What is the primary objective of **ISO 37301**?

**ISO 37301 specifies requirements for establishing, implementing, maintaining, and improving an effective **Compliance Management System (CMS)**.** Published on 13 April 2021, it replaces the guidance-only ISO 19600 by introducing certifiable 'shall' requirements using the **Plan-Do-Check-Act (PDCA)** cycle and **High-Level Structure (HLS)**. It promotes a risk-based approach to identify **compliance obligations** (legal, regulatory, contractual), assess risks/opportunities, foster leadership commitment, and drive continual improvement through performance evaluation and whistleblower protections.

Who is legally or professionally required to comply with **ISO 37301**?

**No organization is legally required to comply with ISO 37301, as it is a voluntary certifiable standard applicable to all sizes and sectors.** It suits entities facing regulatory complexity, ESG demands, or stakeholder expectations for demonstrable integrity, such as large corporates (e.g., Kingspan's multi-site certifications) and SMEs scaling compliance registers. Adoption is driven by market needs for third-party validation via accredited bodies like ANAB.

Does **ISO 37301** require an external audit or third-party certification?

**ISO 37301 enables but does not require external audits or third-party certification.** Certification involves accredited bodies (e.g., ANAB) conducting initial conformity assessments followed by surveillance audits in a typical three-year cycle. Organizations may self-assess using its requirements for internal CMS without pursuing formal certification.

How often should an assessment for **ISO 37301** be performed?

**ISO 37301 requires ongoing performance evaluation through monitoring, measurement, internal audits, and management reviews at planned intervals.** Internal audits are risk-based (frequent for high-risk areas), with top management reviews incorporating KPIs, incidents, and audit results. Certification involves annual surveillance audits within a three-year cycle post-initial assessment.

What are the consequences of non-compliance with **ISO 37301**?

**Non-conformance with ISO 37301 results in loss of certification, corrective action mandates, or audit nonconformities, but no direct legal penalties as it is voluntary.** Poor CMS implementation heightens risks of regulatory fines, litigation, reputational damage, and missed opportunities from inadequate obligation management, whistleblower protections, or risk controls.

An **ISO 37301** be mapped to other international frameworks?

**Yes, ISO 37301 follows the High-Level Structure (HLS), enabling seamless mapping and integration with other ISO management system standards.** Its PDCA cycle and clauses (context, leadership, planning, support, operation, evaluation, improvement) align with companion standards like ISO 37302 (effectiveness), ISO 37303 (competence), and ISO 37002 (whistleblowing) for modular compliance ecosystems.

What is the first step to begin implementing **ISO 37301**?

**The first step is securing top management buy-in and performing contextual analysis to map internal/external issues, interested parties, and compliance obligations.** This defines CMS scope, initiates a centralized **compliance register** prioritizing material risks, and aligns with strategic objectives per clause 4, setting the foundation for risk-based planning.

What is the primary objective of **EMAS**?

**The primary objective of EMAS is to promote continuous improvement in environmental performance through structured environmental management systems, systematic evaluation, public information provision, stakeholder dialogue, and active employee involvement.** As defined in Article 1 of **Regulation (EC) No 1221/2009** (EMAS III), it requires organisations to implement an EMS per Annex II, conduct periodic performance evaluations, produce validated environmental statements per Annex IV, and demonstrate verifiable improvements in core indicators like energy, water, waste, materials, emissions, and biodiversity.

Who is legally or professionally required to comply with **EMAS**?

**No organisation is legally required to comply with EMAS, as it is a voluntary scheme under EU Regulation (EC) No 1221/2009.** Open to any organisation—public or private, any sector or size, inside or outside the EU—registration is pursued professionally for benefits like verified legal compliance, procurement advantages, and ESG reporting synergies. As of September 2025, 4,141 organisations and 16,154 sites are registered, including SMEs via derogations (Article 7).

Does **EMAS** require an external audit or third-party certification?

**Yes, EMAS mandates independent verification and validation by accredited/licensed environmental verifiers.** Verifiers confirm EMS conformity (Annex II), legal compliance (Article 4), internal audits (Annex III), and validate the public environmental statement (Annex IV) before Competent Body registration (Articles 5, 13). Renewal requires full verification every three years (four for SMEs), with annual statement validation.

How often should an assessment for **EMAS** be performed?

**EMAS requires internal audits covering all activities at least every three years (extendable to four for SMEs), with full external verification every three years and annual environmental statement validation.** Per Article 6 and Annex III, intervening years need internal audits and validated updates; management reviews are periodic to ensure continual improvement.

What are the consequences of non-compliance with **EMAS**?

**Non-compliance with EMAS triggers suspension or deletion from the register by national Competent Bodies.** Per Articles 15–17, failure to submit validated statements, demonstrate legal compliance, or meet verification obligations leads to public de-registration, logo use prohibition, and loss of incentives like procurement preferences; no direct fines, but verified breaches block renewal.

An **EMAS** be mapped to other international frameworks?

**Yes, EMAS fully incorporates ISO 14001 EMS requirements (Annex II) and supports mapping to frameworks like CSRD/ESRS via aligned core indicators.** EMAS provides verified data on energy, emissions, and waste for ESRS; Article 45 allows Competent Bodies to recognise equivalent systems, reducing duplication while adding EMAS-specific transparency and legal verification.

What is the first step to begin implementing **EMAS**?

**The first step to implement EMAS is conducting an initial environmental review per Article 4 and Annex I.** This baseline analysis identifies direct/indirect aspects, legal obligations, and significance criteria, forming the foundation for policy, EMS, and statement development before verifier engagement.

ISO 37301 vs EMAS

Standards Comparison

ISO 37301

Voluntary

2021

International certifiable standard for compliance management systems

EMAS

Voluntary

1993

EU regulation for voluntary environmental management and audit.

Quick Verdict

ISO 37301 establishes certifiable compliance management systems globally for risk-based integrity, while EMAS mandates verified environmental performance reporting in the EU for transparency and continual eco-improvement. Organizations adopt ISO 37301 for broad CMS certification; EMAS for premium EU environmental credibility.

Compliance Management

ISO 37301

ISO 37301:2021 Compliance management systems requirements

Cost

€€€€

Complexity

High

Implementation Time

12-18 months

Key Features

Certifiable requirements for compliance management systems
High-Level Structure alignment with other ISO standards
Risk-based compliance obligations and planning approach
Leadership commitment and compliance culture emphasis
Robust whistleblowing protections and speak-up mechanisms

Environmental Management

EMAS

Regulation (EC) No 1221/2009 Eco-Management and Audit Scheme

Cost

€€€€

Complexity

High

Implementation Time

12-18 months

Key Features

Validated public environmental statements
Verified legal compliance checks
Core performance indicators required
Independent verifier accreditation
Continuous improvement via PDCA

Detailed Analysis

A comprehensive look at the specific requirements, scope, and impact of each standard.

ISO 37301 Details

What It Is

ISO 37301:2021 is a certifiable international standard specifying requirements and guidance for Compliance Management Systems (CMS). It provides a systematic, risk-based approach to identify, manage, and improve compliance obligations across legal, regulatory, contractual, and voluntary commitments. Applicable to all organization sizes and sectors, it follows the Plan-Do-Check-Act (PDCA) cycle and ISO High-Level Structure (HLS) for seamless integration.

Key Components

**Leadership and cultureTop management accountability, compliance policy, roles/responsibilities.
**PlanningRisk assessment, objectives, compliance registers.
**SupportResources, competence (per ISO 37303), awareness, whistleblowing (ISO 37002).
**OperationControls, third-party management, investigations.
**Performance evaluationMonitoring, audits, management reviews (ISO 37302 guidance).
**ImprovementNonconformities, continual enhancement. Certification via accredited bodies like ANAB.

Why Organizations Use It

Drives regulatory compliance, reduces risks/fines, builds stakeholder trust, enhances reputation. Supports ESG/SDGs, investor demands, integrates with ISO 9001/14001/27001. Provides third-party validation amid rising complexity.

Implementation Overview

Phased: context analysis, obligation inventory, controls/training, audits/certification. Scalable for SMEs/enterprises; 3-year cycle with surveillance. Tools like platforms aid operationalization; cultural change key challenge.

EMAS Details

What It Is

EMAS (Eco-Management and Audit Scheme), established by Regulation (EC) No 1221/2009, is a voluntary EU framework for organizations to evaluate, report, and improve environmental performance. It uses a PDCA cycle integrated with ISO 14001 principles, emphasizing verified legal compliance and public transparency.

Key Components

Initial environmental review, EMS implementation, internal audits, and management review.
Core indicators (energy, materials, water, waste, emissions, biodiversity) in Annex IV.
Public environmental statement validated annually.
Third-party verification by accredited verifiers; registration via national Competent Bodies.

Why Organizations Use It

Drives resource efficiency and cost savings.
Ensures verified legal compliance, reducing risks.
Enhances stakeholder trust and procurement advantages.
Supports ESG/CSRD reporting synergies.

Implementation Overview

Phased: gap analysis, EMS design, operational rollout, verification (12-18 months typical).
Suited for all sizes/sectors; SME derogations available.
Requires independent verification and ongoing annual statements.

Key Differences

Aspect	ISO 37301	EMAS
Scope	Compliance obligations, risks, CMS across operations	Environmental aspects, performance, EMS with public reporting
Industry	All sectors worldwide, any organization size	All sectors EU-focused, any size with SME flexibilities
Nature	Voluntary certifiable international standard	Voluntary EU regulation with registration
Testing	Accredited certification body audits, 3-year cycle	Licensed verifier validation, annual statements, 3-year renewal
Penalties	Loss of certification, no legal penalties	Registration suspension/deletion, no direct fines

Scope

ISO 37301

Compliance obligations, risks, CMS across operations

EMAS

Environmental aspects, performance, EMS with public reporting

Industry

ISO 37301

All sectors worldwide, any organization size

EMAS

All sectors EU-focused, any size with SME flexibilities

Nature

ISO 37301

Voluntary certifiable international standard

EMAS

Voluntary EU regulation with registration

Testing

ISO 37301

Accredited certification body audits, 3-year cycle

EMAS

Licensed verifier validation, annual statements, 3-year renewal

Penalties

ISO 37301

Loss of certification, no legal penalties

EMAS

Registration suspension/deletion, no direct fines

Frequently Asked Questions

Common questions about ISO 37301 and EMAS

ISO 37301 FAQ

EMAS FAQ

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ISO 37301

EMAS

Quick Verdict

ISO 37301

Key Features

EMAS

Key Features

Detailed Analysis

ISO 37301 Details

What It Is

Key Components

Why Organizations Use It

Implementation Overview

EMAS Details

What It Is

Key Components

Why Organizations Use It

Implementation Overview

Key Differences

Scope

Industry

Nature

Testing

Penalties

Frequently Asked Questions

ISO 37301 FAQ

What is the primary objective of ISO 37301?

Who is legally or professionally required to comply with ISO 37301?

Does ISO 37301 require an external audit or third-party certification?

How often should an assessment for ISO 37301 be performed?

What are the consequences of non-compliance with ISO 37301?

An ISO 37301 be mapped to other international frameworks?

What is the first step to begin implementing ISO 37301?

EMAS FAQ

What is the primary objective of EMAS?

Who is legally or professionally required to comply with EMAS?

Does EMAS require an external audit or third-party certification?

How often should an assessment for EMAS be performed?

What are the consequences of non-compliance with EMAS?

An EMAS be mapped to other international frameworks?

What is the first step to begin implementing EMAS?

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You Guide on how to Start Implementing NIS2 in Your Organization

CIS Controls v8.1 for Cloud & SaaS: A Practical Safeguard Playbook for AWS/Azure/GCP and Microsoft 365

How to Implement CIS Controls v8.1 as a ‘Control Backbone’ for NIS2 & DORA (Step-by-Step Implementation Guide)

Run Maturity Assessments with GRADUM

Check out these other Gradum.io Standards Comparison Pages

CSL (Cyber Security Law of China) vs LEED

FDA 21 CFR Part 11 vs ISA 95

LGPD vs REACH