ISO/IEC 17025 isn’t “compatible.” It’s native. The auditor asks, you show it on screen.
Document control, nonconformities with CAPA, analytical quality control with Westgard, and equipment calibration. All inside Gerencialab, all traced, all ready to open in front of the auditor. No parallel spreadsheet, no PDF folder lost on a server.
What changes when quality lives inside the LIMS
In most labs quality turns into drawer paperwork: the standard in a Word doc, the SOPs in a folder, the nonconformities in a notebook, and the analytical control in a spreadsheet only one person understands. The day the auditor arrives, everyone scrambles. Here it is different. Quality happens alongside the operation: the control that fails already opens the nonconformity, the expired document shows up on the dashboard on its own, and the uncalibrated instrument locks before anyone uses it. You don't scramble to document after the fact, the record is born audit-ready.
The wrong version of the SOP stops circulating.
Ask your team which version of the sampling SOP is current. If the answer takes a beat, you already see the problem. Here the master list is single, every document is born with a standardized code and a controlled version, and the second you publish a new version the previous one goes obsolete on its own. It is document control the way 17025 demands, with the approval flow and read confirmation already inside. The auditor asks for the master list, you open it and it already points to what's valid.
Learn moreThe nonconformity that returns stops returning.
Every audit has that one nonconformity that already showed up last year, got 'handled,' and came right back. It comes back because someone closed the record without touching the root cause. Here the system walks the team through the full PDCA, from investigating the cause to verifying effectiveness, and only clears the close once the action proved it worked. Anyone can open a nonconformity. The hard part is proving the problem won't return, and that's exactly what the auditor wants to see.
Learn moreWestgard evaluates. The wrong result won't pass.
There's an honest test for whether a system is a real LIMS or a spreadsheet with a login: what it does when the control fails. Here the run stops right there, before the report reaches the client's hands. There are 24 control types, the statistical rules standards recognize, and automatic release blocking, at a level many labs only see in expensive market-leading LIMS. The auditor asks for the control chart, you open it on screen with the σ zones and the 7 rules already evaluated.
Learn moreExpired equipment runs no analysis
The rule against using equipment with expired calibration is written in every SOP. The trouble is an SOP blocks no one: it relies on the analyst remembering, on a busy day, to check the label before powering up the instrument. Here the rule leaves the page and becomes a system lock. Each instrument runs through a state workflow, the status light shows where it stands on the spot, calibration notifications fire on their own, and using a failed or expired one is blocked at the source. You don't trust that nobody used it. The system wouldn't let them.
Learn moreSupplier evaluation and complaint handling
Two requirements 17025 demands, and most labs settle both over email, where the evaluation disappears into an inbox and the complaint becomes a thread of messages no one reconstructs later. Here the two live inside the flow, with the record and the handling ready to open in front of the auditor.
Learn moreALCOA+ and end-to-end traceability
Uncomfortable audit question: prove this result wasn't altered after it was signed. In a spreadsheet, the honest answer is 'we can't.' Here nobody erases what was done and you reconstruct the entire life of any record. Data integrity isn't a button you switch on, it's how the system was built: it records who did what and when, preserves history instead of deleting it, and keeps traceability from proposal to report.
Learn moreBuild any form without calling IT
Every lab has that one form the system doesn’t have: the balance check, the cleaning checklist, the inspection of the sample that just arrived, the pH meter log. Today it lives in a notebook or a spreadsheet no one audits. Here you build the form right on the screen, choose the fields, set who approves and publish. In minutes the form becomes a controlled, versioned record, ready for the audit, without opening a ticket for anyone.
Learn moreISO/IEC 17025 requirements map
The worst time to find out where the standard isn't covered is in front of the auditor. Instead of promising 'compliance' and hoping, here you open it clause by clause and point to exactly where each requirement is met, and where it isn't yet. It's the map that takes the audit out of improvisation and the sales pitch out of overstatement.
Learn moreFrequently asked questions
Is Gerencialab ISO/IEC 17025 accredited?
It’s the lab that gets accredited, not the software. What we deliver is a system built around the standard’s requirements, one that sustains your accreditation: document control, quality control, equipment calibration, nonconformity handling and audit trail. You accredit the lab using Gerencialab as the tool.
Can I pass an audit by showing the system on screen?
That’s the whole idea. Instead of hunting PDFs in folders, you open the master list, the NC with the CAPA closed, the parameter’s control chart, the equipment calibration status and the audit trail. The auditor asks, you show it on screen.
Does the analytical quality control really evaluate Westgard on its own?
Yes. The Levey-Jennings control chart is calculated and the 7 Westgard rules are evaluated automatically (1-2s, 1-3s, 2-2s, R-4s, 4-1s, 10x, 7T). There’s also CUSUM and EWMA to detect systematic drift and trends. When a mandatory rule fails, the system can block release and open the NC.
Does the system calculate measurement uncertainty?
Not today. Gerencialab stores the uncertainty stated on the reference material certificate, but it doesn’t have a combined-and-expanded uncertainty calculation engine. That’s on the roadmap. We tell you straight, without selling what we don’t deliver.
What about risk management from clause 8.5?
A formal risk-and-opportunity matrix is still on the roadmap. What exists are correlated operational controls: QC failure action, release blocking, NC creation, and the statistical charts that catch trends before failure. For day-to-day risk-based thinking it helps a lot, but it doesn’t replace a formal risk register yet.
Do I have to pay an add-on for QMS and quality control?
No. Document control, nonconformities, CAPA, analytical quality control and equipment management come with the system. We don’t charge for quality separately.
Want to see the QMS running with your lab’s routine?
Get through the next audit without burning a weekend night hunting for PDFs. Book a demo and see document control, CAPA and Westgard working with a case similar to your lab's.