Here’s what I’ve noticed after helping companies shift from ISO 22000:2005 to ISO 22000:2018: most teams aren’t unsure about food safety—they’re unsure about what needs to change in their current system. They look at the new requirements and think, “Where do we even start?”
A structured gap-analysis template does the heavy lifting. It shows you exactly where your Food Safety Management System (FSMS) stands today, what’s missing, and what needs updating. It also keeps your team aligned so you’re not fixing documents randomly or guessing what auditors expect.
My experience has taught me that organizations transition faster—and with fewer audit findings—when they use a clear, clause-by-clause template. That’s what this article helps you build.
Now that we’ve framed the goal, let’s walk through the sections your gap-analysis template should include.
Understanding What Changed – ISO 22000:2018 Transition Essentials
ISO 22000:2018 didn’t change everything, but the areas it refreshed matter. The shift to Annex SL structure, the introduction of dual-level risk, the stronger leadership expectations, and the refinement of OPRP/CCP classification shape how your FSMS needs to evolve.
In practice, these updates influence how you document risks, assign responsibilities, structure communication, and manage operational controls.
A few years ago, I worked with a medium-sized processor who assumed they only needed to update their hazard analysis. After a quick gap-analysis, they realized their biggest gaps were actually leadership involvement and strategic risk documentation—not food-safety hazards. That insight alone saved them weeks of misdirected work.
This section of the template sets the context: you’re not just comparing words on paper—you’re aligning your system with a new way of thinking.
How to Use the Gap-Analysis Template Effectively
A gap-analysis is only powerful when used correctly. The template should walk your team through the transition in a simple, structured way:
Compare each ISO 22000:2018 clause to what you already have.
Mark your status honestly: Compliant / Partially Compliant / Not Compliant.
Capture evidence—real documents, monitoring logs, training records.
Identify what’s missing and what actions are needed.
Assign responsibilities and timelines.
In my experience, teams move faster when they treat this as a collaborative workshop, not a QA-only task.
Pro Tip: Bring production, maintenance, and procurement into the discussion. They’ll catch gaps QA never sees.
Common pitfall: Some teams check “compliant” just because a document exists. The real question is: Does it meet 2018 requirements—and is evidence available?
Structural Alignment – Mapping 2005 Clauses to the 2018 High-Level Structure (HLS)
ISO 22000:2018 follows Annex SL, the same structure used by ISO 9001 and ISO 14001. This means your FSMS documentation should follow a more consistent, modern format.
Your template should include a mapping table showing:
Where each 2005 clause moved within the 2018 structure
Which existing documents match the new clauses
Where updates are required
Start with structure before touching content. If the architecture is wrong, every document update becomes messy.
Pro Tip: Revise your food safety manual or top-level index first—it’s the “compass” that guides your entire FSMS.
Common mistake: Updating SOPs and PRPs while keeping the old clause numbering. This leads to duplicate documents and confused auditors.
Leadership & Strategic Risk – New Documentation Required in the Gap-Analysis
ISO 22000:2018 expects leadership to demonstrate clear accountability. The standard also requires new documentation for understanding context, identifying interested parties, and evaluating business-level risks.
Your template should include dedicated fields for:
Leadership roles and responsibilities
Evidence of management review involvement
Identified external and internal issues
Interested-party expectations
Strategic risk assessment and mitigation actions
This helps the team avoid missing one of the biggest audit focus areas.
Pro Tip: Separate strategic risks (e.g., supply-chain disruptions) from food-safety hazards. Auditors appreciate the clarity.
Operational Requirements – Updating PRPs, OPRPs & CCPs in the Template
One major area your template must cover is hazard-control logic. ISO 22000:2018 refines how PRPs, OPRPs, and CCPs are classified. The decision-making process is clearer—and slightly different from the 2005 version.
Your gap-analysis should review:
Updated hazard assessment criteria
Correct application of the 2018 decision tree
Monitoring methods for each control measure
Required verification and validation updates
Many companies discover their OPRPs and CCPs shift once they apply the 2018 logic.
Common pitfall: Carrying over CCPs “as is” from the 2005 version without re-evaluating them under the new definitions.
Documented Information – New Controls to Include in the Gap-Analysis
ISO 22000:2018 replaces “documents and records” with “documented information.” It’s a small wording change, but it affects how your FSMS is controlled.
Your template should check for:
Revised procedures
Updated job roles and competency requirements
Internal and external communication processes
Version control alignment across all documents
Evidence that old documents were removed or updated
Traceability and emergency preparedness usually need significant updates, so highlight them clearly.
Pro Tip: Use the gap-analysis to mark which documents need re-approval under the new clause references.
Prioritizing Your Transition Roadmap – Turning Gap-Analysis Results into an Action Plan
A gap-analysis without a roadmap is just a list. Your template should help turn insights into action.
Focus on leadership involvement, risk documentation, and hazard-control updates first—they usually have the biggest impact during certification.
Common pitfall: Trying to fix everything at once. Spread the workload logically to keep momentum sustainable.
FAQs – ISO 22000 Transition Gap-Analysis Explained
Do we need to overhaul all documents to meet ISO 22000:2018?
Not at all. The gap-analysis helps you update only what needs attention. Most systems require refinement, not a complete rebuild.
How long does a proper gap-analysis take?
Most organizations complete it within one to two weeks if evidence is well-organized.
Who should participate in the gap-analysis?
The Food Safety Team Leader, QA, production heads, and someone from management. Cross-functional input always makes the results more accurate.
Conclusion – Your Next Step Toward a Smooth ISO 22000:2018 Transition
A structured gap-analysis simplifies the entire transition. It shows what’s already working, highlights what needs improvement, and helps your team move confidently toward full ISO 22000:2018 compliance.
I’ve supported many organizations through this process, and the ones who succeed quickly are the ones who use a clear template and follow a realistic action plan.
If you want to speed up your transition even more, your next step is straightforward: use a ready-to-fill gap-analysis template or request a customized version tailored to your industry and processes.
Melissa Lavaro is a seasoned ISO consultant and an enthusiastic advocate for quality management standards. With a rich experience in conducting audits and providing consultancy services, Melissa specializes in helping organizations implement and adapt to ISO standards. Her passion for quality management is evident in her hands-on approach and deep understanding of the regulatory frameworks. Melissa’s expertise and energetic commitment make her a sought-after consultant, dedicated to elevating organizational compliance and performance through practical, insightful guidance.
