What is the primary objective of **NIS2**?

**The primary objective of NIS2 is to establish a high common level of cybersecurity and resilience across EU member states by strengthening critical infrastructure and digital services against cyber threats.** It expands upon the original NIS Directive through a size-cap rule covering medium and large entities in sectors like energy, transport, health, digital infrastructure, postal services, waste management, and food production. NIS2 mandates risk management, incident reporting (24-hour early warnings to national CSIRTs, 72-hour notifications, one-month final reports), supply chain security, business continuity, and senior management accountability to ensure harmonized, proactive cybersecurity.

Who is legally or professionally required to comply with **NIS2**?

**NIS2 applies to all medium-sized and large entities classified as 'essential' or 'important' within specified high-criticality sectors across the EU.** Essential entities typically have 250+ employees, €50M+ annual turnover, or €43M+ balance sheet; important entities have 50+ employees, €10M+ turnover, or €10M+ balance sheet—though criticality can override size if an entity is a sole provider of vital services. Covered sectors include energy (electricity, oil, gas, district heating, hydrogen), transport, banking, health, manufacturing, digital providers (cloud computing, online marketplaces), public administration, space, and more; transposition into national law occurred by October 17, 2024, with effects from October 18, 2024.

Does **NIS2** require an external audit or third-party certification?

**NIS2 does not mandate external audits or third-party certification but empowers national authorities and CSIRTs to conduct live spot checks and demand real-time evidence of compliance.** It shifts from static audits to continuous assurance, requiring entities to maintain dynamic risk registers, OT/IT asset inventories, incident logs, and verifiable controls for risk management, supply chain security, and resilience—enforceable through on-demand inspections by bodies like ENISA.

How often should an assessment for **NIS2** be performed?

**NIS2 requires ongoing, continuous risk assessments rather than fixed periodic reviews, with dynamic updates such as quarterly risk registers and asset inventories.** Entities must implement proactive measures including regular vulnerability scans, supply chain reviews, staff training recertification, and closed-loop improvements to address an 'all-hazards' approach, ensuring real-time readiness for spot checks and incident response.

What are the consequences of non-compliance with **NIS2**?

**Non-compliance with NIS2 incurs tiered fines up to €10 million or 2% of total global annual turnover for essential entities, and €7 million or 1.4% for important entities, plus potential business suspension and senior management liability.** National authorities enforce via spot checks, with stricter penalties for essential entities; transposition by October 17, 2024, activates these measures EU-wide.

An **NIS2** be mapped to other international frameworks?

**Yes, EU member states incorporate standards like ISO 27001, NIST CSF, and ENISA guidelines into national NIS2 frameworks to facilitate mapping and compliance.** This alignment supports risk management, incident handling, and supply chain security without direct mandates.

What is the first step to begin implementing **NIS2**?

**The first step to implement NIS2 is to determine applicability by assessing entity size (50+ employees or €10M+ turnover for important entities; higher for essential) and sector classification against the size-cap rule.** Register with national authorities, providing details like name, contacts, sector, and operating states, then conduct a gap analysis of risk management, incident reporting, and governance.

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

**The primary objective of SQF is to provide a rigorous, HACCP-based food safety management system that assures consistent production of safe food products across the supply chain.** Administered by the SQF Institute (SQFI), it integrates **Module 2** (universal system elements like management commitment, HACCP plans, verification, traceability, food defense, allergens, and training) with sector-specific Good Practices modules (e.g., **Module 11** for food manufacturing GMPs). This GFSI-benchmarked framework ensures preventive controls, operational PRPs, and continuous improvement via the triad: "say what you do," "do what you say," and "prove it."

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

**SQF compliance is not legally mandated but is a professional requirement for suppliers to major retailers, brand owners, and foodservice providers worldwide.** It applies to food sector categories (FSCs) including manufacturing, storage/distribution, packaging, primary production, pet food, and supplements. Sites must implement **Module 2** plus relevant GMP/GAP modules; over 14,000 certified sites in 40+ countries use it as a "license to trade" for GFSI-recognized assurance.

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

**Yes, SQF requires annual third-party audits by SQFI-licensed Certification Bodies (CBs) accredited to ISO/IEC 17065.** Initial certification, surveillance, and recertification audits assess **Module 2** and sector modules, with periodic unannounced audits (e.g., every 3 years). Nonconformities are graded (minor=1pt, major=5pts, critical=50pts); passing scores are E (96-100), G (86-95), with F (<70) failing. Auditor safeguards include rotation limits and witnessed audits.

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

**SQF requires annual external certification audits, with internal audits conducted at planned frequencies covering all elements.** **Management review** occurs at least annually (with monthly SQF Practitioner updates), while verification/monitoring (2.5.2) and validation (2.5.1) are ongoing. Crisis/recall plans must be tested annually; Edition 9 mandates sustained records for surveillance.

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

**Non-compliance with SQF results in graded nonconformities, potential certification failure, suspension, or decertification by the CB.** Critical violations (e.g., uncontrolled hazards) trigger immediate suspension; majors require timely CAPA closure (often 30 days). Business impacts include lost GFSI recognition, market exclusion by buyers, increased audits, recalls, and reputational damage.

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

**Yes, SQF maps to other GFSI-benchmarked frameworks through shared HACCP principles, management systems, and preventive controls.** Its **Module 2** aligns with common elements like document control, internal audits, CAPA, and supplier programs, enabling layering (e.g., SQF Quality Code atop existing certifications). GFSI benchmarking ensures equivalence for FSMA preventive controls and Codex standards.

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

**The first step to implement SQF is to register the site in the SQFI assessment database and select applicable modules.** Designate a full-time, on-site **SQF Practitioner** (HACCP-trained, competent in the Code), then conduct a gap assessment against **Edition 9** (effective May 2021). Develop the food safety policy and HACCP-based plan per **Module 2**.

NIS2 vs SQF | GRADUM

Standards Comparison

NIS2

Mandatory

2022

EU regulation enhancing cybersecurity for critical infrastructure

SQF

Voluntary

2023

GFSI-benchmarked certification for food safety management

Quick Verdict

NIS2 mandates cybersecurity resilience for EU critical sectors like energy and transport, while SQF is a voluntary GFSI certification ensuring food safety via HACCP and GMPs. Organizations adopt NIS2 for regulatory compliance to avoid fines; SQF for global market access and buyer trust.

Cybersecurity

NIS2

Directive (EU) 2022/2555 (NIS2)

Cost

€€€€

Complexity

High

Implementation Time

12-18 months

Key Features

Broadened scope with size-cap rule for medium/large entities
Strict multi-stage incident reporting within 24/72 hours
Direct senior management and board accountability
Comprehensive risk management and supply chain security
Fines up to 2% of global annual turnover

Agile Scaling

SQF

Safe Quality Food (SQF) Code Edition 9

Cost

€€€

Complexity

High

Implementation Time

6-12 months

Key Features

Modular structure with Module 2 and sector GMPs
HACCP-based food safety plan mandatory
GFSI-benchmarked global certification
Requires full-time onsite SQF Practitioner
Annual audits including unannounced checks

Detailed Analysis

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

NIS2 Details

What It Is

Directive (EU) 2022/2555, known as NIS2, is an EU regulation expanding the original NIS Directive. It establishes a high common level of cybersecurity resilience for critical infrastructure and digital services across member states. Primary scope covers essential and important entities in 18 sectors like energy, transport, and cloud computing. It adopts a risk-based, all-hazards approach with continuous assurance.

Key Components

Four pillars: risk management, incident reporting, business continuity, corporate accountability.
Strict timelines: 24-hour early warnings, 72-hour notifications, one-month final reports.
Built on standards like ISO 27001, NIST CSF; no formal certification but national audits.
Supply chain security, access controls, encryption required.

Why Organizations Use It

Legal compliance mandatory for covered entities to avoid fines up to 2% global turnover.
Enhances resilience against threats like APTs, ransomware.
Builds stakeholder trust, competitive edge, business continuity.
Supports cross-border cooperation via CSIRTs.

Implementation Overview

Applies to medium/large entities (50+ employees, €10M+ turnover) in EU.
Key steps: risk assessments, incident procedures, management training, supplier audits.
Transposition by October 2024; 12-18 month grace periods in some states.
Continuous spot checks, no certification but evidence-based compliance.

SQF Details

What It Is

Safe Quality Food (SQF) is a GFSI-benchmarked certification program administered by the SQF Institute. It provides a HACCP-based framework for ensuring food safety and quality across the supply chain, from farm to fork, via modular codes tailored to sectors like manufacturing and storage.

Key Components

**Modular architectureUniversal Module 2 (System Elements) paired with sector-specific GMP modules (e.g., Module 11 for processing).
Core elements: Management commitment, HACCP food safety plan, PRPs, verification/validation, traceability, food defense, allergens, training.
Built on Codex HACCP principles; annual third-party audits with scoring (E/G/C/F grades).

Why Organizations Use It

Meets retailer/brand requirements as a 'license to trade'.
Reduces audits, recalls, and risks; aligns with FSMA/EU regs.
Builds food safety culture, supplier trust, and market access.

Implementation Overview

Phased: Gap analysis, documentation, training, internal audits, certification.
Applies to all sizes/industries; requires SQF Practitioner and unannounced audits.

Key Differences

Aspect	NIS2	SQF
Scope	Cybersecurity risk management, incident reporting, governance for critical infrastructure	Food safety management, HACCP, GMPs, quality controls for food supply chain
Industry	Essential/important entities in energy, transport, health, digital services (EU)	Food manufacturing, storage, distribution, retail (global, GFSI-recognized)
Nature	Mandatory EU regulation with national transposition and enforcement	Voluntary GFSI-benchmarked certification standard
Testing	Incident reporting to CSIRTs, national authority spot checks	Annual third-party audits, internal audits, unannounced audits
Penalties	Fines up to 2% global turnover or €10M for essential entities	Loss of certification, no direct legal fines

Scope

NIS2

Cybersecurity risk management, incident reporting, governance for critical infrastructure

SQF

Food safety management, HACCP, GMPs, quality controls for food supply chain

Industry

NIS2

Essential/important entities in energy, transport, health, digital services (EU)

SQF

Food manufacturing, storage, distribution, retail (global, GFSI-recognized)

Nature

NIS2

Mandatory EU regulation with national transposition and enforcement

SQF

Voluntary GFSI-benchmarked certification standard

Testing

NIS2

Incident reporting to CSIRTs, national authority spot checks

SQF

Annual third-party audits, internal audits, unannounced audits

Penalties

NIS2

Fines up to 2% global turnover or €10M for essential entities

SQF

Loss of certification, no direct legal fines

Frequently Asked Questions

Common questions about NIS2 and SQF

NIS2 FAQ

SQF FAQ

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NIS2

SQF

Quick Verdict

NIS2

Key Features

SQF

Key Features

Detailed Analysis

NIS2 Details

What It Is

Key Components

Why Organizations Use It

Implementation Overview

SQF Details

What It Is

Key Components

Why Organizations Use It

Implementation Overview

Key Differences

Scope

Industry

Nature

Testing

Penalties

Frequently Asked Questions

NIS2 FAQ

What is the primary objective of NIS2?

Who is legally or professionally required to comply with NIS2?

Does NIS2 require an external audit or third-party certification?

How often should an assessment for NIS2 be performed?

What are the consequences of non-compliance with NIS2?

An NIS2 be mapped to other international frameworks?

What is the first step to begin implementing NIS2?

SQF FAQ

What is the primary objective of SQF?

Who is legally or professionally required to comply with SQF?

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

How often should an assessment for SQF be performed?

What are the consequences of non-compliance with SQF?

An SQF be mapped to other international frameworks?

What is the first step to begin implementing SQF?

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SOC 2 Audit Survival Guide: 10 Red Flags Auditors Flag and Model Answers for Walkthroughs

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