ISO 9001:2026 gap analysis: what should you review first?

Can you do an ISO 9001:2026 gap analysis before the standard is published? 

You shouldn’t complete a final gap analysis against ISO 9001:2026 yet. That’s because the current draft standard hasn’t yet been finalised and published. Until publication, there may still be wording changes, clarifications or final adjustments, although any major technical changes are unlikely at this stage. 

So, at this stage, treat your ISO 9001:2026 gap analysis as more of a ‘readiness review’. 

That means reviewing your current ISO 9001:2015 QMS against the areas expected to need attention when ISO 9001:2026 is published. 

Naturally, the goal here isn’t to prove compliance with ISO 9001:2026. Not yet. You’re simply identifying where your existing QMS may be weak, outdated or poorly aligned with the likely direction of the revised standard. 

 

What should an early ISO 9001:2026 gap analysis include? 

Aim to answer how prepared your current QMS is for ISO 9001:2026? 

To find out, your early gap analysis should include the following areas. The review should also record the evidence you check, the gaps you find, the risk level of each gap, and whether you need to take action now or after final ISO 9001:2026 publication: 

 

Current ISO 9001:2015 compliance 

Start by reviewing how well your current QMS meets ISO 9001:2015 (the current version). This is the foundation of your transition. If your current system is maintained only for audits, any future changes will be more significant and, therefore, harder to manage. Your gap analysis should check whether your current processes, records, responsibilities, objectives, internal audits, corrective actions and management reviews are properly maintained. 

 

Open issues and repeated nonconformities 

Your gap analysis should include a review of open nonconformities, repeated audit findings, unresolved corrective actions, customer complaints and recurring supplier issues. These are often the clearest signs of weakness in your QMS. 

 

Expected areas of change 

Your early gap analysis should review areas expected to receive more attention in ISO 9001:2026. 

This may include leadership, quality culture, ethics, risks and opportunities, change planning, context, interested parties, climate-related issues where relevant, and the practical effectiveness of the QMS. 

At this stage, be careful with the wording and don’t recommend any major corrective actions based on expectation. All you’re doing is identifying likely priority areas so you can prepare in a sensible manner. 

 

Process effectiveness 

A useful gap analysis goes beyond the existence of documents and policies, although that’s still important. A more useful analysis asks whether your processes work in practice. 

That means reviewing processes in operational context. Follow a process from start to finish using historical data or by simulating it yourself. This helps you grasp how well process owners and staff understand their respective responsibilities, how you measure performance and whether the system helps your organisation improve its quality. 

 

Risk and opportunity planning 

Your gap analysis should review how your organisation identifies, manages and reviews risks and opportunities. This should include whether risks are connected to real processes, whether actions are assigned, whether opportunities are considered in depth, and whether outcomes are reviewed. A risk register on its own isn’t enough. 

 

Change management 

Your gap analysis should include how your organisation plans and controls change. This includes changes to processes, suppliers, staff roles, systems, equipment, locations, services or customer requirements. 

The review should check whether changes are assessed, approved, communicated, implemented and reviewed effectively. This is a useful area to review now because weak change control often causes quality problems long before a standard changes. 

 

Internal audit and management review 

Review whether internal audits are identifying useful evidence, checking the effectiveness of your processes and following up previous issues. Then look at whether management review leads to clearer decisions, actions and improvements. If these processes are weak, your organisation may struggle to manage the ISO 9001:2026 transition effectively. It’s worth implementing corrective actions now. 

 

Documented information 

Your gap analysis should review whether your documented information is current, controlled and useful. Importantly, this doesn’t mean rewriting everything for ISO 9001:2026 now. It just means checking whether your existing documents and records accurately reflect your current system. Outdated procedures, unused forms, uncontrolled records and duplicated documents can all be replaced, condensed or removed. 

 

Competence and awareness 

Competence and awareness include whether people understand their roles, whether training records are up to date, whether process owners know their responsibilities, and whether internal auditors are ready to support the transition. 

There’s no need to train everyone on the final ISO 9001:2026 requirements just yet. Wait until the final standard has been published. 

 

Supplier and outsourced process controls 

Finally, your gap analysis should include supplier and outsourced process controls. Many quality issues are linked to external providers, subcontractors, materials, purchased services or outsourced activities. 

Review whether your suppliers are approved, monitored and reviewed properly. Also check whether any outsourced processes have clear control measures. 

 

What should an ISO 9001:2026 gap analysis not include, yet? 

A good early gap analysis should tell you what’s already strong, what needs attention now, and what should wait until ISO 9001:2026 is published. At this stage, avoid the following: 

 

• Rewriting your entire QMS 

• Renumbering documents around draft clauses 

• Creating new procedures before requirements are confirmed 

• Treating draft information as final 

• Training staff on final requirements before they exist 

• Running a final ISO 9001:2026 transition audit 

• Updating certification scope or formal compliance statements too early 

• Making changes simply because the standard is changing 

When should you complete a full ISO 9001:2026 gap analysis? 

Complete a full ISO 9001:2026 gap analysis once the final version of the standard is published. That’s when you can compare your QMS against the confirmed requirements, identify final gaps, update documents where needed, brief your team and plan your transition audit. 

ISO QSL is here to help you review your current quality management system, identify likely transition priorities and prepare for ISO 9001:2026. 

Whether you need an early review now or a full gap analysis once the final standard is published, our ISO consultants can help you understand where you are, what you can address now and what can wait. Reach out today to schedule your consultation, keep your QMS operating effectively, and maintain your ISO 9001 certification.