NABL accreditation, and what lab software can honestly do about it

What the standard asks: The laboratory decides record retention in line with national, regional and local regulation, and NABL imposes minimum retention periods on top of that. The quality system itself — manual, procedures, controlled copies — must be documented and current.

In SamLab: SamLab holds the records — results, QC runs, registers, reports, ledgers — and holds them on your own machine, with local and off-site backup.

What it does not do: There is no document-control module. Your quality manual, SOPs, their version history and the controlled-copy register live outside SamLab. Be wary of any lab system that implies it writes your quality manual: the manual is a description of how your lab works, and no vendor can know that.

Source: NABL 112A — Specific Criteria for Accreditation of Medical Laboratories · checked 2026-08-08

What the standard asks: “Two levels of QC shall be included on the day of performing the test and subsequently one level every shift/8 hour… The daily QC values shall be documented and LJ charts shall be plotted and reviewed daily. The laboratory shall derive its own mean and SD using a minimum of 20 data points to plot an LJ chart.” The lab must also calculate monthly mean, SD and %CV, and analyse outliers, trends and shifts.

In SamLab: The IQC module carries control materials and their targets, daily runs, Levey-Jennings charts and Westgard rule monitoring. The QC report prints as a record rather than a screenshot: the chart redrawn as vector art, every rule hit with its date, and %CV, bias and sigma with the total allowable error the operator entered shown as the assumption it is — a sigma printed without its TEa is unauditable.

What it does not do: SamLab does not choose your acceptance policy. Whether you derive your own mean and SD from twenty points, or fall back to the manufacturer’s assigned values on a short-shelf-life control such as a CBC, is a decision your SOP makes; the software applies and records what you set.

IQC is a licensed module. It is on the Pro and Enterprise plans and travels with the LIS analyzer add-on — it is not in Express. · Source: NABL 112A — Specific Criteria for Accreditation of Medical Laboratories · checked 2026-08-08

What the standard asks: The laboratory shall participate in EQA/PT in each discipline before gaining accreditation, and again on a change of methodology, a change of equipment or an extension of scope, and “shall document corrective actions taken based on the EQA evaluation report”. Accredited medical labs participate at least once a year per discipline under a two-year plan.

What it does not do: Nothing, and this is the biggest honest gap on the page. EQAS is a subscription to an external scheme; SamLab neither enrols you nor files your returns, and there is no EQAS register inside it — no participation schedule, no Z-score log, no place to file the evaluation report or the corrective action written against it. Today that is your own file, and it is the first thing an assessor asks for.

Source: NABL 163 — Policy for Participation in Proficiency Testing Activities · checked 2026-08-08

What the standard asks: “Imprecision data obtained from the routine application of internal quality control is recommended as the quantitative estimate of the uncertainty of measurement… documented as k X %CV”, with k = 1.96 approximated to 2 at 95% confidence, and “a minimum of six months IQC data should be used to calculate routine imprecision”, updated annually.

In SamLab: SamLab produces the input NABL names. The QC report states %CV per control series for the period you select, derived from your own runs and your own mean rather than the manufacturer’s assigned target.

What it does not do: It does not compute, store or print the MU statement. Nothing stops you doing ±2 × %CV on the figure SamLab gives you, but the software will not do that arithmetic for you, will not hold the rolling six-month window, and will not put an uncertainty column on the patient report.

Source: NABL 112A — Specific Criteria for Accreditation of Medical Laboratories · checked 2026-08-08

What the standard asks: The laboratory shall monitor quality indicators covering “sample collection and identification, transportation and processing, analysis and reporting of results, turnaround time, complaints, downtime of processes, uncertainty of measurements, performance in PT / EQA scheme”.

In SamLab: Turnaround time is measured stage by stage — booked, collected, received, processed, result entered, verified, dispatched — and reported the way an assessor asks for it: the percentage completed within your own promise plus the 90th and 95th percentile, not an average that hides the tail. It also counts the records it cannot measure and prints that number, because 100% within target computed from 4 of 900 samples is missing data, not a good TAT. Sample rejection is covered too, as a ranked Pareto with the rate stated as “n of N booked” and every rejected sample listed with its cause and who entered it.

What it does not do: Complaints and process downtime have no register in SamLab; those two indicators stay on paper. And a stage timestamp only exists if the step was actually recorded — a counter that never scans receipt gets a blank received stamp, which the report shows rather than treating as zero minutes.

TAT and rejection analysis are part of the Analysis suite: Enterprise plan, desktop edition only. · Source: NABL 112A — Specific Criteria for Accreditation of Medical Laboratories · checked 2026-08-08

What the standard asks: Interfaces between the analyzer and the LIS, and between LIS and HIS, “shall be verified to ensure that the interface transmits data in the intended manner and that there is no misfiling of results in the database”. Pre-examination identification and handling must be traceable.

In SamLab: Each specimen carries a barcode, with a sample status that moves through the workflow and timestamps for collection, receipt, processing and dispatch. Analyzer results bind to the barcode they were run under — including the original vial’s barcode when an add-on test reuses a sample already drawn, so a result the analyzer sends under the old number still routes to the right item instead of being misfiled.

What it does not do: Verifying the interface is still your procedure, not the software’s. NABL 112A also asks for a half-yearly re-verification of the whole information system across at least ten different sample types — input, retrieve, screen print, compare, sign and file. SamLab is the thing being verified there; it does not run the verification.

Source: NABL 112A — Specific Criteria for Accreditation of Medical Laboratories · checked 2026-08-08

What the standard asks: “Test reports shall be in accordance with Cl. 7.4.1 of ISO 15189:2022 and also include identification by name and/ or signatures of the person authorizing release.”

In SamLab: A NABL report template prints the accreditation strip with your NABL number and scope, a ULR built automatically as NABL-number / year / invoice and identical on every reprint of that report, the collection → received → reported timeline, two signatories (the person who tested or prepared, and the authorised signatory), the method and instrument behind each parameter, units and reference ranges, and the disclaimer.

What it does not do: If the NABL number is left blank, the strip prints a plain “not issued under NABL accreditation” notice instead of an empty accreditation claim, and the ULR is not generated at all — a ULR is a NABL construct and fabricating one for an unaccredited lab is a false claim on a clinical document. The template gets the format right; the scope printed on it is only as correct as what you entered.

NABL report templates are on every plan, including Express. · Source: NABL 112A — Specific Criteria for Accreditation of Medical Laboratories · checked 2026-08-08

What the standard asks: “There shall be role based authenticated access into the information system and there shall be procedures to inactivate users who are no longer authorized”, and a facility “to demonstrate an audit trail to link the activity undertaken by a user with relation to patient data or software change”.

In SamLab: Sign-in is role-based with per-person permissions, and every entered result carries a revision history: version 1 is the original entry, and every later value is appended with the value it replaced, who entered it, when, whether the value being replaced had been verified and by whom, and the reason typed in Amend Mode. A verified row locks — the value can still be corrected, but never silently.

What it does not do: The revision history is deliberately local to the machine that entered the result rather than synced across branches, so a head office reviewing a branch’s amendments reads them at that branch. Inactivating a leaver is a task someone still has to perform.

Source: NABL 112A — Specific Criteria for Accreditation of Medical Laboratories · checked 2026-08-08

What the standard asks: “The laboratory shall establish and display/make readily available critical limits for tests which require immediate attention for patient management. Test results within the critical limits shall be communicated to the user/authorized person after proper documentation.”

In SamLab: Critical low and high limits are stored per parameter, and typing a panic value raises an immediate re-check prompt at entry — the transposed-digit guard.

What it does not do: The standing critical-value register behind that prompt was removed in July 2026 at a customer’s request: one save writes the whole grid, so every re-save of a bill legitimately holding a panic value re-listed it, and derived parameters contributed values that were never clinically meaningful. The consequence is worth stating plainly on a page about accreditation — SamLab does not currently keep the documented record of who was informed, when and by whom that this clause asks for. That is a call log your lab keeps outside the software.

Source: NABL 112A — Specific Criteria for Accreditation of Medical Laboratories · checked 2026-08-08

What the standard asks: The laboratory must “analyze QC outliers, trends, shifts and their causes and take immediate corrective action”, work through a defined out-of-control procedure, and document corrective actions taken on the EQA evaluation report.

In SamLab: The evidence a corrective action is written against is here — the QC report showing which Westgard rule fired on which date, the rejection log with causes, and the result revision history with the reason recorded on each amendment.

What it does not do: There is no CAPA register: no non-conformity number, no owner, no due date, no closure, no link from a finding to the record that triggered it. The corrective action itself is written and tracked outside SamLab.

Source: NABL 112A — Specific Criteria for Accreditation of Medical Laboratories · checked 2026-08-08

What the standard asks: Internal audit shall cover pre-examination, examination and post-examination processes together with primary sample collection and POCT, and “shall be conducted at least once in 12 months”.

In SamLab: SamLab is a source of evidence for the audit, not a tool for running it. Registers, QC records, TAT figures, rejection logs and result histories export as PDF and Excel for whatever period is being audited.

What it does not do: No audit programme, no checklist, no finding log, no scheduling or reminder. Planning and recording the audit is entirely yours.

Source: NABL 112A — Specific Criteria for Accreditation of Medical Laboratories · checked 2026-08-08