Quick answer
NABL’s Medical (Entry Level) Testing Labs program, NABL M(EL)T, gives small medical labs a Certificate of Compliance for basic routine tests based on satisfactory proficiency testing results in the last six months. Recognition lasts one three-year cycle, covers only tests listed in NABL 128 Annexure A, and isn’t full ISO 15189 accreditation. Labs can switch to full accreditation at any time.
Key takeaways
- NABL M(EL)T is recognition, not ISO 15189 accreditation.
- It’s based on satisfactory PT results in the six months before applying.
- Only basic routine tests in NABL 128 Annexure A can be recognised.
- Valid for one three-year cycle, with yearly PT and one surveillance visit.
- Two consecutive PT failures remove a test from recognition.
What is NABL entry level for medical labs?
NABL’s Medical (Entry Level) Testing Labs program, written as NABL M(EL)T Labs, is a recognition scheme for small medical labs that aren’t ready for full ISO 15189 accreditation. It started in July 2020 and its rules are in NABL document NABL 128 (amended January 2021).
Unlike full accreditation, recognition is decided mainly on your proficiency testing (PT) performance, not a full assessment of your quality system. It’s a first step, and you can switch to ISO 15189 accreditation at any time.
Entry level vs full NABL accreditation
| NABL M(EL)T (entry level) | Full NABL (ISO 15189) | |
|---|---|---|
| What you get | Certificate of Compliance (recognition) | Accreditation |
| Based on | Satisfactory PT results in the last six months | Full assessment against ISO 15189 |
| Tests covered | Basic routine tests listed in Annexure A only | Any test in your accredited scope |
| Validity | One cycle of three years | Ongoing, with regular surveillance and reassessment |
| On-site visit | One surveillance visit in the three years, at any time | Initial assessment plus surveillance |
| Scope changes | Not allowed during recognition | Scope can be extended |
| International recognition | Not covered by ILAC/APAC agreements | Covered by ILAC/APAC agreements |
Which tests can be recognised?
Annexure A of NABL 128 limits the scheme to basic routine tests:
- Clinical biochemistry: glucose, HbA1c, electrolytes (sodium, potassium, chloride), calcium, magnesium, phosphorus, amylase, lipase, LDH, CK, GGT, lipid profile, kidney function tests and liver function tests.
- Haematology: CBC with differential count and red cell indices.
- Clinical pathology: urine routine (dipstick parameters).
- Serology and rapid tests: HIV antibodies and antigen, HBsAg, anti-HCV, CRP, RA factor, ASO, Widal and typhoid IgG/IgM, syphilis (RPR, VDRL, TPHA).
Check your eligibility
Are you ready to apply? Six checks from NABL 128
6 steps to go
Next: get your legal identity documents in order; enrol in an accredited PT program and complete at least one round; investigate and fix the PT parameters that failed; limit your application to the routine tests in Annexure A; get analyzers calibrated or under AMC; complete local registration.
How to apply, step by step
- Join an accredited PT program (run by an ISO/IEC 17043 accredited provider) for each test you want recognised. Only tests covered in the six months before your application count; see our list of EQAS programmes in India.
- Get equipment calibrated or under AMC, preferably through a NABL-accredited calibration lab.
- Apply online through the NABL M(EL)T portal, with your legal identity documents.
- Geo-tag your lab and equipment using NABL’s mobile app.
- Review and decision: NABL reviews your application with your PT results.
- Pay the fee; your certificate and scope become visible in the portal.
- Stay recognised: take part in at least one PT program a year, and expect one on-site surveillance visit during the three years.
Rules for your reports
- Use the NABL M(EL)T claim only for recognised tests, at the recognised location.
- Mark non-recognised tests on the same report with an asterisk and the bold footnote “The parameter marked with an * are not-recognized by NABL”.
- Don’t use the NABL symbol while your application is pending, or after recognition lapses.
Lab software can apply these rules automatically by marking recognised tests in the test master. For full accreditation, see the NABL accreditation process and our NABL audit checklist.
Frequently asked questions
It’s NABL’s Medical (Entry Level) Testing Labs program, NABL M(EL)T Labs, for small medical labs. Labs get a Certificate of Compliance for basic routine tests based on satisfactory proficiency testing results, valid for one three-year cycle. Rules are in NABL 128.
M(EL)T is recognition based mainly on PT performance, limited to basic routine tests and valid for three years, and it isn’t covered by ILAC/APAC agreements. Full NABL accreditation is a complete assessment against ISO 15189 for your chosen scope.
Basic routine tests in Annexure A of NABL 128: routine biochemistry (glucose, HbA1c, electrolytes, LFT, KFT, lipids and others), CBC, urine routine, and rapid serology such as HIV, HBsAg, anti-HCV, CRP, RA, ASO, Widal and syphilis tests.
One cycle of three years. During that time the lab must take part in at least one PT program a year and undergo one on-site surveillance visit.
Yes. NABL 128 allows a lab to switch to the ISO 15189 accreditation program at any time, during the application stage or the recognition period.
Apply online through NABL’s M(EL)T portal with your legal identity documents and PT results from the last six months, geo-tag your lab and equipment with NABL’s app, and pay the fee after a positive decision.
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Sources
- NABL 128: Criteria and procedure for NABL M(EL)T Labs
- NABL announcement of the M(EL)T Labs program (2020)
- NABL M(EL)T portal
Written by the ClinikPe lab operations team in Kolkata. General information, not legal, tax or medical advice; check the sources and your state rules before acting.
