- Managing critical value reporting protocols with timeliness logs
- Handling amended reports with change tracking and notifications
- Protecting patient confidentiality in all reports
- Controlling report formats across departments and platforms
- Archiving reports with retrieval capability
- Monitoring result turnaround times and improving delays
Module 11: External Quality Assessment (EQA) and Proficiency Testing - Selecting accredited EQA providers by test discipline
- Enrolling in appropriate frequency and panel sizes
- Handling EQA samples as routine patient specimens
- Analysing EQA results and identifying performance trends
- Investigating poor performance and implementing corrective actions
- Documenting EQA participation and outcomes in the QMS
- Linking EQA findings to staff training and method reviews
- Preparing EQA data for auditor review
- Using EQA to validate test method stability
- Addressing EQA non-conformities before accreditation audits
Module 12: Internal Audits and Self-Assessment - Developing an internal audit programme with annual schedule
- Selecting and training internal auditors with impartiality
- Creating audit checklists based on ISO 15189 clauses
- Conducting opening and closing meetings with departments
- Gathering objective evidence through observation and records
- Writing non-conformity statements with objective, evidence-based language
- Classifying minor, major, and critical findings
- Tracking corrective actions with root cause analysis
- Verifying effectiveness of implemented actions
- Using audit findings to improve the QMS continuously
Module 13: Management Review Meetings - Scheduling and preparing for formal management reviews
- Agenda development: including key performance indicators, audits, risks
- Compiling reports from quality, technical, and operational leads
- Presenting trends in complaints, errors, EQA, and turnaround times
- Reviewing resource adequacy: staffing, equipment, space
- Updating quality objectives and action plans annually
- Tracking progress on previous meeting action items
- Documenting decisions, attendees, and follow-up responsibilities
- Distributing minutes to all relevant stakeholders
- Linking management review outcomes to strategic planning
Module 14: Complaints, Non-Conformities, and Corrective Actions - Establishing a complaints handling procedure with timeliness
- Logging all complaints: patient, clinician, internal, regulatory
- Investigating root causes using 5 Whys or fishbone analysis
- Developing corrective and preventive action (CAPA) plans
- Implementing interim containment actions
- Verifying long-term effectiveness of corrective actions
- Reporting complaint trends in management reviews
- Using complaints to improve SOPs, training, and systems
- Documenting non-conformities from audits, EQA, and inspections
- Building a closed-loop system for continuous quality improvement
Module 15: Preparing for the External Accreditation Audit - Understanding the accreditation body’s audit process and timeline
- Submitting necessary documentation in advance
- Preparing staff for auditor interviews and walkthroughs
- Conducting mock audits with external assessors
- Organising the audit file: master list, evidence logs, QMS documents
- Preparing the audit room with records, policies, and equipment logs
- Assigning roles: guide, technical expert, documentation assistant
- Practicing communication protocols during the audit
- Anticipating common auditor questions by clause
- Creating a real-time findings tracking sheet for the audit team
Module 16: Post-Audit Actions and Sustaining Compliance - Reviewing the audit report and classification of findings
- Drafting a formal response to the accreditation body
- Developing an action plan for non-conformities with deadlines
- Submitting evidence of corrective actions within required timelines
- Preparing for possible surveillance or follow-up audits
- Updating the QMS based on audit feedback
- Incorporating lessons learned into staff training
- Establishing a compliance monitoring dashboard
- Scheduling ongoing internal audits and staff assessments
- Planning for re-accreditation every 2–3 years
Module 17: Integrating ISO 15189 with Other Systems (LIS, ERP, QMS) - Mapping ISO 15189 requirements to Laboratory Information System (LIS) capabilities
- Validating electronic data integrity and audit trails
- Integrating quality indicators into reporting dashboards
- Ensuring user access controls and role-based permissions
- Managing electronic signatures and record approvals
- Aligning ERP procurement processes with equipment and reagent controls
- Using digital workflows for document approval and training tracking
- Implementing barcode and RFID systems for sample traceability
- Ensuring data backup and recovery protocols
- Complying with cybersecurity and data protection regulations (e.g. HIPAA, GDPR)
Module 18: Special Considerations for Point-of-Care Testing (POCT) - Extending ISO 15189 principles to decentralised testing units
- Establishing oversight for POCT devices across wards
- Validating POCT devices and reagents
- Training non-laboratory staff to required competency levels
- Monitoring POCT quality with internal and external controls
- Conducting regular site visits and audits of POCT locations
- Integrating POCT results into the central LIS
- Managing device maintenance and software updates
- Ensuring specimen labelling and documentation compliance
- Addressing regulatory expectations for POCT accreditation
Module 19: Certification, Recognition, and Career Advancement - Understanding the final steps to official ISO 15189 certification
- Publicising accreditation to clinicians, patients, and funders
- Using certification in proposals, tenders, and funding applications
- Leveraging certification for partnerships and network inclusion
- Becoming a recognised trainer or assessor in your region
- Transitioning from Quality Officer to Quality Manager with documented expertise
- Using The Art of Service Certificate of Completion in performance reviews
- Expanding your professional network through accreditation forums
- Positioning yourself for roles in national reference labs or policy development
- Preparing for advanced certifications (e.g. lead auditor, consultant)
Module 20: Lifelong Mastery and Continuous Improvement - Building a culture of quality across all laboratory functions
- Encouraging staff ownership of compliance and improvement
- Using Kaizen and Lean principles in daily operations
- Tracking leading and lagging quality indicators
- Implementing staff recognition for quality contributions
- Conducting regular gap analyses against updated standards
- Subscribing to international updates on ISO 15189
- Joining global quality collaboratives and forums
- Revisiting course materials annually as part of your QMS review
- Adapting to emerging technologies: AI, automation, digital diagnostics
Module 1: Foundations of ISO 15189 and Accreditation Strategy - Introduction to ISO 15189 and its role in medical laboratory excellence
- Differences between ISO 15189 and other ISO standards (e.g. ISO 9001, ISO 17025)
- Understanding the global recognition and benefits of ISO 15189 accreditation
- Key stakeholders in the accreditation process: regulators, funders, patients, and staff
- Strategic planning: defining your lab’s readiness timeline and goals
- Assessing current compliance gaps using the pre-assessment checklist
- Building a business case for accreditation to secure leadership buy-in
- Creating a project charter with milestones, roles, and accountability
- Understanding the role of national accreditation bodies and their expectations
- Mapping accreditation to improved patient outcomes and operational efficiency
Module 2: Leadership and Organizational Structure for Compliance - Defining the laboratory’s governance model under ISO 15189
- Assigning clear roles: Technical Manager, Quality Manager, Competent Person
- Developing an organogram aligned with ISO 15189 requirements
- Establishing a management structure with delegation of authority
- Ensuring impartiality and independence in testing operations
- Managing conflicts of interest in laboratory decision-making
- Ensuring sufficient staffing and workload balance
- Linking leadership accountability to quality objectives
- Developing a lab mission, vision, and quality policy statement
- Communicating the quality policy to all staff members
Module 3: Document Control and the Quality Management System (QMS) - Overview of a compliant Quality Management System (QMS)
- Designing a document hierarchy: manual, procedures, work instructions, forms
- Creating a master document list with version control
- Implementing a document approval and review process
- Controlling external documents (e.g. manufacturer guidelines, regulatory updates)
- Establishing document retention and archiving policies
- Ensuring document accessibility and security
- Managing electronic document control systems
- Conducting internal audits of document control processes
- Correcting common document control deficiencies found in audits
Module 4: Risk Management and Opportunity Analysis - Understanding risk-based thinking in ISO 15189
- Conducting formal risk assessments for pre-analytical, analytical, and post-analytical phases
- Selecting and applying risk assessment tools: FMEA, SWOT, fishbone diagrams
- Documenting risk registers with impact, likelihood, and mitigation plans
- Linking risk control to Standard Operating Procedures (SOPs)
- Integrating risk reviews into management meetings
- Monitoring effectiveness of risk controls over time
- Identifying opportunities for improvement alongside risk mitigation
- Using risk data to prioritise quality objectives
- Reporting risk outcomes to senior management and accreditation bodies
Module 5: Personnel Competence and Training Programme - Defining roles and required competencies for each position
- Developing job descriptions aligned with ISO 15189 responsibilities
- Creating a training needs analysis for technical and support staff
- Designing an annual training schedule with traceable outcomes
- Implementing initial and ongoing competence assessments
- Documenting training records with dates, formats, and evaluations
- Using direct observation, written tests, and performance reviews
- Managing staff qualifications and certifications (e.g. licences, special tests)
- Handling staff performance issues and retraining plans
- Ensuring temporary and agency staff meet competence requirements
Module 6: Facility and Environmental Conditions - Designing laboratory layout for workflow and safety
- Controlling temperature, humidity, ventilation, and lighting
- Designating clean, pre-analytical, analytical, and hazardous zones
- Ensuring proper storage conditions for reagents and specimens
- Managing biohazard and waste handling areas
- Providing emergency exits, eye wash stations, and safety showers
- Ensuring accessibility for staff with disabilities
- Controlling access to restricted areas with logbooks or electronic systems
- Implementing security measures to protect patient data and specimens
- Conducting regular facility inspections and corrective actions
Module 7: Equipment Management and Calibration - Creating a master equipment inventory with specifications
- Establishing equipment commissioning and acceptance testing
- Scheduling preventive maintenance based on manufacturer and risk criteria
- Tracking maintenance with logs and service records
- Calibrating equipment according to traceable standards
- Implementing calibration labels with expiry dates
- Handling out-of-calibration events and patient result impact assessment
- Controlling software updates and version releases
- Managing equipment downtime and backup plans
- Disposing of equipment with data security and environmental compliance
Module 8: Pre-Analytical Phase: Sample Collection and Handling - Developing specimen collection SOPs by test type
- Training phlebotomists and ward staff on correct techniques
- Validating collection containers and anticoagulants
- Labelling specimens with patient identifiers and collection time
- Training on patient preparation (fasting, medication effects)
- Ensuring proper chain of custody for forensic and legal samples
- Managing home and satellite collection sites
- Setting acceptable and unacceptable sample criteria
- Documenting specimen rejection reasons and trends
- Establishing transport conditions: time, temperature, agitation
Module 9: Analytical Phase: Test Method Validation and Verification - Differentiating between method validation and verification
- Conducting precision, accuracy, linearity, and reportable range studies
- Establishing sensitivity, specificity, and limit of detection
- Verifying manufacturer claims for commercial kits
- Implementing measurement uncertainty calculations
- Setting decision thresholds and clinical cut-offs
- Handling modified or in-house developed tests
- Documenting validation reports with raw data and conclusions
- Managing inter-laboratory comparisons and proficiency testing
- Updating validation after major equipment or reagent changes
Module 10: Post-Analytical Phase: Reporting and Result Release - Designing result reports to meet ISO 15189 and clinical needs
- Ensuring report clarity, units, reference intervals, and interpretive comments
- Validating electronic result transmission (LIS, EMR, portals)
- Setting result authorisation workflows and responsible personnel
- Managing critical value reporting protocols with timeliness logs
- Handling amended reports with change tracking and notifications
- Protecting patient confidentiality in all reports
- Controlling report formats across departments and platforms
- Archiving reports with retrieval capability
- Monitoring result turnaround times and improving delays
Module 11: External Quality Assessment (EQA) and Proficiency Testing - Selecting accredited EQA providers by test discipline
- Enrolling in appropriate frequency and panel sizes
- Handling EQA samples as routine patient specimens
- Analysing EQA results and identifying performance trends
- Investigating poor performance and implementing corrective actions
- Documenting EQA participation and outcomes in the QMS
- Linking EQA findings to staff training and method reviews
- Preparing EQA data for auditor review
- Using EQA to validate test method stability
- Addressing EQA non-conformities before accreditation audits
Module 12: Internal Audits and Self-Assessment - Developing an internal audit programme with annual schedule
- Selecting and training internal auditors with impartiality
- Creating audit checklists based on ISO 15189 clauses
- Conducting opening and closing meetings with departments
- Gathering objective evidence through observation and records
- Writing non-conformity statements with objective, evidence-based language
- Classifying minor, major, and critical findings
- Tracking corrective actions with root cause analysis
- Verifying effectiveness of implemented actions
- Using audit findings to improve the QMS continuously
Module 13: Management Review Meetings - Scheduling and preparing for formal management reviews
- Agenda development: including key performance indicators, audits, risks
- Compiling reports from quality, technical, and operational leads
- Presenting trends in complaints, errors, EQA, and turnaround times
- Reviewing resource adequacy: staffing, equipment, space
- Updating quality objectives and action plans annually
- Tracking progress on previous meeting action items
- Documenting decisions, attendees, and follow-up responsibilities
- Distributing minutes to all relevant stakeholders
- Linking management review outcomes to strategic planning
Module 14: Complaints, Non-Conformities, and Corrective Actions - Establishing a complaints handling procedure with timeliness
- Logging all complaints: patient, clinician, internal, regulatory
- Investigating root causes using 5 Whys or fishbone analysis
- Developing corrective and preventive action (CAPA) plans
- Implementing interim containment actions
- Verifying long-term effectiveness of corrective actions
- Reporting complaint trends in management reviews
- Using complaints to improve SOPs, training, and systems
- Documenting non-conformities from audits, EQA, and inspections
- Building a closed-loop system for continuous quality improvement
Module 15: Preparing for the External Accreditation Audit - Understanding the accreditation body’s audit process and timeline
- Submitting necessary documentation in advance
- Preparing staff for auditor interviews and walkthroughs
- Conducting mock audits with external assessors
- Organising the audit file: master list, evidence logs, QMS documents
- Preparing the audit room with records, policies, and equipment logs
- Assigning roles: guide, technical expert, documentation assistant
- Practicing communication protocols during the audit
- Anticipating common auditor questions by clause
- Creating a real-time findings tracking sheet for the audit team
Module 16: Post-Audit Actions and Sustaining Compliance - Reviewing the audit report and classification of findings
- Drafting a formal response to the accreditation body
- Developing an action plan for non-conformities with deadlines
- Submitting evidence of corrective actions within required timelines
- Preparing for possible surveillance or follow-up audits
- Updating the QMS based on audit feedback
- Incorporating lessons learned into staff training
- Establishing a compliance monitoring dashboard
- Scheduling ongoing internal audits and staff assessments
- Planning for re-accreditation every 2–3 years
Module 17: Integrating ISO 15189 with Other Systems (LIS, ERP, QMS) - Mapping ISO 15189 requirements to Laboratory Information System (LIS) capabilities
- Validating electronic data integrity and audit trails
- Integrating quality indicators into reporting dashboards
- Ensuring user access controls and role-based permissions
- Managing electronic signatures and record approvals
- Aligning ERP procurement processes with equipment and reagent controls
- Using digital workflows for document approval and training tracking
- Implementing barcode and RFID systems for sample traceability
- Ensuring data backup and recovery protocols
- Complying with cybersecurity and data protection regulations (e.g. HIPAA, GDPR)
Module 18: Special Considerations for Point-of-Care Testing (POCT) - Extending ISO 15189 principles to decentralised testing units
- Establishing oversight for POCT devices across wards
- Validating POCT devices and reagents
- Training non-laboratory staff to required competency levels
- Monitoring POCT quality with internal and external controls
- Conducting regular site visits and audits of POCT locations
- Integrating POCT results into the central LIS
- Managing device maintenance and software updates
- Ensuring specimen labelling and documentation compliance
- Addressing regulatory expectations for POCT accreditation
Module 19: Certification, Recognition, and Career Advancement - Understanding the final steps to official ISO 15189 certification
- Publicising accreditation to clinicians, patients, and funders
- Using certification in proposals, tenders, and funding applications
- Leveraging certification for partnerships and network inclusion
- Becoming a recognised trainer or assessor in your region
- Transitioning from Quality Officer to Quality Manager with documented expertise
- Using The Art of Service Certificate of Completion in performance reviews
- Expanding your professional network through accreditation forums
- Positioning yourself for roles in national reference labs or policy development
- Preparing for advanced certifications (e.g. lead auditor, consultant)
Module 20: Lifelong Mastery and Continuous Improvement - Building a culture of quality across all laboratory functions
- Encouraging staff ownership of compliance and improvement
- Using Kaizen and Lean principles in daily operations
- Tracking leading and lagging quality indicators
- Implementing staff recognition for quality contributions
- Conducting regular gap analyses against updated standards
- Subscribing to international updates on ISO 15189
- Joining global quality collaboratives and forums
- Revisiting course materials annually as part of your QMS review
- Adapting to emerging technologies: AI, automation, digital diagnostics
- Defining the laboratory’s governance model under ISO 15189
- Assigning clear roles: Technical Manager, Quality Manager, Competent Person
- Developing an organogram aligned with ISO 15189 requirements
- Establishing a management structure with delegation of authority
- Ensuring impartiality and independence in testing operations
- Managing conflicts of interest in laboratory decision-making
- Ensuring sufficient staffing and workload balance
- Linking leadership accountability to quality objectives
- Developing a lab mission, vision, and quality policy statement
- Communicating the quality policy to all staff members
Module 3: Document Control and the Quality Management System (QMS) - Overview of a compliant Quality Management System (QMS)
- Designing a document hierarchy: manual, procedures, work instructions, forms
- Creating a master document list with version control
- Implementing a document approval and review process
- Controlling external documents (e.g. manufacturer guidelines, regulatory updates)
- Establishing document retention and archiving policies
- Ensuring document accessibility and security
- Managing electronic document control systems
- Conducting internal audits of document control processes
- Correcting common document control deficiencies found in audits
Module 4: Risk Management and Opportunity Analysis - Understanding risk-based thinking in ISO 15189
- Conducting formal risk assessments for pre-analytical, analytical, and post-analytical phases
- Selecting and applying risk assessment tools: FMEA, SWOT, fishbone diagrams
- Documenting risk registers with impact, likelihood, and mitigation plans
- Linking risk control to Standard Operating Procedures (SOPs)
- Integrating risk reviews into management meetings
- Monitoring effectiveness of risk controls over time
- Identifying opportunities for improvement alongside risk mitigation
- Using risk data to prioritise quality objectives
- Reporting risk outcomes to senior management and accreditation bodies
Module 5: Personnel Competence and Training Programme - Defining roles and required competencies for each position
- Developing job descriptions aligned with ISO 15189 responsibilities
- Creating a training needs analysis for technical and support staff
- Designing an annual training schedule with traceable outcomes
- Implementing initial and ongoing competence assessments
- Documenting training records with dates, formats, and evaluations
- Using direct observation, written tests, and performance reviews
- Managing staff qualifications and certifications (e.g. licences, special tests)
- Handling staff performance issues and retraining plans
- Ensuring temporary and agency staff meet competence requirements
Module 6: Facility and Environmental Conditions - Designing laboratory layout for workflow and safety
- Controlling temperature, humidity, ventilation, and lighting
- Designating clean, pre-analytical, analytical, and hazardous zones
- Ensuring proper storage conditions for reagents and specimens
- Managing biohazard and waste handling areas
- Providing emergency exits, eye wash stations, and safety showers
- Ensuring accessibility for staff with disabilities
- Controlling access to restricted areas with logbooks or electronic systems
- Implementing security measures to protect patient data and specimens
- Conducting regular facility inspections and corrective actions
Module 7: Equipment Management and Calibration - Creating a master equipment inventory with specifications
- Establishing equipment commissioning and acceptance testing
- Scheduling preventive maintenance based on manufacturer and risk criteria
- Tracking maintenance with logs and service records
- Calibrating equipment according to traceable standards
- Implementing calibration labels with expiry dates
- Handling out-of-calibration events and patient result impact assessment
- Controlling software updates and version releases
- Managing equipment downtime and backup plans
- Disposing of equipment with data security and environmental compliance
Module 8: Pre-Analytical Phase: Sample Collection and Handling - Developing specimen collection SOPs by test type
- Training phlebotomists and ward staff on correct techniques
- Validating collection containers and anticoagulants
- Labelling specimens with patient identifiers and collection time
- Training on patient preparation (fasting, medication effects)
- Ensuring proper chain of custody for forensic and legal samples
- Managing home and satellite collection sites
- Setting acceptable and unacceptable sample criteria
- Documenting specimen rejection reasons and trends
- Establishing transport conditions: time, temperature, agitation
Module 9: Analytical Phase: Test Method Validation and Verification - Differentiating between method validation and verification
- Conducting precision, accuracy, linearity, and reportable range studies
- Establishing sensitivity, specificity, and limit of detection
- Verifying manufacturer claims for commercial kits
- Implementing measurement uncertainty calculations
- Setting decision thresholds and clinical cut-offs
- Handling modified or in-house developed tests
- Documenting validation reports with raw data and conclusions
- Managing inter-laboratory comparisons and proficiency testing
- Updating validation after major equipment or reagent changes
Module 10: Post-Analytical Phase: Reporting and Result Release - Designing result reports to meet ISO 15189 and clinical needs
- Ensuring report clarity, units, reference intervals, and interpretive comments
- Validating electronic result transmission (LIS, EMR, portals)
- Setting result authorisation workflows and responsible personnel
- Managing critical value reporting protocols with timeliness logs
- Handling amended reports with change tracking and notifications
- Protecting patient confidentiality in all reports
- Controlling report formats across departments and platforms
- Archiving reports with retrieval capability
- Monitoring result turnaround times and improving delays
Module 11: External Quality Assessment (EQA) and Proficiency Testing - Selecting accredited EQA providers by test discipline
- Enrolling in appropriate frequency and panel sizes
- Handling EQA samples as routine patient specimens
- Analysing EQA results and identifying performance trends
- Investigating poor performance and implementing corrective actions
- Documenting EQA participation and outcomes in the QMS
- Linking EQA findings to staff training and method reviews
- Preparing EQA data for auditor review
- Using EQA to validate test method stability
- Addressing EQA non-conformities before accreditation audits
Module 12: Internal Audits and Self-Assessment - Developing an internal audit programme with annual schedule
- Selecting and training internal auditors with impartiality
- Creating audit checklists based on ISO 15189 clauses
- Conducting opening and closing meetings with departments
- Gathering objective evidence through observation and records
- Writing non-conformity statements with objective, evidence-based language
- Classifying minor, major, and critical findings
- Tracking corrective actions with root cause analysis
- Verifying effectiveness of implemented actions
- Using audit findings to improve the QMS continuously
Module 13: Management Review Meetings - Scheduling and preparing for formal management reviews
- Agenda development: including key performance indicators, audits, risks
- Compiling reports from quality, technical, and operational leads
- Presenting trends in complaints, errors, EQA, and turnaround times
- Reviewing resource adequacy: staffing, equipment, space
- Updating quality objectives and action plans annually
- Tracking progress on previous meeting action items
- Documenting decisions, attendees, and follow-up responsibilities
- Distributing minutes to all relevant stakeholders
- Linking management review outcomes to strategic planning
Module 14: Complaints, Non-Conformities, and Corrective Actions - Establishing a complaints handling procedure with timeliness
- Logging all complaints: patient, clinician, internal, regulatory
- Investigating root causes using 5 Whys or fishbone analysis
- Developing corrective and preventive action (CAPA) plans
- Implementing interim containment actions
- Verifying long-term effectiveness of corrective actions
- Reporting complaint trends in management reviews
- Using complaints to improve SOPs, training, and systems
- Documenting non-conformities from audits, EQA, and inspections
- Building a closed-loop system for continuous quality improvement
Module 15: Preparing for the External Accreditation Audit - Understanding the accreditation body’s audit process and timeline
- Submitting necessary documentation in advance
- Preparing staff for auditor interviews and walkthroughs
- Conducting mock audits with external assessors
- Organising the audit file: master list, evidence logs, QMS documents
- Preparing the audit room with records, policies, and equipment logs
- Assigning roles: guide, technical expert, documentation assistant
- Practicing communication protocols during the audit
- Anticipating common auditor questions by clause
- Creating a real-time findings tracking sheet for the audit team
Module 16: Post-Audit Actions and Sustaining Compliance - Reviewing the audit report and classification of findings
- Drafting a formal response to the accreditation body
- Developing an action plan for non-conformities with deadlines
- Submitting evidence of corrective actions within required timelines
- Preparing for possible surveillance or follow-up audits
- Updating the QMS based on audit feedback
- Incorporating lessons learned into staff training
- Establishing a compliance monitoring dashboard
- Scheduling ongoing internal audits and staff assessments
- Planning for re-accreditation every 2–3 years
Module 17: Integrating ISO 15189 with Other Systems (LIS, ERP, QMS) - Mapping ISO 15189 requirements to Laboratory Information System (LIS) capabilities
- Validating electronic data integrity and audit trails
- Integrating quality indicators into reporting dashboards
- Ensuring user access controls and role-based permissions
- Managing electronic signatures and record approvals
- Aligning ERP procurement processes with equipment and reagent controls
- Using digital workflows for document approval and training tracking
- Implementing barcode and RFID systems for sample traceability
- Ensuring data backup and recovery protocols
- Complying with cybersecurity and data protection regulations (e.g. HIPAA, GDPR)
Module 18: Special Considerations for Point-of-Care Testing (POCT) - Extending ISO 15189 principles to decentralised testing units
- Establishing oversight for POCT devices across wards
- Validating POCT devices and reagents
- Training non-laboratory staff to required competency levels
- Monitoring POCT quality with internal and external controls
- Conducting regular site visits and audits of POCT locations
- Integrating POCT results into the central LIS
- Managing device maintenance and software updates
- Ensuring specimen labelling and documentation compliance
- Addressing regulatory expectations for POCT accreditation
Module 19: Certification, Recognition, and Career Advancement - Understanding the final steps to official ISO 15189 certification
- Publicising accreditation to clinicians, patients, and funders
- Using certification in proposals, tenders, and funding applications
- Leveraging certification for partnerships and network inclusion
- Becoming a recognised trainer or assessor in your region
- Transitioning from Quality Officer to Quality Manager with documented expertise
- Using The Art of Service Certificate of Completion in performance reviews
- Expanding your professional network through accreditation forums
- Positioning yourself for roles in national reference labs or policy development
- Preparing for advanced certifications (e.g. lead auditor, consultant)
Module 20: Lifelong Mastery and Continuous Improvement - Building a culture of quality across all laboratory functions
- Encouraging staff ownership of compliance and improvement
- Using Kaizen and Lean principles in daily operations
- Tracking leading and lagging quality indicators
- Implementing staff recognition for quality contributions
- Conducting regular gap analyses against updated standards
- Subscribing to international updates on ISO 15189
- Joining global quality collaboratives and forums
- Revisiting course materials annually as part of your QMS review
- Adapting to emerging technologies: AI, automation, digital diagnostics
- Understanding risk-based thinking in ISO 15189
- Conducting formal risk assessments for pre-analytical, analytical, and post-analytical phases
- Selecting and applying risk assessment tools: FMEA, SWOT, fishbone diagrams
- Documenting risk registers with impact, likelihood, and mitigation plans
- Linking risk control to Standard Operating Procedures (SOPs)
- Integrating risk reviews into management meetings
- Monitoring effectiveness of risk controls over time
- Identifying opportunities for improvement alongside risk mitigation
- Using risk data to prioritise quality objectives
- Reporting risk outcomes to senior management and accreditation bodies
Module 5: Personnel Competence and Training Programme - Defining roles and required competencies for each position
- Developing job descriptions aligned with ISO 15189 responsibilities
- Creating a training needs analysis for technical and support staff
- Designing an annual training schedule with traceable outcomes
- Implementing initial and ongoing competence assessments
- Documenting training records with dates, formats, and evaluations
- Using direct observation, written tests, and performance reviews
- Managing staff qualifications and certifications (e.g. licences, special tests)
- Handling staff performance issues and retraining plans
- Ensuring temporary and agency staff meet competence requirements
Module 6: Facility and Environmental Conditions - Designing laboratory layout for workflow and safety
- Controlling temperature, humidity, ventilation, and lighting
- Designating clean, pre-analytical, analytical, and hazardous zones
- Ensuring proper storage conditions for reagents and specimens
- Managing biohazard and waste handling areas
- Providing emergency exits, eye wash stations, and safety showers
- Ensuring accessibility for staff with disabilities
- Controlling access to restricted areas with logbooks or electronic systems
- Implementing security measures to protect patient data and specimens
- Conducting regular facility inspections and corrective actions
Module 7: Equipment Management and Calibration - Creating a master equipment inventory with specifications
- Establishing equipment commissioning and acceptance testing
- Scheduling preventive maintenance based on manufacturer and risk criteria
- Tracking maintenance with logs and service records
- Calibrating equipment according to traceable standards
- Implementing calibration labels with expiry dates
- Handling out-of-calibration events and patient result impact assessment
- Controlling software updates and version releases
- Managing equipment downtime and backup plans
- Disposing of equipment with data security and environmental compliance
Module 8: Pre-Analytical Phase: Sample Collection and Handling - Developing specimen collection SOPs by test type
- Training phlebotomists and ward staff on correct techniques
- Validating collection containers and anticoagulants
- Labelling specimens with patient identifiers and collection time
- Training on patient preparation (fasting, medication effects)
- Ensuring proper chain of custody for forensic and legal samples
- Managing home and satellite collection sites
- Setting acceptable and unacceptable sample criteria
- Documenting specimen rejection reasons and trends
- Establishing transport conditions: time, temperature, agitation
Module 9: Analytical Phase: Test Method Validation and Verification - Differentiating between method validation and verification
- Conducting precision, accuracy, linearity, and reportable range studies
- Establishing sensitivity, specificity, and limit of detection
- Verifying manufacturer claims for commercial kits
- Implementing measurement uncertainty calculations
- Setting decision thresholds and clinical cut-offs
- Handling modified or in-house developed tests
- Documenting validation reports with raw data and conclusions
- Managing inter-laboratory comparisons and proficiency testing
- Updating validation after major equipment or reagent changes
Module 10: Post-Analytical Phase: Reporting and Result Release - Designing result reports to meet ISO 15189 and clinical needs
- Ensuring report clarity, units, reference intervals, and interpretive comments
- Validating electronic result transmission (LIS, EMR, portals)
- Setting result authorisation workflows and responsible personnel
- Managing critical value reporting protocols with timeliness logs
- Handling amended reports with change tracking and notifications
- Protecting patient confidentiality in all reports
- Controlling report formats across departments and platforms
- Archiving reports with retrieval capability
- Monitoring result turnaround times and improving delays
Module 11: External Quality Assessment (EQA) and Proficiency Testing - Selecting accredited EQA providers by test discipline
- Enrolling in appropriate frequency and panel sizes
- Handling EQA samples as routine patient specimens
- Analysing EQA results and identifying performance trends
- Investigating poor performance and implementing corrective actions
- Documenting EQA participation and outcomes in the QMS
- Linking EQA findings to staff training and method reviews
- Preparing EQA data for auditor review
- Using EQA to validate test method stability
- Addressing EQA non-conformities before accreditation audits
Module 12: Internal Audits and Self-Assessment - Developing an internal audit programme with annual schedule
- Selecting and training internal auditors with impartiality
- Creating audit checklists based on ISO 15189 clauses
- Conducting opening and closing meetings with departments
- Gathering objective evidence through observation and records
- Writing non-conformity statements with objective, evidence-based language
- Classifying minor, major, and critical findings
- Tracking corrective actions with root cause analysis
- Verifying effectiveness of implemented actions
- Using audit findings to improve the QMS continuously
Module 13: Management Review Meetings - Scheduling and preparing for formal management reviews
- Agenda development: including key performance indicators, audits, risks
- Compiling reports from quality, technical, and operational leads
- Presenting trends in complaints, errors, EQA, and turnaround times
- Reviewing resource adequacy: staffing, equipment, space
- Updating quality objectives and action plans annually
- Tracking progress on previous meeting action items
- Documenting decisions, attendees, and follow-up responsibilities
- Distributing minutes to all relevant stakeholders
- Linking management review outcomes to strategic planning
Module 14: Complaints, Non-Conformities, and Corrective Actions - Establishing a complaints handling procedure with timeliness
- Logging all complaints: patient, clinician, internal, regulatory
- Investigating root causes using 5 Whys or fishbone analysis
- Developing corrective and preventive action (CAPA) plans
- Implementing interim containment actions
- Verifying long-term effectiveness of corrective actions
- Reporting complaint trends in management reviews
- Using complaints to improve SOPs, training, and systems
- Documenting non-conformities from audits, EQA, and inspections
- Building a closed-loop system for continuous quality improvement
Module 15: Preparing for the External Accreditation Audit - Understanding the accreditation body’s audit process and timeline
- Submitting necessary documentation in advance
- Preparing staff for auditor interviews and walkthroughs
- Conducting mock audits with external assessors
- Organising the audit file: master list, evidence logs, QMS documents
- Preparing the audit room with records, policies, and equipment logs
- Assigning roles: guide, technical expert, documentation assistant
- Practicing communication protocols during the audit
- Anticipating common auditor questions by clause
- Creating a real-time findings tracking sheet for the audit team
Module 16: Post-Audit Actions and Sustaining Compliance - Reviewing the audit report and classification of findings
- Drafting a formal response to the accreditation body
- Developing an action plan for non-conformities with deadlines
- Submitting evidence of corrective actions within required timelines
- Preparing for possible surveillance or follow-up audits
- Updating the QMS based on audit feedback
- Incorporating lessons learned into staff training
- Establishing a compliance monitoring dashboard
- Scheduling ongoing internal audits and staff assessments
- Planning for re-accreditation every 2–3 years
Module 17: Integrating ISO 15189 with Other Systems (LIS, ERP, QMS) - Mapping ISO 15189 requirements to Laboratory Information System (LIS) capabilities
- Validating electronic data integrity and audit trails
- Integrating quality indicators into reporting dashboards
- Ensuring user access controls and role-based permissions
- Managing electronic signatures and record approvals
- Aligning ERP procurement processes with equipment and reagent controls
- Using digital workflows for document approval and training tracking
- Implementing barcode and RFID systems for sample traceability
- Ensuring data backup and recovery protocols
- Complying with cybersecurity and data protection regulations (e.g. HIPAA, GDPR)
Module 18: Special Considerations for Point-of-Care Testing (POCT) - Extending ISO 15189 principles to decentralised testing units
- Establishing oversight for POCT devices across wards
- Validating POCT devices and reagents
- Training non-laboratory staff to required competency levels
- Monitoring POCT quality with internal and external controls
- Conducting regular site visits and audits of POCT locations
- Integrating POCT results into the central LIS
- Managing device maintenance and software updates
- Ensuring specimen labelling and documentation compliance
- Addressing regulatory expectations for POCT accreditation
Module 19: Certification, Recognition, and Career Advancement - Understanding the final steps to official ISO 15189 certification
- Publicising accreditation to clinicians, patients, and funders
- Using certification in proposals, tenders, and funding applications
- Leveraging certification for partnerships and network inclusion
- Becoming a recognised trainer or assessor in your region
- Transitioning from Quality Officer to Quality Manager with documented expertise
- Using The Art of Service Certificate of Completion in performance reviews
- Expanding your professional network through accreditation forums
- Positioning yourself for roles in national reference labs or policy development
- Preparing for advanced certifications (e.g. lead auditor, consultant)
Module 20: Lifelong Mastery and Continuous Improvement - Building a culture of quality across all laboratory functions
- Encouraging staff ownership of compliance and improvement
- Using Kaizen and Lean principles in daily operations
- Tracking leading and lagging quality indicators
- Implementing staff recognition for quality contributions
- Conducting regular gap analyses against updated standards
- Subscribing to international updates on ISO 15189
- Joining global quality collaboratives and forums
- Revisiting course materials annually as part of your QMS review
- Adapting to emerging technologies: AI, automation, digital diagnostics
- Designing laboratory layout for workflow and safety
- Controlling temperature, humidity, ventilation, and lighting
- Designating clean, pre-analytical, analytical, and hazardous zones
- Ensuring proper storage conditions for reagents and specimens
- Managing biohazard and waste handling areas
- Providing emergency exits, eye wash stations, and safety showers
- Ensuring accessibility for staff with disabilities
- Controlling access to restricted areas with logbooks or electronic systems
- Implementing security measures to protect patient data and specimens
- Conducting regular facility inspections and corrective actions
Module 7: Equipment Management and Calibration - Creating a master equipment inventory with specifications
- Establishing equipment commissioning and acceptance testing
- Scheduling preventive maintenance based on manufacturer and risk criteria
- Tracking maintenance with logs and service records
- Calibrating equipment according to traceable standards
- Implementing calibration labels with expiry dates
- Handling out-of-calibration events and patient result impact assessment
- Controlling software updates and version releases
- Managing equipment downtime and backup plans
- Disposing of equipment with data security and environmental compliance
Module 8: Pre-Analytical Phase: Sample Collection and Handling - Developing specimen collection SOPs by test type
- Training phlebotomists and ward staff on correct techniques
- Validating collection containers and anticoagulants
- Labelling specimens with patient identifiers and collection time
- Training on patient preparation (fasting, medication effects)
- Ensuring proper chain of custody for forensic and legal samples
- Managing home and satellite collection sites
- Setting acceptable and unacceptable sample criteria
- Documenting specimen rejection reasons and trends
- Establishing transport conditions: time, temperature, agitation
Module 9: Analytical Phase: Test Method Validation and Verification - Differentiating between method validation and verification
- Conducting precision, accuracy, linearity, and reportable range studies
- Establishing sensitivity, specificity, and limit of detection
- Verifying manufacturer claims for commercial kits
- Implementing measurement uncertainty calculations
- Setting decision thresholds and clinical cut-offs
- Handling modified or in-house developed tests
- Documenting validation reports with raw data and conclusions
- Managing inter-laboratory comparisons and proficiency testing
- Updating validation after major equipment or reagent changes
Module 10: Post-Analytical Phase: Reporting and Result Release - Designing result reports to meet ISO 15189 and clinical needs
- Ensuring report clarity, units, reference intervals, and interpretive comments
- Validating electronic result transmission (LIS, EMR, portals)
- Setting result authorisation workflows and responsible personnel
- Managing critical value reporting protocols with timeliness logs
- Handling amended reports with change tracking and notifications
- Protecting patient confidentiality in all reports
- Controlling report formats across departments and platforms
- Archiving reports with retrieval capability
- Monitoring result turnaround times and improving delays
Module 11: External Quality Assessment (EQA) and Proficiency Testing - Selecting accredited EQA providers by test discipline
- Enrolling in appropriate frequency and panel sizes
- Handling EQA samples as routine patient specimens
- Analysing EQA results and identifying performance trends
- Investigating poor performance and implementing corrective actions
- Documenting EQA participation and outcomes in the QMS
- Linking EQA findings to staff training and method reviews
- Preparing EQA data for auditor review
- Using EQA to validate test method stability
- Addressing EQA non-conformities before accreditation audits
Module 12: Internal Audits and Self-Assessment - Developing an internal audit programme with annual schedule
- Selecting and training internal auditors with impartiality
- Creating audit checklists based on ISO 15189 clauses
- Conducting opening and closing meetings with departments
- Gathering objective evidence through observation and records
- Writing non-conformity statements with objective, evidence-based language
- Classifying minor, major, and critical findings
- Tracking corrective actions with root cause analysis
- Verifying effectiveness of implemented actions
- Using audit findings to improve the QMS continuously
Module 13: Management Review Meetings - Scheduling and preparing for formal management reviews
- Agenda development: including key performance indicators, audits, risks
- Compiling reports from quality, technical, and operational leads
- Presenting trends in complaints, errors, EQA, and turnaround times
- Reviewing resource adequacy: staffing, equipment, space
- Updating quality objectives and action plans annually
- Tracking progress on previous meeting action items
- Documenting decisions, attendees, and follow-up responsibilities
- Distributing minutes to all relevant stakeholders
- Linking management review outcomes to strategic planning
Module 14: Complaints, Non-Conformities, and Corrective Actions - Establishing a complaints handling procedure with timeliness
- Logging all complaints: patient, clinician, internal, regulatory
- Investigating root causes using 5 Whys or fishbone analysis
- Developing corrective and preventive action (CAPA) plans
- Implementing interim containment actions
- Verifying long-term effectiveness of corrective actions
- Reporting complaint trends in management reviews
- Using complaints to improve SOPs, training, and systems
- Documenting non-conformities from audits, EQA, and inspections
- Building a closed-loop system for continuous quality improvement
Module 15: Preparing for the External Accreditation Audit - Understanding the accreditation body’s audit process and timeline
- Submitting necessary documentation in advance
- Preparing staff for auditor interviews and walkthroughs
- Conducting mock audits with external assessors
- Organising the audit file: master list, evidence logs, QMS documents
- Preparing the audit room with records, policies, and equipment logs
- Assigning roles: guide, technical expert, documentation assistant
- Practicing communication protocols during the audit
- Anticipating common auditor questions by clause
- Creating a real-time findings tracking sheet for the audit team
Module 16: Post-Audit Actions and Sustaining Compliance - Reviewing the audit report and classification of findings
- Drafting a formal response to the accreditation body
- Developing an action plan for non-conformities with deadlines
- Submitting evidence of corrective actions within required timelines
- Preparing for possible surveillance or follow-up audits
- Updating the QMS based on audit feedback
- Incorporating lessons learned into staff training
- Establishing a compliance monitoring dashboard
- Scheduling ongoing internal audits and staff assessments
- Planning for re-accreditation every 2–3 years
Module 17: Integrating ISO 15189 with Other Systems (LIS, ERP, QMS) - Mapping ISO 15189 requirements to Laboratory Information System (LIS) capabilities
- Validating electronic data integrity and audit trails
- Integrating quality indicators into reporting dashboards
- Ensuring user access controls and role-based permissions
- Managing electronic signatures and record approvals
- Aligning ERP procurement processes with equipment and reagent controls
- Using digital workflows for document approval and training tracking
- Implementing barcode and RFID systems for sample traceability
- Ensuring data backup and recovery protocols
- Complying with cybersecurity and data protection regulations (e.g. HIPAA, GDPR)
Module 18: Special Considerations for Point-of-Care Testing (POCT) - Extending ISO 15189 principles to decentralised testing units
- Establishing oversight for POCT devices across wards
- Validating POCT devices and reagents
- Training non-laboratory staff to required competency levels
- Monitoring POCT quality with internal and external controls
- Conducting regular site visits and audits of POCT locations
- Integrating POCT results into the central LIS
- Managing device maintenance and software updates
- Ensuring specimen labelling and documentation compliance
- Addressing regulatory expectations for POCT accreditation
Module 19: Certification, Recognition, and Career Advancement - Understanding the final steps to official ISO 15189 certification
- Publicising accreditation to clinicians, patients, and funders
- Using certification in proposals, tenders, and funding applications
- Leveraging certification for partnerships and network inclusion
- Becoming a recognised trainer or assessor in your region
- Transitioning from Quality Officer to Quality Manager with documented expertise
- Using The Art of Service Certificate of Completion in performance reviews
- Expanding your professional network through accreditation forums
- Positioning yourself for roles in national reference labs or policy development
- Preparing for advanced certifications (e.g. lead auditor, consultant)
Module 20: Lifelong Mastery and Continuous Improvement - Building a culture of quality across all laboratory functions
- Encouraging staff ownership of compliance and improvement
- Using Kaizen and Lean principles in daily operations
- Tracking leading and lagging quality indicators
- Implementing staff recognition for quality contributions
- Conducting regular gap analyses against updated standards
- Subscribing to international updates on ISO 15189
- Joining global quality collaboratives and forums
- Revisiting course materials annually as part of your QMS review
- Adapting to emerging technologies: AI, automation, digital diagnostics
- Developing specimen collection SOPs by test type
- Training phlebotomists and ward staff on correct techniques
- Validating collection containers and anticoagulants
- Labelling specimens with patient identifiers and collection time
- Training on patient preparation (fasting, medication effects)
- Ensuring proper chain of custody for forensic and legal samples
- Managing home and satellite collection sites
- Setting acceptable and unacceptable sample criteria
- Documenting specimen rejection reasons and trends
- Establishing transport conditions: time, temperature, agitation
Module 9: Analytical Phase: Test Method Validation and Verification - Differentiating between method validation and verification
- Conducting precision, accuracy, linearity, and reportable range studies
- Establishing sensitivity, specificity, and limit of detection
- Verifying manufacturer claims for commercial kits
- Implementing measurement uncertainty calculations
- Setting decision thresholds and clinical cut-offs
- Handling modified or in-house developed tests
- Documenting validation reports with raw data and conclusions
- Managing inter-laboratory comparisons and proficiency testing
- Updating validation after major equipment or reagent changes
Module 10: Post-Analytical Phase: Reporting and Result Release - Designing result reports to meet ISO 15189 and clinical needs
- Ensuring report clarity, units, reference intervals, and interpretive comments
- Validating electronic result transmission (LIS, EMR, portals)
- Setting result authorisation workflows and responsible personnel
- Managing critical value reporting protocols with timeliness logs
- Handling amended reports with change tracking and notifications
- Protecting patient confidentiality in all reports
- Controlling report formats across departments and platforms
- Archiving reports with retrieval capability
- Monitoring result turnaround times and improving delays
Module 11: External Quality Assessment (EQA) and Proficiency Testing - Selecting accredited EQA providers by test discipline
- Enrolling in appropriate frequency and panel sizes
- Handling EQA samples as routine patient specimens
- Analysing EQA results and identifying performance trends
- Investigating poor performance and implementing corrective actions
- Documenting EQA participation and outcomes in the QMS
- Linking EQA findings to staff training and method reviews
- Preparing EQA data for auditor review
- Using EQA to validate test method stability
- Addressing EQA non-conformities before accreditation audits
Module 12: Internal Audits and Self-Assessment - Developing an internal audit programme with annual schedule
- Selecting and training internal auditors with impartiality
- Creating audit checklists based on ISO 15189 clauses
- Conducting opening and closing meetings with departments
- Gathering objective evidence through observation and records
- Writing non-conformity statements with objective, evidence-based language
- Classifying minor, major, and critical findings
- Tracking corrective actions with root cause analysis
- Verifying effectiveness of implemented actions
- Using audit findings to improve the QMS continuously
Module 13: Management Review Meetings - Scheduling and preparing for formal management reviews
- Agenda development: including key performance indicators, audits, risks
- Compiling reports from quality, technical, and operational leads
- Presenting trends in complaints, errors, EQA, and turnaround times
- Reviewing resource adequacy: staffing, equipment, space
- Updating quality objectives and action plans annually
- Tracking progress on previous meeting action items
- Documenting decisions, attendees, and follow-up responsibilities
- Distributing minutes to all relevant stakeholders
- Linking management review outcomes to strategic planning
Module 14: Complaints, Non-Conformities, and Corrective Actions - Establishing a complaints handling procedure with timeliness
- Logging all complaints: patient, clinician, internal, regulatory
- Investigating root causes using 5 Whys or fishbone analysis
- Developing corrective and preventive action (CAPA) plans
- Implementing interim containment actions
- Verifying long-term effectiveness of corrective actions
- Reporting complaint trends in management reviews
- Using complaints to improve SOPs, training, and systems
- Documenting non-conformities from audits, EQA, and inspections
- Building a closed-loop system for continuous quality improvement
Module 15: Preparing for the External Accreditation Audit - Understanding the accreditation body’s audit process and timeline
- Submitting necessary documentation in advance
- Preparing staff for auditor interviews and walkthroughs
- Conducting mock audits with external assessors
- Organising the audit file: master list, evidence logs, QMS documents
- Preparing the audit room with records, policies, and equipment logs
- Assigning roles: guide, technical expert, documentation assistant
- Practicing communication protocols during the audit
- Anticipating common auditor questions by clause
- Creating a real-time findings tracking sheet for the audit team
Module 16: Post-Audit Actions and Sustaining Compliance - Reviewing the audit report and classification of findings
- Drafting a formal response to the accreditation body
- Developing an action plan for non-conformities with deadlines
- Submitting evidence of corrective actions within required timelines
- Preparing for possible surveillance or follow-up audits
- Updating the QMS based on audit feedback
- Incorporating lessons learned into staff training
- Establishing a compliance monitoring dashboard
- Scheduling ongoing internal audits and staff assessments
- Planning for re-accreditation every 2–3 years
Module 17: Integrating ISO 15189 with Other Systems (LIS, ERP, QMS) - Mapping ISO 15189 requirements to Laboratory Information System (LIS) capabilities
- Validating electronic data integrity and audit trails
- Integrating quality indicators into reporting dashboards
- Ensuring user access controls and role-based permissions
- Managing electronic signatures and record approvals
- Aligning ERP procurement processes with equipment and reagent controls
- Using digital workflows for document approval and training tracking
- Implementing barcode and RFID systems for sample traceability
- Ensuring data backup and recovery protocols
- Complying with cybersecurity and data protection regulations (e.g. HIPAA, GDPR)
Module 18: Special Considerations for Point-of-Care Testing (POCT) - Extending ISO 15189 principles to decentralised testing units
- Establishing oversight for POCT devices across wards
- Validating POCT devices and reagents
- Training non-laboratory staff to required competency levels
- Monitoring POCT quality with internal and external controls
- Conducting regular site visits and audits of POCT locations
- Integrating POCT results into the central LIS
- Managing device maintenance and software updates
- Ensuring specimen labelling and documentation compliance
- Addressing regulatory expectations for POCT accreditation
Module 19: Certification, Recognition, and Career Advancement - Understanding the final steps to official ISO 15189 certification
- Publicising accreditation to clinicians, patients, and funders
- Using certification in proposals, tenders, and funding applications
- Leveraging certification for partnerships and network inclusion
- Becoming a recognised trainer or assessor in your region
- Transitioning from Quality Officer to Quality Manager with documented expertise
- Using The Art of Service Certificate of Completion in performance reviews
- Expanding your professional network through accreditation forums
- Positioning yourself for roles in national reference labs or policy development
- Preparing for advanced certifications (e.g. lead auditor, consultant)
Module 20: Lifelong Mastery and Continuous Improvement - Building a culture of quality across all laboratory functions
- Encouraging staff ownership of compliance and improvement
- Using Kaizen and Lean principles in daily operations
- Tracking leading and lagging quality indicators
- Implementing staff recognition for quality contributions
- Conducting regular gap analyses against updated standards
- Subscribing to international updates on ISO 15189
- Joining global quality collaboratives and forums
- Revisiting course materials annually as part of your QMS review
- Adapting to emerging technologies: AI, automation, digital diagnostics
- Designing result reports to meet ISO 15189 and clinical needs
- Ensuring report clarity, units, reference intervals, and interpretive comments
- Validating electronic result transmission (LIS, EMR, portals)
- Setting result authorisation workflows and responsible personnel
- Managing critical value reporting protocols with timeliness logs
- Handling amended reports with change tracking and notifications
- Protecting patient confidentiality in all reports
- Controlling report formats across departments and platforms
- Archiving reports with retrieval capability
- Monitoring result turnaround times and improving delays
Module 11: External Quality Assessment (EQA) and Proficiency Testing - Selecting accredited EQA providers by test discipline
- Enrolling in appropriate frequency and panel sizes
- Handling EQA samples as routine patient specimens
- Analysing EQA results and identifying performance trends
- Investigating poor performance and implementing corrective actions
- Documenting EQA participation and outcomes in the QMS
- Linking EQA findings to staff training and method reviews
- Preparing EQA data for auditor review
- Using EQA to validate test method stability
- Addressing EQA non-conformities before accreditation audits
Module 12: Internal Audits and Self-Assessment - Developing an internal audit programme with annual schedule
- Selecting and training internal auditors with impartiality
- Creating audit checklists based on ISO 15189 clauses
- Conducting opening and closing meetings with departments
- Gathering objective evidence through observation and records
- Writing non-conformity statements with objective, evidence-based language
- Classifying minor, major, and critical findings
- Tracking corrective actions with root cause analysis
- Verifying effectiveness of implemented actions
- Using audit findings to improve the QMS continuously
Module 13: Management Review Meetings - Scheduling and preparing for formal management reviews
- Agenda development: including key performance indicators, audits, risks
- Compiling reports from quality, technical, and operational leads
- Presenting trends in complaints, errors, EQA, and turnaround times
- Reviewing resource adequacy: staffing, equipment, space
- Updating quality objectives and action plans annually
- Tracking progress on previous meeting action items
- Documenting decisions, attendees, and follow-up responsibilities
- Distributing minutes to all relevant stakeholders
- Linking management review outcomes to strategic planning
Module 14: Complaints, Non-Conformities, and Corrective Actions - Establishing a complaints handling procedure with timeliness
- Logging all complaints: patient, clinician, internal, regulatory
- Investigating root causes using 5 Whys or fishbone analysis
- Developing corrective and preventive action (CAPA) plans
- Implementing interim containment actions
- Verifying long-term effectiveness of corrective actions
- Reporting complaint trends in management reviews
- Using complaints to improve SOPs, training, and systems
- Documenting non-conformities from audits, EQA, and inspections
- Building a closed-loop system for continuous quality improvement
Module 15: Preparing for the External Accreditation Audit - Understanding the accreditation body’s audit process and timeline
- Submitting necessary documentation in advance
- Preparing staff for auditor interviews and walkthroughs
- Conducting mock audits with external assessors
- Organising the audit file: master list, evidence logs, QMS documents
- Preparing the audit room with records, policies, and equipment logs
- Assigning roles: guide, technical expert, documentation assistant
- Practicing communication protocols during the audit
- Anticipating common auditor questions by clause
- Creating a real-time findings tracking sheet for the audit team
Module 16: Post-Audit Actions and Sustaining Compliance - Reviewing the audit report and classification of findings
- Drafting a formal response to the accreditation body
- Developing an action plan for non-conformities with deadlines
- Submitting evidence of corrective actions within required timelines
- Preparing for possible surveillance or follow-up audits
- Updating the QMS based on audit feedback
- Incorporating lessons learned into staff training
- Establishing a compliance monitoring dashboard
- Scheduling ongoing internal audits and staff assessments
- Planning for re-accreditation every 2–3 years
Module 17: Integrating ISO 15189 with Other Systems (LIS, ERP, QMS) - Mapping ISO 15189 requirements to Laboratory Information System (LIS) capabilities
- Validating electronic data integrity and audit trails
- Integrating quality indicators into reporting dashboards
- Ensuring user access controls and role-based permissions
- Managing electronic signatures and record approvals
- Aligning ERP procurement processes with equipment and reagent controls
- Using digital workflows for document approval and training tracking
- Implementing barcode and RFID systems for sample traceability
- Ensuring data backup and recovery protocols
- Complying with cybersecurity and data protection regulations (e.g. HIPAA, GDPR)
Module 18: Special Considerations for Point-of-Care Testing (POCT) - Extending ISO 15189 principles to decentralised testing units
- Establishing oversight for POCT devices across wards
- Validating POCT devices and reagents
- Training non-laboratory staff to required competency levels
- Monitoring POCT quality with internal and external controls
- Conducting regular site visits and audits of POCT locations
- Integrating POCT results into the central LIS
- Managing device maintenance and software updates
- Ensuring specimen labelling and documentation compliance
- Addressing regulatory expectations for POCT accreditation
Module 19: Certification, Recognition, and Career Advancement - Understanding the final steps to official ISO 15189 certification
- Publicising accreditation to clinicians, patients, and funders
- Using certification in proposals, tenders, and funding applications
- Leveraging certification for partnerships and network inclusion
- Becoming a recognised trainer or assessor in your region
- Transitioning from Quality Officer to Quality Manager with documented expertise
- Using The Art of Service Certificate of Completion in performance reviews
- Expanding your professional network through accreditation forums
- Positioning yourself for roles in national reference labs or policy development
- Preparing for advanced certifications (e.g. lead auditor, consultant)
Module 20: Lifelong Mastery and Continuous Improvement - Building a culture of quality across all laboratory functions
- Encouraging staff ownership of compliance and improvement
- Using Kaizen and Lean principles in daily operations
- Tracking leading and lagging quality indicators
- Implementing staff recognition for quality contributions
- Conducting regular gap analyses against updated standards
- Subscribing to international updates on ISO 15189
- Joining global quality collaboratives and forums
- Revisiting course materials annually as part of your QMS review
- Adapting to emerging technologies: AI, automation, digital diagnostics
- Developing an internal audit programme with annual schedule
- Selecting and training internal auditors with impartiality
- Creating audit checklists based on ISO 15189 clauses
- Conducting opening and closing meetings with departments
- Gathering objective evidence through observation and records
- Writing non-conformity statements with objective, evidence-based language
- Classifying minor, major, and critical findings
- Tracking corrective actions with root cause analysis
- Verifying effectiveness of implemented actions
- Using audit findings to improve the QMS continuously
Module 13: Management Review Meetings - Scheduling and preparing for formal management reviews
- Agenda development: including key performance indicators, audits, risks
- Compiling reports from quality, technical, and operational leads
- Presenting trends in complaints, errors, EQA, and turnaround times
- Reviewing resource adequacy: staffing, equipment, space
- Updating quality objectives and action plans annually
- Tracking progress on previous meeting action items
- Documenting decisions, attendees, and follow-up responsibilities
- Distributing minutes to all relevant stakeholders
- Linking management review outcomes to strategic planning
Module 14: Complaints, Non-Conformities, and Corrective Actions - Establishing a complaints handling procedure with timeliness
- Logging all complaints: patient, clinician, internal, regulatory
- Investigating root causes using 5 Whys or fishbone analysis
- Developing corrective and preventive action (CAPA) plans
- Implementing interim containment actions
- Verifying long-term effectiveness of corrective actions
- Reporting complaint trends in management reviews
- Using complaints to improve SOPs, training, and systems
- Documenting non-conformities from audits, EQA, and inspections
- Building a closed-loop system for continuous quality improvement
Module 15: Preparing for the External Accreditation Audit - Understanding the accreditation body’s audit process and timeline
- Submitting necessary documentation in advance
- Preparing staff for auditor interviews and walkthroughs
- Conducting mock audits with external assessors
- Organising the audit file: master list, evidence logs, QMS documents
- Preparing the audit room with records, policies, and equipment logs
- Assigning roles: guide, technical expert, documentation assistant
- Practicing communication protocols during the audit
- Anticipating common auditor questions by clause
- Creating a real-time findings tracking sheet for the audit team
Module 16: Post-Audit Actions and Sustaining Compliance - Reviewing the audit report and classification of findings
- Drafting a formal response to the accreditation body
- Developing an action plan for non-conformities with deadlines
- Submitting evidence of corrective actions within required timelines
- Preparing for possible surveillance or follow-up audits
- Updating the QMS based on audit feedback
- Incorporating lessons learned into staff training
- Establishing a compliance monitoring dashboard
- Scheduling ongoing internal audits and staff assessments
- Planning for re-accreditation every 2–3 years
Module 17: Integrating ISO 15189 with Other Systems (LIS, ERP, QMS) - Mapping ISO 15189 requirements to Laboratory Information System (LIS) capabilities
- Validating electronic data integrity and audit trails
- Integrating quality indicators into reporting dashboards
- Ensuring user access controls and role-based permissions
- Managing electronic signatures and record approvals
- Aligning ERP procurement processes with equipment and reagent controls
- Using digital workflows for document approval and training tracking
- Implementing barcode and RFID systems for sample traceability
- Ensuring data backup and recovery protocols
- Complying with cybersecurity and data protection regulations (e.g. HIPAA, GDPR)
Module 18: Special Considerations for Point-of-Care Testing (POCT) - Extending ISO 15189 principles to decentralised testing units
- Establishing oversight for POCT devices across wards
- Validating POCT devices and reagents
- Training non-laboratory staff to required competency levels
- Monitoring POCT quality with internal and external controls
- Conducting regular site visits and audits of POCT locations
- Integrating POCT results into the central LIS
- Managing device maintenance and software updates
- Ensuring specimen labelling and documentation compliance
- Addressing regulatory expectations for POCT accreditation
Module 19: Certification, Recognition, and Career Advancement - Understanding the final steps to official ISO 15189 certification
- Publicising accreditation to clinicians, patients, and funders
- Using certification in proposals, tenders, and funding applications
- Leveraging certification for partnerships and network inclusion
- Becoming a recognised trainer or assessor in your region
- Transitioning from Quality Officer to Quality Manager with documented expertise
- Using The Art of Service Certificate of Completion in performance reviews
- Expanding your professional network through accreditation forums
- Positioning yourself for roles in national reference labs or policy development
- Preparing for advanced certifications (e.g. lead auditor, consultant)
Module 20: Lifelong Mastery and Continuous Improvement - Building a culture of quality across all laboratory functions
- Encouraging staff ownership of compliance and improvement
- Using Kaizen and Lean principles in daily operations
- Tracking leading and lagging quality indicators
- Implementing staff recognition for quality contributions
- Conducting regular gap analyses against updated standards
- Subscribing to international updates on ISO 15189
- Joining global quality collaboratives and forums
- Revisiting course materials annually as part of your QMS review
- Adapting to emerging technologies: AI, automation, digital diagnostics
- Establishing a complaints handling procedure with timeliness
- Logging all complaints: patient, clinician, internal, regulatory
- Investigating root causes using 5 Whys or fishbone analysis
- Developing corrective and preventive action (CAPA) plans
- Implementing interim containment actions
- Verifying long-term effectiveness of corrective actions
- Reporting complaint trends in management reviews
- Using complaints to improve SOPs, training, and systems
- Documenting non-conformities from audits, EQA, and inspections
- Building a closed-loop system for continuous quality improvement
Module 15: Preparing for the External Accreditation Audit - Understanding the accreditation body’s audit process and timeline
- Submitting necessary documentation in advance
- Preparing staff for auditor interviews and walkthroughs
- Conducting mock audits with external assessors
- Organising the audit file: master list, evidence logs, QMS documents
- Preparing the audit room with records, policies, and equipment logs
- Assigning roles: guide, technical expert, documentation assistant
- Practicing communication protocols during the audit
- Anticipating common auditor questions by clause
- Creating a real-time findings tracking sheet for the audit team
Module 16: Post-Audit Actions and Sustaining Compliance - Reviewing the audit report and classification of findings
- Drafting a formal response to the accreditation body
- Developing an action plan for non-conformities with deadlines
- Submitting evidence of corrective actions within required timelines
- Preparing for possible surveillance or follow-up audits
- Updating the QMS based on audit feedback
- Incorporating lessons learned into staff training
- Establishing a compliance monitoring dashboard
- Scheduling ongoing internal audits and staff assessments
- Planning for re-accreditation every 2–3 years
Module 17: Integrating ISO 15189 with Other Systems (LIS, ERP, QMS) - Mapping ISO 15189 requirements to Laboratory Information System (LIS) capabilities
- Validating electronic data integrity and audit trails
- Integrating quality indicators into reporting dashboards
- Ensuring user access controls and role-based permissions
- Managing electronic signatures and record approvals
- Aligning ERP procurement processes with equipment and reagent controls
- Using digital workflows for document approval and training tracking
- Implementing barcode and RFID systems for sample traceability
- Ensuring data backup and recovery protocols
- Complying with cybersecurity and data protection regulations (e.g. HIPAA, GDPR)
Module 18: Special Considerations for Point-of-Care Testing (POCT) - Extending ISO 15189 principles to decentralised testing units
- Establishing oversight for POCT devices across wards
- Validating POCT devices and reagents
- Training non-laboratory staff to required competency levels
- Monitoring POCT quality with internal and external controls
- Conducting regular site visits and audits of POCT locations
- Integrating POCT results into the central LIS
- Managing device maintenance and software updates
- Ensuring specimen labelling and documentation compliance
- Addressing regulatory expectations for POCT accreditation
Module 19: Certification, Recognition, and Career Advancement - Understanding the final steps to official ISO 15189 certification
- Publicising accreditation to clinicians, patients, and funders
- Using certification in proposals, tenders, and funding applications
- Leveraging certification for partnerships and network inclusion
- Becoming a recognised trainer or assessor in your region
- Transitioning from Quality Officer to Quality Manager with documented expertise
- Using The Art of Service Certificate of Completion in performance reviews
- Expanding your professional network through accreditation forums
- Positioning yourself for roles in national reference labs or policy development
- Preparing for advanced certifications (e.g. lead auditor, consultant)
Module 20: Lifelong Mastery and Continuous Improvement - Building a culture of quality across all laboratory functions
- Encouraging staff ownership of compliance and improvement
- Using Kaizen and Lean principles in daily operations
- Tracking leading and lagging quality indicators
- Implementing staff recognition for quality contributions
- Conducting regular gap analyses against updated standards
- Subscribing to international updates on ISO 15189
- Joining global quality collaboratives and forums
- Revisiting course materials annually as part of your QMS review
- Adapting to emerging technologies: AI, automation, digital diagnostics
- Reviewing the audit report and classification of findings
- Drafting a formal response to the accreditation body
- Developing an action plan for non-conformities with deadlines
- Submitting evidence of corrective actions within required timelines
- Preparing for possible surveillance or follow-up audits
- Updating the QMS based on audit feedback
- Incorporating lessons learned into staff training
- Establishing a compliance monitoring dashboard
- Scheduling ongoing internal audits and staff assessments
- Planning for re-accreditation every 2–3 years
Module 17: Integrating ISO 15189 with Other Systems (LIS, ERP, QMS) - Mapping ISO 15189 requirements to Laboratory Information System (LIS) capabilities
- Validating electronic data integrity and audit trails
- Integrating quality indicators into reporting dashboards
- Ensuring user access controls and role-based permissions
- Managing electronic signatures and record approvals
- Aligning ERP procurement processes with equipment and reagent controls
- Using digital workflows for document approval and training tracking
- Implementing barcode and RFID systems for sample traceability
- Ensuring data backup and recovery protocols
- Complying with cybersecurity and data protection regulations (e.g. HIPAA, GDPR)
Module 18: Special Considerations for Point-of-Care Testing (POCT) - Extending ISO 15189 principles to decentralised testing units
- Establishing oversight for POCT devices across wards
- Validating POCT devices and reagents
- Training non-laboratory staff to required competency levels
- Monitoring POCT quality with internal and external controls
- Conducting regular site visits and audits of POCT locations
- Integrating POCT results into the central LIS
- Managing device maintenance and software updates
- Ensuring specimen labelling and documentation compliance
- Addressing regulatory expectations for POCT accreditation
Module 19: Certification, Recognition, and Career Advancement - Understanding the final steps to official ISO 15189 certification
- Publicising accreditation to clinicians, patients, and funders
- Using certification in proposals, tenders, and funding applications
- Leveraging certification for partnerships and network inclusion
- Becoming a recognised trainer or assessor in your region
- Transitioning from Quality Officer to Quality Manager with documented expertise
- Using The Art of Service Certificate of Completion in performance reviews
- Expanding your professional network through accreditation forums
- Positioning yourself for roles in national reference labs or policy development
- Preparing for advanced certifications (e.g. lead auditor, consultant)
Module 20: Lifelong Mastery and Continuous Improvement - Building a culture of quality across all laboratory functions
- Encouraging staff ownership of compliance and improvement
- Using Kaizen and Lean principles in daily operations
- Tracking leading and lagging quality indicators
- Implementing staff recognition for quality contributions
- Conducting regular gap analyses against updated standards
- Subscribing to international updates on ISO 15189
- Joining global quality collaboratives and forums
- Revisiting course materials annually as part of your QMS review
- Adapting to emerging technologies: AI, automation, digital diagnostics
- Extending ISO 15189 principles to decentralised testing units
- Establishing oversight for POCT devices across wards
- Validating POCT devices and reagents
- Training non-laboratory staff to required competency levels
- Monitoring POCT quality with internal and external controls
- Conducting regular site visits and audits of POCT locations
- Integrating POCT results into the central LIS
- Managing device maintenance and software updates
- Ensuring specimen labelling and documentation compliance
- Addressing regulatory expectations for POCT accreditation
Module 19: Certification, Recognition, and Career Advancement - Understanding the final steps to official ISO 15189 certification
- Publicising accreditation to clinicians, patients, and funders
- Using certification in proposals, tenders, and funding applications
- Leveraging certification for partnerships and network inclusion
- Becoming a recognised trainer or assessor in your region
- Transitioning from Quality Officer to Quality Manager with documented expertise
- Using The Art of Service Certificate of Completion in performance reviews
- Expanding your professional network through accreditation forums
- Positioning yourself for roles in national reference labs or policy development
- Preparing for advanced certifications (e.g. lead auditor, consultant)
Module 20: Lifelong Mastery and Continuous Improvement - Building a culture of quality across all laboratory functions
- Encouraging staff ownership of compliance and improvement
- Using Kaizen and Lean principles in daily operations
- Tracking leading and lagging quality indicators
- Implementing staff recognition for quality contributions
- Conducting regular gap analyses against updated standards
- Subscribing to international updates on ISO 15189
- Joining global quality collaboratives and forums
- Revisiting course materials annually as part of your QMS review
- Adapting to emerging technologies: AI, automation, digital diagnostics
- Building a culture of quality across all laboratory functions
- Encouraging staff ownership of compliance and improvement
- Using Kaizen and Lean principles in daily operations
- Tracking leading and lagging quality indicators
- Implementing staff recognition for quality contributions
- Conducting regular gap analyses against updated standards
- Subscribing to international updates on ISO 15189
- Joining global quality collaboratives and forums
- Revisiting course materials annually as part of your QMS review
- Adapting to emerging technologies: AI, automation, digital diagnostics