The ISO 9001:2026 Draft International Standard (DIS)
Welcome to our detailed analysis of Clause 4 of the ISO 9001:2026 Draft International Standard (DIS) compared to ISO 9001:2015. This article will walk you through the key changes, clarifications, and one new requirement that organizations need to know to update their Quality Management System (QMS).
Note: Since ISO 9001:2026 is still a Draft International Standard, ISO refers to it as a “document” rather than an official International Standard. This terminology will change upon official publication and does not affect the requirements.
4.1 Understanding the Organization and Its Context
The requirement to assess climate change relevance is still present but has been slightly repositioned in the text. The requirement itself remains unchanged.
There are expanded Notes on External Issues:
- Political and environmental issues are now explicitly listed as examples of external factors.
- No new requirements are created, but the examples now better reflect current global challenges.
More meaningful changes can be found in the Internal Issues:
- The organization’s strategic direction is explicitly included as an internal issue.
- This emphasizes that the QMS should align with where the organization is heading, not just how it operates today.
4.2 Understanding the Needs and Expectations of Interested Parties
The explanatory justification at the beginning of the clause has been removed, making the clause more direct and concise.
Organizations can now determine relevant requirements of interested parties, rather than all possible requirements. This reduces unnecessary work while maintaining compliance, but careful documentation is still needed to justify relevance.
There is now a new explicit step, where organizations must determine which relevant requirements will be addressed through the QMS. Previously, it was enough to identify interested parties and their requirements. This step now requires a one-to-one connection with QMS processes.
Tip: Clearly declare which requirements you will address and ensure compliance with them. This is both a clarification and an operational improvement.
Requirements potentially related to climate change remain unchanged.
4.3 Determining the Scope of the Quality Management System
Repeated references to “quality management system” have been removed to simplify language.
The scope must be available as documented information, replacing the previous term “maintained.” This aligns with ISO’s documentation vs. record concepts rather than changing expectations.
The conditions for claiming conformity remain unchanged, but wording is now aligned with the draft document status.
4.4 Quality Management System and Its Processes
The clause title was simplified from “Quality management system and its processes” to “Quality management system.”
There is some clarification on clause 4.4.2, where documented information must:
- Be available to support process operation
- Be retained as evidence that processes are carried out as planned
This reduces repetition and improves clarity without changing what organizations must do.
Key Takeaways
Overall, Clause 4 introduces one new requirement but primarily focuses on tightening language and clarifying expectations. In summary:
- Subtle changes: Placement of climate change reference, removal of repeated wording.
- Meaningful changes: Strategic direction as an internal issue, explicit step to address relevant requirements.
- Documentation: Scope must be available as documented information; processes must have documented evidence.
- Action: Align QMS with both strategic direction and relevant requirements of interested parties.
By reviewing these potential changes now, you will ensure a smoother transition when the standard is officially published.
