The ISO 9001 is currently undergoing revision and the update is expected to be published by September 2026.
This article offers an overview of what businesses can expect from the update and how to prepare for it.
Current ISO 9001:2015 requirements
As it currently stands, there are 10 clauses in the ISO 9001:2015 standard. They describe the mandatory elements in a QMS, but not how to implement them.
Here’s what’s involved in each of the 10 clauses.
1. Scope of the standard
This clause explains the scope of the standard and highlights what quality management intends to achieve. Businesses must create processes that ensure consistent product and service output and ensure customer satisfaction through conformity to these processes.
2. Normative references
To comprehend the words and terms used in 9001:2015, normative references provide relatable comparisons to the vocabulary used. Businesses must interpret these terms as directed.
3. Terms and definitions
As with clause 2, you must reference ISO 9000:2015 to fully understand the technical meaning of terms and definitions in ISO 9001:2015.
4. Context of the organization
This clause requires a business to regularly determine, review and update information relating to external and internal issues that impact the business in setting and meeting its objectives.
5. Leadership and commitment
This clause outlines the requirements of senior management in developing leadership, commitment and customer focus.
6. Planning for the QMS
The clause sets out the requirements for working with risk and opportunities when you’re planning your QMS. A process for mitigating risks and improving desirable effects must be developed.
7. Support and resource management
This clause ensures the right support is in place for the QMS to be successful. It requires management to provide and monitor competent and appropriate support and resources.
8. Operational planning and control
This clause concerns the planning for your product or service. Requirements include determining and reviewing product design, development, purchasing, manufacturing, delivery and supply.
9. Performance evaluation
The requirements in this clause are a system of evaluating, monitoring and reviewing all aspects of the business, from operational performance to customer satisfaction and the performance of suppliers. It includes the needs for internal audits, monitoring, analysis and management reviews.
10. Improvement actions
This clause is about the steps for improving your QMS through corrective actions and continuous monitoring and improvement.
The status of the ISO 9001 update
The path to the revision and publication of ISO 9001:2026 has been full of setbacks and delays. An anticipated 2021 revision was skipped following a user review and ballot by national standards bodies who voted against it.
Following further evaluation and a later ballot, a majority voted in favor of a revision and the process started officially in 2023.
For five days in December 2023, more than 81 experts representing 46 countries and different stakeholders met in London (and virtually) to start the review and evaluation of the inputs identified to update ISO 9001.
In January 2024, a working group began drafting new revisions. In August, its first draft was rejected by the ISO Central Secretariat. Work on a second draft began, sparking controversy that it had been outsourced.
In October, the anticipated publication date of 2025 was pushed out to 2026. In April 2025, preparation of the Draft International Standard began, and it was released to ISO member bodies for review in August.
In April 2026, the final draft of ISO 9001:2026 is expected, with publication in September/October. Time will tell.
Expected changes to ISO 9001 in the new version
The new version of ISO 9001 is expected to “evolve not revolutionize” the standard, with the core structure remaining unchanged.
According to the ISO TC 176/SC2/WG29 report, “adjustments to ISO 9001 are planned with regard to the aspects of resilience, supply chain management, change management, sustainability, dealing with risks [and] organizational knowledge”.
Significant updates are anticipated in the following key areas.
Integration of ethics and integrity
The revision will focus on integrating ethics and integrity within leadership practices.
Focus on risk management
Emphasis will be placed on proactive strategies, including risk identification, mitigation, and adaptation to evolving threats.
Separation of risk and opportunity
Risks and opportunities will be separated, with guidance on how to address each element.
Emphasis on stakeholder engagement
All stakeholders – customers, employees, suppliers, and the community – will be prioritized to ensure they’re central to the decision-making process.
Integration of digital transformation and Industry 4.0
Elements of Industry 4.0 and digital transformation will be incorporated. Companies must adapt their QMS to leverage digital tools such as AI, IoT, and big data analytics.
Emphasis on sustainability and social responsibility
Explicit requirements for sustainability and social responsibility will be incorporated.
Greater flexibility and simplification
The standard will be more adaptable to different types of organizations, regardless of size or sector, with streamlined and simplified requirements making compliance easier for smaller businesses.
Improved alignment with other management systems
Integration and consistency will be promoted by aligning the standard with other management systems, such as ISO 14001 (Environmental Management) and ISO 45001 (Occupational Health and Safety).
Simplifying compliance with the updated ISO 9001 standard
Organizations have three years to prepare for upcoming updates that will impact their QMS. The best way to prepare for this revision is to:
- conduct a gap analysis of your current QMS
- train staff and make them aware of changes
- update documentation
- invest in relevant technology
- perform internal audits
- engage stakeholders.
isoTracker’s quality management software can help your organization prepare for the upcoming ISO 9001 update. We offer modular, cloud-based quality management software that’s specifically designed to help simplify ISO 9001 compliance for small to medium businesses.
The software is easy to install and easy to use. We currently offer seven modules, for document control, corrective and preventive action (CAPA) and the management of audits, risks, complaints, non-conformances, and training.
We are also currently working on releasing Change Control, Equipment Maintenance and Supplier Management modules.
Each module can stand alone or integrate seamlessly with other modules to provide a complete quality management system.
Contact us at isoTracker to find out how our cloud-based software can help your business prepare for the ISO 9001 update or sign up for a free 60-day trial.
