United States · Accreditation
ISO/IEC 17025 accreditation in the United States
Achieve ISO 17025 accreditation in the US with Sterling: 8,100+ client engagements in 60+ countries, 20+ years.
- Accreditation support
- New York office team
- Effivity software included
- Academy training included
Who asks for ISO 17025 in the US
Clients include
ISO 17025 accreditation in the US at a glance
FDA Laboratory Accreditation for Analyses of Foods (21 CFR 1.1138) requires ISO/IEC 17025 for the organisations it covers. Most US buyers ask for it anyway.
Food testing that FDA relies on increasingly has to come from an accredited laboratory. Under the Laboratory Accreditation for Analyses of Foods rule, a laboratory seeking LAAF accreditation must be accredited to ISO/IEC 17025:2017 for each method by a recognised accreditation body, and must pass proficiency testing for those methods. Beyond food, ISO/IEC 17025 underpins testing and calibration across manufacturing, environmental, construction-materials and consumer-product laboratories, where customers and regulators expect accredited results. This is accreditation, not certification: a US accreditation body such as A2LA or IAS, both of which run testing and calibration laboratory programmes, assesses the laboratory's competence, impartiality and the validity of its results, and witnesses work on-site. Sterling prepares the laboratory, covering the management system, method validation and verification, measurement uncertainty, metrological traceability and proficiency testing planning, while the accreditation body decides; Effivity and Sterling Academy are included. Questions follow.
Who needs ISO 17025 in the US, and what happens without it
For some organisations in the US it is a legal requirement. For most, the question comes from a buyer, a regulator or a partner that wants proof before it signs. These are the organisations that get asked.
- Laboratories testing food for FDA purposesLAAF requires ISO/IEC 17025:2017 accreditation for each method.
- Testing and calibration laboratories seeking US accreditationA2LA and IAS run ISO/IEC 17025 programmes.
- Manufacturers' in-house and contract laboratoriesCustomers and regulators rely on accredited results.
Not sure which of these applies to you?Answer a short set of questions and your readiness report arrives by e-mail.
Take the ISO/IEC 17025 readiness checkISO 17025 requirements in the US
Strip away the vocabulary and ISO/IEC 17025 requires a laboratory to prove six things about its competence and the results it reports.
In the US 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 →
How to get ISO 17025 accreditation in the US
One team from the New York office carries the work from scoping to accreditation. Delivered from the New York office across the US, with remote delivery for teams in other time zones and on-site work as agreed.
- Discovery call and scopeEntities, locations, regulators and target date, agreed before any proposal.
- Gap assessment against ISO/IEC 17025 and the US requirements that apply to youControls you already run for your regulators and customers are reused, not rebuilt.
- Your system built with your team in EffivityRisks, controls, evidence, incidents and reviews in one live system the auditor can see.
- Internal audit, management review and corrective actionsYour internal auditors trained by Sterling; the evidence proven before any external review.
- The accreditation body assessmentThe accreditation body assesses and decides. Sterling supports the assessment.
- End to end, from one team
- Effivity ISO & GRC software
- Preferential Sterling Academy access, with complimentary awareness training for your people
- Internal auditor training for your audit team, as applicable to your standard
- Vulnerability assessment on ISMS engagements
The Sterling Promise: 100% on-time completion, 100% success, 8,100+ client engagements.Sterling does not certify. Certification decisions stay with independent bodies.
How long does ISO 17025 accreditation take in the US?
There is no standard duration: it depends on your scope and on how much of the system already runs. In the US these are the factors that set the timeline.
- Number of tests or calibrations in the requested scope
- Availability of method validation and uncertainty data
- Proficiency testing results available before assessment
- LAAF-specific requirements where applicable
Sterling agrees a dated plan with you on the discovery call, once the scope is known.
How much does ISO 17025 accreditation cost in the US?
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 the US these factors move both.
- Size of the accreditation scope
- Accreditation body application and assessment fees, separate from consulting
- Equipment calibration and reference material needs
- Proficiency testing participation
Sterling gives one customised, all-inclusive proposal after the discovery call, never before the scope is agreed.
ISO 17025 consultants and assessors in the US
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 the US 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.
Laws and regulations that drive ISO 17025 in the US (3)
| Instrument | How it treats the standard |
|---|---|
| FDA Laboratory Accreditation for Analyses of Foods (21 CFR 1.1138) | Requires Accreditation by a recognized accreditation body to ISO/IEC 17025:2017 for each method. |
| A2LA ISO/IEC 17025 testing and calibration laboratory accreditation | Accreditation Signatory status with ILAC MRA as stated on its site. |
| IAS testing and calibration laboratory accreditation | Accreditation Signatory status under ILAC as stated on its site. |
Accreditation, audit language and remote audits in the US
Accreditation, not certification: granted by an accreditation body such as A2LA or IAS after assessment. Sterling prepares the laboratory; the accreditation body decides. Edition and transition details: ISO/IEC 17025 hub →
Audit language
Assessments are conducted in English.
Remote and on-site
Assessments include on-site witnessing of tests or calibrations; document review elements may be remote at the accreditation body's discretion.
ISO 17025 in the US: questions clients ask
Who accredits laboratories to ISO/IEC 17025 in the US?
Two main bodies: the American Association for Laboratory Accreditation (A2LA), which accredits ISO/IEC 17025 testing and calibration laboratories, and the International Accreditation Service (IAS), whose programmes also include testing and calibration laboratories. Both state signatory status in international recognition arrangements. Check that the scope covers your tests or calibrations.
Does FDA require ISO/IEC 17025?
Only in one setting: food testing under the Laboratory Accreditation for Analyses of Foods, 21 CFR 1.1138. There, for each method, the laboratory must be accredited by a recognised accreditation body to ISO/IEC 17025:2017 and must pass proficiency testing. Outside that programme, look to your own contract or regulation.
Is ISO/IEC 17025 a certification?
No. ISO/IEC 17025 is a laboratory accreditation, granted by an accreditation body after assessment, and not a certificate from a certification body. The difference matters when a customer asks for accredited results, because they will look for the accreditation body's name and the scope it granted.
More on ISO 17025 for US 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
- Sterling in New York
- ISO 17025 accreditation in the US and every other standard Sterling delivers there
Other standards US businesses ask Sterling for
Organisations in the US often combine ISO/IEC 17025 with one of these, under one management system where the scopes allow.
Start with a free discovery call from the New York office
A Sterling consultant goes through your entities, your regulators and your target date with you. No proposal until the scope is agreed.
Sources
- FDA Laboratory Accreditation for Analyses of Foods (21 CFR 1.1138) — ecfr.gov (accessed 5 Oct 2026)
- A2LA ISO/IEC 17025 testing and calibration laboratory accreditation — a2la.org (accessed 5 Oct 2026)
- IAS testing and calibration laboratory accreditation — iasonline.org (accessed 5 Oct 2026)
- International Accreditation Service (IAS) — iasonline.org; iaf.nu (accessed 5 Oct 2026)
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