New edition of quality management standard ISO 9001 on the way

What is changing?

The revision of ISO 9001 features limited substantive changes, but introduces several important updates to make the standard clearer, more consistent and future-proof. The main changes are:

• Update to the organization’s context (Clause 4.1)
  Organizations are still required to analyze their context and stakeholders, but there is increased emphasis on relevant trends and developments such as digitalization, sustainability and societal expectations. This ensures that ISO 9001 is better aligned with the changing environment in which organizations operate.
• Leadership and quality culture (5.1 and 7.3)
  Additional requirements are introduced regarding the promotion of a quality-focused culture and ethical behavior within organizations. Top management must demonstrate how they contribute to this, for example, through communication, role modeling and involvement in the quality management system.
• New paragraph on change management (6.3)
  The revised ISO 9001 introduces a new paragraph on the planning and control of changes within the quality management system. This helps organizations to implement changes (in processes, resources or responsibilities) in a structured and controlled way.
• Clearer structure for risks and opportunities (6.1)
  The structure of the requirements regarding risks and opportunities has been revised to create a more logical connection between:
  • Relevant external and internal factors
  • Interested parties and their requirements
  • Risks and opportunities
  • Actions taken in response
    
    The intention is to make the link between risk-based thinking and the achievement of quality objectives more explicit.
• Focus on knowledge management and competence (7.1.6 and 7.2)
  The guidance related to these clauses has been expanded, with additional emphasis on maintaining organizational knowledge and ensuring competence. This aligns with the growing need for continuous learning and knowledge transfer within organizations.
• Annex A clarified
  The informative Annex A has been rewritten to support the interpretation of the requirements. This makes it clearer what ISO 9001 expects from organizations, without adding new obligations.
• Harmonized Structure (HS)
  ISO 9001:2026 will adopt the latest version of the Harmonized Structure, ensuring that its structure and terminology are consistent with other ISO management system standards such as ISO 14001, ISO 45001 and ISO 50001. This makes it easier to integrate multiple systems.

What does this mean for certified organizations?

The revision of ISO 9001 is evolutionary, not revolutionary. The core principles of quality management (customer focus, process approach, continuous improvement) remain unchanged. Nevertheless, it’s advisable to start preparing early, especially since the transition period may be shorter than the usual three years. Kiwa recommends that organizations:

• Study the draft text (DIS) and identify which changes are relevant
• Review internal processes and documentation against the revised requirements
• Inform and, if necessary, train relevant employees
• Develop a transition plan in cooperation with your Kiwa auditor

How Kiwa can support you

Kiwa closely monitors the development of ISO 9001:2026 through the Dutch Standards Committee for Quality Management (NEN) and will share updates as soon as the final version becomes available. We can help ensure a smooth transition with:

• Guidance and audits to align your quality management system with the new standard in time
• Gap-analyses to identify improvement areas and required adjustments
• Training courses on the revised ISO 9001 and its key changes