ISO Certification in the USA: Accredited Audits From a Texas-Based Certification Body
ISO certification in the USA helps you win enterprise deals, qualify as a supplier, and sell overseas. Accredify Global is headquartered in Dallas–Fort Worth, Texas, and certifies US companies to ISO 9001, ISO 27001, ISO 13485, ISO 14001, ISO 45001, and ISO 42001. We first confirm whether you need an ISO certificate, a SOC 2 report, or an assessment, then send a tailored proposal.
What ISO Certification in the USA Gets You
ISO certification in the USA is a third-party audit confirming that your management system meets an international standard and runs as designed. Nothing in US law requires most companies to hold it. Customers, prime contractors, and overseas buyers do, which is why it shows up in purchase orders, supplier portals, and RFPs. The certificate lasts three years, with a surveillance audit every year. Your certificate also travels: buyers in Europe, the Middle East, and Asia recognize accredited ISO certificates without asking for a local equivalent.
American companies often confuse three very different deliverables: an ISO certificate, a SOC 2 report, and a HIPAA or CMMC assessment. Each answers a different buyer. We help you work out which one the request in front of you actually needs before you spend anything.
Accredify Global is headquartered in Dallas–Fort Worth, Texas, and accredited by UAF. UAF is part of the IAF arrangement, so our certificates are recognized internationally. If a contract names a specific accreditation body, we check the clause with you first.
US Requirements in 2026 That Drive Certification
Medical device rules now follow ISO 13485. The FDA's Quality Management System Regulation took effect on 2 February 2026 and incorporates ISO 13485:2016 by reference. Device makers that already run an ISO 13485 system are closer to compliance, though the FDA still inspects them.
Defense contractors face CMMC. CMMC Phase 1 has applied in DoD solicitations since 10 November 2025. Phase 2, which brings third-party Level 2 assessments, was paused on 13 July 2026. Non-bank financial firms covered by the FTC Safeguards Rule have had to report qualifying breaches within 30 days since 13 May 2024.
New editions and state laws keep arriving. ISO 9001:2026 was published on 16 September 2026, with a transition deadline of 30 September 2029. In our home state, the Texas Responsible Artificial Intelligence Governance Act took effect on 1 January 2026, adding to a growing set of state privacy and AI laws.
Sources: FDA QMSR · FTC Safeguards Rule (ACA Group) · Texas AI law (Norton Rose Fulbright) · ISO 9001:2026 transition (Global ACI)
Which Certification US Customers Ask For
The answer depends on who is buying from you, and where they are.
| If you are | Customers usually want | Where to start |
|---|---|---|
| A SaaS or cloud company | SOC 2 at home, ISO 27001 for global deals | ISO 27001 for SaaS and SOC 2 |
| A manufacturer or machine shop | Quality, supplier control, and safety | ISO 9001 and ISO 45001 |
| A medical device company | Quality system aligned with the FDA | ISO 13485 |
| A defense or federal supplier | Quality and cybersecurity evidence | ISO 9001, ISO 27001, and NIST readiness |
| A healthcare or health-tech firm | Protection of health information | ISO 27001 and HIPAA assessment |
| A company using or selling AI | Responsible AI governance | ISO 42001 |
| A food or beverage business | Food safety for retailers and distributors | ISO 22000 and HACCP |
Many US software companies start with SOC 2 because their first enterprise customers are American. As they sell to Europe, the Middle East, or Asia, buyers start asking for ISO 27001 instead. The good news is that most controls overlap, so the second framework costs far less effort than the first. If you already hold one, tell us in your scoping review and we will plan the audit around the evidence you have.
AS9100 and IATF 16949 are sector schemes certified only by recognized bodies; we offer gap assessments for AS9100 and IATF 16949.
How ISO Standards Map to US Rules
Very few US rules require an ISO certificate. Many are easier to meet with one in place.
| US requirement | Who it affects | Where ISO helps |
|---|---|---|
| FDA QMSR | Medical device manufacturers | ISO 13485 is the foundation of the regulation |
| CMMC and DFARS | Defense contractors and subcontractors | ISO 27001 builds the system; CMMC is assessed separately |
| HIPAA Security Rule | Covered entities and business associates | ISO 27001 manages risks and safeguards |
| FTC Safeguards Rule | Non-bank financial institutions | ISO 27001 supports the required security program |
| State privacy and AI laws | Companies handling consumer data or using AI | ISO 27701 for privacy; ISO 42001 for AI governance |
| Federal quality clauses | Federal contractors | ISO 9001 when a higher-level quality standard is required |
For frameworks that end in an assessment rather than a certificate, see our cyber security risk assessment, PCI DSS, AI governance, and compliance services.
Planning an ISO Audit for a US Company
What makes US audits run smoothly, whether you have one office or plants in several states.
Have these ready
- The customer request, RFP clause, or supplier portal requirement
- Every site in scope, including remote employees
- Systems that hold customer, health, or controlled data
- Key suppliers and outsourced processes
Timing tips
- Avoid month-end and quarter-end close weeks
- Fully remote teams can do much of the audit online
- Plants should be seen with production running
- Renewal and RFP dates set the real deadline
How ISO Certification in the USA Works
Six steps from first call to certificate. Read our certification process guide for more.
Is an RFP, a renewal, or a big customer waiting on your certificate? Tell us the date in your scoping review.
Book a free scoping reviewISO Certification Cost for US Companies
No rate card. Your quote comes from audit man-days, set out per site and standard.
What raises it
- More employees in scope, including remote staff
- Plants or offices in several states
- Regulated or high-risk processes
- Standards audited on separate visits
What lowers it
- Combining standards into one integrated audit
- Shared processes across all sites
- Evidence ready before Stage 1
- Internal audit and management review complete
What US Companies Ask a Certification Body
Short answers for founders, quality leaders, and security teams.
| Question | Accredify Global's answer |
|---|---|
| Where are you based? | Dallas–Fort Worth, Texas, with audits nationwide. |
| Who accredits you? | UAF, for twelve standards you can check online. |
| Can you issue our SOC 2? | SOC 2 reports come from CPA firms; see our SOC 2 page. |
| How do customers verify you? | On our verification page. |
| Will you build our system? | No. We audit and certify only. |
| How do you price? | Audit man-days, in a written proposal. |
FAQ: ISO Certification in the USA
Answers on accreditation, SOC 2, FDA, CMMC, HIPAA, cost, and timeline.
How do I get ISO certification in the USA?
Pick the standard your customer, contract or market asks for, run the management system long enough to produce records, and book a certification audit. An accredited certification body carries out Stage 1 and Stage 2 audits and issues a three-year certificate if requirements are met.
Where is Accredify Global based?
Our headquarters is at 10050 Coit Road in Frisco, Texas. We audit organizations across the United States and in 71 countries.
Is Accredify Global accredited?
Yes. Accredify Global is accredited by UAF for twelve standards, including ISO 9001, ISO 27001, ISO 13485, ISO 14001 and ISO 45001. Anyone can check the scope in the UAF directory.
Is a UAF-accredited certificate accepted in the USA?
Yes, by most buyers. UAF is part of the IAF arrangement, so accredited certificates are recognized internationally. If a contract names a specific accreditation body, send us the clause before you book so we can confirm.
Is ISO 27001 or SOC 2 better for a US company?
US enterprise customers often ask for SOC 2, a CPA attestation report. International customers usually ask for ISO 27001, a certificate. Many companies hold both and reuse the same controls.
Does ISO 13485 satisfy the FDA?
Since 2 February 2026, the FDA's Quality Management System Regulation incorporates ISO 13485:2016 by reference, so the requirements are closely aligned. An ISO 13485 certificate does not replace FDA inspections.
Does ISO 27001 help with CMMC?
It helps build the security management system, but CMMC is assessed separately against NIST SP 800-171 controls. Level 2 certification assessments are carried out by authorized C3PAOs.
Does ISO 27001 help with HIPAA?
Yes. HIPAA requires risk analysis and safeguards for health information, and ISO 27001 provides a structured system to manage them. There is no official HIPAA certification.
Do federal contracts require ISO 9001?
Some do. Federal acquisition rules let agencies require higher-level quality standards, and ISO 9001 is the one most often named. Check your solicitation.
Which states have their own privacy laws?
A growing number of states, including California, Texas, Virginia and Colorado, have comprehensive consumer privacy laws. ISO 27701 provides a privacy management system that supports them.
Can audits be remote for US companies?
Parts of an audit can be remote where the rules allow, such as document review and interviews. Manufacturing sites and warehouses are usually audited on site.
Can one certificate cover several US states?
Yes, if the sites run one management system under the same organization. The certificate lists each site, and audits sample sites every year.
How long does ISO certification take in the USA?
Companies with a working management system usually certify 6 to 12 weeks after Stage 1. New systems, more sites or more standards take longer.
How much does ISO certification cost in the USA?
There is no list price. The fee is set by the audit man-days your scope needs, driven by headcount, sites, risk and standards, and is confirmed in a tailored proposal.
Will Accredify Global write our ISO documentation?
No. To stay impartial, a certification body audits and certifies but does not consult. Your team or an independent consultant prepares the documentation.
Get the Certificate Your US Customers Actually Asked For
Share the customer request, your sites, and your timeline. We'll confirm the right ISO certification in the USA, or tell you if you need something else, and send a tailored proposal.
Book your free scoping review →Last reviewed by the Accredify Global certification team.