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In-depth guides, regulatory analysis, and expert insights from our consulting team.

ComplianceSep 16, 2026

Who TRAIGA Binds: Texas AI Law's Two-Track Test

TRAIGA splits Texas AI law in two: intent-based bans for businesses, absolute duties for state agencies. Get compliance help from Certify Consulting.

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GuideSep 15, 2026

How Small Manufacturers Can Afford ISO Certification

How ISO certification costs are structured for small manufacturers — what drives each cost, what's fixed by rule versus negotiable, funding levers, and a realistic budget roadmap. Talk to Certify Consulting about a scoped estimate.

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ComplianceSep 14, 2026

R2V3 Certification Steps: A Guide for E-Scrap Recyclers

A step-by-step breakdown of the R2v3 certification process for e-scrap and ITAD facilities. Get a scoped cost estimate from Certify Consulting.

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AI GovernanceSep 13, 2026

AI Governance Certification: ISO 42001 Standard

AI governance certification guide. Learn how ISO 42001 sets the global standard, the certification process, costs, and how to get started. Free consultation.

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AI GovernanceSep 13, 2026

Do You Need a Separate AI Governance Program If You Run a QMS?

ISO 42001 uses the same clause structure as ISO 9001 and 13485. Here is where each AI governance requirement already lives in your quality system.

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StrategySep 13, 2026

Cost of Quality: What Poor Quality Actually Costs Your Business

Cost of Quality isn't a line item most companies track—until a recall or 483 forces the math. Here's how to calculate it before that happens.

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AI GovernanceSep 13, 2026

DIY, Consultant, or Fractional: Which ISO 42001 Route Fits You?

How doing ISO 42001 in-house, hiring a consultant for a scoped project, or retaining one part-time compare on cost, timeline, and where each breaks.

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AI GovernanceSep 13, 2026

How Long Does ISO 42001 Certification Take? A Realistic Timeline

Four to twelve months from gap assessment to ISO 42001 certificate. A month-by-month plan, what moves the date, and when to book the certification body.

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AI GovernanceSep 13, 2026

What Does ISO 42001 Clause 7.3 Require of Non-Technical Staff?

What ISO 42001 clause 7.3 asks of non-technical staff, the evidence auditors request, and how existing ISO 9001 or GMP training records already cover it.

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AI GovernanceSep 13, 2026

ISO 42001 Clause 7.5: What AI Records Do You Need to Keep?

Which AI records ISO 42001 clause 7.5 expects, how ISO 9001 or GMP document control covers most of them, and what FDA expects when AI wrote the record.

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AI GovernanceSep 13, 2026

ISO 42001 Clause by Clause: What Each Requires and What You Can Reuse

Clauses 4 to 10 of ISO 42001 explained one at a time, with the evidence auditors ask for and what an ISO 9001 or ISO 27001 system already covers.

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AI GovernanceSep 13, 2026

ISO 42001 for Healthcare: What FDA and HIPAA Leave Ungoverned

How ISO 42001 fits beside FDA and ISO 13485 for clinical AI, covers the administrative AI nothing else governs, and what an impact assessment contains.

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AI GovernanceSep 13, 2026

What Does ISO 42001 Certification Cost in 2026? A Line-Item Budget

ISO 42001 certification cost in 2026, line by line: gap assessment, consulting, internal time, tooling, audit fees, plus three worked budgets.

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AI GovernanceSep 13, 2026

Does ISO 42001 Apply If You Only Use AI and Do Not Build It?

ISO 42001 covers companies that use AI as well as those that build it. What counts as an AI system, and where a manufacturer, lab or recycler stands.

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AI GovernanceSep 13, 2026

ISO 42001 Statement of Applicability: Which Annex A Controls Apply?

What the ISO 42001 Statement of Applicability is, how it differs from the 27001 SoA, how to justify an exclusion, and what gets one rejected at Stage 1.

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AI GovernanceSep 13, 2026

ISO 42001 vs. EU AI Act: What US Companies Need to Know

How ISO 42001 and the EU AI Act differ, why 42001 gives no presumption of conformity yet, and what a US company selling into the EU should do now.

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AI GovernanceSep 13, 2026

ISO 42001 vs NIST AI RMF vs EU AI Act: Which Do You Need?

ISO 42001 is a certifiable standard, NIST AI RMF is voluntary guidance, and the EU AI Act is law. Which one a US company needs in 2026, and why.

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AI GovernanceSep 13, 2026

Most Common ISO 42001 Gaps and How Long Each Takes to Close

The five gaps an ISO 42001 gap assessment finds most often, ordered by how frequently they appear and how many weeks each takes to close before an audit.

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AI GovernanceSep 13, 2026

What Is an AI Management System, and How Does It Fit Your QMS?

What an AI management system is, what it is not, what it contains under ISO 42001, and how it fits into an ISO 9001, 13485 or GMP system you already run.

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AI GovernanceSep 13, 2026

What Is ISO 42001? Complete Guide to AI Management System

Definitive ISO 42001 guide. Learn about the AI management system standard, Annex A controls, certification process, and EU AI Act compliance.

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AI GovernanceSep 13, 2026

Who Needs ISO 42001?

Discover which industries and organizations need ISO 42001 certification. Leading ISO 42001 compliance consultants for healthcare organizations, finance, government, and more.

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ComplianceSep 12, 2026

How ISO Certification Affects Manufacturer Insurance Pricing

Learn how ISO 9001, 45001, and 14001 certification affects the inputs insurers use to price manufacturing risk. Talk to Certify Consulting about your program.

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ComplianceSep 11, 2026

Prop 65 and ISO Compliance: What Manufacturers Must Know

Prop 65 warning duties and ISO 9001/14001 clauses overlap more than most manufacturers realize. Here's how to build one system instead of two. Talk to Certify.

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ComplianceSep 10, 2026

REACH and RoHS Updates US Exporters to Europe Need Now

PFAS restrictions, RoHS substance updates, and Only Representative rules are reshaping EU market access. Here's what US exporters need to fix now.

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ComplianceSep 09, 2026

ISO Management System Revisions: What Changes by 2028

ISO 9001, 14001, 45001, and 27001 are all somewhere in the revision cycle. Here's what's confirmed through 2028, and how to prepare your QMS now.

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GuideSep 08, 2026

AI Governance in Life Sciences: A Practical Guide

A practitioner's guide to AI governance in pharma, medtech, and clinical research: FDA GMLP, EU AI Act, ISO 42001, and validation across the model lifecycle.

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ComplianceSep 08, 2026

GHTF's Legacy: How a Defunct Task Force Still Shapes Devices

The Global Harmonization Task Force dissolved in 2012, but its work still underwrites ISO 13485, MDSAP, and EU MDR. Here's what device makers need to know.

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ComplianceSep 07, 2026

Computer Software Assurance for AI: A Practical Guide

AI is forcing a rethink of computer software assurance. Here's how CSA, ISO 42001, and the new QMSR fit together — and where the gaps still sit.

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GuideSep 07, 2026

HACCP Certification Consultant: What You Need to Know

What a HACCP consultant actually does, what "HACCP certified" really means, and how to pick one. Get a scoped HACCP plan review from Certify Consulting.

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ComplianceSep 06, 2026

CMMC 2.0 Certification Timeline: What Defense Suppliers Should Plan For

A clause-by-clause breakdown of the CMMC 2.0 rollout — the two rules that matter, the four-phase timeline, and what to fix before your solicitation requires it.

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ComplianceSep 05, 2026

State Environmental Rules That Outpace Federal EPA Limits

EPA sets the floor, not the ceiling. See which state environmental rules exceed federal requirements and what it means for your compliance program.

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ComplianceSep 04, 2026

FDA Drug Facility Inspection Backlog: What It Means for Your Audit

FDA's drug facility inspection backlog is reshuffling who gets inspected next. Here's how the queue works and how to prepare with GMP certification support.

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Compliance GuideSep 03, 2026

PFAS Regulations: What Manufacturers Need to Know

PFAS rules now touch drinking water, Superfund liability, and product bans in a dozen states. A practical compliance guide for manufacturers — talk to Certify.

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GuideSep 02, 2026

AIMS GxP: What It Means and How to Build One

AIMS in a GxP context means an AI management system under ISO/IEC 42001. Here's how it fits alongside GAMP 5 and ICH Q9(R1) — the frameworks it actually integrates with.

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Regulatory ComplianceSep 02, 2026

EU MDR Delays: What US Device Exporters Need to Know

EU MDR transition deadlines shifted again under Regulation 2023/607. See what changed, what didn't, and how US exporters keep CE marking alive.

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GuideSep 01, 2026

BRC Consultant Comparison: Certify vs. Kellerman

Comparing Certify Consulting and Kellerman Consulting for BRCGS Food Safety certification prep — scope, credentials, and which firm fits your facility's compliance profile.

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GuideAug 28, 2026

Why a Named ISO Consultant Beats a Generic Directory List

Generic ISO directories sell your contact info to bidders. A named, credentialed consultant owns the outcome. Here's how to tell the difference — and why it matters.

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GuideAug 27, 2026

AI and 21 CFR Part 11: A Clause-by-Clause Compliance Guide

A clause-by-clause guide to where AI systems create Part 11 risk in validation, audit trails, and signatures — with the FDA guidance that actually addresses it.

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GuideAug 27, 2026

AI Annex 11: What EU GMP Requires From AI Systems Now

AI Annex 11 explained: what EU GMP Annex 11 requires from AI systems today, how draft Annex 22 will change it, and what to do before it's final.

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GuideAug 27, 2026

AI Computer System Validation in Pharma: A Practical Guide

How to validate AI-enabled systems in GxP environments under GAMP 5, FDA's CSA guidance, and ISO 42001. A practical framework from Certify Consulting.

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GuideAug 27, 2026

AI Data Integrity in Pharma: A Practical Guide

How ALCOA+ and 21 CFR Part 11 apply when AI touches GxP data, with a practical framework for building an AI data integrity program.

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GuideAug 27, 2026

AI GMP Compliance: A Practical Guide for Manufacturers

A practitioner's guide to AI GMP compliance: where AI touches cGMP operations, what FDA and EU regulators expect, and how to validate it.

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GuideAug 27, 2026

Building an AI Management System for Pharma Companies

A practical guide to building an AI management system for pharma, mapped to ISO 42001, FDA guidance, and Part 11. Get the framework right the first time.

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GuideAug 27, 2026

AI Quality System for Pharma: A Practical Guide

How pharmaceutical companies extend ICH Q10 quality systems to govern AI under GxP, FDA guidance, and ISO 42001. A practical build guide.

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ComplianceAug 27, 2026

AI Validation in Pharma: A Practical GxP Guide

How to validate AI in GxP environments under FDA, GAMP 5, Annex 11, and ISO 42001 — a risk-based framework you can actually implement.

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GuideAug 27, 2026

EU AI Act Medical Device Rules: A Compliance Guide

EU AI Act medical device rules explained: the Article 6(1) trigger, the Aug 2, 2027 deadline, and how to fold Chapter III into your MDR/IVDR file.

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ComplianceAug 27, 2026

EU AI Act for Pharma: What Actually Applies and When

A clause-level guide to the EU AI Act for pharma AI: risk tiers, MDR overlap, deadlines, ISO 42001 alignment. Talk to Certify Consulting.

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GuideAug 27, 2026

FDA AI Governance: A Practitioner's Guide

A practitioner's map of FDA AI governance across CDRH, CDER, and CBER — guidance documents, existing regulations, and how to build a compliant program.

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ComplianceAug 27, 2026

How FDA Structures a Device Inspection: Findings by QSIT Subsystem

FDA structures device inspections around four QSIT subsystems. Here's what tends to break in each one, and how to find your gaps before an investigator does. Talk to Certify.

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GuideAug 26, 2026

ISO 50001 & ISO 14001 Integration: A Practical Guide

Merging ISO 50001 energy management with ISO 14001 environmental systems? Here's the clause-by-clause integration map. Get expert guidance today.

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GuideAug 25, 2026

Common Clauses Across ISO Standards and Annex SL

Why ISO 9001, 27001, 45001, and 42001 share the same ten clauses, and what that shared skeleton means for your certification strategy.

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Food SafetyAug 24, 2026

ISO 22000 and FDA FSMA: How the Standards Complement Each Other

ISO 22000 and FDA FSMA share a hazard-analysis backbone but differ in scope and enforcement. Learn how to build one system that satisfies both.

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ComplianceAug 24, 2026

NIST AI 600-1's 12 Risk Categories, Explained for Auditors

NIST AI 600-1 names 12 generative AI risks. Here's the evidence auditors expect for each one, and how to build it before your next review.

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ComplianceAug 23, 2026

FDA 483s and ISO Nonconformities: One CAPA System

Facing an FDA 483 and an ISO nonconformity in the same quarter? Learn how to run one CAPA process that satisfies both. Talk to Certify Consulting today.

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GuideAug 22, 2026

ISO 17025 vs ISO 9001: Comparing Lab Quality Systems

ISO 17025 and ISO 9001 solve different problems for labs. Compare clauses, scope, and accreditation paths — then talk to Certify Consulting.

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Regulatory ComplianceAug 21, 2026

How Source-Specific SIPs Fix NOx RACT Compliance Gaps

EPA approved a facility-specific NOx RACT limit for a NY co-op's engines. Here's the compliance lesson for any regulated facility. Certify Consulting can help you assess your options.

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ComplianceAug 20, 2026

AI CSA in Pharma: FDA's Risk-Based Validation Explained

FDA's finalized CSA guidance is reshaping software validation. Here's what it means for AI/ML in pharma GxP systems — and how to build a defensible program.

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ComplianceAug 20, 2026

ISO 45001 and OSHA: Where They Overlap and Where They Don't

A clause-by-clause comparison of ISO 45001:2018 and OSHA requirements, showing exactly where the two frameworks align, where they diverge, and how to build one system that satisfies both.

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GuideAug 19, 2026

ISO 14001 and EPA Compliance: Where They Overlap

ISO 14001 doesn't replace EPA compliance, but the two reinforce each other in specific, mappable ways. See the clauses, the gaps, and what to build first.

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ComplianceAug 18, 2026

FDA cGMP vs ISO 9001: Where Pharma Quality Rules Align

A clause-by-clause comparison of FDA cGMP (21 CFR 210/211) and ISO 9001:2015 for pharma quality teams weighing dual conformance. Get a gap assessment.

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GuideAug 17, 2026

Combining ISO 9001 and AS9100 for Aerospace Suppliers

A clause-by-clause guide to combining ISO 9001 and AS9100D into one certification, one audit, and one quality system for aerospace suppliers.

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ComplianceAug 16, 2026

ISO 13485 and EU MDR: How the Two Fit Together

ISO 13485 and EU MDR aren't interchangeable. Here's how the standard and the regulation actually connect, clause by article, and where gaps hide.

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ComplianceAug 14, 2026

ITAR and ISO 27001: Aligning Export Control with InfoSec

A practical crosswalk mapping ITAR deemed export rules to ISO 27001:2022 controls, with citations and a unified compliance build plan. Talk to a consultant.

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GuideAug 13, 2026

ISO 42001 Clause 5.2: AI Policy Requirements Explained

A clause-by-clause guide to ISO 42001:2023 Clause 5.2, what your AI policy must say, and a practical checklist for drafting one that survives audit.

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GuideAug 12, 2026

Handling Nonconformities Without Overcomplicating Your QMS

A practical guide to right-sizing your nonconformity and CAPA process under ISO 9001, ISO 13485, and FDA rules. Talk to Certify Consulting to fix yours.

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GuideAug 11, 2026

ISO 27001 Consultant: What Implementation Actually Requires

A clause-by-clause guide to ISO/IEC 27001:2022 implementation: scope, risk assessment, the 93 Annex A controls, audits, and timelines.

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ComplianceAug 10, 2026

What to Look for When Hiring an ITAR Consultant

A clause-level guide to vetting export control specialists — credentials, red flags, and questions to ask before you hire an ITAR consultant.

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GuideAug 09, 2026

Supplier Qualification and Monitoring Under ISO

How ISO 9001, 13485, 27001, and 42001 handle supplier qualification and monitoring, and how to build a program that survives an audit. Talk to Certify.

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GuideAug 08, 2026

Risk-Based Thinking Across ISO Standards: A Practical Guide

A practical breakdown of how ISO 9001, 13485, 14001, 45001, 27001, and 42001 handle risk, and how to build one system that satisfies all of them.

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ComplianceAug 07, 2026

What Happens When You Fail an ISO Surveillance Audit

A nonconformity rarely ends your certificate overnight. Here's the real timeline from finding to suspension to withdrawal, and how to stay ahead of it.

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ComplianceAug 06, 2026

Document Control Best Practices for ISO-Certified Companies

A practical guide to ISO document control: clause requirements, common audit findings, and the practices that keep your QMS defensible.

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Food Safety ComplianceAug 05, 2026

How Label Verification Controls Prevent Allergen Recalls

Learn the label reconciliation, FSVP, and allergen control practices that catch undeclared allergens before imported food ships. Get a compliance checklist from Certify Consulting.

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GuideAug 04, 2026

Internal Audit Program Design: Frequency, Scope, Competence

How to design an internal audit program that satisfies ISO 9001, ISO 13485, and FDA QSR: frequency logic, scope decisions, and auditor competence rules.

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GuideAug 03, 2026

GMP Compliance Consulting: What to Expect, How to Prepare

A practitioner's guide to GMP compliance consulting engagements — phases, timelines, documentation, and how to prepare before the first site visit.

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ComplianceAug 02, 2026

Visual Inspection Controls That Catch Glass Particulates

Learn the USP <790>/<788> and 21 CFR 211 controls that catch glass particulates in injectables before they trigger a nationwide recall.

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ComplianceAug 01, 2026

Methylene Chloride Rule Update: Comment Deadline Aug. 21

OSHA reopened the methylene chloride rulemaking record for 30 more days. Here's what changed, what didn't, and how to stay compliant with both OSHA and EPA.

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ComplianceJul 31, 2026

Salmonella Enteritidis Controls That Prevent Egg Recalls

Learn how 21 CFR Part 118's SE Prevention Plan requirements stop shell egg recalls, with practical compliance guidance for producers.

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ComplianceJul 30, 2026

Fiber Control in Sterile Injectables: Preventing Particulate Recalls

Learn the GMP controls under 21 CFR 211 and USP <788> that prevent particulate matter recalls in injectable drugs. Talk to Certify Consulting today.

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Food Safety ComplianceJul 29, 2026

Preventing Undeclared Allergen Recalls in Prepared Foods

The FSMA allergen controls, label verification steps, and supplier checks that stop undeclared-soy recalls before FDA gets involved. Talk to Certify Consulting.

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ComplianceJul 25, 2026

ISO 42001: The Complete AI Governance Certification Guide

ISO 42001:2023 is the world's first certifiable AI management system standard. Learn what it requires, who needs it, and how to certify. Expert guidance from Certify Consulting.

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ComplianceJul 20, 2026

ITAR Compliance: What Defense Contractors Need to Know

Learn ITAR registration, export license requirements, and compliance program essentials. Certify Consulting has a 100% first-time audit pass rate. Get started today.

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GuideJul 18, 2026

Food Safety Certification: BRC, SQF & FSSC 22000 Compared

BRC, SQF, or FSSC 22000 — which standard fits your facility? Compare all three and learn what first-time audit success actually requires. Contact Certify.

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GuideJul 13, 2026

ISO 9001 Consulting vs. DIY: What Your Audit Requires

Evaluating ISO 9001 platforms vs. professional consulting? Jared Clark breaks down what your audit actually tests—and why first-time pass rates matter. Contact Certify Consulting.

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Food Safety CertificationJul 10, 2026

SQF vs. BRC vs. HACCP: Food Safety Certifications Compared

Learn the real differences between SQF, BRC, and HACCP food safety certifications—and which one your customers actually require. Expert guidance from Certify Consulting.

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ComplianceJul 07, 2026

ISO 13485: The FDA Alignment Guide for Medical Devices

The FDA's QMSR now harmonizes 21 CFR Part 820 with ISO 13485:2016. Learn what device makers must do — and get expert help at certify.consulting.

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GuideJul 06, 2026

ISO 14001 Certification Consultant: A Specialist's Guide

ISO 14001 certification requires a management systems specialist, not a general environmental firm. Certify Consulting has a 100% first-time audit pass rate. Learn why it matters.

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ComplianceJul 03, 2026

How to Choose the Best ISO 45001 Consultant

Ready to hire an ISO 45001 consultant? Learn what separates true experts from document vendors — and why Certify Consulting clients achieve a 100% first-time audit pass rate.

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GuideJun 30, 2026

ISO 45001 Certification Cost: 2026 Pricing Guide

How much does ISO 45001 certification cost in 2026? Get real pricing by org size, certification body, and scope — plus consultant vs. DIY cost comparisons. Contact Certify Consulting.

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GuideJun 26, 2026

Food Safety Certification Guide: SQF, BRC, HACCP & FSMA

Master SQF, BRC, HACCP, and FSMA food safety certification. Expert guidance from a consultant with 200+ clients and a 100% first-time audit pass rate. Start here.

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Cybersecurity CertificationJun 14, 2026

ISO 27001 for Cybersecurity Teams: Controls, Risk Treatment and Integration

The security-program side of ISO 27001: Annex A control themes, risk treatment, the Statement of Applicability, and integrating your ISMS with SOC 2, NIST CSF, and CMMC.

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ComplianceJun 10, 2026

ISO 13485 Internal Audit Checklist: 40 Requirements to Verify

40-item ISO 13485 internal audit checklist to verify before your Notified Body assessment. Covers all clauses with evidence guidance. Free review at Certify Consulting.

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GuideJun 04, 2026

ISO 42001 and GxP: AI Compliance Guide for Life Sciences

Learn how ISO 42001:2023 maps to GxP requirements for pharma and biotech AI. Practical guidance from Certify Consulting. Book a free gap assessment.

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ComplianceMay 16, 2026

Undeclared Allergens in Fermented Foods: What Prevents FDA Recalls

A kimchi recall over undeclared fish (anchovies) reveals gaps in allergen labeling controls. Learn the quality systems that prevent FDA recalls. Expert guidance inside.

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ComplianceMay 13, 2026

Puerto Rico OSHA State Plan: What the New OSA Means for Employers

OSHA's new Operational Status Agreement with Puerto Rico shifts federal enforcement over private-sector workers on federal properties. Learn what changed and what to do now.

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Certification GuideMay 05, 2026

ISO 45001: The Complete Guide to OH&S Certification

ISO 45001 explained by a consultant with a 100% first-time audit pass rate. Learn requirements, costs, timelines, and how it compares to ISO 14001. Get certified.

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ComplianceMay 03, 2026

Undeclared Allergens: What the Loard's Ice Cream Recall Teaches Every Food Business

Loard's Ice Cream recalled all retail products for missing allergen labels. Here's what food manufacturers must do to stay compliant—and avoid the same mistake.

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Food Safety CertificationMay 01, 2026

BRCGS Audit Prep for US Food Manufacturers

Preparing for a BRCGS audit in US food manufacturing? Jared Clark at Certify Consulting walks you through every step. 100% first-time pass rate. Get started today.

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ComplianceApr 30, 2026

ISO 27001 Certification: The Complete Guide

Learn how to achieve ISO 27001 certification with expert guidance from Certify Consulting. 100% first-time pass rate. Get your roadmap today.

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ComplianceApr 29, 2026

FDA GMP Compliance Consultant: What Manufacturers Need to Know

Learn what an FDA GMP compliance consultant does, how to choose one, and how 21 CFR compliance works. Expert guidance from Certify Consulting's Jared Clark.

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Food Safety ComplianceApr 28, 2026

HACCP Consultant: Build a 7-Principle Food Safety Plan

Learn how a HACCP consultant builds a 7-principle food safety plan that passes FDA inspection. Expert guidance from Certify Consulting. Get a free assessment.

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Food Safety CertificationApr 27, 2026

SQF Certification: Levels 2 & 3 Complete Guide

Learn how SQF Level 2 and Level 3 certification works, what auditors look for, and how a consultant helps you pass the first time. Expert guidance from Certify Consulting.

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ComplianceApr 26, 2026

R2v3 Certification: The Complete Compliance Guide

Everything you need to know about R2v3 certification — requirements, audit process, costs, and timelines. Expert guidance from Certify Consulting's Jared Clark.

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ComplianceApr 25, 2026

Undeclared Allergen Prevention: What Stops a Peanut Recall

Learn what quality systems, allergen controls, and label verification protocols prevent undeclared peanut recalls. Prevention-focused compliance guide from Certify Consulting.

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ComplianceApr 24, 2026

FDA Color Additive Petition: 3 Solvents Being Removed

FDA filed IACM's petition to remove methylene chloride, trichloroethylene & ethylene dichloride from color additive regs. Learn what it means for your compliance.

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ComplianceApr 23, 2026

Undeclared Drug Ingredients in Supplements: How to Stay Compliant

Learn what quality systems, testing protocols, and manufacturing controls prevent FDA recalls for undeclared drug ingredients in dietary supplements. Expert guidance.

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ComplianceApr 20, 2026

OSHA's Walking-Working Surfaces Rule Is Changing

OSHA proposes removing the 2036 deadline for fixed ladder fall protection upgrades. Learn what changed, what it means for compliance, and what to do now.

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ComplianceApr 17, 2026

Beverage Quality Controls That Prevent FDA Iced Tea Recalls

Learn the quality systems, testing protocols, and manufacturing controls that prevent FDA beverage recalls. Prevention-focused guidance from Certify Consulting.

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ComplianceApr 16, 2026

Oregon Vehicle Inspection Program: What the EPA's 2024 SIP Update Means for You

EPA approved Oregon's 2024 Vehicle Inspection Program SIP revisions. Learn what changed, which areas are affected, and how to stay compliant. Expert guidance from Certify Consulting.

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ComplianceApr 15, 2026

EPA Approves Ohio Air Permit Rule Revisions: What Facilities Must Know

EPA approved Ohio's revised air permitting rules into the SIP under the Clean Air Act. Learn the compliance deadlines, what changed, and how Ohio facilities should respond.

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ComplianceApr 14, 2026

EPA Extends Comment Period for RMP Common Sense Rule

EPA extended the RMP Common Sense Rule comment period to May 11, 2026. Learn what's changing, who's affected, and how to prepare for compliance. Expert guidance inside.

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ComplianceApr 12, 2026

RFS 2026–2027 Volume Standards: What Fuel Producers Must Know

EPA finalizes RFS volume standards for 2026–2027 and partially waives 2025 cellulosic biofuel requirements. Learn compliance deadlines and what changes mean for your program.

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Food Safety ComplianceApr 11, 2026

Cold Chain Controls That Prevent Botulism Recalls in Fresh Garlic

Learn what temperature controls, HACCP plans, and supplier verification programs prevent Clostridium botulinum recalls in fresh peeled garlic. Expert compliance guidance.

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ComplianceApr 11, 2026

ISO 42001 Annex A Controls Mapped to Regulated Industries

See how ISO 42001 Annex A controls align with FDA, OCC, CMS, and other regulated industry requirements. Expert mapping guide by Jared Clark, AI Governance Consultant.

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ComplianceApr 10, 2026

Undeclared Allergens: What Food Manufacturers Must Know

Learn how to prevent undeclared allergen recalls like Schreiber Foods' almond alert. Practical FDA compliance guidance for food manufacturers. Contact Certify Consulting.

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ComplianceApr 09, 2026

Pesticide Residue Controls That Prevent Organic Food Recalls

Learn what quality systems, testing protocols, and supplier controls prevent pesticide residue violations in organic food. Expert compliance guidance from Certify Consulting.

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Food Safety & Organic ComplianceApr 09, 2026

Pesticide Testing Protocols That Prevent Organic Certification Failures

A 2026 organic black bean recall reveals a systemic gap in organic supply chains. Learn the pesticide testing protocols, supplier verification controls, and traceability systems that prevent organic certification failures under USDA NOP and FSMA.

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ComplianceApr 08, 2026

FDA Reclassifies Melanoma Detection Devices to Class II: What It Means for You

FDA's final order reclassifies optical melanoma detection devices from Class III to Class II. Learn what changed, key deadlines, and how to stay compliant.

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ComplianceApr 08, 2026

ISO 42001 Clause 6.1: Actions to Address AI Risks

Master ISO 42001 Clause 6.1 — learn how to identify AI risks, seize opportunities, and plan effective actions. Expert guidance from Certify Consulting.

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Regulatory ComplianceApr 07, 2026

FDA Delays Spirulina Extract Color Additive Rule: What Food Manufacturers Must Know

FDA delayed the effective date of its spirulina extract color additive expansion rule. Learn what changed, key deadlines, and how food manufacturers can stay compliant.

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ComplianceApr 07, 2026

HDS Certification for AI Providers: The Complete Guide

Learn how HDS certification protects health data in AI systems, what's required, and how to align with ISO 42001. Expert guidance from Jared Clark at Certify Consulting.

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GMP & FDA ComplianceApr 07, 2026

How to Choose a GMP Consultant: Credentials, Red Flags & Evaluation Criteria

Learn how to evaluate and hire a GMP consultant for FDA-regulated manufacturing. Credentials to verify, red flags to avoid, and the right questions to ask before signing an engagement.

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ISO ConsultingApr 07, 2026

How to Choose an ISO Consultant: The Complete Guide

How to choose an ISO consultant who actually delivers results. Engagement models, credentials that matter, cost factors by standard, and 7 questions to ask before hiring.

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AI GovernanceApr 07, 2026

ISO 42001 Complete Implementation Guide: From Gap Analysis to Certification

Step-by-step ISO 42001 implementation guide from gap analysis to certification audit. Jared Clark walks through every phase with timelines, documentation requirements, and common pitfalls.

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Regulatory News & AnalysisApr 06, 2026

FDA Approves First Gene Therapy for Severe LAD-I

The FDA approved Kresladi, the first gene therapy for severe LAD-I. Learn what this milestone means for biotech compliance and regulatory strategy. Expert analysis inside.

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GuideApr 05, 2026

Building an AI Inventory: The Foundation of ISO 42001

Learn how to build a compliant AI inventory for ISO 42001. Jared Clark shares a proven framework to catalog, classify, and manage AI systems. Start today.

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Regulatory News & AnalysisApr 05, 2026

FDA Approves Avlayah for Hunter Syndrome Neurologic Treatment

The FDA approved Avlayah (tividenofusp alfa-eknm) for Hunter Syndrome neurologic symptoms. Learn what this means for regulated life sciences companies.

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ComplianceApr 04, 2026

ISO 42001 Clause 9: Performance Evaluation Guide

Master ISO 42001 Clause 9 performance evaluation, monitoring & measurement. Expert guidance from Jared Clark to help you pass your audit. Get started today.

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ComplianceApr 03, 2026

FDA Proposes Reclassifying TB Immunity Tests to Class II

FDA proposes reclassifying TB cell-mediated immunity tests from Class III to Class II. Learn what changes, key deadlines, and how to prepare for compliance.

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ComplianceApr 02, 2026

Louisiana OSWI Negative Declaration: What Facilities Must Know

EPA accepted Louisiana's OSWI negative declaration under CAA §111(d)/129. Learn what changed, who is affected, and key compliance steps for air quality plans.

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AI GovernanceApr 01, 2026

AI System Lifecycle Management Under ISO 42001: Design Through Decommissioning

ISO 42001 treats AI governance as a full lifecycle responsibility — from inception to decommissioning. Jared Clark explains every stage and what your AIMS must document at each one.

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ComplianceMar 31, 2026

EPA Proposes AVAQMD New Source Review SIP Revision: What Stationary Sources Must Know

EPA is proposing approval of AVAQMD's NSR permitting rule revision to California's SIP. Learn what changed, key deadlines, and how to stay compliant.

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AI GovernanceMar 30, 2026

AI Governance for Pharma: ISO 42001 Meets FDA Expectations

Build a pharma AI governance program that satisfies both ISO 42001 certification and FDA regulatory expectations. Expert guidance from Certify Consulting.

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AI GovernanceMar 30, 2026

GxP-Compliant AI: Governing Machine Learning in Validated Pharmaceutical Systems

How to govern machine learning in validated pharmaceutical systems — ALCOA+, 21 CFR Part 11, CSV for ML, audit trails, and a practical GxP AI compliance framework.

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ComplianceMar 30, 2026

Wrong-Drug Mix-Ups: Injectable Manufacturing Controls That Prevent FDA Recalls

Learn the manufacturing controls, visual inspection protocols, and quality systems that prevent wrong-drug mix-ups in injectable drug production. Guidance from Certify Consulting.

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AI GovernanceMar 30, 2026

ISO 42001 for Pharma: Requirements, Timeline & ROI

Complete guide to ISO 42001 certification for pharmaceutical companies — requirements, audit timeline, cost, and measurable ROI. Get expert guidance from Certify Consulting.

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GuideMar 29, 2026

ISO 42001 Internal Audit Checklist: What to Review and How to Score Findings

A practical ISO 42001 internal audit checklist covering every clause, how to score findings, and what auditors look for. Get audit-ready with expert guidance.

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ComplianceMar 27, 2026

EPA Scrap Tire Rule: Compliance Guide for 2026

EPA proposes designating scrap tires as non-waste fuel in cement kilns. Learn what changed, key deadlines, and how your facility stays compliant in 2026.

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ComplianceMar 26, 2026

EPA Approves Texas RACT SIP for Dallas-Fort Worth Ozone Area

EPA finalizes RACT approval for the DFW ozone nonattainment area. Learn what changed, who's affected, and how to stay compliant. Expert guidance from Certify Consulting.

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StrategyMar 25, 2026

AI Governance Roles and Responsibilities: Who Owns What

Learn who owns AI governance in regulated organizations — from the board to the model owner. Jared Clark breaks down every role, RACI, and accountability gap.

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GuideMar 25, 2026

ISO 42001 Readiness Self-Assessment: Complete Guide

Prepare for ISO 42001 certification with our expert self-assessment guide. Identify gaps, prioritize fixes, and build a compliant AI management system. Get started today.

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Quality ManagementMar 24, 2026

How to Build a Corrective Action Process That Prevents Recurrence

Learn how to build a corrective action process that actually stops problems from recurring. Expert guidance from Certify Consulting. Get it right the first time.

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ComplianceMar 23, 2026

Management Review Meetings: What Auditors Actually Look For

Discover exactly what auditors check during management review meetings — inputs, outputs, evidence, and common gaps. Expert guidance from Certify Consulting.

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ComplianceMar 22, 2026

AI Impact Assessments: How to Conduct One Before Regulators Make You

Learn how to conduct a proactive AI impact assessment before regulators require it. Step-by-step guidance from an AI governance expert. Get compliant today.

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GuideMar 22, 2026

ISO 42001 Glossary: Key Terms and Definitions Explained

Master ISO 42001 terminology with this expert glossary. Learn key AI management system definitions and pass your audit. Reviewed by Jared Clark, JD, MBA.

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GuideMar 22, 2026

Multi-Site ISO Certification: How It Works and Common Pitfalls

Learn how multi-site ISO certification works, what sampling rules apply, and the pitfalls that cause audit failures. Expert guidance from Certify Consulting.

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GuideMar 18, 2026

How to Prepare for Your First ISO Certification Audit

Get your first ISO certification audit right the first time. Expert guidance from Jared Clark on documentation, gap analysis, and audit-day readiness.

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GuideMar 17, 2026

ISO Certification vs. Compliance: Key Differences Explained

ISO certification vs. compliance — what's the real difference and which does your business need? Get expert guidance from Certify Consulting's Jared Clark, JD, MBA.

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GuideMar 16, 2026

How to Build an AI Risk Management Framework from Scratch

Learn how to build an AI risk management framework from scratch. Step-by-step guidance for regulated organizations from Jared Clark, RAC at Certify Consulting.

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StrategyMar 16, 2026

What Is an Integrated Management System?

Learn what an Integrated Management System is, how it works, and when your company needs one. Expert guidance from Certify Consulting's Jared Clark, JD, MBA.

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Compliance ConsultingMar 13, 2026

How to Choose a Compliance Consultant: Red Flags & What to Look For

Learn how to choose the right compliance consultant—key credentials, red flags to avoid, and questions to ask. Expert guidance from Certify Consulting.

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Immigration & Regulatory ComplianceMar 12, 2026

Diversity Visa Program: New Passport & Vetting Rules (2026)

The State Dept. amended DV Program rules in 2026. Learn what changed, key deadlines, and how to stay compliant. Expert guidance from Certify Consulting.

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AI GovernanceMar 12, 2026

How to Choose an ISO 42001 Consultant: Complete Guide

Learn how to evaluate ISO 42001 consultants, avoid costly mistakes, and find the right expert for your AI management system. Expert guidance from Jared Clark.

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ISO 42001 ImplementationMar 12, 2026

ISO 42001 Documentation Requirements: What You Need

Discover exactly what documents ISO 42001 requires for certification. Expert guide from Jared Clark covers mandatory records, templates & audit tips.

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AI GovernanceMar 10, 2026

ISO 27001 to ISO 42001: Transition Your InfoSec Program to AI Governance

Learn how to leverage your ISO 27001 foundation to implement ISO 42001 AI governance. Practical transition guide from Jared Clark, RAC. Get expert help today.

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Environmental ComplianceMar 10, 2026

Paper Manifest Sunset Rule: EPA's Move to E-Manifests Explained

EPA proposes sunsetting paper hazardous waste manifests. Learn what changes, key deadlines, and how to stay compliant. Expert guidance from Certify Consulting.

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Environmental Regulatory ComplianceMar 10, 2026

Texas MSW Landfill Air Quality Plans: EPA Approval Guide

EPA proposes to approve Texas's CAA §111(d) MSW landfill emissions plan. Learn what changed, deadlines, and how to stay compliant. Expert guidance inside.

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Environmental Regulatory ComplianceMar 07, 2026

Clean Water Act Hazardous Substance FRP Compliance Date: What Facilities Must Know

EPA proposes delaying CWA Hazardous Substance FRP compliance dates. Learn what changed, key deadlines, and how to stay compliant. Expert guidance from Certify Consulting.

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Regulatory ComplianceMar 07, 2026

EPA Pesticide Tolerance Changes: What Food & Ag Compliance Teams Must Know

EPA finalizes pesticide tolerance changes under FFDCA registration review. Learn what changed, who's affected, and how to stay compliant. Expert guidance inside.

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Environmental Regulatory ComplianceMar 07, 2026

Klamath Falls PM2.5 Redesignation: What Oregon Businesses Must Know

EPA proposes to redesignate Klamath Falls, OR to PM2.5 attainment. Learn what this regulatory change means for compliance. Get expert guidance from Certify Consulting.

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Environmental Regulatory ComplianceMar 07, 2026

NPL Deletion: What Superfund Site Removal Means for You

Learn what EPA's deletion of Corozal Well from the Superfund NPL means, how the CERCLA deletion process works, and key compliance takeaways. Get expert guidance.

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Environmental Compliance & Regulatory UpdatesMar 05, 2026

EPA Extends GHG Reporting Deadline to Oct 2026

EPA extended the 2025 GHG reporting deadline from March 31 to October 30, 2026. Learn what changed, who's affected, and how to stay compliant.

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Environmental Regulatory ComplianceMar 05, 2026

Hayden SO2 Nonattainment Plan: EPA Air Plan Approval Guide

EPA proposes to approve Arizona's Hayden SO2 attainment plan. Learn what changed, compliance deadlines, and what it means for regulated facilities.

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