Podcast: Predicting the Key Changes to ISO 9001
On November 12th, 2025, I sat down with Exemplar Global Podcast Host & Marketing Leader, Michael Richman, to discuss my predictions on the forthcoming changes to the ISO 9001 standard. You can watch or listen to the full episode here. Below the video is a brief summary of the talk and some key takeaways.
Overview
ISO 9001 is the world’s most recognized Quality Management System (QMS) standard, helping organizations enhance customer satisfaction and improve their processes. The International Organization for Standardization (ISO) typically reviews standards every five to ten years to ensure relevance in today's rapidly changing global environment.
# of sites certified = 1.3 million (QMS) vs. 600k (EMS)
History & Timelines
1st Edition: ISO 9001:1987 <— 7-year gap —> ISO 9001:1994
2nd Edition: ISO 9001:1994 <— 6-year gap —> ISO 9001:2000
3rd Edition: ISO 9001:2000 <— 8-year gap --> ISO 9001:2008
4th Edition: ISO 9001:2008 <— 7-year gap —> ISO 9001:2015
5th Edition: ISO 9001:2015 <— ?-year gap —> ISO 9001:202X (11+ years)
6th Edition: ISO 9001:2026+
Given that the last revision was released in 2015, one would expect the 6th edition to be released somewhere between 2021 and 2023, but that did not take place. Global pandemics and supply chain chaos likely played a major role in the delay.
With advancements in technology, evolving customer expectations, emphasis on sustainability and climate change, and the continued "integrated" approach spearheaded by the QMS standard, it is critical that the ISO 9001 standard evolves to meet these new challenges. My specific wish is to see improved connections between "quality" terminology and global business acumen. It is time.
Current Stage
The current stage of development is at DIS (40.40), but could change after the 12-week voting period today. The new standard could be fully approved this year, skip the FDIS and be published within 3 months, or soon thereafter. *as of 19-Nov, 2025
High-level Summary of Current Changes
ISO 9001 is moving from the 2015 edition to a 2026 release that’s evolutionary, NOT DISRUPTIVE
Same clause layout, with minor change or two to sub-clause titles
Approximately twice the # of pages at ~60 pages long, mostly in Annex A - Clarification on structure, terms, concepts
The core requirements are stable
New emphasis on ETHICS, QUALITY CULTURE, ENVIRONMENTAL AWARENESS
No additions documentation requirements
Pre-Clause 4 (Intro through 3.0) and Annex A
0.1 References ISO/TS 9002 - Guidelines for the application of ISO 9001:2015
0.3.3 Risk-based Thinking moved to back (Annex A)
0.4 No ref to Annex B or correlation matrices as of the time of the DIS publication
3.0 ~20 terms & definitions in the Terms & Definitions section (imagine that!)
Clauses 4–10 (Requirements)
4.1 Context of the Organization: Integrates the 2024 climate-change language (ISO 9001:2015/AMD 1:2024)
4.2 Interested parties → determine which needs must be addressed by the QMS (new expectation)
5.1.1 Leadership → promoting quality culture & ethics; must be demonstrated in day-to-day operations
6.1 Addressing Risks/OFIS → risks and opportunities are separated into two different sections with more detail
6.3 Planning of changes → more rigorous evaluation, communication and evaluation of effectiveness of change
7.1.3 Clarifications to organizational knowledge and examples reflecting digitalization
7.3 Awareness → now includes culture & ethics
8.0 Mostly editorial/terminology tidying and better examples (including digital/IT elements). (Note: more about cyber security, AI, information systems in general would be great.)
9.0 Stresses using data for trend analysis & decision making
10.0 Leadership’s role in continual improvement is more explicit
Annex A
Expanded guidance annex to aid implementation (up to 20 pages or more)
States its intent is to clarify the requirements and “prevent misunderstanding”
Clarifies ISO’s terminology:
“Consider” = organization may exclude after review.
“Take into account” = must be addressed; cannot be excluded.
A.4 – Context: Attempts to explain confusing sub-clause order vs. correcting it (i.e. entire clause 4)
A.5 – Leadership: Reinforces ethics and quality culture as leadership obligations
A.6 – Planning: Expands on "risk-based" and "opportunity-based thinking"
Note: Annex B removed as of today
Top 5 Misses (& a Bonus)
The DIS for ISO 9001:202X introduces meaningful updates, but several important opportunities remain underdeveloped. These “major misses” highlight areas where the standard could better reflect how organizations operate today.
Clearer expectations for process owners: Process ownership remains vaguely defined. Stronger guidance around authority, accountability, and competence would help organizations strengthen cross-functional leadership and performance. ISO/TC 176 should take the addition of the role “process owners” from IATF 16949 clause 5.1 and run with it.
Objectives need greater practical emphasis: While the DIS reinforces the importance of objectives, it doesn’t fully elevate them into a true performance-driving mechanism. Clearer direction on deployment, measurement, and alignment to results would increase their impact. Establishing a requirement that the quality objectives should be UNDERSTOOD seems to be a huge miss, yet again.
Documented information isn’t fully modernized: Clause 7.5 still leans on traditional interpretations of “documentation information”, born out of the 2015 version. Can we go back to calling a record a “record”? Why stick with the confusion caused in the last edition? Furthermore, more recognition of digital workflows, automation, and AI-supported content would bring the standard in line with today’s tools and practices.
Calibration and product controls don’t reflect digital reality: Can we just add CALIBRATION back to clause 7.6 already? Besides that miss, the “fitness for purpose” focus does not adequately address modern measurement systems and their reliability in the context of software, algorithms, digital data, and automated decision tools.
Technology, communication, and integration are underdeveloped: The draft lightly addresses communication technologies and does little to clarify connections with cybersecurity, AI, or related frameworks like ISO 27001 or CMMC. At least put a reference to ISO 27001 in the final release.
BONUS - Limited connection to strategy and the business management systems: The DIS continues to stops short of linking the QMS to strategy, annual planning, and broader business management systems. Organizations would benefit from a clearer bridge between quality management and enterprise execution.
Conclusion
As business and transition leaders look ahead, the message is simple: stay tuned. More clarity is expected in the next week or two, but early signals suggest that certification bodies will need several months to train on the update, making the upgrade timeline around Q1/Q2 2027 - for early adopters. Once the final version (Rev 6) is published, you’ll have a three-year transition - likely stretching into late 2029 - as a realistic deadline.
In the meantime, organizations should prepare for deeper questions around leadership’s cultural impact, ethics, and communication, along with greater expectations to understand environmental and climate context. And as risk-based thinking evolves to include opportunity-based thinking, the focus will increasingly shift toward demonstrating the effectiveness of actions taken, not just identifying what could go wrong.
Stay tuned by connecting with us on our social media outlets below. Also, make sure you check out our new podcast, “Mayhem to Mastery” on all the major podcast platforms.
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