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).
ISO 9001:2015 - Audit questionnaire
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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.
Integrated risk and opportunity management
Seize the opportunities, shape the future
Dr. Patricia Adam is a DQS auditor and professor of international management at the University of Applied Sciences and Arts Hanover. As an expert in organizational development and EFQM assessor with international assignments, she contributes her expertise as an author, in DIN and ISO committees and as a keynote speaker. Patricia Adam is a member of Task Group 4 "Risk" of the Technical Committee 176 (TC 176, Quality Management and Quality Assurance) of the International Organization for Standardization (ISO) and is also involved in the revision of ISO 9000 in the associated WG 2.
The risk-based approach is a recurring theme throughout ISO 9001 since the 2015 revision, as it is a core task of the quality management system to have a preventive effect. In the current version of the standard, the consideration of opportunities also plays a role. Unfortunately, this has hardly been implemented in practice, as my current research project shows: Opportunity management is systematically neglected. Yet the global parameters of what quality can and must achieve have changed rapidly over the past decade. An organization that wants to not only survive, but also profit from the sometimes chaotic conditions of the VUCA* world and satisfy its relevant stakeholders must also manage its opportunities.
As part of TG 4 (Future Topics "Risk"), we found that this is true for organizations around the world. The resulting TG 4 "Risk Paper" therefore proposes that risks and opportunities be understood as two different concepts for dealing with change and that they be systematically decoupled from each other. Opportunity-based thinking would then exist alongside risk-based thinking. This idea is currently being discussed controversially in the context of the revision of ISO 9000 and 9001.
In my opinion, the revision of ISO 9000 and ISO 9001 would benefit from raising the bar for dealing with risks and opportunities. This is because an organization that wants to position itself for the future cannot avoid the targeted definition and control of integrated risk and opportunity management (IRCM). An IRCM goes far beyond what can be found in organizations today. Should the revision of the standard pave the way, even top management would benefit directly: Through better, coordinated decision templates that enable faster and more appropriate decisions for company-specific actions.
*The VUCA model describes the changes in today‘s world. The acronym VUCA stands for Volatility, Uncertainty, Complexity and Ambiguity.
Expand your stakeholder focus.
The management system is user-oriented.
Dr. Moritz Achilles, Director of Quality Management for Room Care and Robotics at Miele & Cie. KG.
The revision of ISO 9001 will undoubtedly expand the stakeholder focus to include a user orientation of the management system. At its core, a quality management system contains an information model that links the various aspects, processes, and tools with one another. This essential information, methods, and processes must be made available to the different user groups in the organization in a user-oriented manner. The structure of the management system should only be based on the individual sections of the standard if the organization allows it. Otherwise, it must be adapted to ensure targeted information.
In addition to internal audits and the annual management review, managers and process owners must be held even more responsible through independent verification of the effectiveness of a management system. Key figures and stress tests can contribute to this, demonstrating not only the performance of the organization but also that of the local management system component. It is crucial that the management system be broken down and applied to each individual area in a systematic and verifiable manner.
The customer is and remains our focus. But can we do more?
Auditor commentary on the topic of service excellence
Christian Ziebe is Managing Director of Impulse - Die Kommunikationsexperten. He has been a DQS lead auditor for management systems and service excellence for many years. He also serves as a moderator for workshops and training courses on modern audit processes, skills, and methods for DQS Academy.
The objective of fulfilling customer requirements is a core aspect of ISO 9001. In addition to the collection and evaluation of customer requirements, the customer can now assert themselves in processes. While external providers were given further detailed requirements in the last revision of the standard, the customer is perhaps even more relevant when it comes to integration into processes, learning from mistakes and delight factors. "Customer experience" is the relevant buzzword here.
This prompts several inquiries: To what extent is the customer integrated into the processes, process descriptions, and swimlanes? What customer experiences do customers have at the touchpoints and in communication with the company? What mistakes do customers make and how can these be rectified? How can we truly engage the customer as part of CIP? Is there a customer idea management system?
Do you have answers to all these questions? If so, your company is certainly "customer savvy". As early as 2011, such aspects were presented in the German DIN SPEC 77224 - Achieving customer delight through service excellence." I believe this is a useful guide to involving the customer and taking a closer look at the organization.
It is also important to consider the role of employees in this process. As stated in DIN SPEC 77224, enthusiastic employees can often inspire customers. Therefore, if the topic of customer experience is being considered for revision of the standard, it is likely that this is because of the impact it can have on the wider management system.
ISO 9001, stick to your scope
An expert statement on the revision
Dr. Frank Bünting is deputy head of the Business Advisory department at the VDMA in Frankfurt, where he is responsible for quality management. He is a member of the ISO TC 176/SC2 working group for the revision of ISO 9001.
As part of the discussion about what the revision of ISO 9001:2015 will contain, there is always speculation about which sustainability topics and verification requirements will be included in the standard. The fact is that apart from the topic of "climate change", which has made it into section 4 of the standard via the new "Harmonized Structure" for management systems, no further sustainability topics will be added. It remains to be seen what practical effects this will have. The scope of ISO 9001:2025 has a different focus and I therefore expect that there will be no impact other than a clear statement.
Furthermore, there are no other product-related sustainability topics in the draft revision. This is not necessary, as the relevant sustainability requirements for products and services are already included in section 8.2. Although legal requirements, for example on CSR reporting, are binding for all companies, they are not related to the scope of the standard and therefore play no role here.
ISO 9001 therefore remains a standard that focuses on quality management and is not diluted by other non-scope requirements.
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.
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.
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 the summer of 2023, there were 25 votes against. But also 36 votes in favour. 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 favour 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 helped 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 is 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.
Video: Online discussion on the topic of risk
The concept of risk in ISO 9001Experts 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".
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.
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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.