Last updated: 8 October 2026
Short answer: NABL accredits Indian medical laboratories against ISO 15189, and the 2022 edition of that standard is now the one that applies - the international transition period ended in December 2025. A LIMS does not make a lab accredited, but it produces most of the evidence an assessor asks to see: sample traceability, audit trails on results, quality control records, equipment logs and controlled access to patient data.
Key takeaways
- ISO 15189:2022 puts more weight on risk management, patient focus and confidentiality.
- Point-of-care testing (POCT) requirements are now part of ISO 15189 itself.
- Most audit findings come down to missing or inconsistent records - exactly what software can make routine.
- Software supports accreditation; your quality system, staff competence and participation in external quality assessment still decide it.
What NABL accreditation means for a medical laboratory
The National Accreditation Board for Testing and Calibration Laboratories (NABL) is a constituent board of the Quality Council of India. For medical laboratories it assesses competence against ISO 15189, together with its own specific criteria for medical labs. Accreditation tells patients, doctors, hospitals and insurers that your results are produced under a documented, checked quality system.
In August 2025 NABL also launched a new medical application portal for ISO 15189:2022 applicant laboratories, designed to make the application process simpler and faster.
What changed in ISO 15189:2022
- Risk management. Labs are expected to identify risks to patients and to result quality, and to act on them - not only to follow procedures.
- Patient focus. The standard is more explicit that the lab's work exists to serve patient care.
- POCT included. Requirements for point-of-care testing, previously in a separate standard (ISO 22870), are now part of ISO 15189.
- New structure. The layout now follows ISO/IEC 17025:2017, with clear sections on impartiality, confidentiality, structure, resources, processes and management system.
The standard was published in December 2022, and ILAC set a three-year transition period that ended in December 2025.
Where laboratories usually struggle in an assessment
Assessors rarely find that a lab cannot run a test. They find that the lab cannot prove how a result was produced. Common gaps include:
- A sample that cannot be traced from collection to report.
- A result edited after authorisation with no record of who changed it or why.
- Internal QC run but not recorded consistently, or not reviewed before patient results were released.
- Equipment maintenance and calibration logged on paper that is incomplete.
- Reagent lots and expiry dates that cannot be linked to the runs that used them.
- Turnaround time targets that exist on paper but are never measured.
How a LIMS supports ISO 15189:2022 readiness
Traceability from collection to report
Barcoded samples and status tracking create a complete chain: who collected the sample, when it arrived, which analyzer ran it, who authorised the result and when the report was delivered.
Audit trails on every result
A secure activity log records each action in the system. When someone asks who changed a value and when, the answer is already there.
Quality control alongside patient testing
Recording QC runs in the same system as patient results makes drift visible early and gives assessors a consistent record of review.
Equipment and reagent records
Instrument logs, maintenance schedules and reagent stock in one place make it easier to show that equipment was fit for use on any given day.
Direct analyzer interfacing
When results move straight from the analyzer into the report, transcription errors - a classic risk in any risk register - disappear. Read how analyzer integration works.
Confidentiality and access control
Role-based access means each person sees only what their job needs, which supports both ISO 15189 confidentiality requirements and India's data protection rules.
Measured turnaround time
TAT monitoring turns a written target into a number you can review every month - useful evidence for management review and continual improvement.
What software cannot do for you
No LIMS confers accreditation. You still need a quality manual and controlled documents, trained and competence-assessed staff, participation in external quality assessment (EQAS) or proficiency testing, internal audits, management reviews and a working system for complaints and corrective action. The software makes the evidence easier to keep; the quality system is still yours to run.
A practical readiness checklist
- Can every sample from last month be traced from collection to delivered report?
- Are all result edits after authorisation logged with user, time and reason?
- Are QC results recorded and reviewed before patient results are released?
- Are equipment maintenance and calibration records complete for every analyzer?
- Do you measure TAT against a target, by test and by branch?
- Is access to patient records limited by role, with logins that are not shared?
- Have you completed an internal audit against the 2022 edition of ISO 15189?
How Lisfi helps
Lisfi keeps barcoded sample tracking, analyzer results, QC, billing and reports on one laboratory record, with audit trails and secure logs. Lisfi Platinum adds role-based access control and NABL-related laboratory workflow support. These features are designed to support labs working toward quality and regulatory requirements; the software does not itself confer accreditation. See all LIMS features or talk to our team about your accreditation plans.
Frequently asked questions
Is NABL accreditation mandatory for diagnostic labs in India?
For most private labs it is voluntary, but it is often expected by hospitals, insurers, corporate clients and government empanelment schemes. Check the rules that apply to your state and the schemes you work with.
Do NABL-accredited labs need to move to ISO 15189:2022?
Yes. The international transition to the 2022 edition ended in December 2025, so assessments are now made against ISO 15189:2022.
Can a LIMS replace our quality manual?
No. A LIMS holds operational records. Your quality manual, procedures and policies remain separate controlled documents.
Which LIMS features matter most for NABL?
Sample traceability, audit trails on results, QC records, equipment logs, role-based access and TAT monitoring.
Written by the Lisfi team at Icon Infoware Technologies, Kochi. This article is general guidance - always confirm current requirements with NABL's official documents.