NABL accreditation requirements: what ISO 15189 asks of a lab

NABL — the National Accreditation Board for Testing and Calibration Laboratories — accredits medical and pathology laboratories against ISO 15189, the international standard for the quality and competence of medical laboratories. Accreditation is a statement about how a lab is run and how it can prove its results are reliable, not a ranking of its equipment or its turnaround time.

What accreditation actually certifies

NABL grants accreditation against a defined scope: specific tests and disciplines, such as clinical biochemistry, haematology or microbiology, rather than a single certificate covering everything a lab does. A lab that adds a new analyser or a new discipline can apply to extend its scope rather than starting over. This also means a certificate on the wall does not automatically cover every test the lab offers — if it matters to a referrer or a patient, the lab should be able to say which of its tests are within scope.

Not compulsory, often expected

A lab does not need NABL accreditation to register, open or bill a patient. It becomes necessary in practice once a lab wants business that depends on it: many insurers, corporate wellness accounts and hospital referral networks will not empanel a lab without accreditation, even though no law requires it to operate. See how to start a pathology lab in India for where this sits alongside the other registrations a new lab needs.

The general route

Sources describing the process consistently mention the same building blocks, though the exact document list and fees are for NABL to confirm:

• A quality manual and standard operating procedures written to ISO 15189, covering the lab's own tests and methods rather than copied generically.
• A trained quality manager responsible for the quality system.
• At least one completed internal audit and a management review, with records of both kept before the lab applies.
• Ongoing participation in proficiency testing or an external quality assurance scheme, covering the disciplines in scope.
• An on-site assessment by NABL assessors, followed — if successful — by periodic surveillance and a renewal assessment before the accreditation's validity runs out.

Treat accreditation as a second-year project once a lab has real test volumes and a working quality system, not a first-week task alongside registration and staffing.

A lighter route for basic-test labs

NABL has run a separate scheme aimed at laboratories that perform only basic routine tests — simpler documentation than full ISO 15189 accreditation, meant as a step a small lab can take before it has the volume or the systems for the full route. Because the scheme's name, eligibility, fee and validity period have varied across the sources checked for this article, confirm the current version directly with NABL before planning around it.

What ISO 15189 asks of a lab's records

Accreditation is assessed on paper as much as on the bench. Three things come up repeatedly in descriptions of what assessors check:

Document control

Controlled documents — the quality manual, SOPs, forms — need to be approved before use, carry a version or edition identifier, and have a register of which version is current. When a document is revised, the obsolete version is marked and kept for a defined period rather than simply deleted, so there is a record of what procedure was in force when a given result was produced.

Records that stay protected and accessible

Instrument logs, calibration and maintenance records, staff competency records, internal audit reports, management review minutes and proficiency-testing results are all the kind of record an assessor expects to see. ISO 15189 does not fix one retention period for every record type — it leaves the laboratory to set its own retention schedule, covering both format and duration, guided by whatever national law or professional body rules apply. What it does ask is that records, in whatever medium they are kept, stay protected from unauthorised change and are not lost to deterioration before that schedule says they can go.

Traceability from sample to report

An assessor generally wants to see that a given result can be traced back to the sample it came from, who collected it, when, and what happened to it in between. A barcoded sample that is scanned at each handoff is usually easier to demonstrate than a paper logbook, because the trail exists automatically rather than depending on someone remembering to write it down.

What this means for the LIS you run

None of this software can accredit a lab — only NABL's assessors do that. What a lab's software can do is make the records above easier to produce on the day an assessor asks for them:

• A result that locks to the sample and the test it belongs to, so the trail from accession to report does not depend on a spreadsheet staying consistent.
• A log of who changed what and when, rather than values that can be overwritten with no record of the earlier one.
• Role-based access, so not everyone at the counter can alter a signed result.
• A retention setting the lab actually controls, rather than records disappearing on a vendor's own schedule.

Ask a vendor to show these on your own test data before you assume the system will hold up under assessment, in the same way you would check its billing or its analyser connections. See what a laboratory information system actually does for the rest of what an LIS is expected to carry.

Where Raydian LIS fits

Raydian LIS keeps an immutable audit trail of sensitive actions, so changes are recorded rather than silently overwritten, and access inside the system is role-based rather than open to everyone at the counter. Samples are barcoded at the counter and tracked from there. Data is purged by category on a defined schedule, with each run recorded for compliance audit, and the preloaded test database — ranges, units and methods — can be edited to match your own lab rather than a generic default. See how LIS security works and what the pathology software includes.

For the retention and traceability expectations ISO 15189 sets more broadly, an EFLM working-group paper on dealing with the standard's retention requirements is a useful starting point before you set your own schedule — see the paper on NCBI. For the accreditation process itself, start at NABL's own site rather than a secondary summary, including this one, for anything you plan to rely on.