Home ISO Standard Update ISO 9001:2015 vs. FDIS ISO 9001:2026 – Clause-by-Clause Comparison and What Organizations Should Expect

ISO 9001:2015 vs. FDIS ISO 9001:2026 – Clause-by-Clause Comparison and What Organizations Should Expect

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CBQA Global Indonesia

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The forthcoming revision of ISO 9001 marks the first major update to the world’s leading Quality Management System (QMS) standard in more than a decade. While the Final Draft International Standard (FDIS) is still progressing through the ISO approval process, organizations are already preparing for the expected transition to ISO 9001:2026.

Although the fundamental principles of quality management remain unchanged, the revision is expected to modernize the standard by incorporating lessons learned over the past decade and addressing emerging global challenges such as digital transformation, sustainability, organizational resilience, climate change, governance, and data-driven decision-making.

This article provides a high-level comparison between ISO 9001:2015 and the expected FDIS ISO 9001:2026, helping organizations understand where changes are likely to occur and how they can begin preparing.


Executive Summary

Organizations should not expect a complete restructuring of ISO 9001. Instead, the revision is anticipated to strengthen existing requirements while introducing clearer expectations in several strategic areas.

Key themes expected in ISO 9001:2026 include:

  • Stronger Quality Culture
  • Climate Change Integration
  • Enhanced Risk and Opportunity Management
  • Organizational Ethics and Integrity
  • Data-Driven Decision Making
  • Organizational Knowledge and Learning
  • Digital Transformation Readiness
  • Improved Organizational Resilience

These additions aim to ensure that Quality Management Systems continue to support organizational success in an increasingly complex business environment.


Clause-by-Clause Comparison

Clause 4 – Context of the Organization

ISO 9001:2015

Organizations identify internal and external issues, interested parties, and define the scope of the Quality Management System.

Expected in ISO 9001:2026

Organizations may be expected to place greater emphasis on:

  • Climate-related issues
  • Business resilience
  • Supply chain disruption
  • Emerging technologies
  • Long-term sustainability risks

The evaluation of external issues is expected to become more dynamic and strategic.


Clause 5 – Leadership

ISO 9001:2015

Leadership demonstrates commitment to the Quality Management System and establishes quality policy and objectives.

Expected in ISO 9001:2026

Leadership responsibilities are expected to expand beyond compliance.

Executives may need to demonstrate leadership in:

  • Building a quality culture
  • Ethical decision-making
  • Employee engagement
  • Organizational values
  • Long-term quality performance

Leadership behavior will become as important as documented responsibilities.


Clause 6 – Planning

ISO 9001:2015

Organizations identify risks and opportunities affecting the QMS.

Expected in ISO 9001:2026

Risk management is expected to become more strategic by integrating:

  • Enterprise risk management
  • Strategic planning
  • Business continuity
  • Opportunity realization

Organizations may also be encouraged to adopt a more proactive rather than reactive approach.


Clause 7 – Support

ISO 9001:2015

Focuses on competence, awareness, communication, documented information, and organizational knowledge.

Expected in ISO 9001:2026

Greater emphasis is anticipated on:

  • Digital competencies
  • Knowledge sharing
  • Organizational learning
  • Data literacy
  • AI-enabled information management

Knowledge management may become a more strategic organizational capability.


Clause 8 – Operation

ISO 9001:2015

Addresses operational planning, design, purchasing, production, and service delivery.

Expected in ISO 9001:2026

Operational controls may increasingly consider:

  • Supply chain resilience
  • Supplier sustainability
  • Digital process integration
  • Agile operational management
  • Business continuity planning

Organizations are expected to strengthen their ability to respond to rapidly changing market conditions.


Clause 9 – Performance Evaluation

ISO 9001:2015

Organizations monitor, measure, analyze, and evaluate performance.

Expected in ISO 9001:2026

Performance evaluation may expand to include:

  • Digital customer feedback
  • Predictive analytics
  • Real-time performance monitoring
  • Business intelligence
  • Stakeholder perception analysis

Traditional customer satisfaction surveys alone may no longer be sufficient.


Clause 10 – Improvement

ISO 9001:2015

Organizations address nonconformities and continually improve the Quality Management System.

Expected in ISO 9001:2026

Continual improvement is expected to become more innovation-oriented.

Organizations may increasingly demonstrate:

  • Organizational learning
  • Innovation initiatives
  • Digital improvement projects
  • Cross-functional collaboration
  • Preventive organizational capability

Improvement will likely extend beyond corrective actions to include transformation initiatives.


High-Level Comparison

AreaISO 9001:2015Expected ISO 9001:2026
Quality CultureLimitedStrong emphasis
Climate ChangeAmendment onlyFully integrated
EthicsIndirectExplicit expectations
LeadershipComplianceCulture leadership
Customer FeedbackSurveysMulti-channel intelligence
Risk ManagementOperationalStrategic
KnowledgeOrganizational knowledgeLearning organization
DataPerformance measurementAnalytics and business intelligence
ImprovementContinual improvementInnovation and resilience

What Should Organizations Do Now?

Organizations do not need to wait for publication before preparing.

CBQA Global recommends the following actions:

  • Monitor official ISO developments.
  • Conduct an initial readiness assessment.
  • Review organizational risks and strategic objectives.
  • Strengthen leadership engagement.
  • Enhance organizational quality culture.
  • Upgrade internal auditor competencies.
  • Evaluate digital capabilities supporting the QMS.
  • Prepare a structured transition roadmap.

Organizations that begin preparing early will be better positioned to achieve a smooth transition while maximizing the business benefits of the revised standard.


How CBQA Global Can Support Your Transition

CBQA Global is committed to helping organizations successfully prepare for ISO 9001:2026 through a comprehensive portfolio of services, including:

  • ISO 9001:2026 Executive Awareness Programs
  • Transition Readiness Assessments
  • Gap Analysis Services
  • Internal Auditor Transition Training
  • Lead Auditor Upgrade Programs
  • Transition Workshops
  • Certification and Recertification Services

By partnering with CBQA Global, organizations can move beyond compliance and use the transition to strengthen business performance, customer confidence, and long-term organizational excellence.

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