Laboratory Software and NABL Readiness: What Software Can and Can't Do
NABL accredits laboratories, not software. What software can do is keep the records an ISO 15189 assessment relies on, accurately and every time. This guide maps those records to what eMedHub supports today, including the gaps you'll need to cover another way.
Updated 30 October 2026
Accreditation Is About the Lab, Not the Software
NABL, the National Accreditation Board for Testing and Calibration Laboratories, assesses medical laboratories against ISO 15189:2022, Medical laboratories — Requirements for quality and competence, along with NABL's own specific criteria. Assessors look at your quality management system, staff competence, equipment, processes and records.
A laboratory information system helps most with the records side: identifying samples, tracing who did what and when, keeping results and their changes, and releasing reports only after review. It cannot run your quality control, calibrate your analysers or write your SOPs.
Be cautious of any vendor that calls its software “NABL certified” or “NABL approved”. NABL does not certify software.
ISO 15189 Record Areas and What eMedHub Supports
Each area is classified honestly. Clause references point to the relevant section of ISO 15189:2022.
- Verified in eMedHub
- Supported through an existing integration
- Requires configuration
- Not currently supported
- Requires product confirmation
| Area | ISO 15189:2022 | Status | Detail |
|---|---|---|---|
| Sample identification | 7.2 Pre-examination | Verified in eMedHub | System-generated sample ID (SID) printed as a Code128 barcode label, linked to the patient's UHID. |
| Sample traceability | 7.2 Pre-examination | Verified in eMedHub | Collector and collection time recorded. Each test moves through statuses from collection to delivery. |
| Sample acceptance & rejection | 7.2 Pre-examination | Verified in eMedHub | Samples can be rejected with a reason and notes; the test returns to pending for a fresh sample. There is no separate 'received in lab' step. |
| Referral (outsourced) examinations | 6.8 Externally provided services | Verified in eMedHub | Partner-lab master and test mapping, with the user and time at each step: collected, transferred, received, result uploaded. |
| Examination records | 7.3 Examination | Verified in eMedHub | Results stored with units, method and reference ranges by gender and age. Machine-entered values are flagged. |
| Analyser results | 7.3 Examination | Supported through an existing integration | Results posted by interface middleware through eMedHub's result API and mapped to tests by analyser code. The middleware itself is outside eMedHub. |
| Internal quality control | 7.3.7 Validity of results | Not currently supported | No IQC data capture, Levey-Jennings charts or Westgard rules. Keep IQC in your analyser software or a QC tool. |
| External quality assessment (PT/EQA) | 7.3.7 Validity of results | Requires product confirmation | No EQA module was identified. Confirm with our team before relying on the software for EQA records. |
| Result review & release | 7.4 Post-examination | Requires configuration | Optional approval step, switched on per site. Department-scoped approvers; a user cannot approve their own request. Single level only. |
| Critical result notification | 7.4 Post-examination | Verified in eMedHub | Real-time in-app alert to the ordering doctor, with read status. Phone calls and read-back are not recorded in the software. |
| Report amendments | 7.4 Post-examination | Not currently supported | Every result edit is kept with old and new values, user and time, but there is no formal 'amended report' version or lock after release. |
| Audit trail & data integrity | 7.6 Data and information management | Verified in eMedHub | Change history on results, approvals, bills and orders. Collection records and test masters do not keep a change history. |
| Access control & authorisation | 6.2 Personnel / 7.6 | Requires configuration | Role-based screen access, and approval rights granted per department. |
| Staff competency records | 6.2 Personnel | Not currently supported | No training or competency records. Maintain these in your HR or quality system. |
| Equipment records & calibration | 6.4–6.5 Equipment | Not currently supported | Analyser master holds code and name only. No calibration or maintenance logs. |
| Reagents & consumables | 6.6 Reagents and consumables | Verified in eMedHub | Batch number, expiry date, reorder levels, expiry reports and per-test consumable mapping. |
| Nonconformity & corrective action | 7.5 / 8.7 | Requires configuration | Hospital-wide incident module with review, root cause, corrective and preventive action. Set up lab categories to use it for lab nonconformities. |
| Document control (SOPs) | 8.3 Documents | Not currently supported | No SOP or controlled-document management. |
| Record retention | 8.4 Records | Requires product confirmation | No configurable retention period in the lab module. Confirm retention and archival arrangements with our team. |
| Quality indicators (TAT) | 8.8 Evaluation | Verified in eMedHub | Turnaround-time report from collection to completion, plus test census and result change log reports. |
| Internal audit management | 8.8 Internal audits | Not currently supported | No audit planning or findings module. Software reports can serve as evidence during an audit. |
A Practical NABL Readiness Checklist for Lab Records
Tick what your lab already does. Use it to plan, not as a substitute for NABL's own documents or a consultant's gap assessment.
Your ticks aren't saved or sent anywhere. They clear when you leave the page.
NABL and Lab Software: Common Questions
Is there NABL-certified laboratory software?
No. NABL (the National Accreditation Board for Testing and Calibration Laboratories) accredits laboratories, not software. A software vendor calling its product 'NABL certified' is describing something NABL does not do. Software can help a lab keep the records NABL assessors look at.
Which standard does NABL use for medical laboratories?
NABL accredits medical laboratories against ISO 15189, together with NABL's own specific criteria for medical laboratories. The current edition of the standard is ISO 15189:2022.
What does ISO 15189 expect from a laboratory information system?
The standard is about the laboratory, not software, but it expects the lab's information systems to protect data integrity and confidentiality, control access, and keep records that make each result traceable: who collected, examined, reviewed and released it, and what changed.
Can eMedHub alone make my lab NABL-ready?
No. eMedHub keeps many of the records an assessor reviews, such as sample IDs, collection details, result history, approvals, reagent lots and TAT. Internal quality control, equipment calibration, document control and competency records need to be managed outside eMedHub today.
Does eMedHub keep an audit trail of result changes?
Yes. Every edit to a result is kept with the previous value, new value, user and time, and can be viewed in the result change log report.
How should a lab handle internal quality control with eMedHub?
Keep IQC records in your analyser's QC software or a dedicated QC tool, and make sure QC is reviewed before patient results are released in eMedHub. Ask us about your specific setup during the demo.
Preparing a hospital for NABH as well? See NABH-ready hospital software.