Accreditation expires. Surveillance visits arrive every 12–18 months. And in most laboratories the evidence lives scattered — spreadsheets, shared folders, email threads, the consultant's laptop — so every assessment starts with weeks of evidence archaeology. The assay data is usually pristine; it's the evidence around it that stalls audits. OnQMS is the layer that keeps that evidence alive, in one place, mapped to the standard.
What OnQMS does
| The assessor asks… | OnQMS answers with |
|---|---|
| "Show me clause 6.5" (or any other) | The ISO/IEC 17025 coverage cockpit: clause-by-clause status with drill-down to the actual records — documents, signatures, change history. |
| "What happened after that questionable z-score?" | Proficiency testing control charts per analyte (z-score, ISO 13528) with the out-of-control → corrective action → effectiveness loop recorded. |
| "Who was authorized to sign this report?" | Competence profiles per person and method: authorizations, training, dated evaluations and expiries — amber before the assessor finds it. |
| "Calibrated against what, traceable to whom?" | Equipment and calibration records with traceability, next-due alerts, and retention rules per your accreditation scheme. |
| "Show me your impartiality analysis and internal audits" | Impartiality risk matrix, internal audit and management review records, nonconformities and CAPA — with tamper-evident history and electronic signatures. |
Country packs: your accreditor's guidelines, inside the app
National standards adopt ISO/IEC 17025 — what changes by country is the accreditation body's own guidelines: retention floors, PT program rules, surveillance cycles, authorized signatories. OnQMS packs cite the local guideline — document, version, section — next to each requirement, and we track the accreditors' document changes monthly:
- INACAL — Peru NTP-ISO/IEC 17025:2017. Annual PT program filed with INACAL each December; DA-acr directives cited by version. Under SUNAT procedure 183-2019, official umpire assays at customs require an INACAL-accredited laboratory.
- INN — Chile NCh-ISO/IEC 17025:2017. PT hierarchy and suspension rules (DA-D01), 9-factor impartiality matrix (DA-D07), symbol rules for mixed reports (INN-R409). Customs Res. Ex. 2941/2014 requires INN-accredited copper concentrate assays.
- IBMETRO — Bolivia NB/ISO/IEC 17025:2018. Five-year record retention (DTA-CRI-031), the 16-month on-site rule (DTA-RE-001). DS 29577 art. 6: export mineral assays require an IBMETRO-accredited laboratory.
- ema — Mexico NMX-EC-17025-IMNC-2018. Authorized signatories, PT plan rules and CENAM traceability — citing the current GEV/CEI documents (ema renamed its entire MP-* scheme in 2025).
- ENAC — Spain UNE-EN ISO/IEC 17025:2017 (identical adoption; in the EU accreditation is regulated by law and ENAC is the single national body). PT per scope family (NT-03) and the scheme's hardest rule: renewal filed 4 months ahead or the accreditation is extinguished (PAC-ENAC). Under RD 3/2023, drinking-water laboratories must hold accredited methods — those handling 300–5,000 samples/year before 2 January 2028.
Also included: CALA (Canada) — where proficiency testing is a condition of accreditation — the US frameworks (A2LA, ANAB, IAS) with the common ILAC-P9/P10 policies, and OAA (Argentina, IRAM 301).
It lives where your data already lives
OnQMS is a module of OnLIMS: it runs on your server, against your SQL Server database, next to the assay data it draws evidence from. No forced cloud migration, no re-keying records into a separate quality tool that never sees your LIMS. Your records — and your 4–5 years of retention — stay yours, with or without us. And it's the first OnLIMS module with a fully bilingual interface (English/Spanish) — the quality manager in Lima and the corporate auditor in Vancouver work on the same screens, each in their own language.
An AI assistant that plays by laboratory rules
OnQMS includes an optional AI assistant built for confidentiality-first labs: it's bring-your-own-model and designed to run with a local model (e.g. Ollama) on your own hardware, so questions and answers never leave your network. Every answer is grounded in your lab's real evidence state and the standard's knowledge base, cites the clause or article it draws from — and when it has nothing to cite, it says so instead of inventing. Ask "what's missing for a 17025 audit?" and it answers from your data, not from imagination.
We'll say it before anyone asks: OnQMS does not accredit you and does not certify compliance — only your accreditation body does that. What OnQMS does is keep your evidence alive, complete and ready to demonstrate. That honesty is the product.
Commercial model
Perpetual license per site plus the Normative Surveillance Plan — no subscription, no hostage data. Country-pack guideline updates are delivered while the Plan is active.
Frequently asked questions
Does OnQMS accredit my laboratory?
No. Accreditation decisions belong exclusively to your accreditation body. OnQMS supports readiness and evidence: it keeps your records complete and ready to demonstrate, clause by clause.
Does OnQMS work without OnLIMS?
OnQMS is a module of OnLIMS. It builds its evidence from the data that already lives in the laboratory's LIMS database — that connection to the real records is the point.
Which countries do the packs cover?
Full packs: INACAL (Peru), INN (Chile), IBMETRO (Bolivia), ema (Mexico), ENAC (Spain). Also included: CALA (Canada), the US frameworks (A2LA, ANAB, IAS) and OAA (Argentina).
What happens if I stop paying support?
The license is perpetual: OnQMS keeps working and your data stays yours. The country packs stop receiving guideline updates when the Normative Surveillance Plan is inactive.
Does my laboratory data leave my server?
No. OnQMS runs on your own server against your own database, like the rest of OnLIMS.
Does the AI assistant send my data to the cloud?
Not if you don't want it to. The assistant is bring-your-own-model and designed for a local model (e.g. Ollama) running on your own hardware — nothing leaves your network. It's off by default, and if you point it at a cloud endpoint instead, OnQMS shows a clear confidentiality warning first.