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

**ISO 37301:2021 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. The standard uses the **Plan-Do-Check-Act (PDCA)** cycle and **High-Level Structure (HLS)** to systematically identify **compliance obligations** (legal, regulatory, contractual), assess **compliance risks** and opportunities, embed a **compliance culture**, and drive **continual improvement** through leadership commitment, whistleblower protections, and performance evaluation.

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 suits any entity facing **compliance obligations**, from SMEs to multinationals, including public bodies and non-profits. Professional drivers include stakeholder demands for demonstrable CMS integrity, supply chain requirements, and market differentiation via third-party certification from 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.** As a certifiable standard, organizations may pursue accreditation through bodies like ANAB-accredited certification bodies, involving initial conformity assessments and surveillance audits in a typical three-year cycle. Certification provides external validation of CMS conformance to HLS clauses.

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

**ISO 37301 requires continual performance evaluation through monitoring, measurement, internal audits, and management reviews at planned intervals.** Internal audits must follow a risk-based program with frequency tied to significance; management reviews occur periodically, informed by KPIs, incidents, and audits. Surveillance audits for certified CMS occur typically annually within a three-year cycle.

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

**Non-conformance with ISO 37301 itself carries no direct penalties, as it is voluntary; however, certification loss or failure to meet internal CMS requirements risks reputational harm, stakeholder distrust, and unmitigated compliance breaches.** Effective CMS prevents external fines from unmet obligations; poor implementation exposes organizations to regulatory actions, litigation, and lost market access.

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

**Yes, ISO 37301 follows the ISO High-Level Structure (HLS), enabling seamless mapping and integration with other management system standards.** Its PDCA cycle and clauses (context, leadership, planning, support, operation, evaluation, improvement) align with HLS-based frameworks, supporting **Integrated Management Systems (IMS)** and joint audits for efficient compliance.

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

**The first step is to determine the **context of the organization**, identifying internal/external issues, interested parties, and CMS scope.** Secure **top management commitment**, inventory **compliance obligations** into a centralized register, and prioritize material risks per the risk-based approach.

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

**The primary objective of BRCGS Global Standard for Food Safety is to ensure the production of safe, legal, authentic, and quality-assured food products through a structured management system.** It combines senior management commitment with a Codex HACCP-based food safety plan and prerequisite programs (GMP/GHP) to control contamination, mislabelling, fraud, and operational risks across manufacturing, processing, and packing sites.

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

**BRC compliance is professionally required for food manufacturers, processors, and packers supplying major retailers, as it is a GFSI-benchmarked prerequisite for market access.** It targets sites producing processed foods, ingredients, primary products like fruit/vegetables, and domestic pet foods under direct management control; retailers and brand owners mandate it contractually for private-label and customer-branded supply chains.

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

**Yes, BRC requires mandatory external audits by accredited certification bodies, resulting in third-party certification valid for one year.** Audits are site-specific, covering announced or unannounced options, with grading (AA/A/B/C/D, "+" for unannounced) based on non-conformance severity; fundamental clause failures can prevent certification.

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

**BRC requires annual on-site audits by certification bodies, supplemented by internal audits at least four times yearly across all clauses.** Internal audits must cover full scope annually with risk-based frequency; management reviews occur at least annually, with quarterly objective reporting and monthly food safety meetings.

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

**Non-compliance with BRC results in audit grading downgrades, certification suspension or withdrawal, and loss of retailer supply contracts.** Critical/major non-conformities in fundamental clauses (e.g., HACCP, traceability) trigger re-audits; commercial impacts include delisting, recall risks, and reputational damage from failures in allergens, pathogens, or labelling.

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

**Yes, BRC maps effectively to frameworks sharing HACCP, prerequisite programs, and management system elements.** Its structure aligns with GFSI-benchmarked schemes, enabling reduced duplicate audits; executives use clause-to-clause mapping for integration while maintaining BRC's site-specific controls.

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

**The first step for BRC implementation is securing senior management commitment through a signed food safety policy and defining site scope.** Assemble a multidisciplinary team, conduct a gap analysis using BRC's Get Started Assessment Tool against the nine clauses, and prioritize fundamental requirements like HACCP and site standards.

ISO 37301 vs BRC

Standards Comparison

ISO 37301

Voluntary

2021

International certifiable standard for compliance management systems

BRC

Voluntary

2022

Global standard for food safety in manufacturing

Quick Verdict

ISO 37301 provides a certifiable compliance management system for all organizations worldwide, emphasizing risk-based planning and culture. BRC delivers food safety certification for manufacturers via HACCP and site controls. Companies adopt ISO 37301 for broad governance, BRC for retailer supply chain access.

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 enables integration with ISO 9001/14001/27001
Risk-based planning for compliance obligations and controls
Leadership commitment mandates tone-from-top and culture building
Confidential whistleblowing channels with anti-retaliation protections

Food Safety

BRC

BRCGS Global Standard for Food Safety

Cost

€€€€

Complexity

High

Implementation Time

6-12 months

Key Features

Senior management commitment and culture plan
Codex HACCP-based food safety plan
Fundamental requirements for certification
Environmental monitoring and risk zoning
Graded audits with unannounced option

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). Applicable to all organization sizes and sectors, it uses a risk-based, PDCA (Plan-Do-Check-Act) approach following the ISO High-Level Structure (HLS) for seamless integration with standards like ISO 9001 and 27001.

Key Components

**Leadership and cultureTop management accountability, compliance policy, roles/responsibilities.
**PlanningCompliance obligations identification, risk assessment, objectives/controls.
**Support/operationResources, competence, awareness, whistleblowing, third-party controls.
**Performance evaluationMonitoring, audits, management reviews.
**ImprovementNonconformities, continual enhancement. Built on HLS with companion standards (ISO 37302/37303); enables third-party certification via accredited bodies like ANAB.

Why Organizations Use It

Drives regulatory compliance, risk reduction, ethical culture; meets investor/ESG demands; provides certification for stakeholder trust and competitive edge amid rising enforcement.

Implementation Overview

Phased: context analysis, obligation register, controls/training, audits/certification. Scalable for SMEs/enterprises globally; 3-year certification cycles with surveillance audits.

BRC Details

What It Is

BRCGS Global Standard for Food Safety is a GFSI-benchmarked third-party certification framework for food manufacturers, processors, and packers. It ensures product safety, legality, authenticity, and quality across supply chains via a structured management system combining senior management commitment, Codex HACCP-based plans, and prerequisite programs like GMP/GHP.

Key Components

Nine core clauses: senior management, HACCP, FSQMS, site standards, product/process control, personnel, high-risk zones, traded products.
13 fundamental requirements (e.g., traceability, allergen management, internal audits) critical for certification.
Grading model (AA/A/B/C/D, + for unannounced) with root cause analysis and CAPA.

Why Organizations Use It

Mandated by retailers for supply chain access.
Reduces duplicative audits, evidences due diligence, mitigates recalls from allergens/pathogens.
Builds trust, operational resilience, aligns with FSMA.

Implementation Overview

Phased: gap analysis, documentation/training, internal audits, certification by accredited bodies.
Applies to global food manufacturers; 6-12 months typical, high CAPEX for site upgrades.

Key Differences

Aspect	ISO 37301	BRC
Scope	Compliance obligations, risks, culture across all operations	Food safety, HACCP, site standards for manufacturing/packing
Industry	All sectors, sizes, global applicability	Food manufacturing, packaging, specific supply chain
Nature	Voluntary certifiable management system standard	Voluntary GFSI-benchmarked food safety certification
Testing	Internal audits, management reviews, certification audits	Annual site audits, internal audits, unannounced options
Penalties	Loss of certification, no legal penalties	Certification withdrawal, market access loss

Scope

ISO 37301

Compliance obligations, risks, culture across all operations

BRC

Food safety, HACCP, site standards for manufacturing/packing

Industry

ISO 37301

All sectors, sizes, global applicability

BRC

Food manufacturing, packaging, specific supply chain

Nature

ISO 37301

Voluntary certifiable management system standard

BRC

Voluntary GFSI-benchmarked food safety certification

Testing

ISO 37301

Internal audits, management reviews, certification audits

BRC

Annual site audits, internal audits, unannounced options

Penalties

ISO 37301

Loss of certification, no legal penalties

BRC

Certification withdrawal, market access loss

Frequently Asked Questions

Common questions about ISO 37301 and BRC

ISO 37301 FAQ

BRC FAQ

You Might also be Interested in These Articles...

Using CIS Controls v8.1 as a ‘Compliance On-Ramp’: Map One Security Program to NIST CSF, ISO 27001, PCI DSS, and NIS2

Use CIS Controls v8.1 as your compliance on-ramp. Map one security program to NIST CSF, ISO 27001, PCI DSS, and NIS2 without duplicating work via practical mapp

What is DORA and which Requirements does the Standard define?

Discover DORA requirements for info security, strict authority monitoring, and steps to achieve compliance. Build a resilient organization with our detailed gui

CIS Controls v8.1, Operationalized: Top 10 Reasons Compliance Monitoring Software Accelerates Real-World Implementation

Operationalize CIS Controls v8.1 with compliance monitoring software. Turn checklists into dashboards, tickets, and audit-proof workflows. Top 10 reasons it acc

Run Maturity Assessments with GRADUM

Transform your compliance journey with our AI-powered assessment platform

Assess your organization's maturity across multiple standards and regulations including ISO 27001, DORA, NIS2, NIST, GDPR, and hundreds more. Get actionable insights and track your progress with collaborative, AI-powered evaluations.

100+ Standards & Regulations

AI-Powered Insights

Collaborative Assessments

Actionable Recommendations

Check out these other Gradum.io Standards Comparison Pages

ISO 55001 vs BRC

Discover ISO 55001 vs BRC: Asset mgmt excellence meets food safety standards. Uncover differences, benefits & strategies for compliance success. Optimize now!

UL Certification vs WEEE

Uncover UL Certification vs WEEE: Compare safety marks, compliance processes & e-waste rules for electronics. Ensure market access & sustainability. Dive in now!

CMMC vs GMP

Compare CMMC vs GMP: Decode DoD cybersecurity tiers vs pharma manufacturing standards. Master compliance gaps, strategies & pitfalls for DIB success now!

ISO 37301

BRC

Quick Verdict

ISO 37301

Key Features

BRC

Key Features

Detailed Analysis

ISO 37301 Details

What It Is

Key Components

Why Organizations Use It

Implementation Overview

BRC 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?

BRC FAQ

What is the primary objective of BRC?

Who is legally or professionally required to comply with BRC?

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

How often should an assessment for BRC be performed?

What are the consequences of non-compliance with BRC?

An BRC be mapped to other international frameworks?

What is the first step to begin implementing BRC?

You Might also be Interested in These Articles...

Using CIS Controls v8.1 as a ‘Compliance On-Ramp’: Map One Security Program to NIST CSF, ISO 27001, PCI DSS, and NIS2

What is DORA and which Requirements does the Standard define?

CIS Controls v8.1, Operationalized: Top 10 Reasons Compliance Monitoring Software Accelerates Real-World Implementation

Run Maturity Assessments with GRADUM

Check out these other Gradum.io Standards Comparison Pages

ISO 55001 vs BRC

UL Certification vs WEEE

CMMC vs GMP