Earlier this year, we shared that the internationally recognised quality management standard, ISO 9001, was undergoing revisions. That process concluded last month with the publication of ISO 9001:2026.
For organisations that rely on ISO 9001 as the foundation of their quality management systems (QMS), this marks the beginning of a new chapter. While many of the core principles have remained unchanged, the new edition addresses emerging challenges organisations are navigating every day.
For Certex, the release of the new edition is particularly noteworthy. We are proud to share that our Impartiality Committee Chairman, Michael McLean, contributed to the revision process as a member of the ISO/TC 176/SC 2 committee responsible for developing the updated standard.
Since its release, we have been hearing many of the same questions from our clients. What has changed? What remains the same? How soon should we start planning for the transition?
The good news is that ISO 9001:2026 is not a complete overhaul. Instead, it refines existing requirements and strengthens key areas to better reflect the realities of the current business landscape.
From the updates that are already generating discussions to the core principles that have remained unchanged, this article offers an early look at what organisations can expect as they begin preparing for the transition to ISO 9001:2026.
Why the Update Matters
Much has changed since ISO 9001:2015 was published more than a decade ago.
Organisations now operate in an environment shaped by rapid technological advancements, increasingly complex supply chains and changing workforce expectations. At the same time, businesses are facing growing pressure to respond quickly to change while maintaining customer confidence and consistent performance.
ISO 9001:2026 recognises these challenges. Rather than reinventing the framework organisations are already familiar with, the updated standard strengthens key areas in the existing structure.
What Has Changed?
While many of the core requirements remain, ISO 9001:2026 introduces several refinements designed to help organisations address the challenges of today's business environments.
One of the most noticeable changes is the size of the standard itself, which is now just over 50 pages. Much of this increase comes from the introduction of Annex A, a new guidance section that provides additional clarification and context for users. The revised edition also includes updated definitions, revised terminology and some rearrangement within clauses.
Beyond these editorial changes, most of the major updates fall into two broad categories.
Reinforcement of existing concepts
Introduction of new concepts
First let's look at the key concepts that have been strengthened in the revised edition.
Clearer Separation of Risks and Opportunities
Risk-based thinking remains an essential element of the standard. However, the revised edition introduces a clearer distinction between risks and opportunities, encouraging organisations to adopt a more balanced approach for future planning.
Historically, most organisations have focused their efforts on identifying risks and preventing problems. The updated standard encourages organisations to look beyond risk mitigation and actively consider opportunities that may drive innovation, improvement and growth. (Clause 6.1.3)
This shift encourages organisations to view their QMS as a tool for growth and improvement rather than simply a compliance mechanism.
Process Management Reinforced
Process management has been a key concept within ISO 9001 for many years, but the 2026 edition has placed renewed emphasis on understanding, managing and improving organisational processes as an interconnected system.
The new edition reinforces the need for organisations to clearly define process inputs, outputs, interactions and resources while ensuring they remain aligned with intended outcomes (Clause 4.4.1). It also highlights the role of leadership in promoting the process approach throughout the organisation rather than treating it as a responsibility limited to the quality team (Clause 5.1.1).
For many organisations, this is unlikely to require significant changes. Instead, it will serve as a reminder of the importance of managing processes as an integrated system that supports consistent outcomes, continual improvement and customer satisfaction.
Greater Emphasis on Managing Change
Change is an inevitable part of modern business. Whether driven by growth, market conditions, emerging technology or customer expectations, organisations are continually adapting to new circumstances.
Reflecting this reality, ISO 9001:2026 places greater focus on communicating change, assessing the results and evaluating the effectiveness (Clause 6.3 - Planning of Changes). The standard also references the need to respond to disruptions in the provision of products or services (Clause 8.2.1).
Together, these updates encourage organisations to take a more structured and proactive approach to managing change while maintaining consistent outcomes.
While these changes reinforce areas that have long been part of ISO 9001, the revised edition also introduces some new concepts. Let's take a closer look at some of these new additions.
Introduction of Quality Culture and Ethical Behaviour
Leadership commitment and employee awareness have long been essential elements of ISO 9001 and quality management systems.
The 2026 edition enhances this with reference to building a culture where quality is embedded throughout the organisation rather than resting solely with the quality function. Leaders are expected to do more than simply establish policies and objectives; they are expected to create an environment where quality becomes part of everyday decision-making, behaviour and organisational culture (Clause 5.1.1 - Leadership and Commitment).
The revised standard recognises that the behaviours and values demonstrated throughout an organisation can directly influence the effectiveness of its QMS. Expectations around ethical conduct encourages organisations to promote accountability, transparency and responsible decision making at all levels. By promoting ethical behaviour alongside quality objectives, organisations can strengthen trust with customers, employees and other stakeholders while supporting a culture that values integrity and continual improvement.
In many ways, the new edition reinforces something successful organisations have long recognised: a successful QMS depends not only on strong systems, but also on the people behind them.
Expanded Annex A for Additional Guidance and Clarification
Another change to the standard is the expansion of Annex A.
The International Organization for Standardization (ISO) describes Annex A as a resource designed to improve clarity and support interpretation of the standard. It provides additional explanatory guidance on terminology, concepts and the intent behind the requirements within the standard.
For organisations implementing ISO 9001 for the first time, this additional guidance may help simplify interpretation, while for others, it provides valuable context that can support consistent application of the requirements.
What Has Not Changed?
While the new edition introduces several important updates, the foundations of ISO 9001 remain firmly in place.
The standard continues to focus on helping organisations to consistently provide products and services that meet customer requirements while improving customer satisfaction.
The process approach remains at the heart of the standard, requiring organisations to understand how their processes interact and contribute to intended outcomes. Likewise, the Plan-Do-Check-Act (PDCA) cycle continues to provide the framework for managing processes, evaluating performance and driving continual improvement.
Customer focus, leadership commitment, risk-based thinking, performance evaluation and continual improvement all remain essential elements of an effective QMS.
Overall, ISO 9001:2026 represents a refinement rather than a transformation. The core principles have remained unchanged, but the revised requirements simply provide organisations with clearer guidance for applying those principles in a modern business environment.
What Should Organisations Do Now?
The publication of the new edition does not mean that organisations must make changes overnight.
Organisations currently certified to ISO 9001 will have a three-year transition period to migrate to the new edition. During this period, organisations can familiarise themselves with the revised requirements and assess whether any adjustments are needed to their QMS.
For many the transition may involve refinement rather than significant redesign of their QMS.
We will continue to share more updates, practical insights and information about migration requirements, timelines and audit expectations.
Certex will also be contacting each of our clients individually at the appropriate time to plan their transition audits to the 2026 versions of both ISO 9001 and ISO 14001. For any companies seeking initial certification in either one of these standards, please reach out for an initial meeting to discuss how to get started.