- Standard
- NABH Certification Standards for Medical Laboratory, 3rd Edition
- Eligibility
- Hospital-based or standalone labs operating for 6+ months with a valid lab registration/licence
- Documents
- Fire NOC (or third-party fire audit), biomedical waste agreement, Pollution Control Board certificate
- NABH fees (2 years)
- Up to 25 patients/day ₹12,500; 26–100 ₹25,000; 101–300 ₹50,000; 301+ ₹80,000 (+18% GST)
- Validity
- 2 years — apply for renewal 6 months before expiry
Who it suits
NABH's medical laboratory certification is open to hospital-based and standalone laboratories that have been operational for at least six months and hold a valid laboratory registration or licence. It suits collection-centre networks, small and mid-sized diagnostic labs and hospital labs that want a structured quality system without, or before, the effort of full NABL accreditation.
Documents NABH asks for
- Valid medical laboratory registration or licence
- Valid fire NOC from the fire department or state government — or a third-party fire audit report
- Valid biomedical waste agreement with an authorised treatment facility
- Valid Pollution Control Board certificate
If any of these is missing or expired, we sort it first — see licences.
Process and fees
Obtain the standards, implement for three months, apply online and pay, then NABH schedules an on-site assessment. The certification committee reviews the findings, non-conformities are closed and certification is granted for two years. Renewal is due six months before expiry.
| Patients per day | Application-cum-certification fee (2 years) |
|---|---|
| Up to 25 | ₹12,500 |
| 26–100 | ₹25,000 |
| 101–300 | ₹50,000 |
| 301 and above | ₹80,000 |
Plus 18% GST; virtual assessment ₹2,000, focus assessment ₹15,000.
What a certified lab runs on
- Documented pre-analytical processes: test requisition, patient identification, sample collection, labelling, transport and rejection criteria.
- Internal quality control on every run with Levey-Jennings charts, and participation in external quality assessment (EQAS) or inter-lab comparison.
- Equipment calibration and maintenance records, and reagent lot verification.
- Critical value reporting with documented communication.
- Report formats with reference ranges, authorised signatures and turnaround-time monitoring.
- Biosafety, spill management and biomedical waste segregation.
Frequently asked questions
What is the difference between NABH lab certification and NABL accreditation?
NABL, a separate constituent board of the Quality Council of India, accredits medical laboratories to the international standard ISO 15189. NABH's medical laboratory certification is a foundation-level certification against NABH's own laboratory standards. Many labs start with NABH certification and move to NABL; schemes and insurers commonly look for NABL.
What documents does a lab need for NABH certification?
NABH asks for a valid medical laboratory registration or licence, a valid fire NOC or third-party fire audit report, a valid biomedical waste agreement and a valid Pollution Control Board certificate, along with at least six months of operation.
How much does NABH lab certification cost?
NABH's application-cum-certification fee for two years is ₹12,500 for labs seeing up to 25 patients a day, ₹25,000 for 26–100, ₹50,000 for 101–300 and ₹80,000 for 301 or more, plus 18% GST.
Official sources
Fees and rules change. Always confirm on the official page before you apply.
Get a free gap assessment for your facility
Tell us your facility type, bed or chair count and city. Dr. Ashutosh Sharma will tell you which NABH programme fits, what it will cost and how long it will realistically take — before you commit to anything.
Related
- NABL for labs (ISO 15189)NABL accreditation for pathology and diagnostic labs to ISO 15189:2022: gap analysis, quality manual, validation, IQC/EQAS and assessment support.
- Allopathic clinics & polyclinicsNABH Allopathic Clinics accreditation (2nd Edition) for OPD clinics, dispensaries and polyclinics: eligibility, fees from ₹5,000 + ₹15,000/yr, process.
- Biomedical waste authorisationBiomedical waste authorisation under the BMW Rules 2016: colour coding, CBWTF agreements, the 30 June annual report and what NABH checks.