United States · Certification
ISO 22000 certification in the United States
Achieve ISO 22000 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 22000 in the US
Clients include
ISO 22000 certification in the US at a glance
One US instrument bears on ISO 22000. It does not name the standard. So why do buyers in the US keep asking for the certificate?
FDA-registered human food facilities covered by the preventive controls rule at 21 CFR Part 117 must have a written food safety plan, prepared or overseen by a preventive controls qualified individual. ISO 22000 takes that hazard-based thinking and wraps it in a full management system: context and leadership, prerequisite programmes, hazard analysis following HACCP principles, operational controls, verification, internal audit and management review. Buyers who require a GFSI-recognised scheme usually ask for FSSC 22000, which builds on it, but ISO 22000 suits ingredient suppliers, packaging and logistics firms, food-service operators and exporters whose customers ask for an internationally recognised food safety standard. Certification is issued by a certification body accredited for ISO 22000 within the international mutual recognition arrangements. Sterling, with 8,100+ client engagements in 60+ countries, aligns the system with FDA obligations and the customer's audit, with Effivity and Sterling Academy included. Questions follow.
Who needs ISO 22000 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.
- FDA-registered human food facilities under preventive controlsA written food safety plan is required.
- Ingredient suppliers, packaging and logistics firmsCustomers ask for an internationally recognised food safety standard.
- Food exportersOverseas buyers recognise ISO 22000.
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 22000 readiness checkISO 22000 requirements in the US
Strip away the vocabulary and ISO 22000 requires a company to prove six things about keeping food safe from supplier to customer.
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 22000 explained →
How to get ISO 22000 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 22000 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 22000 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 sites and product categories
- Existing HACCP or food safety plan
- Prerequisite programme gaps
- Certification body availability
Sterling agrees a dated plan with you on the discovery call, once the scope is known.
How much does ISO 22000 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 sites and production lines
- Certification body audit fees quoted separately from consulting
- Prerequisite programme upgrades
- Option to upgrade to FSSC 22000 later
Sterling gives one customised, all-inclusive proposal after the discovery call, never before the scope is agreed.
ISO 22000 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 22000 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 22000 in the US (3)
| Instrument | How it treats the standard |
|---|---|
| FDA preventive controls for human food (21 CFR Part 117) | Expected in practice Written food safety plan; ISO 22000 not cited. |
| Foundation FSSC — FSSC 22000 (built on ISO 22000) | Related GFSI-recognised FSSC 22000 builds on ISO 22000. |
| 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 22000 covers without naming a standard, and ISO 22000 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 22000 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 22000 in the US: questions clients ask
ISO 22000 or FSSC 22000?
Choose ISO 22000 if buyers want an internationally recognised food safety standard, and FSSC 22000 if they require a GFSI-recognised scheme. FSSC 22000 builds on ISO 22000 and is GFSI-recognised, so ask your customers which one they accept before you decide.
Does ISO 22000 meet FDA requirements?
Not by itself. The FDA requires a written food safety plan, including a hazard analysis, under 21 CFR Part 117, and that rule does not cite ISO 22000. The two can be aligned, so build the plan to meet the FDA rule and the standard together, and confirm your obligations with your counsel.
Who issues the certificate?
An accredited certification body issues it. Choose one accredited for ISO 22000 within the international recognition arrangements, whether the US-based International Accreditation Service has accredited it or a foreign accreditation body has. Confirm the accreditation scope covers food safety in your sector, and note the IAF's functions passed to Global Accreditation Cooperation Incorporated in 2026.
More on ISO 22000 for US organisations
- ISO 22000: the complete guide
- Watch: How to implement ISO 22000
- Catering and hotels: ISO 22000 for the sector
- Feed and animal food: ISO 22000 for the sector
- Food and beverage manufacturing: ISO 22000 for the sector
- Food packaging manufacturing: ISO 22000 for the sector
- Ingredients and supplements: ISO 22000 for the sector
- Retail and wholesale: ISO 22000 for the sector
- Transport, storage and distribution: ISO 22000 for the sector
- Sterling in New York
- ISO 22000 certification in the US and every other standard Sterling delivers there
Other standards US businesses ask Sterling for
Organisations in the US often combine ISO 22000 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 preventive controls for human food (21 CFR Part 117) — ecfr.gov (accessed 5 Oct 2026)
- Foundation FSSC — FSSC 22000 (built on ISO 22000) — fssc.com (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)
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