Carlos Pereira da CruzThe most common mistake organizations make with ISO 9001 revisions is assuming nothing will really change. Then, the new version arrives, and auditors start asking questions. Companies scramble to retrofit their systems, usually under pressure, with wasted effort, and sometimes with findings that could have been avoided.
The Draft International Standard (DIS) for ISO 9001:2026 is now available, introducing some changes in leadership, culture, ethics, risk, and customer focus. Failing to prepare now means exposing your organization to unnecessary risk later — because when the new standard becomes official, “not knowing” won’t be an excuse.
- Stronger focus on risk and opportunity management (Clause 6.1)
- Quality culture and ethical behavior elevated (Clauses 5.1.1 & 7.3)
- Change management requirements expanded (Clause 6.3)
- Continual improvement reframed and strengthened (Clause 10.1)
In this article, we’ll walk through the key differences between ISO 9001:2015 and the DIS, translating what they mean for organizations, quality managers, auditors, and consultants preparing to turn the standard into a real engine of performance.
This article examines the key clause-by-clause differences between ISO 9001:2015 and the new ISO DIS 9001, highlighting what these shifts mean for organizations, quality managers, auditors, and consultants preparing for the transition.
Overview of the revision
The current draft of ISO 9001 is published as a DIS, an intermediate step in the ISO development process. At this stage, national standard bodies receive comments, review, and vote, with further refinements leading to the FDIS (Final Draft International Standard) before the official publication, expected in 2026.
As a word of caution, remember that changes may occur between this DIS version and the FDIS.
Summary of the changes
| Degree of change | Clause number | Clause name |
| Major | 5.1.1 | Leadership and commitment — General |
| 6.1.2 | Actions to address risks | |
| 6.1.3 | Actions to address opportunities | |
| 6.3 | Planning of changes | |
| 7.3 | Awareness | |
| 10.1 (10.3) | General (Improvement) | |
| Moderate | 4.2 | Understanding the needs and expectations of interested parties |
| 7.1.6 | Organizational knowledge | |
| 8.2.1 | Customer communication | |
| 8.4.3 | Information for external providers | |
| 8.5.1 | Control of production and service provision | |
| 8.5.3 | Property belonging to customers or external providers | |
| 9.1.2 | Customer satisfaction | |
| 9.2.2 | Internal audit programme | |
| 9.3.2 | Management review inputs | |
| 9.3.3 | Management review outputs | |
| Small (editorial) | 4.1 | Understanding the organization and its context |
| 4.3 | Determining the scope of the quality management system | |
| 4.4 | Quality management system and its processes | |
| 5.2 | Quality policy | |
| 5.3 | Organizational roles, responsibilities and authorities | |
| 6.1.1 | Actions to address risks and opportunities — General | |
| 6.2 | Quality objectives and planning to achieve them | |
| 7.1.3 | Infrastructure | |
| 7.1.4 | Environment for the operation of processes | |
| 7.1.5 | Monitoring and measuring resources | |
| 7.2 | Competence | |
| 7.5 | Documented information | |
| 8.1 | Operational planning and control | |
| 8.2.1 | Customer communication | |
| 8.3 | Design and development of products and services | |
| 8.5.2 | Identification and traceability | |
| 10.2 | Nonconformity and corrective action | |
| No change | 5.1.2 | Customer focus |
| 7.1.1 | General (Resources) | |
| 7.1.2 | People | |
| 7.4 | Communication | |
| 8.2.2 | Determining requirements related to products and services | |
| 8.2.3 | Review of requirements related to products and services | |
| 8.2.4 | Changes to requirements for products and services | |
| 8.4.1 | General (Control of externally provided processes, products and services) | |
| 8.4.2 | Type and extent of control | |
| 8.5.4 | Preservation | |
| 8.5.5 | Post-delivery activities | |
| 8.5.6 | Control of changes | |
| 8.6 | Release of products and services | |
| 8.7 | Control of nonconforming outputs | |
| 9.1.3 | Analysis and evaluation | |
| 9.1.1 | General (Monitoring, measurement, analysis and evaluation) | |
| 9.2.1 | General (Internal audit) | |
| 9.3.1 | General (Management review) |
Overview of Changes in ISO DIS 9001:2025
Clause 4 – Context of the Organization
4.2 Understanding the needs and expectations of interested parties – A new requirement was added: Organizations must analyze which of the identified requirements of interested parties need to be addressed through the QMS.
Clause 5 – Leadership
5.1.1 Leadership and commitment (General) – A new leadership responsibility was introduced: Top management must actively promote a culture of quality and ethical conduct.
Clause 6 – Planning
6.1.2 / 6.1.3 Risks and opportunities – The previous clause 6.1.2 was split into two:
- 6.1.2 now focuses only on actions to address risks.
- 6.1.3 is dedicated to actions to address opportunities, giving them equal importance to risks.
The DIS introduces stronger wording, requiring organizations to analyze and evaluate risks and opportunities, not just identify them.
6.3 Planning of changes The list of factors to consider has expanded from four to seven, now including:
- Monitoring effectiveness
- Communicating changes
- Reviewing results
Clause 7 – Support
7.1.6 Organizational knowledge – The focus shifts from product/service conformity to achieving the intended results of the QMS as a whole. Knowledge must be retained, applied, and shared, not just “made available.”
7.3 Awareness – Personnel must now also be aware of the organization’s quality culture and ethical behavior standards, not just procedures and objectives.
Clause 8 – Operation
8.2.1 Customer communication – Organizations must now communicate contingency actions to customers in case of service or product disruptions. Examples of communication channels (social media, websites, FAQs) are provided in a note.
8.4.3 Information for external providers – External providers must, where relevant, be informed of requirements related to interactions with customers and other stakeholders.
8.5.1 Control of production and service provision – Documented information must clearly define three elements: characteristics, activities, and results. A note clarifies that organizations can use product/service verification or process validation.
8.5.3 Property belonging to customers or external parties – The obligation to identify, verify, protect, and safeguard external property is stated less explicitly than in ISO 9001:2015, making this requirement less stringent.
Clause 9 – Performance Evaluation
9.1.2 Customer satisfaction – Simplified wording: Organizations must “monitor customer satisfaction.” The note highlights modern feedback sources such as complaints and social media.
9.2.2 Internal audit programme – Internal audits must now include defined objectives, in addition to scope and criteria.
9.3.2 Management review inputs – Management reviews must explicitly consider changes in the needs and expectations of interested parties.
9.3.3 Management review outputs – Continual improvement is reinforced as a core output of management reviews.
Clause 10 – Improvement
10.1 Continual improvement (renumbered from 10.3) – Continual improvement must now address the suitability, adequacy, and effectiveness of the QMS. The clause numbering has changed (no longer 10.3), but the intent is strengthened.
How much has changed?
To summarize, the current DIS revision of ISO 9001 introduces a series of targeted but meaningful updates. Most of the structural framework of ISO 9001:2015 remains intact; organizations familiar with the process approach, risk-based thinking, and continual improvement will find no radical overhaul.
The main body of the standard underwent moderate adjustments, including more precise requirements for risk evaluation, a dedicated sub-clause for opportunities, expanded expectations for change management, a broader treatment of organizational knowledge, and an explicit emphasis on quality culture and ethical behavior.
For most companies, these changes will not require a full redesign of their QMS. Instead, they will need to refine existing processes, strengthen how they justify decisions (including risks, opportunities, and the needs of interested parties), and expand awareness and leadership practices to encompass culture and ethics.
Since this is still the DIS stage, refinements are likely to occur before the Final Draft (FDIS) and publication in 2026. Still, quality professionals can be reassured: The new revision is evolutionary, not revolutionary. Organizations already certified against ISO 9001:2015 will face adjustments — sometimes subtle, sometimes requiring more discipline — but the overall transition effort should be manageable rather than disruptive.
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