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, following the High-Level Structure (HLS) and Plan-Do-Check-Act (PDCA) cycle to systematically identify compliance obligations, assess risks, and foster a culture of integrity.

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

No organizations are legally required to comply with ISO 37301, as it is a voluntary certifiable standard applicable to all sizes and sectors. It is professionally adopted by entities seeking third-party validation of CMS effectiveness, such as large corporates like Kingspan (multiple sites certified) facing regulatory complexity, ESG demands, or stakeholder expectations for demonstrable compliance risk management.

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

ISO 37301 does not require external audits or third-party certification, but enables them through accredited bodies like ANAB. Certification involves initial conformity assessment followed by surveillance audits in a typical three-year cycle, providing external assurance of CMS alignment with requirements for leadership, risk planning, and continual improvement.

How often should an assessment for ISO 37301 be performed?

ISO 37301 requires ongoing monitoring, measurement, internal audits at planned intervals, and management reviews at planned intervals. Performance evaluation is risk-based, with high-risk areas audited more frequently; certification follows a three-year cycle with annual surveillance audits by accredited bodies to ensure continual improvement.

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

Non-conformance with ISO 37301 results in loss of certification, but carries no direct legal penalties as it is voluntary. Internal consequences include weakened CMS effectiveness, heightened compliance risks, reputational damage, and missed opportunities for stakeholder trust; organizations must address nonconformities via root-cause analysis and corrective actions.

Can 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 on context, leadership, planning, support, operation, performance evaluation, and improvement support Integrated Management Systems (IMS) without naming specific frameworks.

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, stakeholders, and CMS scope. This initiates Phase 1 of implementation by inventorying compliance obligations into a centralized register and prioritizing material risks per the standard's risk-based approach.

What is the primary objective of ISO 19600?

ISO 19600:2014 provides guidelines for establishing, developing, implementing, evaluating, maintaining, and improving a compliance management system (CMS). It uses a Plan-Do-Check-Act (PDCA) cycle and high-level structure to embed compliance obligations—laws, regulations, voluntary codes, and contracts—into organizational processes, emphasizing principles of good governance, proportionality, transparency, and sustainability for all organization sizes and types.

Who is legally or professionally required to comply with ISO 19600?

No organization is legally required to comply with ISO 19600, as it is a non-mandatory guideline standard. It applies voluntarily to all types and sizes of organizations—public, private, or non-profit—seeking to manage compliance risks proportionately to their structure, nature, and complexity, with professional adoption driven by governance needs or benchmarking.

Oes ISO 19600 require an external audit or third-party certification?

ISO 19600 does not require external audits or third-party certification, as it provides guidelines rather than auditable requirements. Organizations may conduct internal audits at planned intervals per Clause 9.2, but certification is unavailable; it was withdrawn in 2021 and replaced by certifiable ISO 37301.

How often should an assessment for ISO 19600 be performed?

ISO 19600 requires compliance risk assessments to be performed initially and reassessed whenever changes or issues occur. Ongoing monitoring (Clause 9.1), planned internal audits (Clause 9.2), and management reviews (Clause 9.3) ensure continual evaluation, with frequency scaled to organizational context, obligations changes, and risk profile.

What are the consequences of non-compliance with ISO 19600?

There are no direct consequences for non-compliance with ISO 19600 itself, as it is a voluntary guideline standard. Indirect risks include failure to meet actual legal or contractual obligations, potentially leading to regulatory penalties, reputational damage, or operational disruptions, which a CMS helps mitigate.

An ISO 19600 be mapped to other international frameworks?

Yes, ISO 19600 can be mapped to other international frameworks sharing its high-level structure and PDCA cycle. Its management system architecture supports integration with financial, risk, quality, environmental, and health/safety processes, facilitating unified governance without specifying other standards.

What is the first step to begin implementing ISO 19600?

The first step is understanding the organization's context and determining the CMS scope per Clause 4. This involves identifying internal/external issues, interested parties' requirements, compliance obligations (Clause 4.5), and boundaries as documented information, ensuring proportionality to size, structure, nature, and complexity.

Standards Comparison

ISO 37301 vs ISO 19600

ISO 37301

Voluntary

2021

Certifiable international standard for compliance management systems

ISO 19600

Voluntary

2014

International guidelines for compliance management systems

Quick Verdict

ISO 37301 provides certifiable requirements for effective CMS, enabling third-party validation across all organizations. ISO 19600 offered non-certifiable guidance. Companies adopt ISO 37301 for assurance and integration; legacy users transition for auditability.

Compliance Management

ISO 37301

ISO 37301:2021 Compliance management systems – Requirements

Cost

€€€€

Complexity

High

Implementation Time

12-18 months

Key Features

Certifiable standard replacing guidance-only ISO 19600
High-Level Structure aligns with ISO 9001/14001/27001
Risk-based identification of compliance obligations and controls
Leadership commitment fosters compliance culture and resources
Mandatory confidential whistleblowing with anti-retaliation protections

Compliance Management

ISO 19600

ISO 19600:2014 Compliance management systems — Guidelines

Cost

€€€

Complexity

Medium

Implementation Time

6-12 months

Key Features

PDCA-based management system for compliance
Governance principles: independence and board access
Risk-based obligations identification and controls
Scalable and proportionate to organization size
Integrates with other ISO management systems

Detailed Analysis

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

ISO 37301 Details

What It Is

ISO 37301:2021, titled Compliance management systems – Requirements with guidance for use, is a certifiable international standard for establishing, implementing, and improving Compliance Management Systems (CMS). It replaces guidance-only ISO 19600 and uses a risk-based PDCA cycle within the High-Level Structure (HLS) for broad applicability across organizations.

Key Components

Core clauses: context, leadership, planning, support, operation, performance evaluation, improvement.
Emphasizes leadership commitment, risk assessment, whistleblowing channels, internal audits, and continual improvement.
Built on HLS for integration; companion standards like ISO 37302 (effectiveness) and ISO 37303 (competence).
Certification via accredited bodies (e.g., ANAB) in a three-year cycle.

Why Organizations Use It

Drives regulatory compliance, reduces risks/fines, builds integrity culture, enhances stakeholder trust, and supports ESG/SDGs. Provides third-party validation amid rising complexity; strategic for investor confidence and reputation.

Implementation Overview

Phased: initiate (gap analysis), design (registers/policies), implement (training/controls), evaluate (audits/KPIs), sustain. Scalable for SMEs/enterprises; all sectors/geographies. Requires certification audits, resource allocation, cultural change.

ISO 19600 Details

What It Is

ISO 19600:2014 — Compliance management systems — Guidelines is an international standard providing non-certifiable guidance for establishing, implementing, evaluating, maintaining, and improving a Compliance Management System (CMS). Its primary purpose is to help organizations of any size manage compliance obligations (legal, regulatory, contractual, voluntary) through a scalable, risk-based, PDCA (Plan-Do-Check-Act) approach aligned with ISO's high-level structure.

Key Components

Core clauses cover context, leadership, planning, support, operation, performance evaluation, and improvement.
Emphasizes **principles of good governancecompliance function independence, direct board access, adequate resources.
Focuses on obligations identification, risk assessment, controls, training, monitoring, audits, and continual improvement.
No fixed number of controls; proportionate to organization size/complexity.

Why Organizations Use It

Mitigates compliance risks, reduces penalties, enhances governance.
Builds culture of integrity, stakeholder trust, operational efficiency.
Integrates with other management systems (e.g., ISO 9001, 14001).
Provides benchmarking despite withdrawal (replaced by certifiable ISO 37301).

Implementation Overview

Phased: gap analysis, policy design, risk assessment, controls rollout, monitoring.
Scalable for SMEs (6-12 months) to large firms (12-36 months).
Universal applicability; no certification, but internal audits/management reviews recommended.

Key Differences

Aspect	ISO 37301	ISO 19600
Scope	Requirements for CMS, all obligations	Guidelines for CMS, principles-based
Industry	All sizes/sectors worldwide	All sizes/sectors worldwide
Nature	Certifiable requirements standard	Non-certifiable guidance standard
Testing	Accredited certification audits	Internal audits, no certification
Penalties	Loss of certification	No formal penalties

Scope

ISO 37301

Requirements for CMS, all obligations

ISO 19600

Guidelines for CMS, principles-based

Industry

ISO 37301

All sizes/sectors worldwide

ISO 19600

All sizes/sectors worldwide

Nature

ISO 37301

Certifiable requirements standard

ISO 19600

Non-certifiable guidance standard

Testing

ISO 37301

Accredited certification audits

ISO 19600

Internal audits, no certification

Penalties

ISO 37301

Loss of certification

ISO 19600

No formal penalties

Frequently Asked Questions

Common questions about ISO 37301 and ISO 19600

ISO 37301 FAQ

ISO 19600 FAQ

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See how ISO 37301 and ISO 19600 compare against other standards

Other ISO 37301 Comparisons

Other ISO 19600 Comparisons

What It Is

Key Components

Core clauses: context, leadership, planning, support, operation, performance evaluation, improvement.

Emphasizes leadership commitment, risk assessment, whistleblowing channels, internal audits, and continual improvement.

Built on HLS for integration; companion standards like ISO 37302 (effectiveness) and ISO 37303 (competence).

Certification via accredited bodies (e.g., ANAB) in a three-year cycle.

What It Is

Key Components

Core clauses cover context, leadership, planning, support, operation, performance evaluation, and improvement.

Emphasizes **principles of good governancecompliance function independence, direct board access, adequate resources.

Focuses on obligations identification, risk assessment, controls, training, monitoring, audits, and continual improvement.

No fixed number of controls; proportionate to organization size/complexity.

Aspect

ISO 37301

ISO 19600

Scope

Requirements for CMS, all obligations

Guidelines for CMS, principles-based

Industry

All sizes/sectors worldwide

Nature

Certifiable requirements standard

Non-certifiable guidance standard

Testing

Accredited certification audits

Internal audits, no certification

Penalties

Loss of certification

No formal penalties