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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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.

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 new, harmonized basic structure at the time (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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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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Author
Nadja Goetz

DQS expert for healthcare management systems and BSI-KRITIS audits, auditor and product manager for various quality standards in rehabilitation as well as inpatient and outpatient care.

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