NABL Accreditation for Testing, Calibration and Medical Labs
NABL accreditation is formal recognition that your laboratory is technically competent to produce reliable results, judged against ISO/IEC 17025 or ISO 15189. Since 16 October 2024 it is valid for four years, with yearly on-site surveillance. We check readiness, assemble the application file and manage the process with NABL.
What it is
NABL is the National Accreditation Board for Testing and Calibration Laboratories, a constituent board of the Quality Council of India (QCI). It checks whether a laboratory’s staff, equipment, methods and quality system produce results others can rely on. A lab that passes gets a certificate with a defined scope: the exact tests or calibrations covered.
Accreditation is not the same as ISO 9001 certification. ISO 9001 looks at management processes. NABL accreditation checks technical competence, test by test. The applicable standards are ISO/IEC 17025:2017 for testing and calibration labs, ISO 15189:2022 for medical labs, ISO/IEC 17043:2023 for proficiency testing providers, ISO 17034:2016 for reference material producers and ISO 20387:2018 for biobanks.
Who it applies to
You run a testing lab
Food, water, chemical, mechanical and electrical labs, independent or inside a factory. Picture a Faridabad auto-parts maker whose export buyer wants test reports from an accredited lab: its in-house lab is a natural candidate.
You run a pathology lab
Pathology and diagnostic labs under ISO 15189, from small units to large reference labs. Accreditation sits alongside your clinical establishment registration, not in place of it.
You calibrate or supply reference standards
Labs that calibrate instruments, plus proficiency testing providers, reference material producers and biobanks.
Why it matters
Qualify for regulatory work
Section 43(1) of the Food Safety and Standards Act, 2006 lets the Food Authority, which also runs FSSAI licensing, notify NABL-accredited labs to analyse food samples.
Earn higher CGHS rates
NABL announced on 14 October 2025 that accredited medical laboratories get 15% higher rates than non-accredited labs under CGHS.
Put the NABL symbol on your reports
An accredited lab may use the NABL symbol on reports for tests within its scope. Clients can see the result has been independently vouched for.
Documents required
Quality system
- Quality manual or management system document
- Records of at least one full internal audit
- Minutes of a management review covering all agenda points
Technical evidence
- Proficiency testing results with a satisfactory z-score (below 2), where PT is available
- Proposed scope: tests or calibrations, methods, ranges
- Equipment list with calibration certificates
- Method validation or verification records
Lab and legal entity
- Incorporation or registration documents of the legal entity
- Staff list with qualifications and authorisations
- Premises layout and environmental controls
- Disclosure of any consultant engaged
Which standard applies to your lab
| Type of body | Standard | How NABL charges |
|---|---|---|
| Testing laboratory | ISO/IEC 17025:2017 | Per discipline |
| Calibration laboratory | ISO/IEC 17025:2017 | Per discipline or group |
| Medical laboratory | ISO 15189:2022 | By size (patients per day), plus per collection centre |
| Proficiency testing provider | ISO/IEC 17043:2023 | Per sub-discipline |
| Reference material producer | ISO 17034:2016 | Per category |
| Biobank | ISO 20387:2018 | By activities |
Choose the scope with care. Each test listed needs evidence, but tests left out cannot carry the NABL symbol.
How it works
Run a readiness check
We go through the standard against your lab: quality manual, internal audit, management review and proficiency testing. Every gap gets an owner and a date.
Fix the scope
We help you decide which tests, methods and ranges go into the application, and work out the NABL fees that follow. Here is the catch: a pathology lab with three collection centres pays for each centre, so count them properly.
File the application online
We prepare the application on NABL’s portal with the quality manual, audit and review evidence, PT results and fee payment.
Get through the assessment
NABL reviews the documents, then sends a lead assessor and technical assessors on site, generally for two days. Your technical staff answer on the tests; we coordinate schedules and paperwork.
Close findings and stay accredited
We track corrective actions, the yearly surveillance and the two-yearly reassessment, and report changes to NABL within 15 days.
Timelines
Before you apply
Complete at least one internal audit covering all activities and one management review, and take part in proficiency testing where available.
Every year on site
The certificate is valid for four years. NABL conducts an on-site surveillance every year, and a reassessment every two years.
Within 15 days of a change
Tell NABL within 15 days about changes in ownership, location, key personnel or scope.
What happens if you fall short
Accreditation can be withdrawn
NABL can deny or withdraw accreditation for non-compliance with its terms and conditions in NABL 131, including false claims or fraudulent activity.
Reports lose the symbol
The NABL symbol may only appear on reports for tests inside your accredited scope. Use outside the scope breaches NABL’s conditions.
Clients and schemes walk away
Higher CGHS rates, and work reserved for accredited or notified labs, need a valid accreditation.
Frequently asked questions
How long is NABL accreditation valid?
NABL accreditation is valid for four years. NABL raised validity from two to four years with effect from 16 October 2024. During that period, it carries out an on-site surveillance every year and a full reassessment every two years. So you are assessed each year even though the certificate runs four. Keep internal audits and PT participation on schedule and each visit stays manageable.
What is the NABL application fee for a testing lab?
For a testing laboratory, the application fee is ₹11,000 per discipline under NABL 100A (Amendment 5, 3 February 2026). The annual accreditation fee is ₹24,000 per discipline, paid in advance. Assessments add an overhead of ₹11,000 and assessor honorarium of ₹5,500 a day for the lead assessor and ₹5,000 for each technical assessor. GST at 18% applies. We work out your total before you apply.
How are medical laboratories charged?
Medical labs pay by size, measured in patients per day. Under NABL 100A, the application fee runs from ₹6,000 for a micro lab (up to 25 patients a day) to ₹2,20,000 for a very large lab (over 1,000), plus ₹200 per sample collection centre. Annual fees range from ₹6,000 to ₹2,40,000, plus ₹1,000 per collection centre. GST is extra.
Is proficiency testing required before applying?
Yes, where a programme is available for your tests. NABL requires the applicant to have participated satisfactorily, with a z-score below 2, in a proficiency testing programme run by an accredited PT provider before applying. In practice, PT rounds run on the provider’s calendar, so we help you enrol early and the file is not held up waiting for results.
What is the difference between NABL accreditation and ISO 9001 certification?
NABL accreditation checks technical competence for specific tests; ISO 9001 certifies a management system. A lab with ISO 9001 shows it runs organised processes. A NABL-accredited lab shows that each test in its scope gives reliable results, verified by technical assessors. Many labs hold both, and the two systems sit well together.
Do food testing labs need NABL accreditation?
For regulatory work, effectively yes. Section 43(1) of the Food Safety and Standards Act, 2006 allows the Food Authority to notify laboratories accredited by NABL, or another accreditation agency, for analysing food samples. So a food lab aiming for FSSAI notification usually starts with NABL.
How long does the NABL process take?
It depends on how ready the lab is when it applies. Before applying, you need at least one internal audit and one management review, plus proficiency testing results. After that come document review, the on-site assessment, generally two days, and closure of any non-conformities. A lab with a working quality system moves through these stages without long gaps.
What changes must be reported to NABL?
Changes in ownership, location, key personnel or scope must be reported to NABL within 15 days. This is a condition of keeping accreditation under NABL’s terms and conditions. NABL may also make unannounced visits. A lab moving to new premises, for example, should plan the shift with NABL so that accredited testing continues without a break.
Does Taxhint run tests or act as an assessor?
No. Taxhint does not run a laboratory and does not assess labs for NABL. Your technical staff carry out the tests, and NABL’s assessors judge them. We handle the readiness review, the application file, fee calculations, portal filing, scheduling and tracking of surveillance and changes.
What it costs
Our fee plus the government fee that applies to your case, quoted before you commit. Tell us the situation and we will price it exactly.
NABL’s own fees under NABL 100A (Amendment 5, 3 February 2026), GST at 18% extra:
| Item | Fee |
|---|---|
| Application, testing lab | ₹11,000 per discipline |
| Annual fee, testing lab | ₹24,000 per discipline |
| Application, medical lab | ₹6,000 to ₹2,20,000 by size, plus ₹200 per sample collection centre |
| Application, mechanical calibration | ₹11,000 per group |
| Overhead per assessment | ₹11,000 |
| Assessor honorarium | ₹5,500 a day (lead), ₹5,000 a day (technical) |
NABL has also moved to an upfront payment system from 1 October 2026.
Ready to begin?
Share your lab type and the tests you want accredited, and we will map the standard, the NABL fees and the gaps to close.