United States · Certification
ISO 37301 certification in the United States
Achieve ISO 37301 certification in the US with Sterling: 8,100+ client engagements in 60+ countries, 20+ years.
- Accredited certification
- New York office team
- Effivity software included
- Academy training included
Who asks for ISO 37301 in the US
Clients include
ISO 37301 certification in the US at a glance
One US instrument bears on ISO 37301. It does not name the standard. So why do buyers in the US keep asking for the certificate?
Chief compliance officers at American banks, insurers, healthcare systems and federal contractors answer to many rulebooks at once: state regulators such as New York's Department of Financial Services, federal agencies, and the Justice Department, whose Evaluation of Corporate Compliance Programs asks whether a programme is well designed, adequately resourced and empowered, and working in practice. ISO 37301 is the certifiable management-system standard for compliance itself, with compliance obligations identified and owned, risks assessed, controls, training and communication in place, concerns raised and investigated, and performance monitored and reported to the governing body. It does not create new legal duties; it gives boards and examiners a structured, auditable view of how compliance is run. Certification is issued by a certification body accredited for ISO 37301 within the international mutual recognition arrangements. Sterling's New York office builds the compliance management system around the client's existing obligations, with Effivity and Sterling Academy included. Questions follow.
Who needs ISO 37301 in the US, and what happens without it
In the US 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.
- Banks, insurers and financial firms regulated in New YorkMultiple regulatory regimes including 23 NYCRR Part 500.
- Corporations of any sector facing DOJ scrutinyDOJ evaluates compliance programme design, resourcing and effectiveness.
- Healthcare systems and their vendorsHIPAA and other federal and state obligations.
- Federal contractorsContract compliance obligations.
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 37301 readiness checkISO 37301 requirements in the US
Strip away the vocabulary and ISO 37301 requires a company to prove six things about how it meets its legal and other obligations.
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 37301 explained →
How to get ISO 37301 certified in the US
One team from the New York office carries the work from scoping to certificate. 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 37301 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 the certification body arrives.
- Certification body stage 1 and stage 2, then surveillanceAn accredited body audits and decides. Sterling supports the audits and the three-year cycle.
- 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 37301 certification 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 legal entities, jurisdictions and obligations in scope
- Maturity of the obligations register
- Reporting lines to the governing body
- Certification body availability
Sterling agrees a dated plan with you on the discovery call, once the scope is known.
How much does ISO 37301 certification cost in the US?
The cost has two parts: the consulting work to build and prove the system, and the certification body’s audit fees, which are quoted separately. In the US these factors move both.
- Number of entities and jurisdictions
- Obligations mapping effort
- Certification body audit fees quoted separately from consulting
- Integration with ISO 37001 and ISO/IEC 27001
Sterling gives one customised, all-inclusive proposal after the discovery call, never before the scope is agreed.
ISO 37301 consultants and certification bodies in the US
Two different organisations are involved. A consultant helps you build the system and prove it works; an accredited certification 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 37301 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 37301 in the US (3)
| Instrument | How it treats the standard |
|---|---|
| DOJ Criminal Division — Evaluation of Corporate Compliance Programs (Updated September 2024) | Expected in practice Compliance programme design, resourcing and effectiveness; ISO 37301 not cited. |
| 23 NYCRR Part 500 (New York DFS) | Context One of the regulatory regimes a compliance function manages; ISO 37301 not cited. |
| IAS accreditation of management systems certification bodies | Market driver Accredited certification for management-system standards is available through a US accreditation body; no mandate. |
"Expected in practice" means the instrument asks for the outcomes ISO 37301 covers without naming a standard, and ISO 37301 is what buyers and regulators commonly accept as evidence of them.
Accreditation, audit language and remote audits in the US
Use a certification body accredited for this standard by an accreditation body within the international mutual recognition arrangements (Global ACI — Global Accreditation Cooperation Incorporated, formerly the IAF MLA), US-based (for example IAS, which accredits management systems certification bodies) or foreign; check that the accreditation scope covers the standard and your sector. No body is named here unless its accreditation scope has been verified. Edition and transition details: ISO 37301 hub →
Audit language
Audits are conducted in English; agree the audit and document language with the certification body at application.
Remote and on-site
Remote audit elements are at the certification body's discretion under its accreditation rules; operational sites are normally visited on-site.
ISO 37301 in the US: questions clients ask
Is ISO 37301 recognised by US regulators?
Not by name. The DOJ evaluates the effectiveness of compliance programmes, and its Evaluation of Corporate Compliance Programs does not cite ISO 37301. The standard can help you show a programme that is designed and working, but it carries no formal recognition from regulators. Confirm any enforcement question with your counsel.
ISO 37301 or ISO 37001?
ISO 37301 covers compliance broadly, across all of an organisation's obligations, while ISO 37001 deals specifically with anti-bribery. They are often integrated, so a company exposed to both can run a single management system and ask the certification body to audit them together.
Who issues the certificate?
An accredited certification body issues the certificate. Look for accreditation for ISO 37301 within the international recognition arrangements, from the US-based International Accreditation Service or a foreign body, and confirm the scope covers your sector. The IAF's functions passed to Global Accreditation Cooperation Incorporated in 2026.
More on ISO 37301 for US organisations
Other standards US businesses ask Sterling for
Organisations in the US often combine ISO 37301 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
- DOJ Criminal Division — Evaluation of Corporate Compliance Programs (Updated September 2024) — justice.gov (accessed 5 Oct 2026)
- 23 NYCRR Part 500 (New York DFS) — dfs.ny.gov (accessed 5 Oct 2026)
- IAS accreditation of management systems certification bodies — iasonline.org (accessed 5 Oct 2026)
- International Accreditation Service (IAS) — iasonline.org; iaf.nu (accessed 5 Oct 2026)
- Higher-level contract quality requirements (FAR 46.202-4) — acquisition.gov (accessed 5 Oct 2026)
Talk to a consultant
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