ISO/IEC 17025:2017
Every ISO 17025 requirement inside the system, not in a spreadsheet on the side.
Most LIMS are compatible with the standard. Gerencialab is built inside it: quality control, nonconformities, document control and the audit trail are part of the flow. When the auditor asks for evidence, it's already on screen.
Requirements map
Clause by clause of the standard and how the system meets it natively.
| Clause | Requirement | How Gerencialab meets it |
|---|---|---|
| 4.1 | Impartiality | Role-based segregation of duties with an immutable audit trail. You can show who did what, and when. |
| 6.2 | Personnel | Competence matrix, training records and qualification validity with an automatic alert before it expires. |
| 6.4 | Equipment | Lifecycle registry, calibration with the certificate attached and scheduled maintenance. Expired equipment blocks itself. |
| 6.5 | Metrological traceability | Traceability tree from quote to result, with reference materials controlled by lot and validity. |
| 7.2 | Methods | Versioned method library, with documented validation and a direct link to the analytical parameters. |
| 7.4 | Handling of test items | Sample tracking by barcode and QR, with chain of custody and storage conditions recorded. |
| 7.5 | Technical records | Raw data stored digitally. Nothing changes without a reason, and every change goes into the log. |
| 7.7 | Validity of results | Statistical quality control with Westgard, CUSUM, EWMA and Levey-Jennings charts in real time. |
| 7.8 | Reporting of results | Configurable report with ICP-Brasil digital signature and two-level review before release. |
| 7.10 | Nonconforming work | The nonconformity opens straight in the system, follows a handling flow and links to the corrective action. |
| 8.2 | QMS documentation | Document control with versioning, approval, controlled distribution and read confirmation. |
| 8.7 | Corrective actions | Full flow: root cause, action plan and effectiveness check, with a deadline and an owner. |
| 8.8 | Internal audits | Planning, checklist, finding records and a direct link to the corrective action. |
| 8.9 | Management review | A dashboard with the quality indicators consolidated, ready for the management review meeting. |
Standard coverage
Requirements met natively~85%
Most requirements already run inside the system. Two are still evolving: measurement uncertainty and risk management. We'd rather say that upfront than promise what we don't deliver.
Compatible is not the same as native
Most LIMS call themselves compatible with the standard and leave half of compliance in a spreadsheet on the side. Here the nonconformity opens in the system, the document is versioned in the system and the indicator is calculated by the system. When the auditor arrives, the evidence is already there, with date, author and history.
Want to see this running with your accreditation?
Book a compliance-focused demo. We show the requirements map working with the kind of testing you do.