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ISO 9001:2026 Is Here – What Has Changed and What Does Your Organisation Need to Do?

ISO 9001:2026, Quality management systems – Requirements, was officially published on 16 September 2026, replacing ISO 9001:2015.

For organisations already operating an ISO 9001-certified Quality Management System (QMS), the good news is that this is an evolution rather than a complete redesign of the Standard.

The established foundations of ISO 9001 remain. Customer focus, leadership, the process approach, risk-based thinking, evidence-based decision-making and continual improvement continue to underpin an effective QMS.

What has changed is the emphasis.

ISO 9001:2026 places greater attention on how quality management operates in practice, particularly the connection between leadership, organisational culture, ethical behaviour, strategic direction, risks and opportunities, people and business performance.

For many organisations, the transition should therefore be less about rewriting the entire management system and more about determining where the existing system needs to mature.

What Are The Key Changes In ISO 9001:2026?

1. Stronger focus on leadership, quality culture and ethical behaviour

Leadership has always been central to ISO 9001, but the 2026 edition strengthens the expectation that quality is actively supported by organisational leadership.

This means demonstrating more than having an approved Quality Policy or completing an annual Management Review.

Organisations should consider how leadership:

This is an important shift in emphasis.

A mature QMS should be visible in how people make decisions and perform their work, not simply through procedures, forms and records.

2. Greater alignment between the QMS and business strategy

ISO 9001:2026 reinforces the relationship between the Quality Management System, the organisation’s context and its strategic direction.

The QMS should not operate as a separate compliance framework sitting alongside the business.

Instead, quality objectives, operational processes and performance measures should contribute to the organisation’s broader objectives.

For example, if an organisation has a strategic objective to improve customer retention, relevant quality measures might include:

The important question becomes:

Can the organisation demonstrate how its quality objectives and processes contribute to achieving its strategic direction?

This provides an opportunity for organisations to make their management systems more useful to management, rather than maintaining them primarily for certification.

3. Risks and opportunities receive clearer treatment

Risk-based thinking remains fundamental to ISO 9001, but the 2026 edition provides greater clarity around risks and opportunities.

This distinction is important.

Risk management asks:

What could happen that may prevent us from achieving the intended result?

Opportunity management asks:

What could we change, improve or pursue that could produce a beneficial result?

For example, an organisation may identify a risk that critical operational information is not available when employees are working remotely or in the field.

Controls could include access controls, document management, mobile access, backups and system availability arrangements.

The same analysis may identify an opportunity to digitise the process, improve access to current information and obtain better operational data.

Organisations should therefore review whether their existing risk processes genuinely address both sides of the equation rather than simply maintaining a traditional risk register focused on adverse events.

4. Increased emphasis on employee awareness

People remain fundamental to the effectiveness of any management system.

ISO 9001:2026 strengthens awareness around quality culture and ethical behaviour in addition to the established requirements relating to quality policy, objectives and an individual’s contribution to QMS effectiveness.

This means organisations should look beyond whether a worker has attended an induction or signed a training record.

Consider whether employees actually understand:

Effective awareness should be evident through workplace behaviour and decision-making.

5. Climate change remains part of organisational context

Climate change is not entirely new to ISO 9001.

Climate-related considerations were introduced into ISO 9001:2015 through the 2024 Climate Action Amendment and continue under ISO 9001:2026.

This does not mean every organisation needs a separate climate change procedure or extensive climate risk register.

Instead, organisations need to determine whether climate change is a relevant issue within their context and whether relevant interested parties have climate-related requirements.

Depending on the organisation, considerations could include:

Where these matters are relevant, they should be appropriately considered within the organisation’s planning and operational controls.

6. Recognition of the modern digital business environment

The way organisations operate has changed considerably since ISO 9001:2015 was published.

Cloud systems, digital workflows, mobile applications, automated processes, connected supply chains, remote work, data analytics and artificial intelligence increasingly influence business operations.

ISO 9001:2026 better reflects this contemporary operating environment.

Importantly, the Standard does not require organisations to implement artificial intelligence or any particular technology.

The focus remains on ensuring the organisation has appropriate processes, resources, knowledge, information and controls necessary to achieve the intended results of its QMS.

For organisations undergoing digital transformation, this provides an opportunity to consider whether their QMS has kept pace with how work is actually being performed.

7. Annex A provides greater clarification

The revised Annex A provides additional guidance on concepts, terminology and the intended application of requirements within ISO 9001:2026.

This supports an increasingly important principle in management system auditing:

Effectiveness matters more than paperwork for paperwork’s sake.

Rather than simply asking whether a procedure exists, organisations should consider whether the process is understood, implemented, controlled and achieving its intended result.

This is also an important consideration when reviewing management system documentation during the transition.

Not every existing procedure will need to change.

The priority should be identifying where a change is actually required and ensuring the system remains effective, proportionate and suitable for the organisation.

What Hasn’t Changed?

Organisations should not assume that ISO 9001:2026 means starting again.

The familiar management system framework remains, including:

Clause 4 – Context of the Organisation
Clause 5 – Leadership
Clause 6 – Planning
Clause 7 – Support
Clause 8 – Operation
Clause 9 – Performance Evaluation
Clause 10 – Improvement

ISO 9001:2026 also adopts ISO’s current Harmonized Structure, supporting integration with other ISO management system standards.

For organisations operating an Integrated Management System covering quality, health and safety, environment or other disciplines, this continuity is particularly useful.

What Should ISO 9001:2015-Certified Organisations Do Now?

The first step should be a structured ISO 9001:2026 Gap Analysis.

Rather than immediately rewriting procedures, organisations should compare their existing QMS against the revised requirements and determine what actually needs to change.

The review should consider:

Organisational context and interested parties – Are internal and external issues current, and are relevant interested-party requirements understood?

Leadership and quality culture – Can the organisation demonstrate how leaders actively support quality, ethical behaviour and accountability?

Strategic alignment – Is there a meaningful connection between business strategy, the Quality Policy, quality objectives and operational performance?

Risks and opportunities – Does the organisation appropriately consider both threats to intended outcomes and opportunities for improvement?

Competence and awareness – Do employees understand their contribution to quality and what is expected when quality issues arise?

Objectives and KPIs – Are quality objectives measurable, meaningful and connected to organisational priorities?

Internal audits – Do audit programmes and criteria need updating to address the revised requirements and increased focus on effectiveness?

Management Review – Does the Management Review process provide leadership with useful information about the performance and continuing suitability of the QMS?

Documented information – Which policies, procedures, registers, forms, workflows and records genuinely require amendment?

Transition planning – Who is responsible for each required change, when will it be completed and what evidence will demonstrate implementation?

A practical transition register could track:

ISO 9001:2026 Requirement → Current Arrangement → Gap Identified → Required Action → Responsible Person → Due Date → Document/System Change → Evidence of Completion

Don’t Turn The Transition Into A Documentation Exercise

One of the biggest risks during any ISO transition is immediately rewriting the management system before understanding the actual gaps.

For organisations with an established ISO 9001:2015 system, much of the existing framework may remain suitable.

The better approach is to:

Assess → Identify → Prioritise → Implement → Verify

This reduces unnecessary documentation, focuses resources on genuine gaps and provides clearer evidence that the organisation has systematically addressed the transition.

How Sherm Can Support The ISO 9001:2026 Transition

For organisations using Sherm as their management system platform, the transition can be managed through the existing system rather than creating a separate collection of spreadsheets, documents and action lists.

Sherm can support organisations to bring together the evidence required across areas such as:

This creates an opportunity to use the ISO 9001:2026 transition not simply to update certification documentation, but to review whether the QMS is actually providing management with useful operational information.

The Key Takeaway

ISO 9001:2026 does not require organisations to throw out their existing Quality Management System and start again.

It does, however, encourage organisations to look more closely at whether their QMS is genuinely connected to the way the organisation is led and managed.

The increased emphasis on leadership, quality culture, ethical behaviour, strategic alignment, risks and opportunities, employee awareness and system effectiveness reinforces an important principle:

A Quality Management System should be a business management tool, not simply a collection of documents maintained for an audit.

For organisations already certified to ISO 9001:2015, now is the time to understand the changes, undertake a structured Gap Analysis and develop a practical transition plan.

Need help preparing for ISO 9001:2026?

Sherm provides an integrated platform for managing quality, safety, environmental and operational management system requirements, helping organisations manage risks, actions, audits, documents, competency and performance within one central system.

A structured transition provides an ideal opportunity to simplify existing processes, remove unnecessary administration and strengthen the connection between your management system and the way your organisation actually operates.

For more information, see ISO – ISO 9001:2026: What businesses need to know

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