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, and authentic food products through a structured management system combining senior management commitment and a Codex HACCP-based food safety plan.** It targets manufacture, processing, and packing of processed foods, ingredients, primary products like fruit/vegetables, and domestic pet foods, supported by prerequisite programs (GMP/GHP) to control contamination, allergens, fraud, and operational risks.

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

**BRC compliance is professionally required for food manufacturers, processors, and packers supplying major retailers worldwide, as it is GFSI-benchmarked and mandated in retailer supplier codes.** It applies site-specifically to organizations producing own-brand/customer-branded foods, raw materials for food service, primary products, and pet foods under direct site management control; exclusions are limited to physically segregated, differentiable products.

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

**Yes, BRC requires mandatory external audits by accredited certification bodies, with certificates issued annually based on performance.** Audits are announced or unannounced, covering nine Issue 8 clauses (or seven in Issue 9), with grading (AA/A/B/C/D, + for unannounced) tied to non-conformance severity; fundamental clauses like HACCP and internal audits must comply fully for certification.

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

**BRC requires annual third-party certification audits, plus internal audits at least four times yearly across all clauses.** Sites must conduct risk-based internal audits with full annual coverage, management reviews annually, and ongoing verification of HACCP, corrective actions, and prerequisite programs; unannounced audits enhance frequency for higher grades.

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

**Non-compliance with BRC results in non-certification, grade downgrades, or withdrawal, blocking retailer supply chain access.** Critical/major non-conformities in fundamental clauses (e.g., HACCP, traceability) require full re-audit; repeated failures increase audit frequency, incur costs ($20k–$100k per audit), and risk contract loss, recalls, or reputational damage from contamination incidents.

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

**Yes, BRC maps effectively to GFSI-benchmarked frameworks, providing a foundation for regulatory alignment like FSMA Preventive Controls.** Its HACCP, prerequisite programs, and governance exceed many requirements, though adaptations for terminology (e.g., PCQI designation) and validation cadences are needed; it integrates with modular BRCGS schemes like Packaging or Storage & Distribution.

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

**The first step to implement BRC is securing senior management commitment via a signed food safety policy and gap analysis against the standard's clauses.** Form a multidisciplinary team, define site scope (excluding non-controlled activities), and prioritize fundamental requirements like HACCP development and site standards using BRC's Get Started Assessment Tool.

What is the primary objective of **ISO 13485**?

**ISO 13485:2016 specifies requirements for a quality management system (QMS) where an organization must demonstrate its ability to consistently provide medical devices and related services that meet customer and applicable regulatory requirements.** This standard applies to organizations involved in one or more stages of the medical device life cycle, including design, development, production, distribution, installation, servicing, and decommissioning. It emphasizes documented processes, risk-based controls, validation, traceability, and post-market surveillance across Clauses 4–8 to ensure regulatory compliance and product safety.

Who is legally or professionally required to comply with **ISO 13485**?

**ISO 13485 applies to all organizations whose processes are intended to provide medical devices and related services that meet regulatory and customer requirements.** This includes medical device manufacturers, contract manufacturers, suppliers of sterile services or components, post-market service providers, importers, and distributors whose activities impact device conformity. Organizations must identify their regulatory roles (e.g., manufacturer under EU MDR) and incorporate applicable requirements into the QMS; it is not legally mandatory but is expected by regulators like the FDA (via upcoming QMSR) and EU Notified Bodies for market access.

Does **ISO 13485** require an external audit or third-party certification?

**ISO 13485 certification involves external audits by accredited certification bodies but is voluntary, though often required for market access.** The process includes a Stage 1 documentation review and Stage 2 implementation audit, followed by annual surveillance and triennial recertification. While the standard mandates internal audits (Clause 8.2.4), third-party certification provides objective evidence of conformity, commonly audited against Clauses 4–8 with focus on objective records of effectiveness.

How often should an assessment for **ISO 13485** be performed?

**Internal audits for ISO 13485 must be performed at planned intervals to determine QMS suitability, adequacy, and effectiveness (Clause 8.2.4).** Management reviews occur at planned intervals (Clause 5.6), typically annually, reviewing inputs like audits, complaints, CAPA, and regulatory changes. Reassessments are triggered by significant changes; external surveillance audits are annual, with full recertification every three years.

What are the consequences of non-compliance with **ISO 13485**?

**Non-compliance with ISO 13485 can result in failed certification audits, regulatory enforcement, product holds, recalls, and market exclusion.** Auditors issue nonconformities requiring CAPA; persistent issues lead to certification suspension. Regulators like EU Notified Bodies or FDA may cite gaps in inspections, imposing fines, warning letters, or import bans, with records retained at least two years post-release or device lifetime exposing liability.

Can **ISO 13485** be mapped to other international frameworks?

**Yes, ISO 13485 provides Annex B correspondence to ISO 9001:2015 but is a stand-alone standard with medical device-specific enhancements.** It aligns with ISO 14971 for risk management, excludes certain ISO 9001 elements unsuitable for regulatory purposes, and supports regulatory mappings like EU MDR Annexes or FDA QMSR (effective February 2, 2026), enabling integrated QMS without claiming dual conformity unless all requirements are met.

What is the first step to begin implementing **ISO 13485**?

**The first step to implement ISO 13485 is to establish and document the QMS scope, including justification for any exclusions (Clause 4.1 and 4.2.2).** Define processes needed for QMS effectiveness, identify regulatory roles and requirements, map process interactions, and create the quality manual detailing scope, procedures, and exclusions—commonly from Clause 7 for non-design organizations—ensuring risk-based control and outsourced process oversight.

BRC vs ISO 13485

Standards Comparison

BRC

Voluntary

2022

Global standard for food safety in manufacturing

ISO 13485

Mandatory

2016

International standard for medical device quality management systems

Quick Verdict

BRC ensures food safety via HACCP and audits for manufacturers seeking retailer access, while ISO 13485 mandates QMS with design controls and validation for medical device firms pursuing regulatory approval and patient safety.

Food Safety

BRC

BRCGS Global Standard for Food Safety Issue 9

Cost

€€€€

Complexity

High

Implementation Time

6-12 months

Key Features

GFSI-benchmarked certification for food manufacturers
Nine core clauses with fundamental requirements
Senior management commitment and HACCP plan
Risk-based environmental monitoring and zoning
Graded audits including unannounced for higher confidence

Quality Management

ISO 13485

ISO 13485:2016 Medical devices Quality management systems

Cost

€€€€

Complexity

High

Implementation Time

12-18 months

Key Features

Risk-based QMS for device lifecycle stages
Design development and validation controls
Post-market surveillance and complaint handling
Supplier evaluation and outsourcing controls
Traceability and record retention requirements

Detailed Analysis

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

BRC Details

What It Is

BRCGS Global Standard for Food Safety (Issue 9) is a GFSI-benchmarked certification framework for food manufacturers, processors, and packers. It ensures product safety, legality, authenticity, and quality through a structured management system combining senior management commitment and a Codex HACCP-based food safety plan with prerequisite programs.

Key Components

Nine core clauses: senior management, HACCP, FSQMS, site standards, product/process control, personnel, high-risk zones, traded products.
Fundamental requirements (e.g., traceability, allergen management, internal audits) are non-negotiable.
Built on risk-based hazard analysis including fraud and food defense.
Graded certification (AA/A/B/C/D) via announced/unannounced audits.

Why Organizations Use It

Provides market access to retailers mandating GFSI schemes, reduces duplicative audits, evidences due diligence, mitigates recall risks from allergens/pathogens. Enhances operational resilience, supports FSMA compliance, builds stakeholder trust.

Implementation Overview

Phased approach: gap analysis, HACCP development, training, internal audits, certification audit. Applies to manufacturers globally; 6-12 months typical for mid-sized sites with CAPEX for site upgrades.

ISO 13485 Details

What It Is

ISO 13485:2016 is the international standard titled Medical devices — Quality management systems — Requirements for regulatory purposes. It is a certifiable framework for organizations providing medical devices and related services. Its primary purpose is to ensure consistent meeting of customer and regulatory requirements across the device lifecycle, using a risk-based process approach.

Key Components

Organized into Clauses 4–8: QMS/documentation, management responsibility, resources, product realization, measurement/improvement.
Emphasizes documented procedures, records, validation, traceability.
Built on process approach with regulatory integration, risk management (ISO 14971).
Certification via accredited bodies with stage audits and surveillance.

Why Organizations Use It

Enables market access (EU MDR, FDA QMSR alignment 2026).
Reduces risks via controls, post-market surveillance.
Builds stakeholder trust, supply chain assurance.
Drives efficiency, lowers cost of quality.

Implementation Overview

Phased: gap analysis, documentation, training, validation, audits.
Applies to manufacturers, suppliers, all sizes; global.
Requires internal audits, management review; certification optional but strategic. (178 words)

Key Differences

Aspect	BRC	ISO 13485
Scope	Food safety management, HACCP, site standards, personnel	Medical device QMS, design controls, risk management, post-market
Industry	Food manufacturing, packaging, storage, global retailers	Medical devices, manufacturing, services, global regulators
Nature	Voluntary GFSI-benchmarked certification standard	Voluntary QMS standard for regulatory compliance
Testing	Annual announced/unannounced third-party audits, grading	Certification audits, internal audits, process validation
Penalties	Certification loss, grade downgrade, market exclusion	Certification loss, regulatory non-compliance risks

Scope

BRC

Food safety management, HACCP, site standards, personnel

ISO 13485

Medical device QMS, design controls, risk management, post-market

Industry

BRC

Food manufacturing, packaging, storage, global retailers

ISO 13485

Medical devices, manufacturing, services, global regulators

Nature

BRC

Voluntary GFSI-benchmarked certification standard

ISO 13485

Voluntary QMS standard for regulatory compliance

Testing

BRC

Annual announced/unannounced third-party audits, grading

ISO 13485

Certification audits, internal audits, process validation

Penalties

BRC

Certification loss, grade downgrade, market exclusion

ISO 13485

Certification loss, regulatory non-compliance risks

Frequently Asked Questions

Common questions about BRC and ISO 13485

BRC FAQ

ISO 13485 FAQ

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BRC

ISO 13485

Quick Verdict

BRC

Key Features

ISO 13485

Key Features

Detailed Analysis

BRC Details

What It Is

Key Components

Why Organizations Use It

Implementation Overview

ISO 13485 Details

What It Is

Key Components

Why Organizations Use It

Implementation Overview

Key Differences

Scope

Industry

Nature

Testing

Penalties

Frequently Asked Questions

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?

Can BRC be mapped to other international frameworks?

What is the first step to begin implementing BRC?

ISO 13485 FAQ

What is the primary objective of ISO 13485?

Who is legally or professionally required to comply with ISO 13485?

Does ISO 13485 require an external audit or third-party certification?

How often should an assessment for ISO 13485 be performed?

What are the consequences of non-compliance with ISO 13485?

Can ISO 13485 be mapped to other international frameworks?

What is the first step to begin implementing ISO 13485?

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