ISO 37301 — Compliance Management Systems (CMS)

ISO 37301 helps you prevent breaches, prove due diligence, and embed ethical conduct across your enterprise.

Certifiable Annex SL Works with ISO 37001 & 37002

Outcomes for Boards and Regulators

ExposureReduced legal and regulatory risk
Due DiligenceDocumented, defensible evidence
CultureClear roles, training, accountability
AssuranceAudit-ready monitoring & KPIs

Overview

ISO 37301 specifies requirements for a Compliance Management System that prevents, detects, and responds to non-compliance. It is certifiable and replaces ISO 19600 (guidance). You get a structured approach to identify obligations, assess risks, set controls, monitor effectiveness, and drive continual improvement. Integrates with 9001/27001/45001 via the Annex SL structure.

Outcomes

  • Reduced regulatory and legal exposure
  • Documented due diligence and defensibility
  • Clear accountability, training, and culture
  • Reliable reporting, investigations, and remediation
  • Tangible assurance for boards, regulators, and customers

"Which standard?"

  • Enterprise-wide compliance framework → ISO 37301
  • Specific anti-bribery certification → ISO 37001
  • Confidential reporting & case handling → ISO 37002 (guidance)
  • Enterprise risk framework → ISO 31000 (guidance)

Who Needs ISO 37301?

Regulated industries

Finance, energy/utilities, healthcare, pharma, telecom

High third-party exposure

Construction, oil & gas, logistics, government contracting

Growth & IPO readiness

Internal controls, compliance tooling, audit trail

Global operations

Multi-jurisdictional legal registers and cross-border processes

What ISO 37301 Covers

Clauses map

  • Context & Scope (4): stakeholders, obligations inventory, scope boundaries
  • Leadership (5): governing body commitment, independence, policy, roles, escalation, resources
  • Planning (6): risk assessment, objectives, controls, due diligence criteria
  • Support (7): competence, awareness, confidential reporting, documented information, tooling
  • Operation (8): controls for processes, third-parties, gifts, conflicts, donations, antitrust, privacy alignment, change management
  • Performance (9): monitoring, KPIs, internal audit, MR, investigations, CAPA, discipline
  • Improvement (10): nonconformity, root-cause, continual improvement

Control framework highlights

  • Legal & regulatory register with ownership and review cadence
  • Risk assessment per obligation/process/third-party
  • Risk-based third-party due diligence (onboarding & renewal)
  • Policy suite: code of conduct + ABAC, antitrust, privacy alignment, sanctions/export, HR, gifts
  • Role-based training & comms with tracked completion
  • Speak-up mechanism and case workflow (align ISO 37002)
  • Investigations: triage, evidence, chain-of-custody, outcomes
  • Monitoring & testing: design vs operating effectiveness
  • KPIs & KRIs; records & evidence pack

Evidence pack checklist

  • Compliance policy & code of conduct
  • Governance charter; org chart; independence memo
  • Obligations inventory & change-log
  • Risk method & latest assessment
  • Third-party DD procedures and screenings
  • Policy register with version control
  • Training plan, matrices, completions, attestations
  • Speak-up procedure; case register
  • Monitoring plan; testing results; corrective actions
  • Internal audits; MR minutes; KPI dashboard

KPIs / dashboards

  • % obligations mapped to owners
  • % controls with tests completed
  • Training completion by role/region
  • High-risk third-parties cleared on time
  • Speak-up rate per 1000 FTE
  • Case closure time; substantiation rate
  • Recurrence post-CAPA
  • Audit findings closed on time

Tooling options

Legal register monitoring, case management, third-party risk screening, LMS, policy management, and control testing.

Implementation & Timeline

Discovery & gap

2–4 weeks — maturity baseline, roadmap, quick wins

Design

3–6 weeks — obligations register, risk method, policy suite, RACI, tools

Build & deploy

4–8 weeks — workflows, training, third-party DD, speak-up, monitoring plan

Operate & internal audit

2–4 weeks — trial run, evidence pack, MR, certification readiness

Typical readiness: 10–16 weeks single-site; 12–20 weeks multi-region.

Audit & Certification

Certification cycle

  • Three-year certificate with annual surveillance
  • Stage 1: document readiness and scope
  • Stage 2: effectiveness sampled on processes/sites
  • Multi-site: risk-based sampling by the CB
  • Integration: audit with 37001/9001/27001 to reduce effort

Risks & pitfalls

  • Paper CMS with weak operating effectiveness
  • No owner for the obligations register
  • DD limited to onboarding without renewals
  • Investigations lack chain-of-custody and trending
  • KPIs focus on activity not outcomes

Pricing guidance: Single-site CMS from $XXk depending on scope and tooling. Multi-region: custom. Training: per-seat or private cohort; bundle discounts.

AEC Services for ISO 37301

Gap Assessment & Roadmap

Clause-by-clause maturity review and prioritized plan.

Obligations & Risk Framework

Register, screening, KRIs, and issue taxonomy.

Policy & Control Suite

Code of conduct, ABAC, competition, conflicts, donations, third-party, records.

Third-Party Due Diligence

Risk model, screening criteria, and contract clauses.

Speak-up & Investigations

Channels, SOPs, case management, reporting (align 37002).

Monitoring & Testing

Plan, schedules, sampling, and evidence.

Internal Audit & MR

Programs, checklists, dashboards, and board pack.

Certification Support

CB selection, Stage 1/2 coaching, CAPA closure.

Scope your CMS in 48 hours

ISO 37301 Training

Foundation

1 day — concepts, clauses, evidence.

Learn More

Internal Auditor

2 days — planning, testing, reporting.

Learn More

Implementer/Practitioner

3 days — design and deployment labs.

Learn More

Lead Auditor*

5 days — CQI/IRCA via partners.

Inquire
Bundles: Implementer + Internal Auditor • 37301 IA + 37001 Practitioner

Sectors & Use Cases

Finance

Conduct risk, sanctions, AML interface, product governance.

Energy & Utilities

Permits, concessions, third-party contractors, gifts/hospitality.

Construction & EPC

Subcontractor vetting, bid-rigging prevention, site compliance.

Oil & Gas

Intermediaries due diligence, local content, sanctions.

Public sector & SOEs

Procurement compliance, conflicts, transparency.

Healthcare & Pharma

Promotional compliance, HCP ToV, data protection.

FAQs

Is ISO 37301 certifiable?+

Yes. ISO 37301 specifies requirements and can be third-party certified.

Difference vs ISO 19600?+

ISO 19600 was guidance. ISO 37301 adds certifiable requirements and stronger governance.

Do we need ISO 37001 too?+

Use ISO 37301 for enterprise compliance. Add ISO 37001 if customers or regulators require anti-bribery certification.

How do we manage third-parties?+

Apply risk-based due diligence at onboarding and renewal, use screening, contractual clauses, and ongoing monitoring.

What evidence do auditors expect?+

Obligations register ownership, risk results, control operation logs, case register, CAPA effectiveness, and MR minutes.

Integrate with 9001/27001?+

Yes. Share risk, document control, internal audit, and MR to reduce effort.

Multi-site certification?+

CBs use risk-based sampling. Keep central policy, local procedures, and site evidence aligned.

How fast to certify?+

Typically 10–16 weeks after gap, depending on scope, tooling, and culture.

Resources

CMS Evidence Pack Checklist (PDF)

Audit-ready documentation set.

Download

Third-Party DD Matrix (XLS)

Risk-based onboarding & renewal.

Download

Speak-up & Investigations SOP (DOCX)

Aligned to ISO 37002.

Download

Build a Certifiable Compliance Management System

Discuss scope, jurisdictions, tooling, and certification timelines with an AEC expert.

Global support • Integration with 37001/9001/27001 • Evidence-driven approach