ISO 9001:2026 Quality Culture Requirements: What Manufacturers Need to Know

Most ISO standard revisions follow a familiar routine. Publication lands, the quality team runs a gap assessment, and the gaps get closed before the transition audit.

ISO 9001:2026, however, is different.

With final publication expected in September 2026, the revision is nowhere near as wide-ranging as the 2015 update. Even so, new requirements in the standard around demonstrating quality culture are something companies need to prepare for in advance, rather than waiting until the weeks before their transition audit.

Let’s jump into the requirements and the evidence auditors will use to evaluate compliance with them.

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What’s Changing in ISO 9001:2026?

ISO 9001:2026 isn’t a radical departure from the 2015 version. However, there are several notable changes to the standard:

• Clause 4 (Context): Absorbs the climate change considerations from Amendment 1:2024, so organizations must determine whether climate change is a relevant issue.
• Clause 5 (Leadership): Requires top management to actively promote a culture of quality and ethical conduct.
• Clause 6 (Planning): Separates risks from opportunities into distinct subsections, each with its own required actions. (For a closer look, see our recent post on how ISO 9001:2026 elevates risk-based thinking.)
• Clause 7 (Awareness): Extends what personnel must understand to include quality culture and ethical behavior.
• Digital technology and AI: AI and digital technology appear as a contextual consideration under strategic direction. While the standard doesn’t add new requirements around technology use, this underscores growing expectations in industry around digital maturity.
• Annex A: Grows to roughly 15 pages of guidance on interpreting the standard, absorbing the cross-references that previously lived in Annex B.

While this is the first time quality culture shows up as formal requirements in the standard, the expectation itself isn’t new.

“Auditors were asking me that 10 years ago: how are you making sure everyone understands quality? Show me how you’re building up your quality culture and making sure it remains strong,” says Stephanie Ojeda, VP of Product Management at AssurX. Ojeda spent 18 years in quality working in pharmaceutical, biotech, medical device, and food and beverage.

Who’s Responsible for Quality Culture under ISO 9001:2026?

It’s worth noting that the new quality culture requirements aren’t solely the quality department’s responsibility. Clause 5 requires leadership to visibly champion quality and ethical conduct. While Clause 7 requires that the rest of the organization understand what quality culture and ethical behavior mean in their own work.

As always, ISO isn’t prescriptive about how plants should meet the requirements. That gives companies flexibility in how they demonstrate quality culture, but no single program or document is likely to satisfy the requirements on its own.

“It’s more about integrating quality into daily operations. People say quality is everyone’s responsibility. This is more about proving how you’re standing behind that idea,” Ojeda says.

What a Real Culture of Quality Looks Like

Culture is evidenced more by how an organization behaves than anything its documents say. In other words, what happens when production targets and quality standards conflict?

“It’s not going to be in an SOP. It’s not going to be a quality culture procedure. It’s more observational,” Ojeda says. “How are people responding when something goes wrong? Not just the quality team, but the production team. Do people feel comfortable bringing up problems?”

For example, an auditor may be listening for statements like “It was a quality issue, but we had to hit our number, so we had to keep going.”

Viewed through this lens, there are several things quality leaders should look for when assessing culture in their organization:

• Whether people raise problems freely: An operator who stops the line and then spends the afternoon defending the decision learns not to stop it next time.
• How trade-offs resolve under schedule pressure: Push and pull between production and quality is normal. The question is whether meeting production quotas usually wins out over quality concerns.
• Committing resources to quality: Does leadership invest in systemic fixes, or does the quality team have to fight for every dollar aimed at prevention?
• Leadership participation: Who’s in the room during quality management reviews is a specific tell. “It shouldn’t just be the quality director, the quality manager, and the quality team. It should be cross-functional. You should see executive leadership. You should see the plant manager,” Ojeda says.

How Will Auditors Evaluate Quality Culture?

Since culture isn’t something you can inspect directly, auditors are likely to follow three lines of inquiry to build a holistic picture:

• Conversations with employees: Auditors may ask people across different functions what quality means to them and how issues get raised. Answers that line up between production and quality are a good sign.
• Quality records: Management review minutes, CAPA records, and training records are all places auditors will likely look for evidence. Effectiveness checks are especially important, since that’s what shows whether the organization is actually following through on issues.
• Leadership involvement: How do leaders show up in significant CAPAs and resourcing decisions? Leadership responsiveness when the quality team needs resources is a key signal, as is documentation of making decisions that prioritize quality over production.

How the QMS Captures Evidence of Quality Culture

Quality management system (QMS) software isn’t a stand-in for quality culture, but it does document its evidence in numerous places. An integrated QMS also pulls those records into one place, which matters because scattered quality data is exactly the condition the new requirements push against.

“It shows real evidence that quality doesn’t just exist in a silo, with different teams pursuing their own priorities while quality just acts as the police,” says Ojeda.

A connected QMS generates that documentation as a byproduct of normal operations, including:

• Escalation trails: These show who raised an issue, when, and what happened next, with the timestamps to prove it.
• CAPA and complaint handling records carried through to effectiveness checks: These demonstrate the plant verifies fixes work, instead of closing the CAPA as soon as the action is implemented.
• Management review records: These document who attended and the decisions they made, showing whether and how teams prioritize quality when faced with production pressure.
• Change management and employee training records: These show that teams are communicating important changes and training employees on them.

What Should Manufacturers Do Now to Prepare?

The usual first move after a revision publishes is a documentation gap assessment. That approach won’t work here. What the requirement calls for instead is a behavior-based gap assessment, which means looking at how the organization actually operates.

“What behaviors are you expecting from employees? Is that stated somewhere in quality objectives or training?” says Ojeda. “How are you escalating quality concerns, and can you show me an example of when that’s happened? Is quality part of the business performance discussion?”

Rewriting a procedure takes an afternoon. Building a year of cross-functional management review records that show how the organization actually behaves takes far longer.

“You can’t just put something together in two weeks. An auditor is definitely going to see through that,” Ojeda says.

That’s why manufacturers need to start thinking about how they will demonstrate compliance with the new requirements now, focusing on tasks like:

• Documenting expected behaviors somewhere durable: Quality objectives and employee training content both count, and both are records an auditor can ask for.
• Capturing escalations as events: An escalation with a date, an owner, and an outcome is evidence that problems rise to the appropriate level of attention.
• Getting the right people into management reviews now: Attendance patterns take time to establish, so this is a habit worth building sooner rather than later.

What Mistakes Should Manufacturers Avoid?

As for where manufacturers are likely to stumble in demonstrating quality culture, Ojeda says it’s the tendency to focus solely on paperwork rather than behavior.

“People will see these quality culture requirements, and they’re going to think, ‘Let’s make a quality culture SOP so we can demonstrate to an auditor that we have a defined quality culture,’” she says.

The irony here is that a quality culture SOP is itself evidence of a weak quality culture. That’s because it demonstrates that the organization’s instinct, when asked to change behavior, is to write a procedure.

Another related trap is when quality operates as the police, patrolling processes owned by others. Where the standard points instead is toward quality interacting with every other group in the organization rather than existing as a siloed function.

The gap between organizations that sail through their ISO 9001 audits and organizations that struggle with them existed long before the new standard was drafted. In the end, those plants that are able to demonstrate quality culture in their 2029 transition audit are those that start generating the evidence for it in 2026.

About the Author

Stephanie Ojeda is Vice President of Product Management for the Life Sciences industry at AssurX. Stephanie brings over 18 years of experience leading quality assurance functions across industries including pharmaceuticals, biotechnology, medical devices, food & beverage, and manufacturing.