ISO/IEC 17025 lab software with live method validation, uncertainty and PT as one accreditation file.
ISO/IEC 17025:2017 asks a testing or calibration lab to prove technical competence — validated methods, calculated measurement uncertainty, calibrated equipment with unbroken metrological traceability to the SI, proficiency-testing participation, and a management system that keeps impartiality and confidentiality intact. V5 replaces the method binder plus the calibration spreadsheet plus the PT log with one accreditation file the A2LA or UKAS assessor can navigate in an hour.
You're shopping because the last A2LA surveillance visit flagged missing uncertainty budgets and a lapsed PT round.
Method validation records live as Word files with no traceability to the SOP that references them
Measurement uncertainty budgets are one-off spreadsheets that nobody re-opens between assessments
Equipment calibration certificates arrive as PDFs and the traceability chain to the NMI is invisible
PT rounds get skipped because nobody owns the ILAC P9 frequency schedule
Impartiality risks are declared once at hire and never reviewed
The assessor asks for the last 12 months of internal audits and nonconformity actions — you spend a week compiling
ISO/IEC 17025 accreditation, run as one file.
Method validation & verification
Validation studies for non-standard methods and verification for standard methods per §7.2.2 — specificity, LOD/LOQ, linearity, range, precision (repeatability/intermediate reproducibility), trueness, robustness — linked to the SOP, the equipment used and the analyst's competency record.
Measurement uncertainty budgets
Per §7.6, a live GUM-compliant uncertainty budget for every reported quantity — Type A and Type B components, sensitivity coefficients, combined and expanded uncertainty (k=2), re-computed automatically when a contributing calibration, reference material or reagent lot changes.
Equipment calibration with traceability chain
Every instrument carries its calibration certificate, the calibrating lab's accreditation scope, the reference standard, and the unbroken chain to a National Metrology Institute — so §6.5 metrological traceability is a click, not a binder hunt. Due-date alerts fire before the certificate lapses.
Proficiency testing (PT) / ILC scheduling
PT participation planned against ILAC P9 frequency guidance and the scope of accreditation — schedule, provider, sample receipt, result submission, z-score / En-value review, and corrective action for unsatisfactory rounds. No round slips off the calendar.
Impartiality & confidentiality register
Per §4.1 and §4.2 — impartiality risk register with mitigation, staff declarations refreshed on role change, and confidentiality obligations for third-party samples and client data with named accountability.
Test report & opinion/interpretation
§7.8 test reports with all mandatory content, decision-rule application per §7.8.6 for statements of conformity, and controlled opinions & interpretations per §7.8.7 — each report electronically signed by an authorised signatory listed on the scope of accreditation.
What changes the day this goes live.
- Method validation, SOP and analyst competency are one linked object, not three folders
- Uncertainty budgets re-compute when a calibration certificate changes — no stale numbers on reports
- Traceability to the SI is one click from any reported result to the NMI certificate
- PT participation matches ILAC P9 frequency for every scope item automatically
- The A2LA / UKAS assessor gets a self-service evidence pack instead of a document request list
The frameworks a technical manager owns.
ISO/IEC 17025:2017
General requirements for the competence of testing and calibration laboratories — structural, resource, process and management-system requirements, including §7.7 quality control of results and §8 management system options A and B.
ILAC P9 · P10 · P14
ILAC policy on participation in PT (P9), metrological traceability of measurement results (P10), and uncertainty in calibration (P14) — the assessor's rulebook on the technical requirements above §17025 itself.
Accreditation body scope
A2LA, UKAS, ANAB, DAkkS, INMETRO and other ILAC-MRA signatories — scope of accreditation with named methods, ranges and measurement uncertainties published and re-issued as the lab extends scope.
ISO/IEC 17025 software, answered.
Does V5 compute measurement uncertainty automatically?
V5 hosts the GUM-compliant uncertainty budget for each measurand — sensitivity coefficients, Type A/B components with distributions, combined standard uncertainty and expanded uncertainty at k=2. When a contributing calibration certificate, reference-material certificate or reagent lot is updated, the affected budgets and any reports still in draft are re-computed and flagged for review before signature.
How is metrological traceability to the SI demonstrated?
Each instrument's calibration certificate references the calibrating lab, its accreditation body and scope, the reference standards used, and the traceability chain up to a National Metrology Institute (NIST, NPL, PTB, LNE, INMETRO…). V5 renders that chain as a graph so §6.5 traceability is auditable in seconds — no binder rebuild between assessments.
Does V5 replace our LIMS?
No. V5 is the accreditation and management-system layer — methods, validation, uncertainty, competency, PT, calibration, impartiality, nonconformity, internal audit, management review. Sample throughput and analytical result capture stay in the LIMS; V5 references the LIMS record on the test report and evaluates §7.7 quality-control performance from the LIMS QC data.
How is the scope of accreditation managed?
The scope is a live object — every accredited method with its measurand, range and reported uncertainty. Extending scope opens a workflow: validation study → uncertainty budget → competency demonstration → PT plan → scope amendment to the accreditation body. Nothing goes on a report as accredited work until the scope object shows it.
Run ISO/IEC 17025 on one live accreditation file.
Free trial. Real validation, real uncertainty, real PT, real traceability.