Key takeaways
- ISO 9001:2026 introduces new expectations around quality culture, ethical behavior, risk and opportunity management, technology and sustainability.
- Organizations with mature quality management systems likely won’t need a complete overhaul, but they should assess and address gaps created by the updated requirements.
- The new standard places greater emphasis on leadership accountability, digital and AI competencies and data integrity in increasingly automated environments.
- Organizations have until September 2029 to transition. Conducting gap assessments, updating processes and training employees early can help support a smoother certification process.
ISO 9001, the highly regarded quality management framework, has been updated for the first time in more than 10 years. In September 2026, the International Organization for Standardization published ISO 9001:2026, replacing ISO 9001:2015.
If your organization already has a mature quality management system (QMS), you will not need to overhaul your program to maintain certification. Instead, you will need to adapt to some revised requirements.
Keep reading to learn what’s new in ISO 9001:2026 and the steps your organization should take to achieve compliance with the updated standard.
What is ISO 9001?
ISO 9001 is an internationally recognized standard for quality management systems. The framework was designed to help organizations deliver consistent products and services and improve overall efficiency.
Businesses and organizations in any industry can find ISO 9001 beneficial. It is most commonly used by:
- Manufacturers
- Service providers
- Healthcare organizations
- Educational institutions
- Construction companies
- Technology companies
- Public organizations
ISO 9001 is voluntary, but certification can be a business driver since many organizations prefer their partners to be certified.
What’s new in ISO 9001:2026?
ISO 9001 was updated to the 2026 version to reflect modern business realities, such as advanced technologies, complex global supply chains and evolving corporate governance expectations. Below are the key changes that will directly impact your operations and upcoming audits:
1. Moving from compliance to quality culture and ethics
What’s new: Under clauses 5.1 and 7.3, leadership accountability has been significantly sharpened. It is no longer enough to mandate quality policies from the top down. Top management must now actively foster, measure and demonstrate a shared, proactive quality culture alongside ethical behavior across all levels of the workforce.
2. Clearer distinction: Managing risks versus capitalizing on opportunities
What’s new: Clause 6.1 moves away from the broader concept of generalized risk-based thinking. The new 2026 framework strictly separates actions to mitigate operational risks (such as cyberthreats and logistical disruptions) from proactive initiatives aimed at pursuing strategic business opportunities.
3. Formal integration of technology, AI and data integrity
What’s new: The standard modernizes how organizational knowledge and infrastructure are managed. Clauses 7 and 8 have been updated to explicitly cover digital workflows, automation, data handling and AI knowledge systems. Organizations must ensure their teams possess the necessary digital competencies and have protocols in place to validate data integrity in automated or paperless environments.
4. Sustainability and climate change mandates
What’s new: The climate change considerations previously introduced in the 2024 amendments to clauses 4.1 and 4.2 are now fully incorporated into the fabric of ISO 9001:2026. Businesses must evaluate whether climate-related issues or broader sustainability (ESG) factors affect their strategic direction and quality objectives.
Timeline: What is the ISO 9001:2026 transition period?
With a September 2029 deadline, organizations have three years to transition from ISO 9001:2015 to the 2026 version.
Do not wait until the final year. The initial phases of this rollout will require internal gap assessments, training updates for your staff and scheduling audits with accredited bodies.
What should businesses do to transition to ISO 9001:2026?
Here are some steps your organization can take to help ensure it’s ready for certification under the new ISO 9001:2026 standard by the 2029 deadline:
- Review the changes in the 2026 version and identify the areas most relevant to your organization.
- Conduct a comprehensive gap analysis that identifies which parts of your current QMS meet the ISO 9001:2026 requirements and which parts fall short.
- Make the necessary changes to processes, documentation and governance. Use this time to simplify, streamline or improve how the system supports the business.
- Communicate the changes to leaders, managers and employees to help them understand their role in making the QMS effective.
- Work with your certification body to finalize an audit plan.
ISO 9001 requirements
ISO 9001 follows the standard ISO structure, with clauses and Annex A. Clauses 4-10 are required, while Annex A provides guidance.
The controls in clauses 4-10 can be tailored to address your organization’s operations and risk profile. If there is a control that does not apply to your organization, you may skip it with a documented, justifiable reason.
To secure certification, your organization will need to undergo an audit conducted by an ISO-accredited certification body.
Here’s a breakdown of ISO 9001 clauses 4-10:
Clause 4: Context of the organization (plan): Analyzes internal and external issues and stakeholder needs.
Examples of common clause 4 controls include:
- Annual SWOT or business environment assessment to identify internal and external issues.
- Stakeholder analysis identifying customer, regulatory, supplier and employee requirements.
- Documented scope statement defining what parts of the organization are included in the QMS.
Clause 5: Leadership (plan): Focuses on management commitment, policies and assigned roles.
Common controls include:
- Approved quality policy communicated to all employees.
- Defined organizational chart with assigned QMS roles and responsibilities.
- Management review meetings where leadership evaluates QMS performance and commitment.
Clause 6: Planning (plan): Addresses risks, opportunities and quality objectives.
Common controls include:
- Risk and opportunity register with assigned owners and mitigation actions.
- Documented quality objectives with measurable targets (examples include 98% on-time delivery, <1% defect rate).
- Change management process to assess impacts before implementing significant operational changes.
Clause 7: Support (do): Manages resources, competence, awareness, communication and documentation.
Common controls include:
- Employee training and competency records for required job roles.
- Document control procedures ensuring only current versions of policies and procedures are used.
- Internal communication processes such as quality meetings, newsletters or dashboards.
Clause 8: Operation (do): Controls product and service creation and delivery.
Common controls include:
- Standard operating procedures (SOPs) and work instructions for production or service delivery.
- Supplier qualification and evaluation process for critical vendors.
- Inspection, testing or quality review checkpoints before release of products or services.
Clause 9: Performance evaluation (check): Monitors, measures, audits and reviews QMS performance.
Common controls include:
- Internal audit program with scheduled audits and corrective action tracking.
- KPI monitoring for metrics such as customer satisfaction, defects, rework or on-time delivery.
- Formal management reviews of audit results, KPIs, risks and improvement opportunities.
Clause 10: Improvement (act): Handles nonconformities, corrective actions and continual improvement.
Common controls include:
- Corrective action process for investigating root causes of nonconformities.
- Continuous improvement program using employee suggestions, Lean or Six Sigma initiatives.
- Lessons learned reviews and effectiveness checks to verify that corrective actions resolved the issue.
Read more
At Wipfli, we can help your organization transition to ISO 9001:2026 and prepare for a successful audit. We can conduct a gap assessment and help you design and implement controls to close any identified gaps. Get started with ISO 9001:2026.