I have worked with ISO 9001 quality systems since 1997.
That matters, because I am not an ISO skeptic.
Quite the opposite.
I have worked through ISO 9001:1994, 2000, 2008 and 2015, and for most of that time I watched the standard get better.
The 1994 version was cumbersome and documentation-heavy. Too much energy could be spent proving that you had documented a process rather than determining whether the process actually worked.
ISO 9001:2000 was a major improvement. It pushed organizations toward the process approach. The 2008 revision refined that framework. Then 2015 incorporated risk-based thinking throughout the system rather than treating preventive action as a separate exercise.
ISO itself describes essentially the same evolution: away from prescriptive documentation and toward processes, performance and risk-based thinking.
I think the original ISO 9001:2015 may have been the pinnacle of the standard.
And I don’t say that merely because I liked the language.
ISO genuinely helped make me a better manager.
When ISO Actually Works
When I was helping install ISO at the company where I work today, one of the concepts being pressed heavily was the process approach.
One of my auditors at the time, John, became something of a mentor to me. He had spent years in quality and would occasionally tell stories from companies he had worked with or audited. He wasn’t just teaching me how to pass an audit. He was teaching me how to look at a business.
I remember auditing one particular production department.
At the time, we had seven two-person teams working within the department. Each team earned its own production incentive.
The employees complained constantly about the distribution of work.
One team thought another always received the easy jobs. Someone else felt like his team always got stuck with the difficult ones. And because incentives were calculated team by team, there wasn’t much reason for one team to stop what it was doing and help another.
It was easy to look at that and see a people problem.
The audit made me see a process problem.
I had fourteen people working in the same department, but the incentive system encouraged them to behave like seven competing islands.
So we changed it.
We kept an individual component, but added a departmental incentive based on the performance of the entire group. Production mattered. Quality and scrap mattered. Attendance mattered.
Something interesting happened.
People started helping one another.
The employees didn’t suddenly become different people. Management changed the system around them, and behavior changed with it.
That lesson has stayed with me for years.
The process approach taught me to stop asking only, Who is causing the problem? and start asking, What in the system is producing this result?
That is ISO doing exactly what I want ISO to do.
It helped management see something we weren’t seeing. It improved the process. It improved teamwork. It ultimately supported production and quality.
I have seen that value repeatedly over nearly thirty years.
Which is precisely why I recognize the difference when ISO gives me a requirement that does none of those things.
Then Climate Change Entered My Quality Manual
During my most recent surveillance audit, my auditor asked how we had addressed ISO’s 2024 climate-change amendment.
We hadn’t.
I had read the amendment. I concluded that climate change had no meaningful relationship to our ability to manufacture conforming product, and I moved on.
My auditor wrote the finding.
And here’s the important part:
He was right to write it.
I respect him. He is a good auditor. He is methodical, fair and follows the standard.
This wasn’t an auditor going on a political crusade.
This wasn’t a certification body inventing a requirement.
The requirement was there.
In February 2024, ISO amended ISO 9001:2015 to require organizations to determine whether climate change is a relevant issue. ISO also added a note stating that relevant interested parties can have climate-related requirements.
ISO’s own technical committee explained that the language was being inserted across management-system standards following a decision by ISO’s Technical Management Board. The committee said the additional wording was intended to put a spotlight on climate change and was being incorporated across ISO management-system standards as a matter of urgency.
So my auditor did his job.
I disagreed with the requirement. He listened. There wasn’t much to argue about.
The words were in the standard.
So I wrote a benign statement saying, in effect, that management had evaluated climate change and determined that it did not present a relevant risk to our quality management system.
The finding was closed.
No process improved.
No defect was prevented.
No customer was served better.
No employee learned anything.
No hose became better hose.
A requirement was satisfied.
That experience bothered me because after nearly thirty years with ISO, I know what useful quality-system discipline looks like.
This wasn’t it.
It was compliance speech: a sentence written because the standard required management to have an auditable answer to a question management otherwise had no reason to ask.
The Problem Isn’t Climate Change
This is where I want to be very precise, because my argument can easily be misunderstood.
My objection is not that climate could never be relevant to a business.
Of course it could.
ISO 9001 already required organizations to understand the internal and external issues relevant to their purpose and their ability to achieve the intended results of the QMS.
If drought threatens your water supply, consider it.
If extreme weather repeatedly shuts down your plant, consider it.
If changing environmental regulations affect your product, consider them.
If a hurricane destroys your sole-source supplier every three years, you would be foolish not to consider that risk.
That was already the brilliance of risk-based thinking.
Management identifies the risks relevant to its organization.
The 2024 amendment did something different.
ISO selected one external issue from the universe of possible external issues and named it individually.
That matters.
The moment the standard specifically tells me to determine whether climate change is relevant, ISO has made a decision about which external issue deserves special consideration.
The naming itself creates the auditable position.
And that raises an obvious question.
Why that risk?
Let Me Tell You What Actually Keeps Me Up at Night
I run a manufacturing business.
Do you know what poses a very real threat to my ability to manufacture conforming product?
Supply-chain consolidation.
I have watched private-equity firms and large corporations acquire smaller suppliers, consolidate operations, alter service levels, change pricing structures and disrupt relationships that took decades to build.
If a critical compounder disappears, changes formulation, stretches a lead time or decides my volume isn’t worth bothering with anymore, I have a real problem.
A product problem.
A customer problem.
A quality problem.
That is the kind of external issue that can keep me awake at night.
ISO doesn’t specifically tell me to evaluate private-equity consolidation.
Nor should it.
ISO doesn’t know my supply chain.
ISO doesn’t know my customers.
ISO doesn’t know my equipment.
ISO doesn’t know which supplier would cripple my production if it disappeared tomorrow.
I do.
That was the beauty of Clause 4.1 and risk-based thinking in the first place.
One manufacturer might worry about a sole-source resin supplier. Another might worry about port congestion. Another might worry about electrical reliability. Another might worry about a retiring employee who possesses thirty years of tribal knowledge.
Management determines relevance.
Once the standards body starts selecting which external issues deserve to be named separately, it is no longer merely providing the framework.
It is establishing priorities within the framework.
That is not a quality judgment.
It is a judgment about which issues organizations should be required to consider.
And that is where I begin to object.
The Gaps Become Jurisdiction
This is the heart of my concern with ISO 9001:2026.
I don’t expect the new standard to contain some dramatic declaration announcing that private businesses must embrace a new political or economic philosophy.
That isn’t how institutional expansion normally happens.
It happens through gaps.
A broader definition.
A new note.
A slightly expanded concept of an interested party.
A reference to social conditions.
A reference to ecological concerns.
A new expectation surrounding culture or organizational behavior.
Every individual sentence can sound perfectly benign.
The problem is what happens next.
Standards are audited.
If the written standard creates an auditable subject, a good auditor has to address it.
My climate finding proved that to me.
An auditor does not need to be unreasonable for mission creep to occur. In fact, the more professional and by-the-book the auditor is, the more important the wording becomes.
The auditor can only audit what the standard gives him jurisdiction to audit.
If climate change had never been named, there would have been no climate-change finding.
Once it was named, my auditor correctly asked for evidence that we had addressed it.
That is why I care so much about seemingly harmless language.
The gaps become jurisdiction.
And once jurisdiction exists, the burden begins shifting to the company to demonstrate why something does or does not apply.
Who Is an “Interested Party”?
This is also why I am watching the continued evolution of the term interested parties.
There is a version of this concept that makes perfect sense within a QMS.
Customers are relevant.
Regulatory authorities are relevant where their requirements affect the products we manufacture.
I have no problem with that.
But during my recent audit, my auditor gave me a friendly warning about where he believed the next standard was heading.
He knew I wasn’t thrilled about the climate amendment. He also knew that our existing interested-party analysis was fairly narrow.
He told me I should expect increasing discussion around the community as an interested party or stakeholder. Schools were one example he mentioned.
He wasn’t threatening me.
He wasn’t writing another finding.
He was giving me a weather report.
And my reaction remains the same:
What does the local school system have to do with my quality management system?
Our company can support a school.
We can sponsor a team.
We can donate to a food bank.
We can plant trees in a park.
We can decide that being a good corporate citizen matters to us.
Those decisions may be good, moral and worthwhile.
But they are decisions for ownership and management.
They are not quality requirements.
A QMS should not become the vehicle through which every theory of corporate responsibility eventually becomes an auditable concern.
From Quality Management to Stakeholder Management
This concern exists within a much larger shift in management philosophy.
The World Economic Forum, among others, has spent years advocating stakeholder capitalism and common ESG measurements extending corporate responsibility beyond shareholders and customers.
Its Stakeholder Capitalism Metrics organize corporate disclosures around People, Planet, Prosperity and Principles of Governance and include subjects ranging from greenhouse-gas emissions and diversity to community investment and social impacts.
I am not claiming the World Economic Forum controls ISO.
It doesn’t need to.
My concern is that international institutions increasingly speak the same language and operate within the same intellectual ecosystem: stakeholders, communities, climate, sustainability, social impact and global objectives.
That language may be entirely appropriate inside a sustainability standard.
It may be appropriate inside an environmental management standard.
A company may voluntarily adopt an ESG reporting framework if its owners believe doing so benefits the company.
My question is narrower:
Why does it belong in ISO 9001?
ISO or GSO?
ISO was formally established in 1947 after representatives from 25 countries met in London in 1946 to discuss international standardization. ISO describes its original purpose as facilitating the coordination and unification of standards developed by national standards bodies.
That mission makes sense to me.
A thread should be a thread.
A measurement should mean the same thing in Ohio as it does in Germany.
A test method should produce comparable results in Michigan and Japan.
Standards make trade possible.
Standards make manufacturing easier.
Standards solve real problems.
But look at ISO’s own page for the forthcoming ISO 9001:2026.
ISO says the revision addresses modern business needs and stakeholder expectations. It says the revision is intended to meet the evolving needs of users and their communities.
The same page associates ISO 9001:2026 with United Nations Sustainable Development Goals including Responsible Consumption and Production, Reduced Inequalities, Sustainable Cities and Communities, and Climate Action.
To be fair, those badges do not mean ISO 9001 contains a mandatory clause requiring a company to “reduce inequalities.” I don’t want to claim something the standard does not say.
But I am still entitled to ask:
What does reducing inequality have to do with whether I manufacture a conforming product?
This is where the joke in my title comes from.
ISO began as the International Organization for Standardization.
If a quality standard gradually becomes a framework for global stakeholder expectations, community concerns, social objectives and environmental priorities that reach beyond product quality, at what point are we dealing with something different?
At what point does ISO start looking more like a Globalist Standards Organization?
I would very much like that joke to remain a joke.
We’ll know more in September.
“But ISO Is Voluntary”
The obvious answer to everything I have written is simple:
Nobody is forcing me to maintain ISO 9001 certification.
That is true.
And it matters.
ISO is not the government. A certification body cannot walk into my business unless we invite it. We choose to participate.
But anyone who works in manufacturing knows that voluntary can become complicated.
Customers ask for ISO certification.
Supplier-approval systems use it.
Procurement departments use it as a shortcut for determining whether a supplier has a functioning quality system.
Some industries effectively require it.
In our case, however, we actually have a choice.
We are not trapped underneath a sector-specific automotive certification structure such as IATF 16949 that makes ISO 9001 certification effectively unavoidable.
Walking away would still cost us.
Our third-party certification expense is roughly $5,000 per year.
The larger cost is internal. When I account for management time spent preparing for audits, conducting internal audits, maintaining the system, reviewing records, addressing findings and managing the certification process, I estimate the real annual commitment is closer to $30,000.
Dropping certification would not make all of that disappear.
Nor should it.
I still want the QMS.
I still want internal audits.
I still want corrective action.
I still want document control, calibration, training, risk analysis and management review.
I still want the disciplines ISO taught me.
And some customers would likely replace the certificate with their own supplier audits. We could trade one third-party audit for several customer audits.
That is a genuine downside.
But this is the distinction I increasingly think manufacturers need to remember:
The quality system and the certificate are not the same thing.
You can keep the system and reject the mission creep.
That option carries a cost.
So does surrendering the boundary.
Grade Me in September
ISO currently lists the sixth edition of ISO 9001 as releasing on September 16, 2026.
So rather than waiting for the final standard and then pretending I predicted whatever it happens to contain, I want to put my test on the record now.
When ISO 9001:2026 is released, I am going to look for five things:
- Expanded interested-party obligations that reach materially beyond customers, applicable regulators and parties directly relevant to product conformity or QMS performance.
- Community or stakeholder language that creates new expectations unrelated to the organization’s ability to provide conforming products and satisfy customers.
- Social or ecological concepts in auditable requirements without a clear connection to quality performance.
- Expansion or elevation of the climate-change requirement beyond determining relevance.
- New auditable but poorly defined concepts—including areas such as culture or behavior—that create substantial room for auditor interpretation without clearly measurable quality outcomes.
ISO’s own 2026 materials already describe a stronger focus on leadership, quality culture and accountability, along with closer alignment to other ISO management-system standards. I am not automatically opposed to any of those things. A strong quality culture obviously matters.
The question will be how the words are written.
Does the new language help organizations make better products, improve processes, manage genuine risks and satisfy customers?
Or does it create new jurisdiction?
Those are different things.
If the final standard keeps the boundary where I believe it belongs, I will say so.
If my community prediction is wrong, I will say so.
If my concern about social or ecological language is overstated, I will say so.
If ISO surprises me positively, Part II will acknowledge it.
But if vague language creates precisely the audit surface I am worried about, I intend to say that too.
No moving the goalposts after September.
Maybe Complaining Isn’t Enough
There is one final criticism of my position that is fair.
ISO standards do not simply descend from Geneva onto helpless American manufacturers.
The United States participates in the process.
ASQ administers the U.S. Technical Advisory Group to ISO/TC 176, the committee responsible for quality-management standards. The TAG develops U.S. positions, and ASQ says people with a material interest in the work are welcome to participate.
So somebody could reasonably tell me:
If you don’t like where ISO 9001 is going, why weren’t you in the room?
Fair question.
Maybe I should be.
I am seriously considering becoming more involved through ASQ and the U.S. TAG process.
And perhaps that is the larger lesson for small manufacturers.
For decades, many of us treated ISO as plumbing.
The standard worked. We maintained the system. We passed the audit. We went back to making things.
Maybe we became too comfortable allowing other people to decide what the next generation of the standard should value.
International standards do have enormous influence over private business.
That influence is precisely why the people who own, operate and manage small manufacturing companies should pay attention to how those standards are written.
I don’t want to destroy ISO 9001.
I want to preserve what made it valuable.
I want the process approach that taught me how to fix a dysfunctional incentive system.
I want the corrective-action system that forces us to confront failures.
I want risk-based thinking that makes management ask what could prevent us from serving our customers.
I want objective evidence.
I want continual improvement.
I want quality.
What I don’t want is a quality management system slowly becoming a vehicle through which international institutions acquire jurisdiction over questions that have nothing to do with quality.
ISO 9001 was supposed to be about quality.
It still can be.
But if manufacturers want to keep it that way, perhaps it is time we started showing up.
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