NABL (ISO 15189) Readiness Checklist — Histopathology Laboratory
Use this self-assessment to prepare a histopathology / cytology laboratory for NABL accreditation under ISO 15189. Tick each item, add evidence references, and act on gaps.
1. Quality Management System
- Quality manual in place and controlled
- Quality policy and measurable quality objectives defined
- Document control procedure (issue, review, versioning, obsolete removal)
- Master list of SOPs; each SOP authorised, dated and version-controlled
- Control of records procedure with defined retention
- Scope of accreditation clearly defined for histopathology / cytology
2. Organisation & Personnel
- Organisation chart and defined responsibilities
- Job descriptions for pathologists, technologists and support staff
- Qualification and registration records on file
- Induction and ongoing training records
- Documented competency assessment (initial + periodic)
- Authorisation/signatory list for reporting
- Confidentiality and impartiality declarations
3. Facilities & Safety
- Adequate, segregated space (grossing, processing, microtomy, staining, reporting)
- Ventilation / fume extraction at grossing and reagent areas
- Temperature and humidity monitored where required
- Biosafety and chemical safety risk assessments
- PPE available and used; safety data sheets accessible
- Biomedical waste segregation per BMW Rules 2016
- Spill kits, first-aid and emergency procedures in place
- Controlled access and specimen security
4. Equipment & Calibration
- Equipment inventory with unique IDs
- Installation / performance verification records
- Calibration schedule and traceable calibration records (thermometers, balances, timers, microtomes, pipettes)
- Preventive maintenance schedule and logs
- Breakdown / service records and impact assessment
- Temperature logs for fridges, freezers, water baths, ovens, wax baths
- Equipment out-of-service labelling procedure
5. Pre-examination (Pre-analytical)
- Test request form with adequate patient + clinical details
- Two-identifier specimen labelling and matching
- Specimen collection, fixation and transport instructions issued
- Fixative type/ratio and fixation time recorded
- Documented sample acceptance / rejection criteria
- Accessioning with unique number and traceability
- Cold-ischaemia / turnaround monitoring where relevant
6. Examination (Analytical)
- Validated / verified SOPs for grossing, processing, embedding, microtomy, staining and IHC
- Grossing performed/supervised by authorised staff with dictation records
- H&E and special-stain control slides run and reviewed
- IHC positive and negative controls with every batch
- Antibody validation and optimisation records
- Reagent and antibody lot-change verification
- Uncertainty / limitations understood where applicable
7. Post-examination (Post-analytical)
- Standardised report format with required elements
- Report review and authorisation by a pathologist
- Turnaround-time targets defined and monitored
- Critical / significant value communication and record
- Amended-report procedure with audit trail
- Structured / synoptic reporting for cancers where applicable
- Referral (second opinion) and specimen send-out procedure
8. Reagents & Consumables
- Reagent inventory with lot numbers and expiry
- Storage conditions monitored
- New-lot / new-batch acceptance checks
- Reagent preparation and QC records
- Reagent change / rotation schedule with records
9. Quality Assurance (IQC & EQA)
- Internal quality control (daily control slides, staining QC) with records
- Participation in an EQA / proficiency-testing programme
- EQA results reviewed; corrective action on poor performance
- Inter-observer / peer review process (as applicable)
- Quality-indicator monitoring (TAT, rejection rate, re-cut rate, discrepancies)
10. Continual Improvement
- Internal audit programme and schedule
- Non-conformance recording and control
- Root-cause analysis and corrective/preventive action (CAPA)
- Complaints handling procedure and records
- Management review at defined intervals with actions
- Risk management and opportunities for improvement
11. Records & Retention
- Defined retention periods for reports, blocks, slides and records
- Secure, retrievable archival of blocks and slides
- Backup and confidentiality of electronic records (LIS)
- Traceability from request → block → slide → report
Disclaimer
This checklist is an educational readiness aid and is a simplified interpretation. It does not replace the official NABL / ISO 15189 requirements, assessor guidance, or your accreditation body's current documents. Always refer to the latest official standards.
Unimeditrek Pvt. Ltd. · www.unilabequipments.com · Educational template — adapt to your laboratory.