Two-minute brief
ISO 37301 requirements explained: video brief
A two-minute brief on the compliance-specific requirements ISO 37301:2021 adds inside the shared management system structure.
Key takeaways
- Compliance obligations and the compliance risk assessment sit in clause 4.
- Culture, governance and the compliance function sit in clause 5.
- Training is built into the employment process.
- Raising concerns and investigations are operational requirements.
- Compliance reporting and record-keeping sit in clause 9.
Compliance content inside clauses 4 to 10
ISO 37301:2021 uses the harmonised structure shared by the ISO management system standards, clauses 4 to 10, and adds the compliance-specific requirements inside it. This short film walks through where they sit.
Clause 4 covers context, including the compliance obligations the organisation must meet and the compliance risk assessment that identifies, analyses and evaluates the risk of failing to meet them, as well as whether climate change is a relevant issue. Clause 5 covers leadership, with compliance culture, governance and the compliance function; where an organisation has no separate governing body, the requirements addressed to it apply to top management. Clause 6 covers planning, objectives and change.
People, controls, reporting
Clause 7 adds compliance to the employment process and to training, so that people understand the obligations relevant to their roles. Clause 8 covers operation: controls that address compliance risks, procedures for raising concerns, and investigation processes. Clause 9 covers performance evaluation, including feedback, indicators, compliance reporting and record-keeping, alongside internal audit and management review, and clause 10 covers improvement, nonconformity and corrective action.
The standard applies to public, private and not-for-profit organisations of any size, above all regulated businesses, listed companies, group subsidiaries and government suppliers. ISO 37301:2021 with Amendment 1:2024 was confirmed unchanged by ISO in August 2026, so no transition is pending. Certification is assessed and decided by an independent, accredited certification body, under the same rules as other ISO management system standards.
ISO 37301 replaced ISO 19600, a guideline with no requirements, on 13 April 2021, turning compliance management into a requirements standard on the harmonised structure. A certificate attests that the compliance management system conforms to the standard and operates; it is not a legal opinion that every obligation has been met. Top management gives a compliance function responsibility and authority for operating the system, with direct access to the governing body, independence and adequate resources. Clause 8.3 requires a process for raising concerns about attempted, suspected and actual noncompliance, with confidentiality, the option of anonymity and protection from retaliation, and clause 8.4 an investigation process. A small company needs a short but complete obligations register, a clear policy and one person with the authority and time to run the function.
ISO 37301 at a glance
- Purpose
- Compliance management: one system for the obligations you must meet and the commitments you choose to make, with the culture, controls and reporting to prove it
- Relevant to
- Public, private and not-for-profit organisations of any size; above all regulated businesses, listed companies, group subsidiaries and government suppliers
- Edition
- ISO 37301:2021 with Amendment 1:2024; confirmed unchanged by ISO in August 2026, so no transition is pending
- Certification
- Assessed and decided by an independent, accredited certification body
- Sterling's role
- Register, risk assessment and implementation with your team, Effivity, training, internal audit and certification readiness, then Sustain™
- Cost and timing
- Total investment for an ISO 37301 CMS depends on the current maturity of your processes, the scope, locations and number of employees. The process typically takes 4 to 8 months
ISO 37301: questions people ask
Can a small organisation implement ISO 37301?
Yes. The standard expects a system proportionate to the organisation's obligations, risks, size and complexity. A small company usually needs a short but complete obligations register, a clear policy, one person with the authority and time to act as the compliance function, a few controls where the risk is real and a way for staff to raise a concern.
What is the difference between ISO 37301 and ISO 19600?
ISO 19600:2014 was a guideline with no requirements, so nobody could be certified against it. ISO 37301:2021 replaced it on 13 April 2021 as a requirements standard with guidance for use, on the harmonised structure, and an accredited certification body can now certify against it.
Is ISO 37301 certification mandatory?
No law requires it in general. Regulators, licensing authorities, listing rules, lenders and customers expect an effective compliance programme, but the certificate itself is a choice, made because it gives the programme a recognised structure and an independent check that outsiders can rely on.
Does ISO 37301 certification mean we comply with the law?
No. The certificate attests that your compliance management system conforms to ISO 37301 and is operating; it is not a legal opinion that every obligation has been met. What the system gives you is a systematic way of knowing your obligations, managing the risks and evidencing what you did, which is what regulators and courts weigh when something goes wrong.
Does Sterling issue the ISO 37301 certificate?
No. Sterling consults; an independent, accredited certification body conducts the audit and takes the decision. A provider offering to do both is offering paper.
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