If you’ve made it this far, you’re probably in one of two situations: your laboratory has been asked by a customer, a regulator or a conformity assessment program to provide accredited results, or it’s already accredited and needs to get through the next Cgcre assessment without surprises, maintaining or expanding its ISO/IEC 17025 scope.
Either way, this guide brings together what you need to know right now: from the basic definition to the difference between accreditation and certification, covering what is in force in 2026, cost, timeline, technical and management requirements, assessment preparation and how to sustain compliance day to day, without relying on a last-minute scramble.
What is ISO/IEC 17025?
ISO/IEC 17025, “General requirements for the competence of testing and calibration laboratories,” is published jointly by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC), and developed by ISO’s Committee on conformity assessment (CASCO). Created in 1999 and revised in 2005 and 2017, it is the criterion accreditation bodies around the world use to assess whether a laboratory operates competently and produces reliable results.
The standard applies to any laboratory that performs testing, calibration or sampling associated with subsequent testing or calibration, regardless of size or nature: independent laboratories serving third parties, in-house industrial laboratories, and public, university and research laboratories. It does not follow the ten-clause structure of ISO 9001 and ISO 14001, but the common structure of CASCO standards, with five blocks of requirements: general (impartiality and confidentiality), structural, resource, process and management system.
What sets ISO/IEC 17025 apart from a management system standard is its focus on technical competence. Documented processes are not enough: the laboratory must demonstrate that personnel are competent and authorized for each activity, that equipment is calibrated with metrological traceability to the International System of Units (SI), that methods have been verified or validated, that measurement uncertainty is evaluated and that the validity of results is continuously monitored, including through participation in proficiency testing.
Another important point: accreditation is granted by scope. A laboratory is not “accredited to ISO/IEC 17025” in a generic sense, but accredited for specific tests or calibrations, with declared methods, ranges and, in the case of calibration, calibration and measurement capabilities (CMC). In Brazil, accredited calibration laboratories are part of the Brazilian Calibration Network (RBC), and testing laboratories belong to the Brazilian Testing Laboratory Network (RBLE).
The laboratories that typically seek accreditation are instrument calibration laboratories (dimensional, mass, pressure, temperature, electrical, force, torque), laboratories for chemical, microbiological, environmental, food, materials and product testing, laboratories serving Inmetro conformity assessment programs or agencies such as MAPA (Brazil’s Ministry of Agriculture) and ANEEL (Brazil’s electricity regulator), and in-house industrial laboratories that want their results accepted by customers without retesting.
ISO/IEC 17025 in 2026: what is in force and what may change
Unlike ISO 9001 and ISO 14001, which got new versions in 2026, ISO/IEC 17025 has not been revised. What is in force and what is merely movement in the accreditation ecosystem are two different things, and it’s worth not confusing them:
| Topic | Status in 2026 | What it means for the laboratory |
|---|---|---|
| Version of the standard | ISO/IEC 17025:2017 in force, confirmed in the ISO systematic review completed in August 2023 | No version transition is under way; the requirements assessed remain the same |
| Next systematic review | ISO standards are reviewed every five years; the next review of 17025 is expected around 2028 | A possible new version has no date yet, and any transition would only be defined after publication |
| International accreditation | ILAC and IAF merged on January 1, 2026, forming the Global Accreditation Cooperation Incorporated (Global ACI) | Mutual recognition of accredited results between countries continues, now under a single international organization |
| ISO 9001:2026 | New version published on September 16, 2026 | Directly affects laboratories that use Option B of clause 8 (management system based on ISO 9001) and laboratories that are also ISO 9001 certified |
| Harmonization of CASCO standards | ISO/IEC 17020 (inspection bodies) was revised in March 2026 with elements common to the other standards in the 17000 series | Doesn’t change 17025, but signals the direction of a future revision: more harmonization of impartiality, confidentiality and management requirements |
In practice, if your laboratory is seeking accreditation or preparing for a reassessment now, the reference is ABNT NBR ISO/IEC 17025:2017, together with Cgcre’s normative documents (such as NIT-Dicla-031, the regulation on laboratory accreditation).
The point of attention in 2026 is for laboratories that adopt Option B: since their management system is based on ISO 9001, the transition to ISO 9001:2026 needs to be planned in parallel with maintaining accreditation.
ISO/IEC 17025 accreditation vs. ISO 9001 certification: what’s the difference?
| Aspect | ISO 9001 certification | ISO/IEC 17025 accreditation |
|---|---|---|
| What it attests | That the organization has a quality management system in place | That the laboratory is technically competent to produce valid results |
| Who grants it | Accredited certification body | Accreditation body (in Brazil, Cgcre/Inmetro) |
| Coverage | Organization or processes defined in the scope | Specific tests and calibrations, with methods and ranges declared in the accredited scope |
| Focus of the assessment | Processes, risks and continual improvement | Personnel competence, equipment, metrological traceability, methods, uncertainty and validity of results |
| Assessment team | Management system auditors | Lead assessor and technical assessors or experts in the scope area |
| Monitoring of results | Does not require proficiency testing | Requires monitoring of the validity of results, including proficiency testing or interlaboratory comparisons |
| Relationship between the two | Stand-alone standard | Can use ISO 9001 as the basis of the management system (Option B), but having ISO 9001 does not replace accreditation |
A common communication mistake is to say the laboratory is “ISO 17025 certified.” The correct term is accredited, and the use of the mark and references to accreditation follow Cgcre’s own rules (NIE-Cgcre-009).
What are the benefits of ISO/IEC 17025 for a laboratory?
Beyond formal recognition, accreditation solves concrete management and market problems:
1- Opens commercial and regulatory doors: many industrial customers, conformity assessment programs and regulators only accept results from accredited laboratories, which makes accreditation a prerequisite for operating in certain segments.
2- Ensures international acceptance of results: thanks to mutual recognition agreements between accreditation bodies, a report or certificate issued by an accredited laboratory tends to be accepted in other countries without repeating the test or calibration.
3- Reduces rework and disputes over results: validated methods, evaluated uncertainty and a decision rule agreed with the customer reduce arguments over reports and the need for retesting.
4- Builds confidence in internal decisions: for in-house industrial laboratories, reliable results mean releasing lots, approving suppliers and adjusting processes based on data that withstands scrutiny.
Institutionalizes technical competence: the standard requires that personnel competence, authorization and monitoring be recorded, which reduces dependence on a single experienced technician.
5- Integrates with the company’s management system: laboratories that already operate within an ISO 9001 certified organization can reuse document control, internal audit, corrective action and management review, concentrating effort on the technical requirements.
How much does ISO/IEC 17025 accreditation cost and how long does it take?
There is no fixed market price, and the investment depends on a combination of factors:
| Factor | Impact on cost/timeline |
|---|---|
| Size of the scope | Each additional group of calibration services or class of tests increases assessment time and fees |
| Technical diversity of the scope | Scopes covering several areas require more assessors and technical experts |
| Current technical maturity | Methods already validated, uncertainty already estimated and a quality control history shorten the path |
| Metrological traceability | Equipment without traceable calibration must be calibrated before the assessment, which involves third-party cost and lead time |
| Proficiency testing | Prior participation in proficiency testing is expected, and the availability of rounds varies by field |
| Accreditation body fees | In Brazil, Cgcre fees are public and set out in NIE-Cgcre-140, including application, document review, assessment and annual maintenance |
| Infrastructure and environmental conditions | Facility upgrades and environmental control may be needed before the assessment |
| External consulting | Optional, but speeds up the gap assessment, method validation and uncertainty estimation |
As a general benchmark, laboratories starting from scratch usually take 12 to 18 months from the decision to the granting of accreditation, including the gap assessment, management system implementation, method validation, uncertainty estimation, participation in proficiency testing, internal audit, management review and the Cgcre assessment process. Laboratories that already operate within a company with a mature ISO 9001, or that centralize evidence in a management system, tend to shorten that timeline, although the technical part can rarely be cut short.
What are the requirements and mandatory documents of ISO/IEC 17025?
The standard gives more flexibility than the 2005 version on how to document, but it requires specific evidence, both management and technical. The items assessors check most often in practice:
- Commitment to impartiality and analysis of risks to impartiality (4.1)
- Handling of customers’ confidential information (4.2)
- Identification of the legal entity, structure, responsibilities and scope of activities (5)
- Competence requirements by role, training records, authorization and monitoring of personnel (6.2)
- Facility and environmental conditions monitored when they affect results (6.3)
- Calibration program, intermediate checks and equipment records (6.4)
- Evidence of metrological traceability of results (6.5)
- Approval and evaluation criteria for suppliers of critical products and services, including external calibrations and subcontracted tests (6.6)
- Review of requests, tenders and contracts, including the decision rule agreed with the customer (7.1)
- Method verification and validation records (7.2)
- Sampling plan and method, where applicable (7.3)
- Technical records that allow the activity to be repeated under conditions as close as possible to the original (7.5)
- Evaluation of measurement uncertainty (7.6)
- Plan for ensuring the validity of results, with internal controls and participation in proficiency testing or interlaboratory comparisons (7.7)
- Test reports and calibration certificates with the information required by the standard (7.8)
- Records of complaints, nonconforming work and corrective actions (7.9, 7.10 and 8.7)
- Data control and information management, including validation of software and spreadsheets used in the laboratory (7.11)
- Laboratory risks and opportunities and action planning (8.5)
- Internal audit results and management review minutes (8.8 and 8.9)
Beyond the standard, the assessor checks compliance with the normative documents of the accreditation body. In Brazil, this includes the accreditation regulation (NIT-Dicla-031), the rules on use of the mark (NIE-Cgcre-009), the requirements for participation in proficiency testing and, where applicable, program-specific documents such as those of MAPA, ANEEL or legal metrology.
The most common mistake isn’t a missing document; it’s technical evidence that doesn’t hold up: a “validated” method without the data that proves the validation, an uncertainty calculation spreadsheet that was never verified, or a technician issuing results for a test for which they have no recorded authorization. Technical assessors spot this gap quickly, because they watch the test or calibration being performed and cross-check what they see against the records.
How to prepare for the ISO/IEC 17025 accreditation assessment
A structured path reduces nonconformities on assessment day:
- Maturity assessment (gap analysis) against ABNT NBR ISO/IEC 17025:2017 and Cgcre documents.
- Definition of the intended scope, with methods, ranges and, for calibration, measurement capabilities.
- Structuring of the management system (Option A or Option B), with impartiality, confidentiality and document control.
- Organization of personnel, equipment and metrological traceability.
- Verification or validation of methods, uncertainty estimation and definition of the decision rule.
- Assurance of the validity of results, with internal controls and proficiency testing.
- Internal audit and management review, with correction of the nonconformities found.
- Cgcre assessment process: application, document review, on-site assessment at the laboratory and handling of nonconformities.
The earlier technical evidence is generated as a routine, rather than pulled together in a rush before the assessors’ visit, the lower the risk of nonconformity, and the less strain on the team along the way.
What the assessor checks in the ISO/IEC 17025 accreditation assessment
Before organizing your preparation, it helps to know exactly what’s being checked. In the ISO/IEC 17025 assessment, the Cgcre team checks whether the management system works and, above all, whether the technical competence declared in the scope shows up in practice at the bench.
| Area of the standard | What the assessor checks | Typical evidence expected | How Qualiex and Metroex help |
|---|---|---|---|
| Impartiality and confidentiality (4.1 and 4.2) | Whether risks to impartiality have been identified on an ongoing basis and customer information is protected | Impartiality risk analysis, signed confidentiality agreements | Risks module with a configurable methodology, to keep the impartiality risk analysis separate from other risks and reviewed periodically |
| Personnel (6.2) | Whether each person who performs, analyzes or releases results has defined competence and has been trained, authorized and monitored | Competence matrix, training records, authorizations by test or calibration | Training module to record qualifications and track expirations, avoiding outdated authorizations |
| Equipment and traceability (6.4 and 6.5) | Whether equipment that affects results is calibrated with traceability, with intermediate checks and acceptance criteria | Calibration program, certificates, review of certificates, check records | Metroex with management of standards and equipment in a single database: calibration dates, intermediate checks, maintenance, traceability records and automatic expiration notifications |
| Suppliers (6.6) | Whether external calibration laboratories, proficiency testing providers and reference material suppliers are approved and reassessed | Selection criteria, performance evaluation, proof of suppliers’ accreditation | Suppliers module with approval, documents with expiration dates, periodic evaluation and a Supplier Portal |
| Methods and uncertainty (7.2 and 7.6) | Whether methods have been verified or validated and uncertainty has been evaluated consistently with the scope | Validation reports, verified uncertainty calculation worksheets, technical procedures | Metroex with measurement uncertainty evaluation and calculations configurable by type of test or calibration; in Qualiex, a Documents module with version control and an approval workflow for procedures and validation reports |
| Requests, technical records and reporting of results (7.1, 7.5 and 7.8) | Whether requests are reviewed, technical records allow the activity to be reconstructed and reports and certificates carry the required information | Reviewed tenders and contracts, raw records, certificates and reports issued | Metroex with the laboratory’s end-to-end workflow: item intake, request review, quotation and contract, data capture at the point of measurement recording who did it, when and how, and certificate issuance with customizable layout and an authenticity QR Code |
| Ensuring the validity of results (7.7) | Whether a monitoring plan exists, proficiency testing results are analyzed and deviations trigger action | Schedule of controls and proficiency testing, results, trend analysis | Indicators module with targets and late-collection alerts to track the validity assurance plan over time |
| Complaints and nonconforming work (7.9 and 7.10) | Whether complaints and nonconforming work are recorded, assessed for impact and handled, including recall of results when necessary | Complaint records, impact assessment, customer communication | Occurrences module with cause analysis, action plan and effectiveness verification |
| Internal audit and management review (8.8 and 8.9) | Whether the audit program covers all requirements and management reviews proficiency testing, complaints, risks and changes | Audit program and reports, management review minutes | Audits module with checklists for the standard and planning of auditors, auditees, locations and items, and a Minutes and Decisions module linked to indicators and action plans |
In practice, the two systems complement each other: Metroex handles the laboratory’s technical operation (standards, execution of tests and calibrations, calculations, uncertainty and certificates), and Qualiex handles the management system (documents, risks, occurrences, audits, management review, suppliers and training). Whichever software you use, requirement 7.11 still applies: calculations and configurations used to generate results must be validated by the laboratory before use.
ISO/IEC 17025 accreditation assessment preparation checklist
We’ve broken the 8 preparation steps into individual blocks. Copy each one into your team’s task management tool and use it as a tracking checklist up to the assessment date.
Step 1. Maturity assessment
Before implementing anything, you need to know exactly where the laboratory stands against the standard and Cgcre’s documents. Without that, effort gets scattered across points that are already resolved.
- Review the requirements of ABNT NBR ISO/IEC 17025:2017 item by item
- Gather the Cgcre normative documents that apply to the intended scope
- Identify what already exists, what partially exists and what doesn’t exist
- Prioritize gaps by technical criticality and the time left until the application
Step 2. Definition of the scope
The scope is the heart of accreditation: it defines exactly which results the laboratory will be able to issue as accredited.
- List the tests or calibrations that will be part of the initial scope
- Define methods, reference standards, ranges and, for calibration, measurement capabilities
- Assess whether it’s worth starting with a smaller scope and expanding later by extension
- Confirm the laboratory has enough technical track record for each item in the scope
Step 3. Management system, impartiality and confidentiality
These elements form the stated foundation of the laboratory: how it is organized, how it protects customers and how it ensures technical decisions free from pressure.
- Choose between Option A (own system) and Option B (system based on ISO 9001)
- Draft the impartiality risk analysis and the formal commitment from management
- Establish confidentiality rules for internal and external personnel
- Implement document and record control
Step 4. Personnel, equipment and traceability
This is where technical competence starts to be proven: who does the work, with what, and with what measurement assurance.
- Define competence requirements by role and record training and authorizations
- Set up the calibration program and intermediate checks for equipment
- Review the calibration certificates received against the acceptance criteria
- Make sure calibration suppliers are accredited or have proven traceability
Step 5. Methods, uncertainty and validity of results
Having adequate staff and equipment is of no use if methods aren’t proven and results aren’t monitored.
- Verify standardized methods and validate in-house or modified methods
- Estimate measurement uncertainty and validate calculation spreadsheets or software
- Agree with customers on the decision rule for statements of conformity
- Build the plan for ensuring the validity of results, with internal controls and participation in proficiency testing
Step 6. Internal audit
Before welcoming the Cgcre team, the laboratory audits itself. It’s the last chance to find and fix problems before they become a formal nonconformity.
- Draw up the internal audit program covering all requirements and the whole scope
- Include witness audits of tests or calibrations, not just record review
- Record every finding, including technical ones
- Open an action plan for each nonconformity found
Step 7. Management review
The standard requires management to formally review the laboratory’s performance, not as a bureaucratic formality but as a real decision about what changes from that point on.
- Gather proficiency testing and internal control results
- Review complaints, nonconforming work and audit results
- Assess changes in volume, type of work, personnel, resources and risks
- Record decisions and actions in formal minutes
Step 8. Cgcre assessment
The final step: Cgcre reviews the documentation and then verifies at the laboratory whether everything that was declared works in practice.
- Gather the legal and technical documentation required for the application
- Submit the application with the proposed scope through Cgcre’s system
- Prepare the technical team to demonstrate tests or calibrations during the assessment
- Handle the nonconformities raised within the deadline set by the regulation
How to maintain ISO/IEC 17025 accreditation (surveillance and reassessment)
Accreditation isn’t granted once and forgotten: Cgcre carries out periodic surveillance and reassessment evaluations to confirm that the laboratory remains competent for the entire accredited scope, at a frequency set by the current accreditation regulation (NIT-Dicla-031).
Between one assessment and the next, the laboratory must also keep participating in proficiency testing, report significant changes (key personnel, facilities, equipment, methods) and pay the annual maintenance fee. Scope expansions are made through an extension request, with its own assessment.
Nonconformities not addressed on time can lead to partial or total suspension of accreditation, and during a suspension the laboratory cannot issue accredited results within the affected scope.
The biggest risk at this stage is rarely a lack of technical knowledge; it’s operational: losing track of when a piece of equipment needs calibration, when a technician’s authorization needs review, when the next proficiency testing round should have been done or when a calibration supplier lost its accreditation, especially when those controls are scattered across spreadsheets, emails and shared folders.
Common mistakes in ISO/IEC 17025 accreditation
The same mistakes show up, with few variations, in initial assessments, surveillance and reassessments:
| Most common mistakes | Root cause | How Qualiex and Metroex solve it |
|---|---|---|
| Equipment with expired calibration, or a certificate received without review against the acceptance criteria | Calibration program tracked in a spreadsheet, with no alert and no defined owner | Metroex with management of standards, intermediate checks and automatic email expiration notifications |
| A technician issuing results for a test for which they have no recorded authorization | Training done, but authorization and competence monitoring not formalized | Training module with records of qualifications and expiration control per employee |
| An unsatisfactory proficiency testing result with no investigation or action | Proficiency testing treated as an obligation fulfilled, not as a source of information | Occurrences module with cause analysis, action plan and effectiveness verification |
| An uncertainty or results calculation spreadsheet used without validation or version control | Spreadsheet created by one technician and copied between computers over the years | Metroex with calculations and uncertainty evaluation configured in the system itself, validated once and applied consistently to every activity |
| A certificate or report issued with data transcribed incorrectly from paper to spreadsheet | Manual paper collection, typed in later by someone else | Metroex App with data capture at the point of measurement, even without an internet connection, automatic calculations and real-time validations |
| An external calibration laboratory or proficiency testing provider without periodic evaluation | Supplier approved once and never reassessed | Suppliers module with documents with expiration dates, periodic evaluation and notifications of pending evaluations |
| An impartiality risk analysis done for the initial accreditation and never revisited | Impartiality treated as a declaration, not as an ongoing risk | Risks module with periodic reassessment and action plans with an owner and deadline |
| An internal audit that only reviews documents, without observing technical execution | Audit program copied from a generic management system template | Audits module with registrable checklists for the standard and planning of each audit, with auditors, auditees, locations and items |
How Qualiex and Metroex help maintain ISO/IEC 17025 compliance
Sustaining compliance between one assessment and the next, with calibrations, personnel authorizations, proficiency testing, suppliers and technical documents all coming due at the same time, is exactly where most laboratories lose time and take on risk.
Scattered spreadsheets, deadlines with no clear owner and forgotten corrective actions are the most common causes of nonconformity in surveillance and reassessments.
An accredited laboratory has to sustain two fronts at once: the technical operation, which generates the results, and the management system, which ensures that operation stays under control. That’s why ForLogic serves ISO/IEC 17025 with two solutions that work side by side.
Metroex, software specialized in metrology, calibration and testing, organizes the laboratory’s technical routine end to end: item intake, request review, quotation and contract, technical records, measurement uncertainty evaluation, management of standards and equipment, all the way to issuing and sending certificates and reports to the customer.
Calculations and certificate layouts are customizable, data can be captured through the app right at the point of measurement, even without internet, and each certificate comes with a QR Code for authenticity verification.
The Metrology Control module structures planning with work orders, standardized execution and an organized history for assessments. Implementation and support are carried out by specialists in metrology and quality.
Qualiex, Quality Management Software, centralizes documents, occurrences and nonconformities, risks, action plans, minutes and decisions, audits, indicators, suppliers and training on a single platform, with integrated modules, an audit trail and automatic deadline alerts.
This is where the impartiality risk analysis, the handling of complaints and nonconforming work, the internal audit program and management review live. For laboratories that are part of a company already using Qualiex for ISO 9001, this also means integrating the laboratory’s management system with the QMS on the same platform, which is especially useful for those adopting Option B and needing to track the transition to ISO 9001:2026.
With both fronts organized, technical and management evidence is ready whenever the assessor asks, with no last-minute digging through files.
If your laboratory is preparing for its next assessment, whether initial accreditation, surveillance, reassessment or scope extension, talk to a ForLogic specialist and see how Metroex and Qualiex can support your operation.
Frequently asked questions about ISO/IEC 17025
Is ISO/IEC 17025 accreditation required by law?
As a rule, no. Accreditation is voluntary. But it becomes required in practice when a regulation, a conformity assessment program or a regulator determines that tests or calibrations must be performed by an accredited laboratory, as happens in several Inmetro programs and in ministries and regulatory agencies. It’s also common for industrial customers to require accredited results by contract.
What is the difference between being accredited and being certified?
Certification attests that an organization has a management system in place, as with ISO 9001. Accreditation goes further: it formally recognizes that the laboratory is technically competent to perform specific tests or calibrations and produce valid results. That’s why the correct term for ISO/IEC 17025 is “accredited laboratory,” not “certified.”
Who can accredit my laboratory to ISO/IEC 17025?
In Brazil, accreditation is granted by Cgcre (Inmetro’s General Accreditation Coordination). In other countries, by national accreditation bodies. For results to be accepted internationally, the body must be a signatory to the mutual recognition arrangements of Global ACI, the entity formed in 2026 by the merger of ILAC and IAF.
Does having ISO 9001 replace ISO/IEC 17025 accreditation?
No. ISO 9001 proves the management system, but doesn’t assess technical competence, metrological traceability, method validation or measurement uncertainty. The reverse is closer: a laboratory that operates in line with ISO/IEC 17025 meets the principles of ISO 9001, and the standard itself allows the laboratory’s management system to be based on ISO 9001 (Option B), as long as the technical requirements of 17025 are met.
Does the publication of ISO 9001:2026 affect my accreditation?
Not directly, because ISO/IEC 17025:2017 remains in force and has not been changed. The impact shows up in two cases: laboratories that adopt Option B, whose management system relies on ISO 9001, and laboratories of ISO 9001 certified companies, which will go through the transition by September 2029. In those cases, it’s worth planning the adjustment to ISO 9001:2026 in an integrated way with maintaining accreditation.
Do I need to accredit every test or calibration the laboratory performs?
No. Accreditation is granted by scope, and the laboratory chooses which activities to include. It’s common to start with a smaller scope, where technical competence is already well established, and expand it later through an extension. Results outside the accredited scope can continue to be issued, but cannot be presented as accredited.
Do I need to hire a consultant to accredit the laboratory?
It isn’t mandatory. A consultant can speed up the gap assessment, method validation and uncertainty estimation, especially in laboratories with no prior accreditation experience. Laboratories with an experienced technical team, or supported by software that already centralizes management evidence, often run the process in-house at a lower cost.
What happens if the laboratory has nonconformities in the assessment?
There is no such thing as a permanent “fail.” The nonconformities raised by the assessment team must be handled within the deadline set in Cgcre’s regulation, with evidence of the actions taken. The decision to grant, maintain or extend accreditation is only made after those records are reviewed. Nonconformities that compromise the validity of results may require a new visit and delay the granting or, in the case of laboratories already accredited, lead to suspension of the affected scope.
