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Compliance
Standards & regulation

NABL

NABL accreditation — National Accreditation Board for Testing and Calibration Laboratories

Built in India, for the paperwork Indian assessors actually ask for.

NABL applies ISO/IEC 17025 and ISO 15189 in India, and adds its own document requirements on top — most visibly the Unique Laboratory Report number that has to appear on every accredited report. Generic LIMS products treat ULR as a text field. ErgoLIMS allocates it in the database, atomically, which is the difference between a numbering scheme and a numbering problem.

18 characters, allocated atomically
ULR format
Testing · Calibration · Medical
Packs
Forward-only, resets each 1 January
Numbering

Who this is for: NABL-accredited labs and labs preparing their first application, in testing, calibration or medical disciplines.

ULR allocation that cannot collide

The ULR is composed as certificate number (6) + year (2) + site (1) + running serial (8) + type (1). Allocation happens inside a single atomic database statement, so two analysts issuing reports at the same moment cannot receive the same number, and the serial can only ever move forward — there is no path that back-dates or reuses one.

  • Per tenant, per certificate, per year, per site sequence — resets every 1 January
  • Certificate number normalised (separators stripped, upper-cased, padded to six) so a typo cannot fork the sequence
  • Type digit reflects reality: F for a full report, P where some requested tests were not ready at issue
  • A lab with no accreditation certificate on record gets no ULR, rather than a fabricated one
  • The ULR is stored on the report, not derived at print time, so a reprint years later shows the number that was issued

Scope of accreditation

Accreditation is granted per test, per method, per matrix, per range — and reporting an out-of-scope test under the accreditation symbol is one of the fastest ways to earn a non-conformity.

  • Methods carry their accreditation status, so in-scope and out-of-scope tests are distinguishable
  • Reports can separate accredited from non-accredited results rather than presenting them identically
  • Authorised signatories are held per department, with the signatory snapshot stored on the issued report

Proficiency testing and inter-laboratory comparison

PT participation is a NABL condition, not an optional quality exercise. Rounds, results and performance are tracked in the system with the statistics computed rather than typed in.

  • PT rounds with provider, scheme, assigned value and reported value
  • z-score computed and flagged satisfactory / questionable / unsatisfactory at the standard 2 and 3 thresholds
  • Unsatisfactory outcomes can be linked to a CAPA, so the follow-up is traceable to the round that triggered it

Report structure

Report layouts are built in Report Studio, so a lab can hold a NABL-format layout and a customer-specific layout side by side without maintaining two systems.

  • Per-customer and per-document-type templates across eight document types
  • Blocks for opinions and interpretations, and for statements of conformity with the decision rule (§7.8.6, §7.8.7)
  • QR verification on issued certificates, with revoked certificates returning a clear gone response rather than silently still verifying
  • Signature handling configurable per lab: e-signature, signature image, or both
Day one

Selecting NABL at signup turns these on

The testing and calibration packs enable the full ISO 17025 module set. The medical pack (ISO 15189) enables the same core minus the ones that only apply to testing labs.

Measurement uncertainty Method validation Proficiency testing Internal audits Management review Complaints CAPA Reference materials OOS investigations Amendments Subcontractors Document control QC charts Specifications Statistical tools SLA management Field sampling

accreditation code: nabl_testing · nabl_calibration · nabl_medical

Straight answers

What ErgoLIMS does not do here

Every vendor page lists what the software handles. These are the boundaries, so you find them now rather than three weeks into an evaluation.

  • NABL accredits laboratories, not software. There is no such thing as a NABL-approved LIMS, and any vendor claiming one is describing something that does not exist.
  • The system does not decide whether a test is within your scope — it stores the status you record against each method and reports accordingly.
  • ISO 15189 medical labs are supported through the NABL medical pack, but the clinical domain templates are lighter than the testing ones.
  • ULR allocation requires the accreditation certificate number to be on record. Without it, no ULR is issued.

Questions we get asked

No, and neither is any other LIMS. NABL accredits laboratories against ISO/IEC 17025 or ISO 15189. What a LIMS can do is hold the evidence and enforce the controls an assessor will look for. Treat any "NABL certified software" claim as a warning sign.

Bring your assessor’s checklist

The most useful demo is the one where you read the audit trail yourself and try to break an authority check. We would rather you found the limits in the demo than after signing.