August 2023: Simple majority in favor of revision. In the vote of the ISO/TC 176 SC2 technical committee in summer 2023, a simple majority of members voted in favor of a revision of the ISO 9001 quality management system standard. This was announced by the committee on August 3, 2023. The timetable for the revision is now also becoming more concrete.

The facts

The vote resulted in 36 votes in favor of a revision, 25 members voted against and 17 abstained. In a corresponding vote in 2020, a timely revision of the standard was narrowly rejected by 36 votes to 32.

An article published on August 4, 2023 by the German Society for Quality (DGQ e.V.), which is closely associated with the committee, also reveals how far-reaching the revision could be and which quality management topics may be affected or added. According to the 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".

However, the basic structure of the standard is to be retained. The revision will merely replace the previously used High Level Structure (HLS ) with the new Harmonized Structure (HS), as was already done when the new ISO/IEC 27001:2022 was revised.

The decision to revise the ISO 9001 standard "prematurely" is presumably due to current changes in the business environment, such as increasing complexity and dynamics and the use of new technologies, which make adjustments urgently necessary with regard to the application of quality management systems. The next steps envisage the usual procedure for revisions of ISO management system standards, such as the establishment of working groups and the appointment of project managers.

The timetable

With the ISO/TC 176 Annual Plenary 2023 in October 2023 in Kigali (Rwanda), an initial timetable is now also available. According to this, the revised version of DIN EN ISO 9001:2015 should be published in December 2025. However, it is not yet possible to predict when a first draft of the revision might be available. According to Technical Committee 176 of the International Organization for Standardization (ISO), the responsible working group will meet in December 2023.

A decision was also made at the annual meeting to revise the two standards ISO 9000 (Quality management systems - Fundamentals and terminology) and ISO 19011 (Guidelines for auditing management systems).

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ISO 9001:2015 - Audit questionnaire

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Profound knowledge of our experts on

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

New topics

Sustainability, digitalization, global uncertainty: it is of course eagerly awaited which innovations the responsible working group will agree on - and what we will have to prepare for in quality management in the future.

In an announcement dated October 27, 2023, the DGQ assumes that the focus will be on developing supplementary guidance. The focus will certainly also be on globalization issues and sustainability aspects such as the EU's ESG (environmental, social and governance) criteria. The seven QM principles are also likely to be revised.

What experts would like from the revision

The target corridor for a revised ISO 9001 is currently the end of 2025. 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
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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
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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.

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
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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.

Certification according to ISO 9001:2015

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First ISO meeting in December 2023: Confirmation of the planned direction of the 9001 revision

 

In its announcement of December 21, 2023, the German Society for Quality (DGQ e.V.) reports on the first meeting of the working group of the ISO TC 176 committee responsible for quality management from December 4 to 8 in London at the British Standards Institution. Among other things, the planned objectives and scope of the revision were confirmed and the "design specification" for the project, which outlines the scope of the revision, was confirmed as a guideline.

 

"The meeting focused on the relevance assessment of the so-called 'emerging topics', which were identified as potentially significant developments in the run-up to the revision," reports Thomas Votsmeier, Head of Standardization at the 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." Corresponding requests for interpretation from previous years were reviewed and evaluated at the meeting. 

 

In addition, the standards representatives present held initial discussions on differentiating between the concepts of risks and opportunities, as proposed as input for the revision. Formulations with regard to documentation requirements and the understanding of the integration of a quality management system into the management of the overall organization were also discussed.

 

The next steps

Following an intensive round of discussions, the responsible standardization experts are now preparing a first internal draft for the revised ISO 9001 - the so-called Working Draft - and distributing it for comments within the working group. The processing of the collected comments will then be on the agenda in February 2024.

 

When the 9001 revision was announced, ISO had already indicated that the quality management system standard would not undergo any fundamental changes. Rather, the aim is to adapt it to the Harmonized Structure as a framework for all ISO management system standards, and to develop guidelines to clarify requirements in the annex or in the form of so-called "notes". This also includes expanding the Standard's annex to avoid misinterpretation.

 

ISO 9000 also to be revised

The ISO 9000 quality management standard is also being revised in parallel with ISO 9001. Against this background, the corresponding working group of TC 176 SC 1 is deliberating on adapting the QM principles and introducing new or amended definitions. The possible new conceptualization of the term "risk" also plays a major role here. The results of both revisions will be harmonized.

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.

Revision ISO 9001 - Conclusion

ISO 9001 has its roots in the founding of ISO/TC 176 in 1979, when the Technical Committee of the International Organization for Standardization (ISO) was tasked with developing a universal, globally applicable quality management standard. After around six years of development, the first draft standard based on the British standard BS 5750:1975 was published in 1985. 12 more years were to pass before the first publication of the "ISO 9000" series of standards (ISO 9000/1/2/3/4) in 1987.

The first revision of the series of standards took place in 1994 with minor adjustments. The 2000 revision, on the other hand, brought a fundamental revision and the anchoring of process orientation, which replaced the 20 elements. The merging of ISO 9001, ISO 9002 and ISO 9003 into a single standard was also new. The fourth edition was published in 2008 with some minor adjustments.

The last revision took place in 2015 and the next one is planned for 2025. It remains to be seen what requirements and future issues companies will be confronted with. However, the clear objective of the revision is already defined: to adapt the standard to the current circumstances in which an organization operates. The history of ISO 9001 is therefore characterized by continuity and reliability.

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.

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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.

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