ISO/IEC 17025 requirements map
See, clause by clause, what the system offers today, the status of each feature and what remains the laboratory's responsibility. ISO/IEC 17025 accreditation is granted to the laboratory for the applicable scope, not to the software.
Illustrative system screen. Demo data that does not represent client results.
What you'll find in this area
4.1 Impartiality · Available
Access profiles and group permissions, audit trail and a register of impartiality risks in the risk module. Limit: 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.
4.2 Confidentiality · Available
Role-based access and group permissions, with client data restricted by permission, and a portal with individual access per client. Limit: 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.
6.2 Personnel competence · Available
Competence matrix per employee, with evidence, training and authorizations for activities, plus read confirmation of procedures. Limit: Blocking people without authorization is optional and comes turned off. Competence criteria and staff evaluation are defined by the laboratory.
6.3 Environmental conditions · Available
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. Limit: There is no integration with sensors or data loggers: readings are entered by staff. Limits and frequency are defined by the laboratory.
6.4 Equipment and calibration · Depends on configuration
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. Limit: The default is to warn. Blocking applies to equipment flagged as critical or when the laboratory turns on blocking mode.
6.5 Metrological traceability · Available
Calibration certificates recorded with uncertainty and k factor, and reference materials controlled by lot and expiry date, as registered. Limit: The metrological traceability chain and the competence of calibration providers are documented and evaluated by the laboratory.
6.6 Suppliers and external services · Available
Supplier qualification and approval, with a supplier quality index (IQF) and evaluation history. Limit: Supplier selection, evaluation and monitoring criteria are defined by the laboratory.
7.1 Review of requests and proposals · Available
Proposals have a review field and status, an approval workflow and a record of the decision rule agreed with the client. Limit: Assessing technical capability and resources to meet each request is done by the laboratory.
7.2 Methods · Available
Methods with draft and published versions, change history and earlier versions that can be restored. Limit: Selecting, verifying and technically validating methods is up to the laboratory.
7.3 Sampling · Partial
Sampling schedules with calendar and frequency that create work orders automatically, plus field sampling records in the app. Limit: There is no statistical sampling plan, such as ISO 2859 or AQL. The sampling method and plan are defined by the laboratory.
7.4 Receipt and handling of samples · Available
Pre-receipt and technical inspection of samples with barcode scanning, unique identification and a history of the stages up to disposal. Limit: Acceptance criteria, storage conditions and handling of deviations at receipt are defined by the laboratory.
7.5 Technical records · Available
History of each result with author, date and values before and after the change, linked to the sample and the report. Limit: The content of records and the reasons for changes are the laboratory team's responsibility.
7.6 Measurement uncertainty · In development
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. Limit: 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.
7.7 Ensuring the validity of results · Available
Analytical quality control with configurable control types, Westgard rules and Levey-Jennings, CUSUM and EWMA charts. Limit: The control plan, acceptance criteria and participation in proficiency testing are defined by the laboratory. The action on failure follows each rule's setup.
7.8 Reporting of results · Available
Reports in configurable templates, with comparison against registered limits, marking of accredited tests, partial reports and revisions archived with reason and owner. Limit: 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.
7.9 Complaints · Available
Customer service desk with ticket number, response-time tracking and submission through the client portal. Limit: Investigating, deciding on and responding to each complaint is up to the laboratory.
7.10 Nonconforming work · Available
Nonconformity records with cause analysis, action plan and an effectiveness review step that requires evidence. Limit: Assessing the impact, deciding to halt or release work and notifying the client are up to the laboratory.
7.11 Control of data and information · Available
Role-based access control, change history with author and date, and an audit trail on results data. Limit: Validating the system for its intended use, including calculations and method spreadsheets, is done by the laboratory.
8.2 Management system documentation · Partial
The management system manual, policy and procedures can be controlled in the documents module, with versioning and approval. Limit: There is no dedicated module for quality policy and objectives. Defining, communicating and monitoring them is up to the laboratory.
8.3 Document control · Available
Documents with versioning, approval, distribution, read confirmation, periodic review and online editing. Limit: Document content, approvers and review intervals are defined by the laboratory.
8.4 Control of records · Partial
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. Limit: The records retention and disposal policy belongs to the laboratory. There is no full data export in a single package, and returning data is covered in the contract.
8.5 Risks and opportunities · Available
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. Limit: Identifying risks, setting the matrix criteria and evaluating the effectiveness of actions are the laboratory's responsibility.
8.6 Improvement · Available
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. Limit: Choosing improvement opportunities and analyzing client feedback are done by the laboratory.
8.7 Corrective actions · Available
Nonconformity with cause analysis, an action plan with deadlines and owners, and an effectiveness review that requires evidence. Limit: Cause analysis and the decision on whether actions were effective are up to the laboratory.
8.8 Internal audit · Available
Annual audit program, ISO/IEC 17025-based checklist, findings log and report. Limit: Auditor competence and independence and checklist content are defined by the laboratory.
8.9 Management review · Available
Agenda built from nonconformity, audit, risk, customer service and quality control data, plus minutes that can be signed. Limit: Decisions, review outputs and action follow-up belong to the laboratory's management.
How to read the map
The map helps you plan where the system supports the routine and where the laboratory needs procedures or additional evidence.
Status in text.
Each item states its status: available, depends on configuration, partial or in development.
Limit of each feature.
Each item also states what remains the laboratory's responsibility.
Full map.
The ISO/IEC 17025 page has the requirements map with examples of records.
Frequently asked questions
Does Gerencialab meet every ISO/IEC 17025 requirement?
ISO/IEC 17025 accreditation is granted to the laboratory for the applicable scope, not to the software. The platform is a support tool. Demonstrating competence and meeting the standard are the laboratory's responsibilities. The map shows the supporting features for each clause and the current limits.
Why do some items show as partial or in development?
Because the status reflects what the system does today. Measurement uncertainty is in development. Sampling (7.3), management system documentation (8.2) and control of records (8.4) have partial coverage, described in each item.
How does the system handle 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.
Is there a risks and opportunities module?
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. High and critical risks require a treatment strategy and can be turned into a nonconformity.
Does the map help prepare for an audit?
It helps you locate the records for each topic. Look up records and history on screen and prepare evidence according to the procedures and requirements that apply to your laboratory.
Want to see the QMS with your laboratory's routine?
Free online demo, about 30 minutes long. Our team adapts the examples to your laboratory's routine.