Coming Soon: updates to ISO 9001 Quality Management System (QMS) Standards

WHY IS ISO 9001:2015 CHANGING? 

ISO 9001 certification is the internationally recognized standard for quality management systems, and it sets the foundation for ensuring consistent product and service quality. The International Organization for Standardization (ISO) typically reviews standards every five to ten years to ensure they keep up with technological advancements, evolving customer expectations, and new challenges such as sustainability and climate change. 

The current ISO 9001:2015 standard will be going through changes to stay relevant and effective in today’s rapidly evolving business environment. For example, digital transformation is growing exponentially with Internet of Things (IoT), Industry 4.0, Artificial Intelligence (AI), Machine Learning (ML) and big data analytics for quality management. Another goal of the updates is to improve compatibility among the standards. Since the standard is already over ten years old, it was time to revise it. In this blog post, I explain more about the background to the ISO 9001 update, the process and what your organization should do now. These changes are brought about by ISO 9001:2026. 

ISO 9001:2015 was the first standard in the then new High-Level Structure. The revised version of the quality management standard has been adapted to the now current Harmonized Structure. Otherwise, no fundamentally new requirements are foreseeable for the ISO 9001 revision. According to the current status, the changes are mainly of an editorial nature where content has been linguistically clarified and standardized. Overall, the future ISO 9001 certified companies should not face major hurdles in implementation. 

Significance of the new ISO 9001 revision for companies 

ISO 9001 is the world's most widely used international management system standard. She is considered the "mother of all norms". In many industries, appropriate certification is a prerequisite for being active in the market. Sooner or later, certified companies will have to switch to the new standard in order to continue to have a valid certificate. However, there is no final version yet. Companies should keep up to date with the development of the standard. After the publication of the updated standard, it is important to deal with the changes quickly. 

The most important Updates at a glance 

1. New (known) structure - In the future, we are expecting that ISO 9001:2026 will follow the Harmonized Structure (HS) introduced by ISO/IEC 27001. This ensures a uniform structure and easier integration with other management systems. 
   
2. Climate change in the text of the norm - As early as spring 2024, ISO ordered companies to take climate change into account in their management systems. This was solved via directly valid amendments (AMD 1:2024-02). The new ISO 9001 revision is expected to include the topic of climate change. It is important that: 
   

   - climate change is anchored in the management system from the very beginning;
   - the relevance for the company is assessed;
   - the requirements of interested parties are taken into account. 

3. Opportunities and risks in separate chapters - Until now, companies have focused too much on the risks when taking measures to deal with opportunities and risks. Opportunities often remained underrepresented. Therefore, the standard-setter has divided this up and now names opportunities (Chapter 6.1.3.) separately from risks (6.1.2). 
4. Quality Culture and Ethics - In Chapter 7.3 "Awareness" there is expected to be a requirement "Quality culture of the organization and ethical behavior". In the future, top management must promote a culture of quality and ethical behavior (Chapter 5.1.1). In addition, the organization must ensure that people who carry out activities under the supervision of the organization are aware of the quality culture. 
5. Stronger integration of Quality Management into corporate strategy - It is expected that top management is called upon to develop a quality policy that takes into account the context of the organization. What is new is that their strategic orientation is also to be supported. 
6. Informative appendix partially deleted - The informative Appendix A "Explanation of the structure, terminology, and concepts" has been fundamentally revised. Annex B (Other ISO/TC 176 International Standards on Quality Management and Quality Management Systems) has been deleted without replacement. 
7. Timetable and transition periods 
   - Working Draft (December 2023 to February 2024) 
   - Committee Draft 1 (March 2024 to December 2024) 
   - Committee Draft 2 (January 2025 to June 2025) 
   - Draft International Standard (July 2025 to March 2026) 
   - Final Draft International Standard (April 2026 to June 2026) 
   - International Standard (July 2026 to August 2026, published in September 2026) 

The most important facts

 The current version of the standard is ISO 9001:2015

 The revision is expected to come into force in September 2026 and will be called ISO 9001:2026

 The Draft International Standard (DIS) is currently available 

 The central change is the adaptation to the Harmonized Structure (HS)

 Companies should deal with the new standard text at an early stage 

Organizations will have a three-year window to transition to the new standard once it is published, providing ample time to make the necessary adjustments. 
 

How to prepare for the innovations of ISO 9001 

As soon as the standard text of the new ISO 9001 is available, companies should deal with it in concrete terms and implement changed requirements accordingly in the QMS. The changes must then be carried into the company. For example, companies can use a gap analysis to determine where there is a need for change. In principle, forward-looking planning enables existing systems to be adapted in ample time.  

ISO 9001 Certification Process

TÜV SÜD reviews your documentation and on site activities to verify compliance with ISO 9001, after which your organization must address any non conformances by identifying and correcting their root causes. Once requirements are met, TÜV SÜD issues the certification and mark, followed by annual surveillance audits to maintain validity, with occasional unannounced audits in special cases.

Can ISO 9001 be integrated with other management systems? 

Yes, quality management systems according to ISO 9001 can be integrated very well with other management systems. For example, with: 

• Environmental management systems according to ISO 14001 
• Management systems for safety and health at work according to ISO 45001 
• Energy management systems according to ISO 50001 
• Information security management system according to ISO/IEC 27001 
• Asset management systems according to ISO 55001 

Find out more about integrated management systems.  

TÜV SÜD For ISO 9001 certification 

TÜV SÜD's auditors are highly qualified and experienced in evaluating management systems for a wide range of industries. 

Worldwide on site: Thanks to our global network of experts, you can have international subsidiaries certified by one and the same testing body. 

Strong seal of approval: Set an example for quality and integrity. TÜV SÜD stands for reliability, independence and neutrality worldwide. 

Quality counts: With the world-famous test mark, you communicate your quality standards - and stand out from the competition. 

Learn more by visiting our ISO 9001 Certification and Auditing webpage.

Contact us for more info and subscribe to our Auditing and Systems Certification emails.