ISO/IEC 17025: see which controls Gerencialab helps you organize
Technical records, documents, equipment, quality control and traceability can be managed on the same platform. Check the matrix of available features and see which activities remain the laboratory's responsibility.
Documented coverage, requirement by requirement
The matrix below shows how the available features help support relevant records and controls. Some obligations depend on procedures, technical decisions, validations and evidence kept by the laboratory.
| Clause | Topic | Available feature | Limit / laboratory responsibility | See demo |
|---|---|---|---|---|
| 4.1 | Impartiality | Access profiles and group permissions, audit trail and a register of impartiality risks in the risk module. | Analyzing impartiality risks and the measures taken is up to the laboratory. The system does not prevent the same person from reviewing and signing a report; that separation depends on the configured profiles.Permissions and access logs do not replace the impartiality policy or the management of risks to impartiality. | Request a demo |
| 4.2 | Confidentiality | Role-based access and group permissions, with client data restricted by permission, and a portal with individual access per client. | Confidentiality commitments with clients and staff, such as agreements and contracts, are the laboratory's. Encryption at rest for the database and files is not part of the product in the current version. | Request a demo |
| 6.2 | Personnel competence | Competence matrix per employee, with evidence, training and authorizations for activities, plus read confirmation of procedures. | Blocking people without authorization is optional and comes turned off. Competence criteria and staff evaluation are defined by the laboratory. | Request a demo |
| 6.3 | Environmental conditions | Manual logging of environmental readings on a set schedule, with overdue-reading alerts and a control chart with Nelson rules. An out-of-spec reading opens a nonconformity. | There is no integration with sensors or data loggers: readings are entered by staff. Limits and frequency are defined by the laboratory. | Request a demo |
| 6.4 | Equipment and calibration | Equipment register with life cycle, calibration with certificate and uncertainty, maintenance and expiry alerts. Using expired or failed equipment triggers an alert or a block, depending on the setup. | The default is to warn. Blocking applies to equipment flagged as critical or when the laboratory turns on blocking mode. | See the feature |
| 6.5 | Metrological traceability | Calibration certificates recorded with uncertainty and k factor, and reference materials controlled by lot and expiry date, as registered. | The metrological traceability chain and the competence of calibration providers are documented and evaluated by the laboratory.Sample traceability, from request to report, is a different topic and does not replace metrological traceability. | See the feature |
| 6.6 | Suppliers and external services | Supplier qualification and approval, with a supplier quality index (IQF) and evaluation history. | Supplier selection, evaluation and monitoring criteria are defined by the laboratory. | See the feature |
| 7.1 | Review of requests and proposals | Proposals have a review field and status, an approval workflow and a record of the decision rule agreed with the client. | Assessing technical capability and resources to meet each request is done by the laboratory. | See the feature |
| 7.2 | Methods | Methods with draft and published versions, change history and earlier versions that can be restored. | Selecting, verifying and technically validating methods is up to the laboratory.Method version control is not the same as technical validation of the method. | Request a demo |
| 7.3 | Sampling | Sampling schedules with calendar and frequency that create work orders automatically, plus field sampling records in the app. | There is no statistical sampling plan, such as ISO 2859 or AQL. The sampling method and plan are defined by the laboratory. | See the feature |
| 7.4 | Receipt and handling of samples | Pre-receipt and technical inspection of samples with barcode scanning, unique identification and a history of the stages up to disposal. | Acceptance criteria, storage conditions and handling of deviations at receipt are defined by the laboratory. | See the feature |
| 7.5 | Technical records | History of each result with author, date and values before and after the change, linked to the sample and the report. | The content of records and the reasons for changes are the laboratory team's responsibility. | See the feature |
| 7.6 | Measurement uncertainty | Records the uncertainty entered for the parameter, for the result and on the calibration certificate (value, unit and k factor). It also stores the value calculated by the laboratory's own method spreadsheet. | The system does not calculate combined or expanded uncertainty and does not build an uncertainty budget. Estimating uncertainty is the laboratory's responsibility; a dedicated calculation is in development. | Request a demo |
| 7.7 | Ensuring the validity of results | Analytical quality control with configurable control types, Westgard rules and Levey-Jennings, CUSUM and EWMA charts. | The control plan, acceptance criteria and participation in proficiency testing are defined by the laboratory. The action on failure follows each rule's setup.ISO/IEC 17025 does not require Westgard rules. The laboratory chooses its control tools. | See the feature |
| 7.8 | Reporting of results | Reports in configurable templates, with comparison against registered limits, marking of accredited tests, partial reports and revisions archived with reason and owner. | Report content, the decision rule and statements of conformity are defined and checked by the laboratory. The uncertainty shown on the report is the value entered, since the system does not calculate it.With an A1 certificate on file, the report receives an ICP-Brasil digital signature. A3 certificates and timestamping are not available in the current version. | See the feature |
| 7.9 | Complaints | Customer service desk with ticket number, response-time tracking and submission through the client portal. | Investigating, deciding on and responding to each complaint is up to the laboratory. | See the feature |
| 7.10 | Nonconforming work | Nonconformity records with cause analysis, action plan and an effectiveness review step that requires evidence. | Assessing the impact, deciding to halt or release work and notifying the client are up to the laboratory.Handling nonconforming work (assessing impact, suspending work, informing the client) is different from the corrective action in clause 8.7, used when the cause must be eliminated. | See the feature |
| 7.11 | Control of data and information | Role-based access control, change history with author and date, and an audit trail on results data. | Validating the system for its intended use, including calculations and method spreadsheets, is done by the laboratory. | See the feature |
| 8.2 | Management system documentation | The management system manual, policy and procedures can be controlled in the documents module, with versioning and approval. | There is no dedicated module for quality policy and objectives. Defining, communicating and monitoring them is up to the laboratory. | See the feature |
| 8.3 | Document control | Documents with versioning, approval, distribution, read confirmation, periodic review and online editing. | Document content, approvers and review intervals are defined by the laboratory. | See the feature |
| 8.4 | Control of records | Records kept in the system with author, date and access control, archived report revisions and an audit trail with a minimum retention of 5 years. | The records retention and disposal policy is set by the laboratory. | Request a demo |
| 8.5 | Risks and opportunities | Register of risks and opportunities with a configurable probability and impact matrix, heat map, periodic assessments and FMEA. High and critical risks require a treatment strategy and can open a nonconformity. | Identifying risks, setting the matrix criteria and evaluating the effectiveness of actions are the laboratory's responsibility.Analytical quality control does not replace the assessment of risks and opportunities. | Request a demo |
| 8.6 | Improvement | 5W2H action plan with improvement actions linked to their source (nonconformity, audit, risk, management review or customer service) and effectiveness checks by someone other than the person who carried them out. Satisfaction survey (NPS) to hear from clients. | Choosing improvement opportunities and analyzing client feedback are done by the laboratory. | Request a demo |
| 8.7 | Corrective actions | Nonconformity with cause analysis, an action plan with deadlines and owners, and an effectiveness review that requires evidence. | Cause analysis and the decision on whether actions were effective are up to the laboratory. | See the feature |
| 8.8 | Internal audit | Annual audit program, ISO/IEC 17025-based checklist, findings log and report. | Auditor competence and independence and checklist content are defined by the laboratory. | Request a demo |
| 8.9 | Management review | Agenda built from nonconformity, audit, risk, customer service and quality control data, plus minutes that can be signed. | Decisions, review outputs and action follow-up belong to the laboratory's management.The indicators gathered for the agenda are inputs. They do not replace the decisions and records required from management. | Request a demo |
What the platform does and what the laboratory does
Platform
Organizes records, keeps links between pieces of information, applies configured rules, makes queries easier and preserves history according to the available features.
Laboratory
Defines the methods, uncertainties, technical criteria, competence, risks, decisions, validations, procedures and evidence that support its accreditation scope.
ISO/IEC 17025 accreditation is granted to the laboratory for the applicable scope, not to the software.
What changes when quality and operations are in the same system
When results, equipment, documents and nonconformities are on the same platform, it becomes simpler to look up the links between these records. Actions can be linked to their origin, such as a nonconformity, an audit or a risk. Each document has its version and approval recorded, and a change to a result shows the author, the date and the previous and new values.
This helps gather the evidence requested in internal and external audits and reduce work with parallel spreadsheets. Assessing conformity remains with the laboratory and the accreditation body.
Examples of records
Screens that show quality routine tasks. In the demo, we use examples close to your tests.
Illustrative system screen. Demo data that does not represent client results.
Change history of a result
See who entered, corrected, reviewed and signed a result, with the date and the previous and new values. The trail covers the monitored records and system access. Supports technical records (7.5) and control of data (7.11).
See this flow in the demoIllustrative system screen. Demo data that does not represent client results.
Lifecycle of a controlled procedure
Follow a document from draft to current version, with review, approval, distribution and read confirmation recorded. The content and the approvers are defined by the laboratory. Supports document control (8.3).
See this flow in the demoIllustrative system screen. Demo data that does not represent client results.
Handling a nonconformity
Record the occurrence, analyze the cause, build the action plan with deadlines and owners and record the effectiveness review with evidence. Supports nonconforming work (7.10) and corrective actions (8.7).
See this flow in the demoIllustrative system screen. Demo data that does not represent client results.
Equipment calibration due date
Follow the equipment lifecycle and the calibration expiry warnings. By default, using expired equipment triggers a warning; blocking applies to critical equipment or when the laboratory turns that mode on. Supports equipment management (6.4).
See this flow in the demoFrequently asked questions about ISO/IEC 17025 and Gerencialab
Does Gerencialab receive ISO/IEC 17025 accreditation?
No. Accreditation applies to the laboratory and the scope of its activities. Gerencialab offers tools that can support the records and controls used to demonstrate competence.
Does the system calculate measurement uncertainty?
The system records the uncertainty entered for the parameter, the result and the calibration certificate, or the value calculated by the laboratory's method spreadsheet. The system does not calculate combined or expanded uncertainty; that calculation is in development. Check the scope with our team during the demo.
Is it possible to show the traceability of a sample?
The platform gathers the history of the sample's stages and records. During the demo, we show the flow that applies to your methods.
Does the system have a formal register of risks and opportunities?
Yes. Risks and opportunities module with a configurable probability and impact matrix, heat map, assessments and FMEA. Risk identification and treatment actions are defined by the laboratory. Analytical quality control does not replace this assessment.
Does the system prevent the use of equipment with an expired calibration?
By default, the system warns. Using expired or rejected equipment triggers a warning, and blocking applies to equipment marked as critical or when the laboratory turns on blocking mode.
Which Westgard rules does the system apply?
The system applies 6 rules when evaluating each run (1-2s as a warning, 1-3s, 2-2s, R-4s, 4-1s and 10x) and shows the 7T trend on the dashboard, with Levey-Jennings, CUSUM and EWMA charts. The action taken when a rule is violated is configured by the laboratory: warning, flagging the batch as blocked, logging a quality control nonconformity or reanalysis. ISO/IEC 17025 does not determine which rules to use. In the system, the list of Westgard rules is fixed in the current version; the control plan and acceptance criteria are defined by the laboratory.
Can the report be digitally signed?
ICP-Brasil digital signature on reports with an A1 certificate. A3 certificates and timestamping are not available in the current version. Without an A1 certificate on file, the report goes out with an electronic signature stamp.
See the matrix applied to your type of testing
Free online demo, about 30 minutes long. Our team adapts the examples to your laboratory's routine.