ISO/IEC 17025 accreditation in Brazil

ISO 17025 accreditation in Brazil at a glance

For a laboratory in Brazil, accreditation is the credential that makes a result trusted beyond the building. Cgcre, the accreditation coordination of Inmetro, accredits testing and calibration laboratories against ABNT NBR ISO/IEC 17025:2017 and clinical laboratories against ABNT NBR ISO 15189:2022, and Global ACI lists it as a Full Member and MRA signatory with ISO/IEC 17025 recognised since November 2000. Inmetro publishes databases of accredited laboratories and warns that scopes can be cancelled at any time, so buyers check them before relying on a report. Sterling cannot accredit anyone: its New York office prepares laboratories by building the quality system, validating methods, estimating measurement uncertainty, arranging proficiency testing and rehearsing the assessment, with Effivity and Sterling Academy included with the engagement.

Who needs ISO 17025 in Brazil, and what happens without it

In Brazil the question rarely comes from a law. It comes from the buyer, the regulator or the partner that wants proof before it signs. These are the organisations that get asked.

• Testing laboratories for industry, food and environmentAccreditation by Cgcre is how a Brazilian test result earns recognition.
• Calibration laboratoriesCgcre accredits calibration laboratories, and users look for the accredited scope.
• In-house laboratories of manufacturersCustomers and regulators ask for competent measurement and traceable results.
• Laboratories serving health, food and cosmetics makersProduct registration and good practice evidence rely on dependable test data.
• Laboratories moving into new methods or fieldsScope extensions are assessed by the accreditation body.

ISO 17025 requirements in Brazil

Strip away the vocabulary and ISO/IEC 17025 requires a laboratory to prove six things about its competence and the results it reports.

In Brazil these six sit alongside the local laws and regulations listed under drivers below; one system can evidence both. The detail is on the global hub: ISO/IEC 17025 explained →

• ISO 17025 requirements, clause by clause in plain language
• The documents ISO 17025 expects
• ISO 17025 checklist

How to get ISO 17025 accreditation in Brazil

One team from the New York office carries the work from scoping to accreditation. Clients across Brazil are served from Sterling's New York office, on-site where the work needs it and remotely otherwise.

1. Discovery call and scopeEntities, locations, regulators and target date, agreed before any proposal.
2. Gap assessment against ISO/IEC 17025 and the Brazilian requirements that apply to youControls you already run for your regulators and customers are reused, not rebuilt.
3. Your system built with your team in EffivityRisks, controls, evidence, incidents and reviews in one live system the auditor can see.
4. Internal audit, management review and corrective actionsYour internal auditors trained by Sterling; the evidence proven before any external review.
5. The accreditation body assessmentThe accreditation body assesses and decides. Sterling supports the assessment.

The Sterling Promise: 100% on-time completion, 100% success, 8,100+ client engagements.Sterling does not certify. Certification decisions stay with independent bodies.

• ISO 17025 gap analysis
• ISO 17025 implementation plan
• ISO 17025 internal audit

How long does ISO 17025 accreditation take in Brazil?

There is no standard duration: it depends on your scope and on how much of the system already runs. In Brazil these are the factors that set the timeline.

• Number of methods and measurement disciplines in the scope
• Maturity of uncertainty, traceability and validation records
• Proficiency testing participation
• Assessor availability

Sterling agrees a dated plan with you on the discovery call, once the scope is known.

• What drives the ISO 17025 timeline
• Scope and timeline estimator

How much does ISO 17025 accreditation cost in Brazil?

The cost has two parts: the consulting work to build and prove the system, and the accreditation body’s fees, which are quoted separately. In Brazil these factors move both.

• Scope size and the number of methods
• Equipment calibration, reference materials and environmental control
• Accreditation body assessment fees, quoted separately from consulting
• Proficiency testing schemes

Sterling gives one customised, all-inclusive proposal after the discovery call, never before the scope is agreed.

• What makes up the cost of ISO 17025

ISO 17025 consultants and assessors in Brazil

Two different organisations are involved. A consultant helps you build the system and prove it works; the accreditation body then audits or assesses it and decides. Keeping the two separate is what makes the result credible to buyers and regulators.

• Check that the body’s accreditation or approval covers ISO 17025 and your sector, and that its certificates can be verified online.
• Ask the consultant how the local requirements in Brazil are mapped into the same system, so nothing runs twice.
• Ask for client references in your sector; Sterling’s client letters are available on request.
• Agree who owns the evidence and the tool after the engagement; with Sterling the system stays yours, in Effivity.

ISO 17025 in Brazil: questions clients ask

More on ISO 17025 for Brazilian organisations

• ISO/IEC 17025: the complete guide
• Watch: How to implement ISO/IEC 17025
• Calibration laboratories: ISO/IEC 17025 for the sector
• Chemical and microbiological testing: ISO/IEC 17025 for the sector
• Construction materials testing: ISO/IEC 17025 for the sector
• Environmental laboratories: ISO/IEC 17025 for the sector
• Food and agriculture: ISO/IEC 17025 for the sector
• Government and forensic laboratories: ISO/IEC 17025 for the sector
• In-house manufacturing laboratories: ISO/IEC 17025 for the sector
• ISO 17025 accreditation in Brazil and every other standard Sterling delivers there

Other standards Brazilian businesses ask Sterling for

Organisations in Brazil often combine ISO/IEC 17025 with one of these, under one management system where the scopes allow.

All 21 standards Sterling delivers in Brazil →