Management system guidance

Updating your quality management system

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How are you preparing for ISO 9001:2026?

ISO 9001:2026 is the upcoming updated version of the international quality management system standard, with publication expected in September 2026.

The Draft International Standard (DIS) was released in June 2025, and the final version will incorporate changes and new requirements for aspects such as risk management, supply chain oversight, sustainability, and emerging technologies like artificial intelligence (AI) and the internet of things (IoT).

Organizations certified to the ISO 9001:2015 standard must transition to the new version within three years following publication.

Who is this information for?

This article is for business owners and quality managers and serves as a reliable resource for ISO 9001:2026 transition preparation. It provides sound, actionable advice when preparing for the new requirements, whilst maintaining a cautious balance between providing useful planning information and acknowledging the preliminary nature of the draft requirements.

What is expected in the new version?

While the final standard is still a work in progress, this information is based on the DIS and subject to change, key changes will focus on incorporating modern business demands like increased risk and resilience, supply chain management, sustainability, digitalization, organizational knowledge, and ethical conduct.

The 2026 draft requirements introduces several targeted updates, many aligning ISO 9001 more closely with the harmonized structure of other ISO management system standards. Among the main changes proposed in the draft (DIS), which may change in the final version:

  1. The proposed amendment in Clause 5.1 Leadership and commitment promotes quality culture and ethical behaviour, with new guidance on how these can be demonstrated.
  2. A clearer separation of risk and opportunity management is proposed for Clause 6.1, with new and updated Subclauses 6.1.1–6.1.3, and expanded guidance.
  3. The climate change amendments from Amd 2024 are now integrated into Clauses 4.1 and 4.2 to ensure organizations formally consider climate-related risks, opportunities, and stakeholder expectations around environmental impact and sustainability commitments. Clause 7.1.5 now proposes a requirement to validate software used for monitoring and measurement, ensuring accurate and reliable quality data.
  4. Some amendments to requirements in Clauses 4 to 10 are proposed. In addition, some notes have been added or amended to explain the current requirements better.

Additionally, Annex A has been significantly expanded to provide improved and more detailed guidance aligned with Clauses 4 to 10 of the standard.

What about the unchanged requirements?

In order to reassure businesses that are already compliant with ISO 9001:2015, the continuity of the unchanged ISO 9001:2015 requirements will remain, so expect to undertake targeted updates to the 2026 version rather than a complete overhaul of your quality management system.

Although new themes such as sustainability, digital quality, and resilience are to be woven into the proposed standard, they are likely to add new dimensions to consider rather than a radical departure from the previous requirements.

What is the projected transition timeline?

Stay informed about the ISO 9001:2026 changes by keeping up with the latest updates and expert insights to ensure your business is ready for the 2026 transition. Subscribe to industry newsletters, network with or follow trusted ISO professionals. Below is a realistic timeline with a phase-based approach, however, timelines are not yet definitive until the new version is officially released, it is likely that by:

  1. September 2025: Draft International Standard (DIS) released, allowing businesses and certification bodies to provide feedback.
  2. September 2026: Final publication of ISO 9001:2026 expected. The standard three-year transition period is expected, during which time, certified organizations must update their management systems to the new standard.
  3. September 2026 to 2027: Early-phase in which companies should start analyzing gaps and aligning their QMS with the new requirements. During this early-phase transition period, we will update our customers with the documentation they need to revise their quality management system.
  4. September 2027 to 2028: Mid-phase in which Certification bodies will update their auditing protocols to assess compliance with the revised standard. This will allow businesses plenty of time to upgrade their quality management systems to incorporate the additional requirements.
  5. September 2028 to 2029: Final-phase in which all businesses must get their systems audit-ready before the transition period ends and complete the formal transition audit before ISO 9001:2015 certifications become invalid.

During the early-phase transition period, organizations can still get certified to the 2015 version, but they will need to convert to the 2026 version by the end of the transition period which is expected in September 2029 to maintain their certification.

Considering an early assessment against the FDIS?

For businesses considering an early assessment against the Final Draft International Standard (FDIS) version, which was released in September 2025, it is worth noting that the FDIS version is out for comment and membership balloting, and it will therefore be subject to change.

What should my business do?

As the ISO 9001:2026 update approaches, organizations must proactively prepare for the anticipated changes. This 7-step preparation process involves understanding the new requirements, assessing current systems, and planning for necessary adjustments.

  1. Monitor Progress: Stay informed and await the final release of the standard and official transition guidelines from Certification Bodies and industry authorities. Once it’s released, purchase a copy of ISO 9001:2026.
  2. Conduct a Gap Analysis: Understand how the current QMS aligns with the new standard. We recommend starting this process early to identify areas that need improvement. Use our free Gap Analysis Tool to assess where your quality management system stands today and identify areas for improvement.
  3. Develop an Action Plan: Start planning by reviewing key changes, engaging leadership, and considering necessary updates to your quality management system before the new standard takes effect.
  4. Review and Update Documentation: As needed, revise your quality manuals, policies, procedures, and other documented information to meet the new requirements.
  5. Train Staff: Ensure employees are aware of the changes and their implications, and that staff at all levels know the upcoming changes and understand their roles in implementing them.
  6. Engage with Stakeholders: Involve relevant parties in the transition process to ensure a smooth implementation.
  7. Undertake Readiness Audits: After completing steps 1 to 6 above, perform internal audits to assess your business’s readiness for the new requirements. These pre-assessments allow businesses to correct issues before the official transition audit.

Our quality management system templates offer a reliable way of achieving process-based compliance to ISO 9001:2015 and will ease the eventual transition to the new version of ISO 9001:2026.

The three-year transition period, which is expected to end in September 2029, is plenty of time to achieve compliance even if you are beginning from scratch today.

How should I plan for the 2026 transition?

The greatest resource of any organization is its people, so strategies for managing real and perceived change, or concerns and attitudes, should be addressed during transition planning. It is likely that during the first few months, Top management will need to regularly reinforce the benefits of the transition project to ensure that your employees maintain focus and motivation for upgrading the quality management system.

Adjusting the quality management system documents should also be expected as staff become accustomed to the requirements and suggest usability improvements. Instant business or quality improvements may be initially observed; however, experience suggests that there is a lag phase before consistent improvements become the norm.

The benefits to the organization of a properly functioning quality management system are not just restricted to the knowledge that it complies with regulatory requirements, but that it has the discipline to manage customer requirements effectively.

What about our existing ISO 9001:2015 documentation?

The extent of the documented information will differ from one organization to another because of the organization's size and its activities, processes, products, and services; the complexity of processes and their interactions, and the competence of personnel. In ISO 9001:2015, the quality manual helped to establish and document the framework of your organization's quality management system while articulating those aspects of the QMS to any interested parties.

While there is still no requirement for a quality manual or documented procedures in ISO 9001:2026, it is suggested that they should not simply be binned if they add value. You will be expected to maintain the integrity of the quality management system during the transition process.

You do not need to renumber your existing documentation to correspond to the new clauses. It is down to each organization to determine whether the benefits gained from renumbering will exceed the effort involved. You do not need to restructure your management system to follow the sequence and titles of the requirements. Providing all of the requirements in ISO 9001:2026 are met, your organization’s quality management system will be compliant.

The following criteria can be used to assess the different types of ISO 9001:2015 documents and information that your organization should retain and maintain as documented information by determining whether the information:

  1. Communicates a message internally or externally;
  2. Provides evidence of process and product conformity;
  3. Provides evidence that planned outputs were achieved;
  4. It is a source of knowledge sharing.

Suppose any of the above criteria apply to any type of document or information within your organization's domain, it should be retained and maintained as a form of 'documented information' per Clause 7.5.

More on ISO 9001:2015

 

More information on PDCA

Planning

Context

ISO 9001:2015
ISO 14001:2015
ISO 45001:2018
4.1 Organizational Context 4.1 Organizational Context 4.1 Organizational Context
4.2 Relevant Interested Parties 4.2 Relevant Interested Parties 4.2 Relevant Interested Parties
4.3 Management System Scope 4.3 Management System Scope 4.3 Management System Scope
4.4 QMS Processes 4.4 EMS Processes 4.4 OH&S Management System

Planning

ISO 9001:2015
ISO 14001:2015
ISO 45001:2018
5.1 Leadership & Commitment 5.1 Leadership & Commitment 5.1 Leadership & Commitment
5.2 Quality Policy 5.2 Environmental Policy 5.2 OH&S Policy
5.3 Roles, Responsibilities & Authorities 5.3 Roles, Responsibilities & Authorities 5.3 Roles, Responsibilities & Authorities
    5.4 Consultation & Participation

Support

ISO 9001:2015
ISO 14001:2015
ISO 45001:2018
6.1 Address Risks & Opportunities 6.1.1 Address Risks & Opportunities 6.1.1 Address Risks & Opportunities
6.2.1 Quality Objectives 6.1.2 Environmental Aspects 6.1.2 Hazard Identifcation
6.2.2 Planning to Achieve Objectives 6.1.3 Compliance Obligations 6.1.3 Legal & Other Requirements
6.3 Planning for Change 6.1.4 Planning Action 6.1.4 Planning Action
  6.2.1 Environmental Objectives 6.2.1 OH&S Objectives
  6.2.2 Planning to Achieve Objectives 6.2.2 Planning to Achieve Objectives
 

Doing

Support

ISO 9001:2015
ISO 14001:2015
ISO 45001:2018
7.1 Resources 7.1 Resources 7.1 Resources
7.2 Competence 7.2 Competence 7.2 Competence
7.3 Awareness 7.3 Awareness 7.3 Awareness
7.4 Communcation 7.4.1 Communcation - General 7.4.1 Communcation - General
7.5 Documented Information 7.4.2 Internal Communcation 7.4.2 Internal Communcation
  7.4.3 External Communcation 7.4.3 External Communcation
  7.5 Documented Information 7.5 Documented Information

Operations

ISO 9001:2015
ISO 14001:2015
ISO 45001:2018
8.1 Operational Planning & Control 8.1 Operational Planning & Control 8.1.1 General
8.2 Customer Requirements 8.2 Emergency Preparedness 8.1.2 Eliminating Hazards
8.3 Design & Development   8.1.3 Management of Change
8.4 Purchasing   8.1.4 Outsourcing
8.5 Product & Service Provision   8.2 Emergency Preparedness
8.6 Release of Products & Services    
8.7 Nonconforming Outputs    
 

Checking

Monitoring, measurement, analysis and evaluation

ISO 9001:2015
ISO 14001:2015
ISO 45001:2018
9.1 Monitoring & Measurement 9.1.1 Performance Evaluation 9.1.1 Performance Evaluation
9.2 Internal Audit 9.1.2 Evaluation of Compliance 9.1.2 Evaluation of Compliance
9.3 Management Review 9.2 Internal Audit 9.2 Internal Audit
  9.3 Management Review 9.3 Management Review
 

Acting

Improvement

ISO 9001:2015
ISO 14001:2015
ISO 45001:2018
10.1 Improvement - General 10.1 Improvement - General 10.1 Improvement - General
10.2 Nonconformity & Corrective Action 10.2 Nonconformity & Corrective Action 10.2 Incident, Nonconformity & Corrective Action
10.3 Continual Improvement 10.3 Continual Improvement 10.3 Continual Improvement
 

How to apply the latest quality management principles

The latest and current quality management principles (QMPs), stated in ISO 9000:2015, are intended to provide the foundation by which any organization can continually improve its performance.

You can learn to apply the latest quality management principles in the context of your business's own particular operations by reviewing and documenting its activities in the context of each quality management principle.

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ISO Navigator™ is our FREE online training tool that shows you how to apply the principles of PDCA to your operations. We also offer many helpful templates that get you on the road to documenting your management system, please visit the download page.