Checklists

Self-assessment tools for every Quality Systems Essential

Use these interactive checklists to evaluate your TB laboratory's current status against each of the twelve Quality Systems Essentials, identify gaps, and plan your next implementation steps across all four phases.

All Phases Phase 1 Phase 2 Phase 3 Phase 4

Twelve Quality Systems Essentials

Checklists are available for each essential below. Select the phase that matches your laboratory's current stage of implementation to access the appropriate set of assessment items.

Facilities & Safety

Assess laboratory infrastructure, biosafety measures, and physical working conditions.

Organization

Evaluate management structure, roles, responsibilities, and quality policy.

Personnel

Review staff qualifications, training records, and competency assessment.

Equipment

Check equipment inventory, maintenance schedules, and calibration status.

Purchasing & Inventory

Examine procurement processes, stock management, and supplier evaluation.

Process Management

Assess standard operating procedures and workflow documentation.

Information Management

Review data handling, reporting systems, and information security practices.

Documents & Records

Evaluate document control, record-keeping, and version management.

Customer Focus

Assess how the laboratory gathers and responds to user feedback and needs.

Assessment

Check internal audit practices, external assessments, and proficiency testing.

Nonconforming Event Management

Review how errors, incidents, and nonconformities are identified and addressed.

Continual Improvement

Evaluate mechanisms for ongoing quality improvement and corrective action.

How to Use the Checklists

Each checklist is aligned to a specific Quality Systems Essential and implementation phase. Work through the items systematically to assess your laboratory's current practices.

Select the phase that matches your laboratory's progress.
Complete the checklist for each essential, marking items as met, partially met, or not met.
Use the results to identify gaps and prioritize next steps.
Revisit checklists periodically to track improvement over time.

For detailed guidance on navigating the tool, see the User Instructions.

A softly lit desk with a notepad and pen beside a laboratory clipboard, warm cream and muted green tones, calm and professional.

Download Checklists for Offline Use

All checklist materials are available as downloadable resources for laboratories with limited internet access. Visit the Download page to access offline versions.

The interactive checklists on this page are designed to help laboratory teams work through each of the twelve Quality Systems Essentials in a structured, stepwise manner. Rather than relying on guesswork or informal impressions, staff can systematically evaluate their current practices against recognized standards for laboratory quality management. Each checklist presents focused questions that prompt honest self-assessment, encouraging teams to examine not only visible outcomes but also the underlying processes, documentation, and personnel practices that sustain quality over time.

Using these tools supports a practical roadmap toward accreditation and continual improvement. As laboratories progress through the four implementation phases, the checklists serve as a reliable reference point for measuring growth and identifying where attention is needed next. Teams can revisit the same checklists at different stages, making it possible to track changes and confirm that improvements are genuinely taking hold. This repeatable approach transforms quality management from a one-time exercise into an ongoing, embedded habit within the organization.

The self-assessment format also fosters valuable discussion among laboratory staff. When personnel from different roles and functions work through the checklists together, they gain a fuller picture of how their laboratory operates day to day. This collaborative review often surfaces practical insights that might otherwise go unnoticed, such as gaps in communication, equipment maintenance routines, or record-keeping practices. By encouraging open dialogue around each essential, the checklists help build a shared sense of ownership for quality across the entire team.

Beyond identifying gaps, the checklists are intended to guide action. Each completed assessment can feed directly into planning conversations about what to address next, whether that involves updating documents, refining inventory procedures, strengthening safety measures, or improving customer service. The structure of the tool helps users translate findings into concrete next steps, ensuring that the effort invested in self-assessment leads to meaningful change rather than simply producing a report that sits on a shelf. This practical orientation keeps the focus on implementation.

The design of these checklists reflects a broader commitment to strengthening diagnostic services in tuberculosis laboratories and beyond. Developed with input from international partners and grounded in consensus around essential quality practices, the tools are meant to be accessible to laboratories at various stages of development. They support a phased, realistic approach to quality improvement that recognizes the constraints and capacities of different settings. Whether a laboratory is just beginning its quality journey or working toward full accreditation, these checklists offer a clear and supportive path forward.