What is the primary objective of **ISO 22000**?

**ISO 22000 enables organizations to provide safe products through a Food Safety Management System (FSMS) that prevents, eliminates, or reduces food safety hazards to acceptable levels.** It ensures compliance with statutory, regulatory, and customer requirements via interactive communication, **PRPs**, hazard analysis, **CCPs/OPRPs**, verification, traceability, and withdrawal. Published June 19, 2018, the standard uses **two nested PDCA cycles**—organizational for governance and operational (Clause 8) for HACCP integration—across Clauses 4–10 using the **High-Level Structure (HLS)**.

Who is legally or professionally required to comply with **ISO 22000**?

**No organization is legally required to comply with ISO 22000, as it is a voluntary international standard.** It applies professionally to any entity in the food chain—**primary producers, feed producers, processors, packaging providers, transport, storage, retail, food services**—directly or indirectly affecting safety, including animal food. Certification demonstrates FSMS effectiveness to customers, regulators, and markets, often demanded by retailers or GFSI schemes like FSSC 22000.

Does **ISO 22000** require an external audit or third-party certification?

**ISO 22000 does not require external audit or third-party certification, but certification provides independent FSMS verification.** Performed by accredited bodies via stage 1 (readiness) and stage 2 (implementation) audits, it confirms Clauses 4–10 compliance, with annual surveillance and triennial recertification. Evidence includes leadership, hazard plans, PRPs, internal audits, and management reviews.

How often should an assessment for **ISO 22000** be performed?

**Internal audits for ISO 22000 must be conducted at planned intervals, risk-based to prioritize high-risk processes.** **Management reviews** occur at predetermined intervals, typically annually or per significant changes, reviewing performance data, audits, nonconformities, and context. Verification of PRPs, CCPs/OPRPs, and traceability is ongoing, with full FSMS reassessments annually or before changes.

What are the consequences of non-compliance with **ISO 22000**?

**Non-compliance with ISO 22000 risks certification suspension, market exclusion, recalls, legal liability, and brand damage.** As a voluntary standard, direct penalties are absent, but failures in PRPs, hazard controls, or traceability can cause foodborne illness outbreaks, regulatory fines under local laws, supply chain rejection, and financial losses from litigation or lost contracts.

Can **ISO 22000** be mapped to other international frameworks?

**Yes, ISO 22000:2018 aligns with other ISO management system standards via its High-Level Structure (HLS) in Clauses 4–10.** This enables integrated systems sharing PDCA, risk-based planning, audits, and reviews. It forms the foundation for GFSI schemes like **FSSC 22000**, incorporating all ISO 22000 requirements plus sector PRPs (ISO/TS 22002 series).

What is the first step to begin implementing **ISO 22000**?

**The first step is determining organizational context, FSMS scope, and interested parties per Clause 4.** Conduct a gap analysis against Clauses 4–10, appoint leadership and a food safety team, and establish a food safety policy with objectives (Clause 5–6), setting boundaries for PRPs, hazard analysis, and controls.

What is the primary objective of **EU AI Act**?

**The primary objective of the EU AI Act is to establish a risk-based regulatory framework that prohibits unacceptable-risk AI practices, imposes strict obligations on high-risk AI systems, mandates transparency for limited-risk systems, and promotes safe AI innovation while protecting health, safety, and fundamental rights.** Regulation (EU) 2024/1689, effective 1 August 2024, classifies AI into four tiers via Articles 5–6 and Annexes I/III, requiring lifecycle controls like risk management (**Article 9**) and conformity assessments (**Article 43**).

Who is legally or professionally required to comply with **EU AI Act**?

**Providers, deployers, importers, distributors, and authorized representatives of AI systems used in the EU must comply with the EU AI Act, including third-country entities if outputs are used in the EU.** Providers develop or place high-risk systems on the market (**Article 3(3)**); deployers are professional users (**Article 3(4)**). Obligations span the value chain, with high-risk duties on those enabling market access (**Articles 16, 25**).

Does **EU AI Act** require an external audit or third-party certification?

**High-risk AI systems require conformity assessment, which may involve third-party notified bodies for certain Annex III uses or when harmonized standards are unavailable.** Internal assessments suffice otherwise (**Annex VI**), but third-party certification enables CE marking (**Article 48**) and EU database registration (**Article 49**). Notified bodies issue certificates (**Article 44**) after QMS and technical documentation review (**Articles 17, 43**).

How often should an assessment for **EU AI Act** be performed?

**Conformity assessments for high-risk AI must be performed before market placement and after substantial modifications, with continuous post-market monitoring.** Risk management systems operate lifecycle-wide (**Article 9**); logs retained at least six months (**Article 19**); serious incidents reported promptly (**Article 73**). Periodic notified body audits apply where required (**Annex VII**).

What are the consequences of non-compliance with **EU AI Act**?

**Non-compliance with the EU AI Act incurs tiered administrative fines up to 7% of worldwide annual turnover or €40 million for prohibited practices, 4% or €20 million for other violations like data governance failures.** Additional sanctions include market withdrawal, product recalls (**Article 74**), and Union safeguard procedures. GPAI providers face dedicated enforcement (**Article 101**).

Can **EU AI Act** be mapped to other international frameworks?

**No, the EU AI Act cannot be directly mapped to other international frameworks in this FAQ, as it must stand alone.** Its risk-based structure, conformity assessments (**Annexes VI–VII**), and GPAI rules (**Chapter V**) are unique; organizations assess alignments independently via harmonized standards (**Article 40**).

What is the first step to begin implementing **EU AI Act**?

**The first step to implement the EU AI Act is to conduct an AI inventory and classify all systems by risk tier against Article 5 prohibitions and Annexes I/III.** Document classifications (**Article 6(4)**), identifying providers/deployers, to prioritize prohibited practices (effective February 2025) and high-risk obligations (August 2026).

ISO 22000 vs EU AI Act

Standards Comparison

ISO 22000

Voluntary

2018

International standard for food safety management systems

EU AI Act

Mandatory

2024

EU regulation for risk-based AI governance

Quick Verdict

ISO 22000 provides voluntary FSMS certification for global food chains, ensuring hazard control and supply chain safety. EU AI Act mandates risk-based compliance for AI systems in EU, prohibiting harms and requiring conformity assessments. Companies adopt ISO 22000 for market access; AI Act for legal compliance.

Food Safety

ISO 22000

ISO 22000:2018 Food safety management systems

Cost

€€€€

Complexity

High

Implementation Time

6-12 months

Key Features

Adopts High-Level Structure for integrated management systems
Dual nested PDCA cycles for governance and operations
Integrates HACCP with PRP, OPRP, CCP categorization
Risk-based thinking at organizational and hazard levels
Interactive communication across entire food chain

Artificial Intelligence

EU AI Act

Regulation (EU) 2024/1689 Artificial Intelligence Act

Cost

€€€

Complexity

Medium

Implementation Time

18-24 months

Key Features

Risk-based four-tier AI classification framework
Prohibitions on unacceptable-risk AI practices
High-risk conformity assessments and CE marking
GPAI systemic risk evaluations and reporting
Post-market monitoring and EU database registration

Detailed Analysis

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

ISO 22000 Details

What It Is

ISO 22000:2018 is an international certification standard for Food Safety Management Systems (FSMS). It provides a framework for organizations in the food chain to ensure safe products through hazard control, meeting statutory and customer requirements. Key approach integrates HACCP principles with risk-based management using two nested PDCA cycles.

Key Components

Clauses 4-10 following High-Level Structure (HLS).
PRPs, hazard analysis, CCPs/OPRPs, traceability, verification.
Built on Codex HACCP, interactive communication, continual improvement.
Voluntary certification by accredited bodies with audits.

Why Organizations Use It

Demonstrates food safety assurance to customers/regulators.
Enables market access, supplier qualification, GFSI alignment.
Reduces risks of recalls, litigation, supply disruptions.
Builds trust, supports integration with ISO 9001/14001.

Implementation Overview

Phased: gap analysis, PRPs, hazard control plan, training, audits.
Applies to all food chain organizations, scalable by size.
Involves internal audits, management reviews; certification every 3 years.

EU AI Act Details

What It Is

The EU AI Act (Regulation (EU) 2024/1689) is a comprehensive EU regulation for artificial intelligence, directly applicable across Member States. Its primary purpose is to foster trustworthy AI by addressing risks to safety, fundamental rights, and society. It uses a risk-based approach, tiering systems as unacceptable (prohibited), high-risk, limited-risk (transparency), or minimal-risk.

Key Components

Prohibitions on manipulative AI and biometric categorization (Article 5)
High-risk obligations: risk management (Article 9), data governance (Article 10), documentation (Articles 11-13), oversight (Article 14), cybersecurity (Article 15)
GPAI model duties: documentation, systemic risk assessments (Chapter V)
Conformity assessments, CE marking, EU database registration
Fines up to 7% global turnover

Why Organizations Use It

Mandatory for EU market access and outputs used in EU
Reduces legal risks, penalties, market exclusion
Enhances trust, competitiveness in regulated sectors
Drives better AI quality via lifecycle governance

Implementation Overview

Phased (6-36 months): inventory/classify AI, build QMS/RMS, conformity assessments, post-market monitoring. Targets providers/deployers globally; high complexity, cross-functional teams needed. (178 words)

Key Differences

Aspect	ISO 22000	EU AI Act
Scope	Food safety management systems across food chain	Risk-based AI systems impacting safety/rights
Industry	Food chain organizations worldwide	All sectors using AI in EU
Nature	Voluntary ISO certification standard	Mandatory EU regulation with fines
Testing	Internal audits, management reviews, certification audits	Conformity assessments, notified bodies, post-market monitoring
Penalties	Loss of certification, no legal fines	Up to 7% global turnover fines

Scope

ISO 22000

Food safety management systems across food chain

EU AI Act

Risk-based AI systems impacting safety/rights

Industry

ISO 22000

Food chain organizations worldwide

EU AI Act

All sectors using AI in EU

Nature

ISO 22000

Voluntary ISO certification standard

EU AI Act

Mandatory EU regulation with fines

Testing

ISO 22000

Internal audits, management reviews, certification audits

EU AI Act

Conformity assessments, notified bodies, post-market monitoring

Penalties

ISO 22000

Loss of certification, no legal fines

EU AI Act

Up to 7% global turnover fines

Frequently Asked Questions

Common questions about ISO 22000 and EU AI Act

ISO 22000 FAQ

EU AI Act FAQ

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ISO 22000

EU AI Act

Quick Verdict

ISO 22000

Key Features

EU AI Act

Key Features

Detailed Analysis

ISO 22000 Details

What It Is

Key Components

Why Organizations Use It

Implementation Overview

EU AI Act Details

What It Is

Key Components

Why Organizations Use It

Implementation Overview

Key Differences

Scope

Industry

Nature

Testing

Penalties

Frequently Asked Questions

ISO 22000 FAQ

What is the primary objective of ISO 22000?

Who is legally or professionally required to comply with ISO 22000?

Does ISO 22000 require an external audit or third-party certification?

How often should an assessment for ISO 22000 be performed?

What are the consequences of non-compliance with ISO 22000?

Can ISO 22000 be mapped to other international frameworks?

What is the first step to begin implementing ISO 22000?

EU AI Act FAQ

What is the primary objective of EU AI Act?

Who is legally or professionally required to comply with EU AI Act?

Does EU AI Act require an external audit or third-party certification?

How often should an assessment for EU AI Act be performed?

What are the consequences of non-compliance with EU AI Act?

Can EU AI Act be mapped to other international frameworks?

What is the first step to begin implementing EU AI Act?

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Practical Implementation Blueprint for Regulation S-K Item 106: Cybersecurity Governance and Risk Management Disclosures in 10-Ks

NIST CSF 2.0 Deep Dive: Mastering the Updated Framework Core Functions

Run Maturity Assessments with GRADUM

Check out these other Gradum.io Standards Comparison Pages

SAFe vs BRC

AEO vs EMAS

ISO 14064 vs U.S. SEC Cybersecurity Rules