Disclaimer 1: This document is the Final Draft International Standard (FDIS), not the officially published standard. Please be aware that the content may still change before final publication.
Once the standard is officially released, you will automatically receive the final published version at no additional cost.
Disclaimer 2:You can pre‑order BS EN ISO 9001:2026 as either a tracked changes version or a clean copy.
Tracked changes version - Pre‑order the tracked changes version to get immediate access to a clean (non-annotated) copy of the ISO/FDIS 9001:2026. When BS EN ISO 9001:2026 is officially published later this year, you’ll automatically receive the final tracked changes edition and a clean copy of the published standard.
Clean version only - If you only need the clean standard, you can pre‑order the clean version of BS EN ISO 9001:2026 and receive immediate access to the ISO/FDIS 9001:2026 today.
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What is ISO/FDIS 9001 - Quality management systems requirements about?
ISO/FDIS 9001 is the final draft of the latest edition of the world’s most widely adopted quality management system (QMS) standard.
Used by over a million organizations globally, BS EN ISO 9001 sets out the requirements organizations use to consistently deliver products and services that meet customer, regulatory and stakeholder expectations, while driving continual improvement.
Who is ISO/FDIS 9001 - Quality management systems requirements for?
ISO/FDIS 9001 is relevant for any organization, regardless of size, sector, or maturity, that:
- Want to develop or improve their quality management system
- Already uses BS EN ISO 9001:2015 and wants to prepare for transition.
- Want to strengthen leadership accountability and quality culture.
Key users include:
- Senior leaders and top management.
- Quality professionals.
- Process owners and improvement teams.
- Auditors and consultants.
What does ISO/FDIS 9001 - Quality management systems requirements cover?
ISO/FDIS 9001 sets out the final draft requirements for a Quality Management System (QMS) that organizations can use to consistently deliver products and services that meet customer, statutory and regulatory requirements, while enhancing customer satisfaction and driving continual improvement.
BS EN ISO 9001:2026 identifies key requirements that organizations will need to meet, including:
- Establish, implement, maintain and continually improve a quality management system.
- Align quality objectives with strategic direction, ensuring quality supports business performance and resilience.
- Demonstrate leadership accountability, including fostering ethical behaviour and a positive quality culture.
- Understand organizational context, including interested parties and potential climate change impacts.
- Manage risks and opportunities separately, supporting opportunity-based thinking.
- Use data and evidence effectively, through monitoring, measurement, analysis, internal audits and management reviews.
- Embed awareness of the quality management system across the organization, building a strong culture and supporting people to understand their role in delivering quality outcomes.
The standard applies to the processes, products and services an organization provides and does not prescribe how those processes must be undertaken or documented, giving flexibility to suit different sizes, sectors and maturity levels.
A new feature of BS EN ISO 9001:2026 is Annex A, included in ISO/FDIS 9001. This annex provides substantial supplementary clarification to help users better understand the structure, terminology and intent of the requirements, supporting effective implementation and ongoing development of an organization’s quality management system.
Organizations can use ISO/FDIS 9001 in whole or in part to prepare for the transition to BS EN ISO 9001:2026, even if they are not seeking immediate third-party certification.
Why should you use ISO/FDIS 9001 - Quality management systems requirements?
Using ISO/FDIS 9001 helps your organization prepare confidently for the transition to BS EN ISO 9001:2026.
The final draft gives you early visibility of the revised document, allowing you to plan, adapt and align before the standard is formally published.
What's changed?
Since the last major revision in 2015, the business environment has changed significantly.
The upcoming BS EN ISO 9001:2026 revision ensures the standard remains relevant, practical and fit for modern organizations - not just as a way to demonstrate conformity or achieve certification, but as a strategic framework for governance, culture and improvement.
The changes to the standard include the following:
- Stronger leadership focus – Greater emphasis on leadership accountability for quality, ethical behaviour and quality culture.
- Quality culture embedded – Ethical behaviour and quality culture are now explicit in awareness requirements across the organization.
- Clearer separation of risk and opportunity – Introduction of opportunity-based thinking to support resilience and improvement.
- Refined terminology and structure – some terms and definitions now included to supplement ISO 9000.
- Enhanced understanding through Annex A – New supplementary annex providing clearer explanations of structure, terminology and clause intent.
Accessing the ISO/FDIS 9001 document now ahead of the standard launch, will help your organization to get ahead in preparing for the upcoming changes.