NABL accreditation for a medical laboratory confirms, through independent assessment, that the lab meets ISO 15189:2022 and NABL's specific criteria and policy documents for the examinations in its scope. The route runs from gap analysis and quality system building, through internal audit and an application on NABL's online portal, to on-site assessment, closure of nonconformities and an accreditation decision.
Accreditation tells referring clinicians, hospital management and patients that your results can be trusted. It also brings discipline: a well-prepared lab catches its own errors earlier. Below is each step, what to prepare and where labs lose time.
What NABL accreditation covers
NABL, the National Accreditation Board for Testing and Calibration Laboratories, is a constituent board of the Quality Council of India. It accredits medical laboratories against ISO 15189:2022, Medical laboratories: Requirements for quality and competence, supplemented by its own specific criteria and policy documents. These cover areas such as proficiency testing and metrological traceability.
Accreditation is scope-specific. It is granted for named examinations, in defined disciplines, at a defined site, not for the laboratory as a whole. Many labs start with a core scope, such as routine biochemistry and haematology, and add disciplines later.
NABL has offered entry-level options for smaller labs; check the current schemes and documents on NABL's website before you decide which route fits your lab.
The NABL accreditation process at a glance
| Step | What to prepare | Common pitfalls |
|---|---|---|
| 1. Gap analysis | Review against ISO 15189:2022 and NABL criteria; proposed scope | Scope too broad for resources |
| 2. QMS documentation | Quality manual, procedures, examination SOPs, document control | Templates that do not match bench practice |
| 3. Training and competence | Job descriptions, training records, competence assessments, authorisations | Training signed off without any competence check |
| 4. IQC and EQA | IQC rules per examination, EQA enrolment, investigation records | EQA outliers left uninvestigated |
| 5. Internal audit and management review | Audit programme covering all clauses, review minutes with actions | Audits done once just before applying |
| 6. Online application | Application form, documents and scope on NABL's portal | Scope wording that does not match SOPs |
| 7. Document review | Responses to NABL queries on your documents | Slow or partial responses |
| 8. Pre-assessment (if opted or required) | Working system and records ready for review | Treating it as a formality |
| 9. On-site assessment | Staff available, records retrievable, examinations to witness | Staff unable to explain their SOPs |
| 10. Nonconformity closure | Root cause, correction, corrective action and objective evidence | Correction without root cause |
| 11. Accreditation decision | Prompt answers to any further queries | Assuming closure is automatic |
| 12. Surveillance and reassessment | Continued audits, reviews, IQC and EQA | Standards slipping after the certificate |
Before you apply: building the system
Gap analysis and scope
Start with a gap analysis against ISO 15189:2022 and NABL's specific criteria; our ISO 15189:2022 checklist helps. Decide your initial scope realistically. Every examination included needs method verification, IQC, EQA or an alternative, measurement uncertainty where applicable, and authorised staff.
QMS documentation
Write documents that describe what your staff actually do. Examination SOPs should cover specimen requirements, procedure, calibration, IQC, reference intervals, critical limits and reporting. Control version, approval and withdrawal of obsolete copies at the bench.
Training, competence and authorisation
Assessors interview bench staff, not just the quality manager. Each person needs documented training, a competence assessment (direct observation, result review, blind samples) and clear authorisation for the work they perform and the reports they release.
IQC, EQA and calibration
Run IQC with rules that suit each examination's performance, and keep charts that show review and action. Enrol in EQA or proficiency testing for your scope where available, and use alternatives such as inter-laboratory comparison where it is not. Make sure calibration of equipment, including pipettes and thermometers, meets NABL's traceability policy.
Internal audit and management review
NABL expects the management system to be operating before you apply, which normally means at least one full internal audit and management review with evidence of follow-up. Confirm the current expectation in NABL's documents. Audits should cover every clause and discipline in scope, using trained auditors independent of the work.
After you apply: from assessment to decision
Applications are made through NABL's online portal with your proposed scope and supporting documents. NABL reviews them and may raise queries; answer fully and quickly, because gaps here delay everything that follows.
Depending on NABL's current process, a pre-assessment may be opted for or required. Treat it as a genuine rehearsal that exposes weak records, scope wording or staff awareness.
The on-site assessment is carried out by a team that usually includes a lead assessor and technical assessors for the disciplines in your scope. Expect witnessed examinations, vertical audits that trace one sample from request to report, record reviews and staff interviews.
You then submit corrective actions with objective evidence within the period NABL specifies. NABL considers the assessment report and your responses before taking an accreditation decision, and the certificate lists the accredited scope.
Staying accredited: surveillance and reassessment
NABL carries out periodic surveillance and full reassessment at intervals it sets. Notify NABL of significant changes such as new premises or key personnel, and claim accreditation only for examinations on your certificate; new ones need a scope extension.
Worked example: a 30-bed hospital lab in Thrissur
A 30-bed hospital in Thrissur runs a small laboratory with biochemistry, haematology, clinical pathology and serology. It has one pathologist, a quality manager who also works at the bench, and a small team of technologists on shifts.
The gap analysis shows the usual picture. Biochemistry IQC runs without documented rules, and EQA covers biochemistry only. Competence has never been formally assessed, refrigerator temperature logs have gaps on Sundays, and pipettes were calibrated by a provider whose traceability has not been checked.
The quality manager proposes an initial scope of routine biochemistry and haematology, leaving serology for later. Over the next months the team writes SOPs from actual practice, chooses IQC rules per analyte, enrols haematology in EQA and switches to a calibration provider that meets NABL's traceability policy. A temperature logger with alarms closes the weekend gap.
Two technologists are trained as internal auditors and audit each other's sections, and a management review follows. Only then does the hospital apply. The assessment raises a few nonconformities, mostly about record completeness, closed with evidence rather than new paperwork.
Common mistakes
- Applying for a scope larger than verified methods and EQA can support
- Buying a documentation package and never adapting it to the lab's real workflow
- Holding a single internal audit just before submission, with no time to act on findings
- Ignoring calibration traceability for small equipment such as pipettes and thermometers
- Closing nonconformities with a correction only, with no root cause or effectiveness check
- Letting the system drift between surveillance visits
Key takeaway: NABL accreditation rewards labs that build a working quality system first and apply second. Choose a scope you can defend, run your system for real, and let the evidence speak.
Frequently Asked Questions
How do I get NABL accreditation for a medical laboratory?
Do a gap analysis against ISO 15189:2022 and NABL's specific criteria, build and run your quality system, train and authorise staff, run IQC and EQA, and complete an internal audit and management review. Then apply on NABL's online portal. NABL reviews your documents, assesses the lab on site and decides on accreditation once nonconformities are closed.
Which standard does NABL use for medical labs?
NABL accredits medical laboratories against ISO 15189:2022, Medical laboratories: Requirements for quality and competence, supplemented by NABL's specific criteria and policy documents. Testing and calibration laboratories are accredited against ISO/IEC 17025:2017 instead. Always check NABL's website for the current versions of its criteria and policy documents before preparing your application.
Is NABL accreditation mandatory for labs in India?
Accreditation is generally voluntary, but some government schemes, insurers, hospital networks and contracts require or favour NABL-accredited laboratories. Requirements differ between programmes and can change, so confirm with the relevant authority or contracting body whether accreditation is a condition for the work you want.
Can a small lab get NABL accreditation?
Yes. Accreditation is scope-based, so a small lab can start with a limited set of examinations it can fully support. NABL has offered entry-level options for smaller labs, so check its current schemes. The core needs stay the same: documented procedures, competent staff, IQC, EQA and a working management system.
What happens after NABL accreditation is granted?
The lab enters an accreditation cycle with periodic surveillance and reassessment at intervals set by NABL. You must keep running internal audits, management reviews, IQC and EQA, notify NABL of significant changes, and extend your scope before claiming accreditation for new examinations.
Next steps
If you are leading a lab towards NABL, our ISO 15189 Advanced: Medical Laboratory Quality & Competence course covers the standard in practical depth, and Laboratory Quality Management System builds the foundations for teams new to quality. For related reading, see our ISO 15189:2022 checklist and internal quality control in medical labs. If you are unsure which suits your role, speak to a counsellor.
Looking for structured certification?
Explore Innoryx courses or speak to a counsellor about the right program for you.