Analysis

ISO TC 176 ISO 9001 2026: How the Standard Was Developed

ISO TC 176 ISO 9001 2026 development process: how ISO Technical Committee 176 developed the new standard, from DIS to FDIS to publication.

Konstantin Dolgan, Ph.D.
Konstantin Dolgan, Ph.D.

Quality Systems Engineer & Product Development Expert

August 8, 2026 10 min read
ISO TC 176 ISO 9001 2026: How the Standard Was Developed

At a glance

ISO TC 176 ISO 9001 2026 development process: how ISO Technical Committee 176 developed the new standard, from DIS to FDIS to publication.

  • Focus: ISO TC 176 · ISO 9001 revision process
  • Read time: 10 minutes
  • Updated: August 8, 2026

What Is ISO TC 176?

ISO TC 176 ISO 9001 2026 development: how ISO 9001 2026 was developed by ISO Technical Committee 176. ISO 9001 2026 development process involved national member body input, DIS ballot, and FDIS approval.

ISO Technical Committee 176 (ISO TC 176) is the body responsible for developing and maintaining the ISO 9000 family of quality management standards. Established in 1979, TC 176 is one of ISO's most active and influential technical committees, with participation from national standards bodies representing more than 90 countries. Its work covers the full ISO 9000 family, including ISO 9000 (fundamentals and vocabulary), ISO 9001 (requirements), ISO 9004 (guidelines for sustained success), and ISO 19011 (guidelines for auditing management systems).

Key Insight

Key Takeaway:: This article covers essential ISO 9001:2026 requirements and what they mean for certified organizations transitioning from ISO 9001:2015.

For the authoritative source, see the ISO 9001 standard page on ISO.orgISO 9001 standard page on ISO.orghttps://www.iso.org/standard/62085.html and the ISO TC 176 committeeISO TC 176 committeehttps://committee.iso.org/home/tc176sc2 responsible for the revision.

TC 176 operates through three subcommittees: SC 1 (Concepts and Terminology), SC 2 (Quality Systems), and SC 3 (Supporting Technologies). ISO 9001 is developed and maintained by SC 2, which is currently chaired by the British Standards Institution (BSI). The secretariat for SC 2 is held by the American National Standards Institute (ANSI).

ISO TC 176 ISO 9001 2026: The Development Process

The ISO Standard Development Process

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ISO standards follow a defined development process that typically takes 3–5 years from initiation to publication. The process for ISO 9001:2026 followed this sequence:

Systematic Review (2021): Every ISO standard is subject to a systematic review every five years to determine whether it should be confirmed, revised, or withdrawn. The 2021 systematic review of ISO 9001:2015 resulted in a decision to revise the standard, based on feedback from a global user survey.

New Work Item Proposal (2021): TC 176/SC 2 approved a new work item proposal to revise ISO 9001:2015. The proposal identified the key areas for revision based on the user survey findings.

Working Draft (2022–2023): Working groups within SC 2 developed draft text for the revised standard. Multiple working drafts were circulated internally for comment and revision.

Committee Draft (2023): A Committee Draft (CD) was circulated to TC 176 member bodies for comment. National standards bodies reviewed the draft and submitted comments, which were addressed by the working group.

Draft International Standard (2024): The Draft International Standard (DIS) was published in August 2024 for a five-month public comment period. National standards bodies and their stakeholders submitted comments on the DIS, which were reviewed and addressed by the working group.

Final Draft International Standard (2025–2026): The Final Draft International Standard (FDIS) was prepared based on the DIS comments and circulated to TC 176 member bodies for a final approval vote. The FDIS was approved in August 2026.

Publication (September 2026): ISO 9001:2026 was published on September 16, 2026.

What the 2021 User Survey Revealed

The 2021 user survey was the primary driver of the ISO 9001:2026 revision. The survey collected feedback from thousands of ISO 9001 users worldwide — certified organizations, certification bodies, consultants, and auditors — and identified several key themes:

Quality culture: Survey respondents consistently identified organizational culture as a critical factor in QMS effectiveness, but noted that ISO 9001:2015 did not adequately address it. This feedback directly led to the new Clause 5.1.1 requirement.

Climate change: The survey was conducted at a time of growing awareness of climate-related risks, and many respondents noted that the standard did not address climate change. This feedback, combined with the 2024 climate change amendment, led to the formal integration of climate change into Clause 4.1.

Risk management clarity: Some users found the single Clause 6.1 in ISO 9001:2015 insufficiently clear about the relationship between risk identification, risk planning, and quality objectives. This led to the restructuring of Clause 6.1 into three sub-clauses.

Digitalization: Survey respondents noted that the standard did not address the growing role of digital tools and technologies in quality management. This led to the new Annex A guidance on digitalization.

Stability: Despite identifying areas for improvement, the overwhelming majority of survey respondents wanted the standard to remain stable in its overall structure and approach. This feedback shaped the decision to make targeted changes rather than a major structural revision.

Key Insight

The 2021 user survey is publicly available from ISO and provides valuable insight into the rationale behind each change in ISO 9001:2026. Quality managers preparing for the transition should read the survey findings to understand the intent behind the new requirements.

Why the Changes Are What They Are

Understanding the development process helps explain why ISO 9001:2026 makes the specific changes it does — and why it does not make changes that some users expected.

Why no AI requirements?: Many users expected ISO 9001:2026 to include specific requirements for AI governance in quality management. TC 176 decided against this, noting that AI-specific requirements would be better addressed through sector-specific standards and that the existing requirements of ISO 9001 (process control, documented informationdocumented information/glossary#documented-information, competence) already provide an adequate framework for managing AI-related quality risks. The Annex A guidance on digitalization provides direction without creating new mandatory requirements.

Why no digital transformation requirements?: Similarly, TC 176 decided not to include specific requirements for digital transformation, noting that the pace of technological change makes it inappropriate to prescribe specific digital approaches in a standard intended to remain relevant for a decade or more.

Why the consolidation of Clause 10?: The consolidation of Clauses 10.1 and 10.3 reflects feedback that the separation of "general improvement" and "continual improvementcontinual improvement/glossary#continual-improvement" in the 2015 edition was confusing and added no practical value. The consolidated Clause 10.1 is clearer and easier to implement.

Key Resources

The following resources support your ISO 9001:2026 transition planning:

  • Track the forthcoming standard: ISO/FDIS 9001:2026 on ISO.orgISO/FDIS 9001:2026 on ISO.orghttps://www.iso.org/standard/88464.html is listed as under development with publication planned for September 2026. The final standard will be available through ISO and national standards bodies after publication.
  • IAF transition guidance: The International Accreditation Forum (IAF)International Accreditation Forum (IAF)https://www.iaf.nu publishes mandatory documents that certification bodies must follow during the transition period.
  • Free gap analysis template: Download our ISO 9001:2026 Gap Analysis TemplateISO 9001:2026 Gap Analysis Template/resources/gap-analysis-template — a clause-by-clause PDF worksheet covering all 29 requirements with ★ markers for the three new clauses.
  • Free transition checklist: Download our ISO 9001:2026 Transition ChecklistISO 9001:2026 Transition Checklist/resources/transition-checklist — a 30-item action checklist covering all four transition phases.
  • Transition guide: Our comprehensive ISO 9001:2026 transition guideISO 9001:2026 transition guide/article/how-to-transition-iso-9001-2015-to-2026 covers the full three-year transition window with a step-by-step action plan.
  • Certification costs: See our ISO 9001:2026 certification cost guideISO 9001:2026 certification cost guide/article/iso-9001-2026-certification-cost-guide for current pricing by organization size and region.
  • Internal audit preparation: Our ISO 9001:2026 internal audit guide and checklistISO 9001:2026 internal audit guide and checklist/article/iso-9001-2026-internal-audit-guide-checklist covers all new clause requirements.
  • Frequently asked questions: Visit our ISO 9001:2026 FAQ pageISO 9001:2026 FAQ page/faq for answers to the most common questions about the new revision.

Frequently Asked Questions: ISO TC 176 and ISO 9001:2026

When will the next revision of ISO 9001 after 2026 occur?

ISO standards are subject to systematic review every five years. The next systematic review of ISO 9001:2026 will occur in approximately 2031. Whether this leads to a revision depends on the outcome of that review and the user survey that accompanies it.

Can I participate in the development of future ISO 9001 revisions?

Yes. ISO standards are developed through national standards bodies. In the US, ANSI coordinates US participation in TC 176. In the UK, BSI manages UK participation. In most countries, national standards bodies accept applications from organizations and individuals to participate in technical committees. Contact your national standards body for information on how to participate.

Where can I find the DIS and FDIS documents for ISO 9001:2026?

The DIS and FDIS documents are available for purchase from ISO.org and from national standards bodies. The final published standard (ISO 9001:2026) is also available for purchase from the same sources.

Is TC 176 working on any other standards related to ISO 9001:2026?

TC 176 is continuously working on supporting standards and guidance documents. Current work includes updates to ISO 9000 (vocabulary), ISO 9004 (sustained success), and ISO 19011 (auditing guidelines). The ISO 9004 and ISO 19011 standards may be updated to reflect the changes in ISO 9001:2026.

ISO TC 176ISO 9001 revision processISO 9001:2026 developmentDISFDISstandard development

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This article is provided for informational and educational purposes only. It does not constitute legal, regulatory, certification, or professional advice. ISO 9001:2026 is an evolving standard and information may change as it is interpreted and implemented. Author attribution reflects the primary writer; it does not imply personal liability for any consequences arising from reliance on this content. Always consult your certification body and qualified professionals for advice specific to your organisation. See our Terms of Use for full details.

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Konstantin Dolgan, Ph.D.
Konstantin Dolgan, Ph.D.Quality Systems Engineer & Product Development Expert
Ph.D. Materials & Infrastructure Systems EngineeringCertified New Product Development Professional (NPDP)Forbes The Next 1000 (2021)7 Granted US Patents

Konstantin Dolgan, Ph.D., is a product development engineer and quality systems architect who first encountered ISO 9001 from the inside — as an R&D engineer designing API 610 centrifugal pumps inside a certified manufacturer. He has since led the development of over 1,000 physical products and holds a Ph.D. in Materials and Infrastructure Systems Engineering from Louisiana Tech University.

Expertise:Quality data architecture and traceabilityNew product development under ISO 9001 clause 8.3Design control and documented informationRoot cause analysis and risk-based thinkingISO 9001 for manufacturing and engineeringAI applied to quality managementERP integration and records management