A tailored course, built for your situation
Mastering ISO 15189 Implementation for High-Complexity TB Labs
A step-by-step framework to align lab processes, documentation, and quality systems with ISO 15189 standards , tailored for TB diagnostics and research environments
$199 one-time
24-hour access provisioning
30-day money-back guarantee
Hand-built implementation playbook
12 modules. 12 chapters per module. 144 chapters total.
12 modules, each with 12 chapters (144 chapters total), text-based, plus downloadable templates and a hand-built implementation playbook delivered alongside course access.
Struggling to turn ISO 15189 requirements into daily lab reality without overloading your team?
The situation this course is for
You're a lab consultant leading quality system transformation, but ISO 15189 feels abstract when applied to real sputum diagnostics, genetic diversity tracking, and pulmonary data workflows. You need actionable structure , not theory , to close gaps without disrupting operations.
Who this is for
Laboratory Consultant | TB & Microbiology Specialist | Quality Systems Implementer
Who this is not for
This is not for general lab technicians or administrators without direct responsibility for ISO compliance or quality management system design.
What you walk away with
- Translate ISO 15189 clauses into lab-specific procedures
- Build audit-ready documentation that survives external review
- Design internal audit cycles that prevent nonconformance backlogs
- Integrate quality metrics into routine lab reporting
- Lead cross-functional alignment between technical and administrative teams
The 12 modules (with all 144 chapters)
Module 1. Foundations of ISO 15189 in High-Complexity Labs
Establish the core principles of ISO 15189 with a focus on TB and microbiology contexts. Learn how to distinguish between technical and managerial requirements and align them with current lab workflows.
12 chapters in this module
- Scope of ISO 15189
- Role of lab leadership
- Document hierarchy basics
- Risk-based thinking intro
- Pre-analytical controls
- Sample integrity standards
- Personnel competency rules
- Equipment validation steps
- Reagent traceability
- Data integrity expectations
- External quality assessment
- Internal audit triggers
Module 2. Document Control Systems That Scale
Build a sustainable document management system that prevents version conflicts, ensures access control, and supports audit readiness across multiple lab sites and collaborators.
12 chapters in this module
- Master document list
- Version numbering logic
- Access permissions setup
- Change approval workflow
- Review cycle scheduling
- Electronic vs paper balance
- Metadata tagging system
- Retention policies
- Decentralized editing rules
- Cross-lab harmonization
- Document audit trail
- Retirement procedure
Module 3. Designing Lab-Specific SOPs
Create SOPs that reflect actual lab operations in TB diagnostics, including sputum processing, genetic analysis, and biosafety protocols, while meeting ISO clause requirements.
12 chapters in this module
- SOP scope definition
- Step-by-step formatting
- Critical step identification
- Safety integration points
- Reagent substitution rules
- Instrument-specific variants
- Staff training linkage
- Deviation documentation
- Multilingual adaptation
- Emergency procedure merge
- Validation sign-off steps
- Periodic review triggers
Module 4. Internal Audit Design and Execution
Develop a risk-based internal audit plan tailored to TB lab operations, with checklists, sampling strategies, and reporting formats that drive corrective actions.
12 chapters in this module
- Audit frequency planning
- Risk-based checklist design
- Sampling strategy selection
- Auditor competency criteria
- Observation documentation
- Nonconformance classification
- Root cause analysis method
- Corrective action tracking
- Follow-up verification steps
- Leadership reporting format
- Audit calendar sync
- External auditor prep
Module 5. Managing Nonconformities and CAPA
Implement a closed-loop system for identifying, documenting, and resolving nonconformities with emphasis on TB testing accuracy and biosafety deviations.
12 chapters in this module
- Nonconformance definition
- Incident logging format
- Severity classification
- Immediate containment steps
- Root cause tools
- Fishbone diagram use
- 5 Whys technique
- Action owner assignment
- Timeline for resolution
- Effectiveness check method
- CAPA register setup
- Trend analysis reporting
Module 6. Personnel Competency and Training
Build a competency framework that validates technical skills, ensures ongoing training, and meets ISO requirements for staff qualification in high-complexity labs.
12 chapters in this module
- Role-specific competencies
- Initial assessment method
- Observation checklist design
- Training record format
- Refresher cycle planning
- Cross-training strategy
- New hire onboarding steps
- External collaborator rules
- Performance review sync
- Certification tracking
- Gap remediation process
- Competency audit trail
Module 7. Equipment and Reagent Management
Ensure full traceability and validation of lab equipment and reagents used in TB diagnostics, from procurement to decommissioning.
12 chapters in this module
- Equipment inventory setup
- Validation checklist
- Calibration scheduling
- Maintenance logs
- Reagent lot tracking
- Storage condition monitoring
- Expiry alert system
- Substitution approval process
- Vendor qualification steps
- Certificate of analysis use
- Emergency sourcing rules
- Decommissioning protocol
Module 8. Pre-Analytical Process Controls
Strengthen specimen handling, labeling, transport, and storage protocols to reduce pre-analytical errors in TB sputum samples.
12 chapters in this module
- Specimen labeling rules
- Collection container type
- Transport time limits
- Temperature monitoring
- Chain of custody form
- Rejection criteria definition
- Contamination prevention
- Sample accessioning
- Biosafety during handling
- Patient identifier checks
- Urgent sample pathway
- Sample storage conditions
Module 9. Analytical Quality and Method Validation
Validate and maintain analytical methods used in TB detection and genetic diversity studies, ensuring reliability and compliance.
12 chapters in this module
- Method selection criteria
- Validation protocol design
- Accuracy testing steps
- Precision assessment
- Sensitivity thresholds
- Specificity checks
- Reference material use
- Interference testing
- Carryover evaluation
- Reportable range setup
- Method transfer rules
- Ongoing verification
Module 10. Post-Analytical Reporting and Data Integrity
Ensure accurate, secure, and timely reporting of TB test results with robust data management and audit trail practices.
12 chapters in this module
- Result verification steps
- Critical value reporting
- Electronic signature use
- Data backup frequency
- Access log review
- Report format standardization
- Turnaround time tracking
- Result correction process
- Confidentiality safeguards
- Audit trail maintenance
- Data export controls
- System downtime protocol
Module 11. External Quality Assessment Participation
Prepare for and succeed in external proficiency testing programs with structured response and improvement plans.
12 chapters in this module
- Program selection criteria
- Sample handling rules
- Testing under routine conditions
- Result submission process
- Performance evaluation
- Outlier investigation
- Corrective action planning
- Follow-up testing
- Peer comparison use
- Accreditation linkage
- Trend tracking
- Reporting to leadership
Module 12. Sustaining Accreditation and Continuous Improvement
Embed continuous improvement into lab culture, using metrics, feedback loops, and leadership engagement to maintain ISO compliance long-term.
12 chapters in this module
- KPI selection for labs
- Monthly performance review
- Staff feedback collection
- Process optimization cycle
- Change control procedure
- Management review inputs
- Accreditation renewal prep
- Stakeholder communication
- Resource planning
- Lessons learned capture
- Benchmarking strategy
- Future readiness planning
How this maps to your situation
- Building from foundational ISO understanding
- Strengthening documentation and audit readiness
- Implementing lab-specific quality controls
- Sustaining compliance through continuous improvement
Before vs. after
Before
Overwhelmed by abstract ISO requirements and inconsistent documentation practices across teams.
After
Confidently leading a unified, audit-ready lab with clear procedures, trained staff, and sustainable quality systems.
What's included with your purchase
- 12 modules with 12 chapters each (144 chapters)
- Downloadable templates and worked examples for every module
- Hand-built implementation playbook delivered alongside course access
- 30-day money-back guarantee
Delivery and format
- Course and learning environment access provisioned within 24 hours of purchase
- Hand-built implementation playbook delivered alongside course access
Format: Text-based modules and chapters in the Art of Service learning environment, plus downloadable templates and worked examples for every chapter, plus the hand-built implementation playbook delivered alongside course access.
Time investment: Approximately 3-4 hours per module, designed for flexible, self-paced learning alongside lab responsibilities.
If nothing changes
Without structured implementation, labs risk noncompliance, failed audits, data integrity issues, and compromised patient results , especially under increased scrutiny in TB and microbiology research.
How this compares to the alternatives
Unlike generic ISO training, this course is built specifically for high-complexity TB and microbiology labs, with real-world templates and decision frameworks that reflect actual lab workflows and reporting demands.
Frequently asked
Who is this course for?
Lab consultants, quality managers, and technical leads working in TB, microbiology, or high-complexity diagnostic labs preparing for ISO 15189 accreditation.
How is the course structured?
12 modules, each containing 12 chapters (144 chapters total).
Are the templates customizable?
Yes, all downloadable templates are provided in editable format for adaptation to your lab’s specific needs.
$199 one-time. Approximately 3-4 hours per module, designed for flexible, self-paced learning alongside lab responsibilities..
Within 24 hours your account in the learning environment is provisioned and the tailored implementation playbook is delivered alongside it.
30-day money-back guarantee·
144 chapters·
Hand-built playbook included·
Account access within 24 hours