ISO 9001: 2026 keeps the familiar Quality Management System framework / structure, while placing clearer emphasis or expanded requirements on organizational context, leadership, quality culture and how organizations address risks and opportunities. And of course, we are still using the same PDCA approach.
For organization certified to ISO 9001: 2015, the transition is a good time to review how the QMS works in practice, and this page would explain Clause 4, 5 and 6: The foundation for understanding the organization, setting leadership expectations and planning actions.
WHAT THE CLAUSE 4 HAS CHANGED?
Clause 4.1 and 4.2 continues to require organizations to understand the internal and external issues that can affect the QMS, identify relevant interested parties, determine the QMS scope and establish the processes needed for the system.
The 2024 climate change amendment is formally integrated into ISO 9001:2026 edition. Organizations should determine whether climate change is relevant to their context and whether interested parties have related requirements or expectations. The revision also gives more attention to external and internal context, including external factors such as political and environmental issues, be it locally or regionally, as well as internal context expanded to include strategic direction and resources.
Review your context and interested party information. Consider whether climate change or other changes in the business environment affect your ability to deliver conforming products and services or meet customer requirements.
For example, flooding may disrupt delivery, political conflict may affect material supply, a change in business strategy may introduce a new product line or economy fluctuation increases material costs. These issues may need to be reflected in your context of organization, interested party’s needs and expectations register, SWOT or PESTEL and risk assessment, update it when organization’s circumstances change.
These are not a totally new requirement, but it is requirement enhancement.
WHAT THE CLAUSE 5 HAS CHANGED?
Clause 5 continues to require top management to demonstrate leadership and commitment to the QMS. The 2026 edition gives clearer attention to promoting a quality culture and ethical behavior. It also strengthens the focus on risk-based and opportunity-based thinking. Leadership responsibilities apply to relevant roles across the organization, within their areas of responsibilities, not only solely on Management Level or Quality Department alone.
What is Quality Culture? A Quality Culture is an environment, shared attitudes or shared practices where the team members genuinely care about the quality of the work in their pursuit of excellence, continuous improvement and meet customer’s expectations. Consider how leaders and employees respond when quality problems arise. Do employees raise quality concerns openly?
What is Ethical Behavior? Act honestly, professionally and fairly even short-term pressure exists. Being open about quality decisions and actions, when they are affected by other stakeholders. Do managers’ report result honestly, including when production targets are missed? Do teams follow required quality checks when facing pressure to meet a delivery date? During Management Review Meeting, report “red” quality dashboard honestly?
Review how the organization communicates its quality values and encourages people to act on them. Evidence may include quality briefings, employee orientation, quality objectives, escalation records and corrective action records.
Another significant change under this clause is that Top Management shall actively encourage teams to identify risks and consider relevant opportunities. Examples may include reducing process errors, improving inspection methods or reviewing whether new technology could support consistent results, for example process automation, Artificial Intelligence (AI) integration or process optimization initiatives.