ISO 9001:2026 revision: How to prepare for the next update

The upcoming ISO 9001:2026 revision is the first major update since 2015. In the last decade, business practices, technology and customer expectations have evolved dramatically. Digitalization, AI, sustainability and global supply chain complexity are now central to how organizations operate — and ISO 9001:2026 is expected to reflect these realities.  

Organizations that wait until the final clauses are published risk scrambling to meet new requirements, facing higher costs and even disrupting operations. According to PwC’s Global Compliance Study 2025, more than 70% of organizations say compliance complexity has increased significantly in just the past two years — reinforcing why preparation cannot be left to the last minute.  

The foundation of preparation for any ISO revision is an effective gap analysis. It’s about identifying where your systems stand today and what you need to close the distance between current practices and the changes with the revision. 

Three major gaps to address for ISO 9001:2026 readiness  

Technical compliance gaps 

The first area to review is your existing alignment with ISO 9001:2015. Technical compliance provides the baseline for transition readiness. Organizations should: 

• Evaluate how well current processes deliver consistent, predictable outcomes. 
• Review documentation to ensure it is accurate, current and audit-ready. 
• Examine CAPA systems and internal audit processes for effectiveness. 

Outdated or incomplete documentation, weak corrective action tracking and inconsistent audits are common pitfalls that must be addressed early. 

Cultural readiness gaps 

A strong quality culture is the backbone of successful transitions. Gartner research shows that companies with a strong culture of quality see 75% fewer customer-facing product mistakes, 46% fewer overall mistakes, and save an average of $67 million in productivity for every 5,000 employees. Yet only 40% of companies report having such a culture — highlighting why cultural readiness is just as important as technical compliance when preparing for ISO 9001:2026. 

Gallup research reinforces this point, showing that engaged employees deliver 14% higher productivity, 23% higher profitability and 63% fewer safety incidents - proving cultural alignment is not a soft factor, but a measurable driver of transition success. 

Cultural readiness means assessing:  

• Leadership commitment to prioritizing quality through change. 
• Employee engagement, looking for both champions of quality and potential resistance points. 
• Communication effectiveness, ensuring messages about transition are transparent and well understood. 

Without strong cultural foundations, even technically compliant systems can struggle to maintain performance under new requirements. 

Capability and resource gaps 

ISO 9001:2026 is expected to put more emphasis on digitalization and integration. This means reviewing your organization’s broader capacity to manage change: 

• Technology: Can current systems support enhanced digital requirements? For more on how AI and digitalization will shape these requirements, read our blog on ISO 9001:2026 — Digitalization, AI, and the future of quality management. 
• Skills: Workforce reskilling and training must be prioritized to meet emerging demands. 
• Financial resources: Are budgets in place for system upgrades, training and certification costs? 
• Operational capacity: Can changes be made without disrupting core business performance? 

Understanding these resource and capacity gaps helps ensure the transition is both effective and sustainable. 

How to address these gaps for the ISO 9001:2026 revision 

Conducting gap analysis systematically ensures you don’t overlook critical areas. Download our Gap analysis framework - preparing for ISO 9001:2026 white paper for a comprehensive guide.  

A proven framework includes:  

• Phase 1 - Preparation & scope: Define objectives, engage stakeholders, build a cross-functional team and map a realistic timeline. 
• Phase 2 - Current state analysis: Assess compliance with ISO 9001:2015, process effectiveness, leadership and cultural maturity and technology readiness. 
• Phase 3 - Future-state requirements: Anticipate needs for enhanced risk management, digital integration, sustainability and stronger supply chain oversight. 
• Phase 4 - Gap identification & prioritization: Identify critical compliance gaps, quick wins, resource-intensive challenges and long-term opportunities for competitive advantage. 

This structured approach helps organizations move beyond checklist audits to a comprehensive readiness plan.  

Common gap analysis challenges and solutions 

Even with a clear framework, organizations often encounter obstacles. Here are some of the most common and how to solve them: 

Scope overload 

• Challenge: Attempting to review everything at once often leads to incomplete or superficial analysis. 
• Solution: Phase assessments into manageable components with clear objectives. 

Cultural vs. technical integration 

• Challenge: Many organizations assess culture and compliance separately, missing how they interact.  
• Solution: Build cross-functional teams and apply consistent measurement across both areas. 

Limited resources and time 

• Challenge: Comprehensive assessments can stretch capacity. Nearly half of organizations cite resource constraints as their top barrier to achieving and maintaining ISO certifications.  
• Solution: Prioritize high-impact areas, use automation to streamline evidence collection and align with existing audits or reviews. 

Stakeholder resistance 

• Challenge: Employees may resist honest assessment due to fear of criticism or added workload. 
• Solution: Foster a no-blame culture, frame findings as opportunities, and use transparent communication. 

Operational disruption 

• Challenge: Assessments that compete with daily work risk slowing down operations. 
• Solution: Spread analysis across longer timeframes and integrate with business cycles to minimize impact. 

Supporting successful transition planning 

The insights gained from gap analysis should feed directly into your transition plan. To ensure success: 

• Build a phased roadmap that balances thoroughness with continuity of operations. 
• Secure leadership buy-in and resource allocation early. 
• Communicate openly with employees to reduce uncertainty and maintain engagement. 
• Use gap analysis findings to reassure customers and stakeholders that quality performance will be maintained throughout the transition. To learn more about managing the cultural and leadership aspects of this shift, see our blog on ISO 9001 Change Management: Readiness for the 2026 Update. 

Early adopters of ISO 9001:2026 can also strengthen customer trust and market positioning. Certification is often a requirement in tenders, and organizations that demonstrate readiness ahead of competitors can gain reputational advantage. 

Conclusion: Turning preparation into advantage 

The ISO 9001:2026 revision is more than a compliance milestone. It represents a chance for organizations to evaluate systems, strengthen culture and build capabilities that will drive long-term advantage. 

An ISO 9001 gap analysis is the first step in this journey. By identifying technical, cultural and capability gaps — and addressing them through a structured framework — organizations reduce costs, avoid disruption and position themselves as trusted partners. 

A modern digital QMS like Ideagen Quality Management supports this journey, making it easier to automate evidence collection, track progress and sustain improvements. By starting now, organizations can ensure they are not only compliant with ISO 9001:2026 but also stronger, more resilient and more competitive in the years ahead. 

Ideagen Quality Management recieved nine Leader badges in Quality Management (QMS) G2 summer report. The biggest risk isn't starting before you're ready—it’s waiting while competitors move ahead. Why not utilize our instant-access demo functionality and see for yourself how we can support your quality strategy.