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). The standard promotes a risk-based approach to identify compliance obligations, assess risks, embed a culture of integrity, and ensure continual improvement through leadership commitment and performance evaluation.

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 is professionally adopted by entities seeking third-party assurance for managing compliance obligations, including legal, regulatory, contractual, and voluntary commitments. Large corporates like Kingspan have certified multiple sites, driven by investor demands, reputational risk, and ESG pressures.

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

**ISO 37301 enables but does not require external audit or third-party certification.** Certification is optional via accredited bodies like those under ANAB/ANSI, following a typical three-year cycle with initial assessment and surveillance audits. Organizations implement internal audits and management reviews for conformance, with certification providing external validation of CMS effectiveness.

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

**ISO 37301 requires continual performance evaluation through monitoring, measurement, internal audits at planned intervals, and management reviews.** Assessments are risk-based: high-risk areas audited more frequently. Certification involves surveillance audits annually or per the three-year cycle; continual improvement mandates ongoing reviews using KPIs aligned with ISO 37302 maturity models.

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

**Non-conformance with ISO 37301 results in loss of certification, internal corrective actions, and potential escalation of unmanaged compliance risks.** As a voluntary standard, direct penalties do not apply, but failure exposes organizations to regulatory fines, litigation, reputational damage, and stakeholder distrust from unaddressed obligations like whistleblowing or third-party risks.

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 framework aligns with companion standards like ISO 37302 (effectiveness), ISO 37303 (competence), and ISO 37002 (whistleblowing), supporting Integrated Management Systems (IMS) without referencing specific external frameworks.

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

**The first step is securing top management commitment and determining the organization's context per Clause 4.** This involves analyzing internal/external issues, identifying interested parties' expectations, scoping the CMS, and inventorying compliance obligations into a centralized register, prioritizing material risks for risk-based planning.

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

**The primary objective of WELL is to advance human health and well-being through performance-based building design, operations, and policies across 10 concepts: Air, Water, Nourishment, Light, Movement, Thermal Comfort, Sound, Materials, Mind, and Community.** Administered by the International WELL Building Institute (IWBI), WELL v2 requires meeting **24 mandatory Preconditions** and earning points from **102 Optimizations** (plus 6 in Innovation) to achieve certification tiers: Bronze (40 points), Silver (50 points with 1 point minimum per concept), Gold (60 points with 2 points minimum per concept), or Platinum (80 points with 3 points minimum per concept).

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

**WELL is voluntary and not legally mandated for any organization.** It applies to building owners, developers, operators, and tenants pursuing certification for new or existing buildings via pathways like WELL Certification (owner-controlled), WELL Core (base buildings with ≥75% leased space), or WELL for Residential. Professionals such as architects, engineers, and WELL APs often engage for market differentiation, ESG reporting, and occupant health outcomes.

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

**Yes, WELL mandates third-party documentation review and on-site performance verification (PV) by authorized WELL Performance Testing Agents.** This includes two rounds of review (preliminary and final) via IWBI's digital platform, plus testing for air (e.g., CO₂ ≤900 ppm), water, light, thermal comfort, and sound at ≥50% occupancy. Pre-testing is recommended to identify gaps.

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

**WELL certification requires recertification every three years, with annual reporting for select features like air quality monitoring.** Continuous monitoring pathways (e.g., CO₂ data, calibrated sensors recalibrated annually) support ongoing compliance. Performance assessments occur during initial PV and recertification, typically involving on-site testing every three years.

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

**Non-compliance with WELL results in certification denial, additional curative review fees, and delayed timelines.** Failed Preconditions prevent any certification level; unmet points limit tier achievement. No statutory penalties apply as WELL is voluntary, but projects may incur extra costs for re-testing, appeals, or remediation (e.g., HVAC upgrades for air thresholds).

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

**Yes, IWBI provides official crosswalks mapping WELL features to frameworks like LEED.** These align overlapping requirements (e.g., air filtration, materials), enabling streamlined dual certification, reduced documentation, and integrated ESG reporting without duplicating efforts.

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

**The first step is project enrollment/registration on IWBI's digital platform and scorecard development.** This identifies applicable features, Preconditions, targeted points/tier, and evidence needs for the project type (e.g., existing building), followed by a gap analysis and optional pre-testing for high-risk concepts like Air and Water.

ISO 37301 vs WELL

Standards Comparison

ISO 37301

Voluntary

2021

Certifiable international standard for compliance management systems

WELL

Voluntary

2014

Certification framework for occupant health in buildings

Quick Verdict

ISO 37301 establishes certifiable compliance management systems for risk-based integrity across organizations, while WELL certifies buildings for occupant health via air, water, and wellness metrics. Companies adopt ISO 37301 for governance assurance; WELL for productivity and ESG differentiation.

Compliance Management

ISO 37301

ISO 37301:2021 Compliance management systems – Requirements with guidance

Cost

€€€€

Complexity

High

Implementation Time

12-18 months

Key Features

Certifiable requirements standard replacing guidance-only ISO 19600
High-Level Structure alignment for IMS integration
Risk-based compliance obligations identification and management
Top management commitment and culture emphasis
Confidential whistleblowing channels with anti-retaliation protections

Building Health & Wellness

WELL

WELL Building Standard v2

Cost

€€€€

Complexity

High

Implementation Time

12-18 months

Key Features

10 core concepts covering air to community health
Mandatory preconditions and point-based optimizations
On-site performance verification testing required
Tiered certifications from Bronze to Platinum
Continuous monitoring pathways for compliance

Detailed Analysis

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

ISO 37301 Details

What It Is

ISO 37301:2021 – Compliance management systems – Requirements with guidance for use is a certifiable international standard specifying requirements for establishing, implementing, maintaining, and improving effective Compliance Management Systems (CMS). It applies universally across organization sizes and sectors, using a risk-based approach and Plan-Do-Check-Act (PDCA) cycle aligned with ISO High-Level Structure (HLS).

Key Components

Core clauses: context, leadership, planning, support, operation, performance evaluation, improvement.
Emphasizes leadership commitment, compliance culture, whistleblowing protections, risk assessment, monitoring, audits, and continual improvement.
Built on HLS for integration; supports companion standards like ISO 37302 (effectiveness) and ISO 37303 (competence).
Certification via accredited bodies (e.g., ANAB).

Why Organizations Use It

Demonstrates systematic compliance to stakeholders, reduces risks/fines, enhances reputation.
Meets investor/ESG demands; provides audit evidence.
Drives efficiency, cultural integrity; supports UN SDGs.

Implementation Overview

Phased: gap analysis, obligation register, controls, training, audits.
Scalable for SMEs/enterprises; 3-year certification cycle.
Global applicability; 2024 Amendment adds climate action.

WELL Details

What It Is

The WELL Building Standard (WELL v2) is a performance-based certification framework administered by the International WELL Building Institute (IWBI). It focuses on designing, operating, and verifying buildings to advance human health and well-being through evidence-based strategies across environmental quality, operations, and policies.

Key Components

**10 core conceptsAir, Water, Nourishment, Light, Movement, Thermal Comfort, Sound, Materials, Mind, Community (plus Innovation).
24 Preconditions (mandatory) and 102 Optimizations (point-based).
Built on public health research; certification via Bronze (40 pts), Silver (50), Gold (60), Platinum (80) with concept minimums.

Why Organizations Use It

Enhances occupant productivity, retention, ESG reporting.
Differentiates assets with verified health outcomes.
Mitigates risks like poor IEQ; boosts rents/values.
Builds stakeholder trust via rigorous verification.

Implementation Overview

Phased: gap analysis, scorecard, documentation, on-site testing, recertification (3 years).
Applies to new/existing buildings, all sizes/industries.
Requires third-party review and performance verification.

Key Differences

Aspect	ISO 37301	WELL
Scope	Compliance obligations, risks, culture across operations	Building health, air/water quality, occupant well-being
Industry	All sectors, sizes, global applicability	Real estate, offices, healthcare, global buildings
Nature	Voluntary certifiable management system standard	Voluntary performance-based building certification
Testing	Accredited audits, 3-year certification cycles	On-site performance verification, 3-year recertification
Penalties	Loss of certification, no legal penalties	Loss of certification, no legal penalties

Scope

ISO 37301

Compliance obligations, risks, culture across operations

WELL

Building health, air/water quality, occupant well-being

Industry

ISO 37301

All sectors, sizes, global applicability

WELL

Real estate, offices, healthcare, global buildings

Nature

ISO 37301

Voluntary certifiable management system standard

WELL

Voluntary performance-based building certification

Testing

ISO 37301

Accredited audits, 3-year certification cycles

WELL

On-site performance verification, 3-year recertification

Penalties

ISO 37301

Loss of certification, no legal penalties

WELL

Loss of certification, no legal penalties

Frequently Asked Questions

Common questions about ISO 37301 and WELL

ISO 37301 FAQ

WELL FAQ

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ISO 37301

WELL

Quick Verdict

ISO 37301

Key Features

WELL

Key Features

Detailed Analysis

ISO 37301 Details

What It Is

Key Components

Why Organizations Use It

Implementation Overview

WELL 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?

WELL FAQ

What is the primary objective of WELL?

Who is legally or professionally required to comply with WELL?

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

How often should an assessment for WELL be performed?

What are the consequences of non-compliance with WELL?

An WELL be mapped to other international frameworks?

What is the first step to begin implementing WELL?

You Might also be Interested in These Articles...

Your Compliance Command Center: How Modern Tools Orchestrate Cross-Departmental Adherence

Unpacking the True Cost: A Guide to Calculating TCO for Modern Compliance Monitoring Software

Beyond the Boardroom: 5 Ways Modern Compliance Software Elevates Every Department

Run Maturity Assessments with GRADUM

Check out these other Gradum.io Standards Comparison Pages

SAFe vs SAMA CSF

C-TPAT vs ISO 56002

NIST 800-53 vs ISO 28000