The revision of ISO 9001, the internationally recognised standard for quality management systems, will likely be delayed until late 2026. The revised standard was originally scheduled for publication at the end of 2025. A first draft - the Committee Draft ISO 9001 (CD1) - was published in April 2024 and submitted to the members of the ISO Committee ISO TC 176 for discussion. At the most recent ISO meeting in the fall of 2024, it was decided that an additional draft, known as Committee Draft 2 (CD2), must be created.

ISO 9001:2015 - Audit questionnaire
Loading...

ISO 9001:2015 - Audit questionnaire

More than just a checklist!

Profound knowledge of our experts on

  • Selected audit questions
  • Possible evidence
  • Key figures and examples of implementation

Focus on a high-quality revision

This decision was taken because the current state of the document was not considered mature enough for the next step - publication as a Draft International Standard (DIS). Consequently, TC176 SC2 WG 29 will prepare a Committee Draft 2 (CD2) and submit it for a further round of comments. 

"This step is necessary to address issues that still require clarification," explains Thomas Votsmeier, head of standardization at DGQ, member of the ISO committee and technical head of the corresponding mirror committee at DIN. "These relate on the one hand to the harmonization of the terms and principles of ISO 9000 with the requirements of ISO 9001, and on the other hand to ensuring the unambiguous and correct use of the ISO Annex SL Harmonized Structure specification."

The revised project plan extends the original duration from 24 months to 36 months, with publication of the revised standard now scheduled for the fall of 2026.

Revision of ISO 9001: new and changed requirements

However, fundamental changes to the standard are not expected. The focus will be on harmonizing the structure of the standard with other management system standards - but also on clarifying specific requirements in the annex. Issues such as ethics and integrity, vision, mission and values, quality culture, and managing opportunities and risks in quality management will play a role. At the same time, ISO 9000, which governs the definitions and principles of quality management, is being revised and expanded to include new definitions.

Overall, the delay that has now occurred illustrates the complexity of the revision process and ISO's efforts to develop a sound and forward-looking version of the standard.

Revision of ISO 9001: milestones to date

In August 2023, a simple majority of the members of ISO/TC 176 SC2 voted in favor of revising the ISO 9001 quality management system standard. A similar vote in 2020 had rejected an "early" revision of the quality management standard. The decision to revise the ISO 9001 quality management standard "ahead of time" is due to the current changes in the business environment. The drivers for this decision were and are the increasing complexity and dynamics in the overall global economic and political environment, as well as the use of new technologies. Against this background, ISO/TC 176 concluded that adjustments to the application of quality management systems are urgently needed.

Emerging Themes - key topics for the revision of ISO 9001

At a further meeting in London in December 2023, the planned objectives and scope of the revision were confirmed and the project's "design specification", which outlines the scope of the revision, was approved as a guideline. "The focus of the meeting was to assess the relevance of the so-called 'emerging themes', which were identified as potentially significant developments in the run-up to the revision," reports Thomas Votsmeier, Head of Standardization at DGQ. "These include the current impact of global changes - including ESG aspects, for example - as well as changes in the application of QM and the use of new technologies." Requests for interpretation on quality management from previous years were reviewed and evaluated at the meeting.

In addition, the standardisation representatives present held initial discussions on a differentiation of the concepts of risks and opportunities, which was intended as input for the revision. Formulations regarding documentation requirements and the understanding of the integration of a quality management system into the management of the overall organisation were also discussed.

ISO 9000 also being revised

The quality management standard ISO 9000 is being revised in parallel with ISO 9001. Against this background, the corresponding working group of TC 176 SC 1 is considering adapting the seven principles of quality management and introducing new or modified definitions. The possible new concept of risk assessment in quality management also plays an important role. The results of both revisions will be coordinated. ISO 19011 - the guideline for auditing management systems - is also to be revised, but there is no concrete timetable yet.

What experts would like from the revision

The target corridor for a revised ISO 9001 is currently in 2026. The expectations for a revised QM standard that takes into account the topics of today and tomorrow already exist. We have been asking.

Dr. Wilhelm Griga, Senior Quality Manager Digital Industries at Siemens AG, Germany
Loading...

Focus on crucial "emerging trends"

A user's statement on the revision

Dr Wilhelm Griga is Senior Quality Manager at Siemens AG, Digital Industries with a focus on organizational development, digital transformation, agile management systems, sustainable non-conformance management and modern audit management. He is a member of the Siemens internal working group for the revision of ISO 9001.

My expectation of the revision of ISO 9001:2015 is that the conversion effort for organizations will be minimized and at the same time an improved, demonstrable implementation quality will be achieved. The revision of the quality management standard should help to intensify the focus on quality worldwide, establish more effective and environmentally friendly processes and further increase customer satisfaction.

We welcome the fact that the revision focuses on selected "emerging trends" that are crucial for a quality management system. This implies that new technologies and business models are integrated into the requirements in order to meet future market demands.

Despite the adjustments, ISO 9001 should remain a generic standard that is applicable to organizations of different sectors and sizes worldwide. This approach enables a uniform, reliable assessment of quality systems and creates trust among customers and business partners.

moderatorin-dqs-martina scharwey
Loading...

QM as an expression of a culture of positive leadership and change

An expert's statement on the revision

Martina Scharwey is Senior Lead Auditor at DQS GmbH and TQM assessor. She is an expert in the areas of KPI management, process, quality and risk management.

Certification according to ISO 9001:2015

How much effort do you need to make to have your quality management system certified to ISO 9001:2015? Find out for yourself. Free of charge and without obligation.

Contact us

Processes, their expected results and sequence as well as resources must be determined and availability ensured. Do these requirements of ISO 9001:2015 still fit into today's and, above all, tomorrow's world, in which flexibility, resilience, agility and change are increasingly important criteria for success? My answer is: yes and no, or rather it depends - on the organization or the business unit. Service providers and service areas in organizations particularly need to work in an agile and flexible manner. Can the outcome of a process be planned or determined? No, often not. This must be taken into account in the revision of ISO 9001.

Resilience and agility of the organization as new standard requirements are meaningful, but are not sufficient on their own. Requirements must be determined with regard to a corporate culture based on trust instead of power and control, a culture of positive leadership and change, and the sustainable use of the opportunities offered by digitalization.

In addition, personnel-intensive areas that cannot be digitized easily or replaced by AI are particularly exposed to the consequences of demographic and population change, as well as the radically changed expectations of the younger generation. Human resources are therefore one of the essential risks that ISO 9001 should address with additional requirements.

DQS_Auditor_Markus Reimer.jpg
Loading...

From "status quo quality" to "future quality"

An auditor's statement on the revision

Dr. Markus Reimer has been working as an auditor at DQS in Frankfurt/Main for over 15 years. As an author and keynote speaker, he has been inspiring his readers and listeners in German-speaking countries for many years on his topics of quality, innovation, sustainability, knowledge, and agility.

ISO 9001 is being revised after all. And why shouldn't it?

I am actually opposed to a revision. And I'm not the only one, because in the deciding vote of the ISO/TC 176 SC2 technical committee in summer 2023, there were 25 votes against. But also 36 votes in favor. 36 is more than 25, so the decision has been made and we will now think about the 36 committee members who believe a revision is essential. What is driving them?

There are indeed several topics that are considered worthy of integration, perhaps even necessary. These are - at the very least - "adjustments with regard to resilience, supply chain management, change management, sustainability, dealing with risks [and] organizational knowledge". Based on what I have learned since 2015, I wonder: even more focus on "risks"? In my view, this topic features quite prominently in the current standard. The fact that in practice, it is not treated the same way, well, that's not really the standard's fault. But what is surprising is that there is no additional, heightened, perhaps even sharpened focus on "opportunities"?

Opportunities?

Opportunities! A topic covered by the norm and hardly present in daily practice. We are so busy defending ourselves against risks, i.e. defending ourselves against what we might lose, that we no longer have time to look at opportunities, i.e. what we might gain. From my point of view, that would be a topic to focus on. The future is defined above all by making use of opportunities. Focusing solely on risks - however necessary - primarily preserves the status quo. Safeguarding the status quo in a highly dynamic context? As difficult as it is dangerous!

In this context, we may ask to what extent the focus on "sustainability" threatens the existing, the tried and tested, the successful ... and how it can be averted to the extent possible. We may ask this question. Perhaps adding: "What's next?"

But wouldn't it also be possible to ask what opportunities can be found in this topic? Not opportunities in the sense of "even more", "even cheaper" and "even faster". Perhaps the question may also be asked about opportunities for current and future "interested parties": not just "status quo quality", but "future quality". And haven't topics such as "artificial intelligence" rushed from a distant horizon directly into our own time? And here they are. And now what?

ISO 9001 is being revised! I am now in favor of it after all. But the revision won't be easy. But then again, what is easy about quality management? At least if you understand and make use of it correctly.

ISO 9001 revision from 2015

The "major revision" of ISO 9001:2015 for quality management systems was the talk of the town at the time: the context of the organization, the consideration of relevant interested parties, the focus on the responsibility of top management, the knowledge of the organization and the risk-based approach are just some of the keywords behind which there is considerable potential for improvement in business practice.

The then-new, harmonized basic structure (High Level Structure HLS) and the new requirements required a rethink in many cases. In addition to major changes, the revision of ISO 9001 at that time also included numerous small improvements that help companies to make their management system fit for the future.

The history of ISO 9001

The unbroken success story for quality management systems began more than 35 years ago. On August 28, 1986, DQS issued the first ISO 9001 certificate based on the draft version. Join us on a journey through time and read our article on the revisions and history of ISO 9001.

risk
Loading...

Video: Online discussion on the topic of risk

The concept of risk in ISO 9001.

Experts from the ISO committee TC 176 TG 4 "Risk" from the USA, Germany, Israel and Mexico discuss the concept of risk in ISO 9001. Also present: Prof. Dr. Patricia Adam, DQS auditor and member of Task Group 4 "Risk".

Revision of ISO 9001 - a brief summary

The revision of ISO 9001 has been delayed until 2026, and key issues such as ethics and integrity, vision, mission and values, quality culture, and managing opportunities and risks will play an important role in the revision. In addition, the structure of the standard will be adapted to the "Harmonised Structure" to enable better coordination with other management system standards. Clarification of specific requirements, particularly in the explanatory Annex, is also planned. These points illustrate the importance of careful planning and implementation of the revision in order to develop a sound and future-oriented version of the standard. ISO 9000 (Quality management systems - Fundamentals and vocabulary) and ISO 19011 (Guidelines for auditing management systems) are also included in the revision.

DQS - the right partner right from the start

DQS was founded in 1985 as Germany's first certification body. Since then, we have been one of the world's leading audit and certification experts. The founding partners DGQ (Deutsche Gesellschaft für Qualität e. V.) and DIN (Deutsches Institut für Normung e. V.) are important partners for training and further education as well as standardization work.

We are actively involved in committees and bodies on behalf of our clients and contribute our expert knowledge to our audits. Our claim begins where audit checklists end. Take us at our word.

Trust and expertise

Our texts and brochures are written exclusively by our standards experts or long-standing auditors. If you have any questions about the text content or our services to our author, we look forward to hearing from you.

Author
Nadja Goetz

Product manager ISO 9001 as well as DQS expert for health management systems and BSI-KRITIS audits, auditor and product manager for various quality standards of rehabilitation as well as inpatient and outpatient care.

Loading...

Relevant articles and events

You may also be interested in this
Instructor Led Training

ISO 9001 | Quality Management | Executive Awareness Training | South Africa

On demand
Online or Classroom | English
Instructor Led Training

ISO 13485 | Medical Device Quality Management (MDQMS) | Lead Auditor Practical Training | South Africa

On demand
Classroom | English
Instructor Led Training

ISO 13485 | Medical Device Quality Management (MDQMS) | Lead Implementer Training | South Africa

Jun 23-27 , 2025, 08:00-16:00
Online or Classroom | English
Instructor Led Training

ISO 13485 | Medical Device Quality Management (MDQMS) | Clause by Clause Training | South Africa

On demand
Online or Classroom | English
Instructor Led Training

ISO 13485 | Medical Device Quality Management (MDQMS) | Awareness Training | South Africa

On demand
Online or Classroom | English
Instructor Led Training

ISO 9001 | Quality Management | Lead Auditor Practical Training | South Africa

May 26-30 , 2025, 08:00-16:00
Online or Classroom | English
Instructor Led Training

ISO 9001 | Quality Management | Implementation and Facilitation Training | South Africa

On demand
Online or Classroom | English
Instructor Led Training

ISO 9001 | Quality Management | Awareness Training | South Africa

Jun 09 , 2025, 08:00-16:00
Online or Classroom | English
Instructor Led Training

ISO 9001 | Quality Management | Internal Auditor Training | South Africa

Jun 23-27 , 2025, 08:00-16:00
Online or Classroom | English
Instructor Led Training

ISO 9001:2015 Combo Training Course (South Africa)

On demand
Online or Classroom | English