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ISO 9001:2026 Changes: Clauses, Requirements & Guide

Learn the ISO 9001:2026 changes clause by clause, compare 2015 vs 2026, and understand requirements, implementation, gap analysis and transition.

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ISO 9001:2026 Changes: Clause-by-Clause Guide, Requirements & Implementation

ISO 9001:2026 Changes: Clause-by-Clause Guide, Requirements & Implementation
Explore the ISO 9001:2026 changes clause by clause, including new requirements, 2015 vs 2026 differences, implementation, gap analysis and transition guidance.

ISO 9001:2026 Changes: Clause-by-Clause Guide, Requirements & Implementation

ISO 9001:2026 is now the current edition of the ISO 9001 Quality Management System standard. Published on 16 September 2026, it replaces ISO 9001:2015 and retains the familiar Quality Management System structure while introducing clearer wording, stronger emphasis on leadership and quality culture, greater clarity around risks and opportunities, and a new Annex A intended to explain key terms and the intent of requirements.

For organizations already certified to ISO 9001:2015, the release of ISO 9001:2026 means it is time to review the existing QMS, identify relevant changes and prepare for transition. For organizations seeking certification for the first time, the 2026 edition is the version that should now be considered when planning a new ISO 9001 Quality Management System.

This guide explains the ISO 9001:2026 changes clause by clause, compares ISO 9001:2026 with ISO 9001:2015, explains the practical requirements for implementation, and outlines what organizations should consider before certification.

What Is ISO 9001:2026?

ISO 9001:2026 is the sixth edition of ISO 9001, the internationally recognized standard for Quality Management Systems.

It provides requirements for establishing, implementing, maintaining and continually improving a QMS so that an organization can consistently provide products and services that meet customer and applicable requirements.

ISO 9001:2026 can be applied by organizations of different sizes, structures and industries. Manufacturing companies, construction businesses, engineering firms, logistics providers, IT companies, healthcare organizations, educational institutions, professional service companies, trading businesses and government suppliers can all establish a QMS based on the standard.

ISO confirms that ISO 9001 is the only standard in the ISO 9000 family that organizations can be certified to. Certification itself is not mandatory unless a customer, contract, tender, regulator or other business requirement makes it necessary.

The purpose of ISO 9001:2026 is not simply to create more documents. The QMS should provide a practical framework for managing processes, responsibilities, customer requirements, operational controls, performance, risks and opportunities, corrective action and continual improvement.


Why Was ISO 9001 Revised in 2026?

ISO standards are periodically reviewed to ensure that they remain relevant to organizations and their changing operating environments.

ISO 9001:2015 provided the foundation for the previous generation of quality management systems. The 2026 revision continues that foundation rather than replacing the entire management-system approach.

According to ISO/TC 176, the revision focuses on improving clarity and usability. Areas receiving greater emphasis include leadership, quality culture, accountability, risks and opportunities, and alignment with other ISO management-system standards. The revised standard also introduces a new Annex A to help clarify terminology and the intent behind requirements.

This means organizations should not automatically assume that an ISO 9001:2015 system has to be completely rebuilt.

A more practical approach is:

Review → Compare → Identify gaps → Update → Implement → Audit → Improve → Transition


What Are the Main ISO 9001:2026 Changes?

The most important point about ISO 9001:2026 is that it builds on the established ISO 9001 framework.

The revision should therefore be approached as a structured update to the QMS rather than an entirely new management system.

Important themes include:

  • Clearer requirements and wording
  • Stronger focus on leadership
  • Greater emphasis on quality culture
  • Clearer accountability
  • Greater clarity around risks and opportunities
  • Continued emphasis on customer requirements
  • Stronger connection between organizational context and the QMS
  • Greater alignment with other ISO management-system standards
  • New Annex A explaining key terms and the intent of requirements
  • Continued emphasis on performance evaluation and continual improvement

These themes affect how organizations should review their current QMS, even where the underlying process already exists.


ISO 9001:2026 Clause-by-Clause Requirements

The most useful way to understand ISO 9001:2026 is to look at the standard clause by clause.

Clauses 1, 2 and 3 provide introductory material, references and terminology. The main management-system requirements begin with Clause 4.

The operational QMS requirements are primarily contained in Clauses 4 through 10.


Clause 4: Context of the Organization

Clause 4 addresses the organization's context and establishes the foundation for the QMS.

An organization needs to understand the circumstances that can affect its ability to achieve the intended results of its Quality Management System.

This includes considering relevant internal and external issues and identifying interested parties and their relevant requirements.

What should organizations review for ISO 9001:2026?

Organizations should review whether their existing context analysis still accurately reflects the business.

Consider:

  • Changes in the organization's structure
  • Changes in markets or customers
  • Technology changes
  • Regulatory developments
  • Supply-chain conditions
  • Competitive pressures
  • Internal capabilities
  • Organizational knowledge
  • Relevant interested parties
  • Customer expectations
  • Risks and opportunities affecting QMS performance

The purpose is not to create a long list of external issues simply to satisfy an audit.

The context should actually help management understand the conditions that can influence the effectiveness of the QMS.

ISO 9001:2026 implementation consideration

A useful review should connect organizational context to the rest of the QMS.

For example, if a company has become more dependent on outsourced production, that change should have implications for supplier controls, operational planning, risk management and performance monitoring.

This is where Clause 4 becomes practical rather than purely documentary.


Clause 5: Leadership

Leadership remains a central part of ISO 9001:2026.

The 2026 revision places greater emphasis on leadership, quality culture and accountability.

Top management should demonstrate that quality is part of the way the organization is managed rather than something delegated entirely to the quality department.

What should management review?

Management should consider whether:

  • Quality objectives are connected with business objectives
  • Responsibilities are clearly assigned
  • Customer requirements are understood
  • Employees understand the importance of quality
  • Management actively supports the QMS
  • Resources are available
  • Quality performance is reviewed
  • Problems are addressed at the appropriate level
  • Continual improvement is encouraged

Quality culture under ISO 9001:2026

A quality culture is not created by writing the words “quality culture” into a procedure.

It is demonstrated through management behaviour.

Examples include:

  • Taking customer complaints seriously
  • Investigating recurring problems
  • Allocating resources to quality improvement
  • Encouraging employees to report issues
  • Following agreed processes
  • Reviewing quality performance
  • Taking corrective action
  • Learning from failures
  • Making quality part of everyday decision-making

This is particularly important for organizations transitioning from ISO 9001:2015 to ISO 9001:2026.


Clause 6: Planning

Clause 6 addresses planning within the QMS.

This includes quality objectives, planning actions and consideration of risks and opportunities.

Organizations should understand how risks and opportunities can affect the intended results of the QMS and determine appropriate actions.

ISO 9001:2026 and risks and opportunities

Risk-based thinking was already an important part of ISO 9001:2015.

The 2026 revision provides greater clarity around risks and opportunities, making it particularly important for organizations to review how these concepts are currently handled.

A useful risk and opportunity process should connect with actual business activities.

For example:

Risk: Dependence on a single critical supplier

Possible consequence: Production interruption

Action: Qualify an alternative supplier and establish monitoring criteria

Performance measure: Supplier delivery and conformity performance

This is more useful than maintaining a generic risk register that is disconnected from business processes.

Quality objectives

Quality objectives should be measurable where appropriate and relevant to the organization's activities.

Examples may include:

  • Customer complaint reduction
  • On-time delivery
  • Product conformity
  • Service response time
  • Rework reduction
  • Supplier performance
  • Customer satisfaction
  • Process efficiency
  • Corrective-action closure
  • Defect reduction

The objectives should be monitored and reviewed rather than created only for certification purposes.


Clause 7: Support

Clause 7 covers the resources and support needed to operate an effective QMS.

This includes areas such as:

  • Resources
  • Competence
  • Awareness
  • Communication
  • Documented information
  • Organizational knowledge
  • Infrastructure
  • Monitoring and measurement resources

Competence

Employees performing work that affects QMS performance should have the necessary competence.

Organizations should therefore review:

  • Job responsibilities
  • Qualification requirements
  • Training
  • Experience
  • Competence evaluation
  • Awareness
  • Training effectiveness

A training attendance sheet alone does not necessarily demonstrate competence.

The organization should be able to show how it determines whether employees are capable of performing their assigned responsibilities.

Organizational knowledge

Knowledge required for processes should be identified and maintained.

This can include:

  • Technical knowledge
  • Customer requirements
  • Process knowledge
  • Lessons learned
  • Product knowledge
  • Regulatory knowledge
  • Supplier knowledge
  • Operational experience

Organizations should consider what happens when an experienced employee leaves.

If important operational knowledge exists only in one person's memory, the organization may have a knowledge-management weakness.

Documented information

ISO 9001:2026 continues to require appropriate documented information.

However, organizations should avoid creating unnecessary paperwork.

Useful documented information can include:

  • Policies
  • Procedures
  • Process information
  • Work instructions
  • Forms
  • Records
  • Quality objectives
  • Audit evidence
  • Management-review records
  • Corrective-action records
  • Monitoring results

The objective should be controlled and useful information, not documentation for its own sake.


Clause 8: Operation

Clause 8 is one of the most important parts of ISO 9001 because it connects the QMS with the organization's actual products and services.

It covers operational planning and control, customer requirements, design and development where applicable, externally provided processes, production and service provision, release, and nonconforming outputs.

Clause 8.1 — Operational Planning and Control

Organizations need to plan, implement and control the processes required to meet product and service requirements.

This means the QMS should be connected to actual operations.

Depending on the organization, this could involve:

  • Production planning
  • Service delivery
  • Project planning
  • Inspection
  • Testing
  • Procurement
  • Outsourcing
  • Customer communication
  • Acceptance criteria
  • Operational controls
  • Process monitoring

Clause 8.2 — Requirements for Products and Services

Organizations need to determine and review applicable requirements for products and services.

This includes understanding what the customer expects and ensuring that the organization can meet the requirements before making commitments.

Relevant controls can include:

  • Customer enquiries
  • Quotations
  • Contracts
  • Purchase orders
  • Technical specifications
  • Regulatory requirements
  • Delivery requirements
  • Changes to customer requirements

Customer requirements should not be assumed.

They should be identified, reviewed and communicated to the people responsible for fulfilling them.

Clause 8.3 — Design and Development

Where design and development applies, the organization needs appropriate controls for the design and development process.

This may include:

  • Design planning
  • Inputs
  • Controls
  • Reviews
  • Verification
  • Validation
  • Outputs
  • Design changes

Not every organization needs Clause 8.3 in the same way.

An organization that manufactures products based on its own designs may have extensive design controls, while a business providing a standardized service may have a different applicability determination.

Clause 8.4 — Externally Provided Processes, Products and Services

Supplier and outsourced-process controls remain an important part of the QMS.

Organizations should determine appropriate controls based on the effect of externally provided products and services on their ability to meet requirements.

Supplier management may include:

  • Supplier evaluation
  • Supplier selection
  • Approved supplier lists
  • Purchase specifications
  • Supplier performance monitoring
  • Incoming inspection
  • Re-evaluation
  • Corrective action

A supplier should not necessarily be treated as low risk simply because it has worked with the organization for several years.

Supplier performance should be monitored according to actual business risk and requirements.

Clause 8.5 — Production and Service Provision

Production and service processes should operate under controlled conditions.

Depending on the business, controls can include:

  • Work instructions
  • Process parameters
  • Competent personnel
  • Suitable equipment
  • Monitoring
  • Inspection
  • Identification
  • Traceability
  • Property belonging to customers or external providers
  • Preservation
  • Post-delivery activities
  • Change control

The evidence expected will vary according to the organization's activities.

Clause 8.6 — Release of Products and Services

The organization should verify that applicable requirements have been met before releasing a product or service.

Evidence may include:

  • Inspection records
  • Test results
  • Approval records
  • Service completion records
  • Customer acceptance
  • Release authorization

Clause 8.7 — Control of Nonconforming Outputs

Organizations need a controlled approach for dealing with products or services that do not meet requirements.

This can involve:

  • Identification
  • Segregation
  • Correction
  • Rework
  • Rejection
  • Customer notification
  • Concession where appropriate
  • Verification after correction

The organization should also look beyond individual defects and identify recurring problems that may require corrective action.

Future Clause 8 content

Clause 8 is broad enough to support a dedicated future article such as “ISO 9001:2026 Clause 8: Operation Requirements Explained.”

That future article can cover operational planning, customer requirements, design and development, supplier controls, production, service provision, release and nonconforming outputs in substantially greater detail without making the current article dependent on an excessive Clause 8 discussion.


Clause 9: Performance Evaluation

Clause 9 focuses on understanding whether the QMS is actually working.

It covers:

  • Monitoring
  • Measurement
  • Analysis
  • Evaluation
  • Customer satisfaction
  • Internal audit
  • Management review

Monitoring and measurement

Organizations should identify meaningful performance indicators.

These may include:

  • Defect rates
  • Customer complaints
  • Delivery performance
  • Customer satisfaction
  • Supplier performance
  • Rework
  • Process efficiency
  • Audit findings
  • Corrective-action performance

The important point is not the number of KPIs.

The important point is whether the information helps management understand QMS performance and make appropriate decisions.

Customer satisfaction

Customer satisfaction information can come from different sources.

Examples include:

  • Complaints
  • Surveys
  • Customer reviews
  • Repeat business
  • Returns
  • Warranty information
  • Customer meetings
  • Delivery performance
  • Customer feedback

A company should not rely solely on a customer survey if other available information shows recurring customer problems.

Internal audit

Internal audits should evaluate whether the QMS conforms to applicable requirements and is effectively implemented and maintained.

A useful internal audit should examine how processes actually operate.

Auditors can ask:

  • What is the process?
  • Who is responsible?
  • What requirements apply?
  • What records are generated?
  • What can go wrong?
  • How is performance measured?
  • What happens when requirements are not met?
  • What improvement actions have been taken?

Management review

Top management should review the QMS at appropriate intervals.

Management review inputs can include:

  • Audit results
  • Customer feedback
  • Process performance
  • Quality objectives
  • Supplier performance
  • Nonconformities
  • Corrective actions
  • Risks and opportunities
  • Changes affecting the QMS
  • Improvement opportunities

The outputs should lead to decisions and actions where appropriate.


Clause 10: Improvement

Clause 10 addresses improvement, nonconformity, corrective action and continual improvement.

An effective QMS should not merely maintain the current situation.

It should provide a mechanism for identifying problems and improving processes.

Nonconformity and corrective action

When a problem occurs, an organization should determine an appropriate response.

A useful corrective-action process considers:

  1. What happened?
  2. What requirement was not met?
  3. What immediate correction is necessary?
  4. Why did the problem occur?
  5. Is the problem likely to happen again?
  6. What corrective action is required?
  7. Was the action effective?

This helps distinguish correction from corrective action.

Correction addresses the immediate problem.

Corrective action addresses the cause and helps prevent recurrence.

Continual improvement

Continual improvement can include:

  • Process improvements
  • Reduced defects
  • Improved customer service
  • Better supplier performance
  • Reduced waste
  • Improved efficiency
  • Improved employee competence
  • Better use of data
  • Technology improvements
  • Simplified processes

Improvement does not always mean implementing a major new project.

Small, consistent improvements can also strengthen QMS performance.


ISO 9001:2026 vs ISO 9001:2015

ISO 9001:2026 should not be viewed as a completely different management-system model.

The fundamental structure remains recognizable.

Area ISO 9001:2015 ISO 9001:2026
QMS framework Established framework Framework retained and refined
Organizational context Required Continued with greater clarity
Leadership Required Stronger emphasis on leadership and accountability
Quality culture Present through QMS principles and leadership Greater emphasis
Risks and opportunities Required Greater clarity
Planning Required Continued
Support Required Continued
Operation Required Continued
Performance evaluation Required Continued
Improvement Required Continued
Annex A Existing supporting material New Annex A to clarify key terms and intent
Alignment with other ISO standards Harmonized structure Further alignment and clarity

ISO describes the 2026 edition as building on the established framework rather than abandoning it.


What Has Not Changed in ISO 9001:2026?

Organizations should avoid assuming that every part of their QMS needs to change.

The central purpose remains quality management and the consistent delivery of products and services that meet customer and applicable requirements.

The familiar management-system areas remain important:

  • Context
  • Leadership
  • Planning
  • Support
  • Operation
  • Performance evaluation
  • Improvement
  • Customer focus
  • Process management
  • Internal auditing
  • Management review
  • Corrective action
  • Continual improvement

The practical question for an existing organization is therefore not:

“How do we rebuild everything?”

It is:

“Which parts of our existing QMS need to be changed, clarified or strengthened to meet ISO 9001:2026?”


ISO 9001:2026 New Requirements and Clarifications

The term “new requirements” should be used carefully.

Not every updated phrase represents an entirely new process that organizations must create from scratch.

Some changes are intended to make existing expectations clearer.

For implementation purposes, organizations should pay particular attention to:

  • Leadership involvement
  • Quality culture
  • Accountability
  • Organizational context
  • Risks and opportunities
  • Customer requirements
  • Operational controls
  • Performance evaluation
  • Continual improvement
  • Terminology and intent explained through Annex A

ISO/TC 176 specifically describes the revision as including clearer wording and greater clarity around risks and opportunities, while also strengthening emphasis on leadership, quality culture and accountability.


ISO 9001:2026 Implementation

Implementing ISO 9001:2026 should start with the organization's existing business processes.

A practical implementation sequence is:

1. Understand the 2026 standard

Management and relevant personnel should understand the revised requirements and how they apply to the organization.

2. Define the QMS scope

Identify the locations, activities, products and services covered by the Quality Management System.

3. Review organizational context

Update internal and external issues and relevant interested-party requirements.

4. Review leadership responsibilities

Confirm that management responsibilities, authority and accountability are clear.

5. Review risks and opportunities

Compare the existing risk-based approach with the 2026 requirements and update it where necessary.

6. Review processes

Map the organization's key processes and their interactions.

7. Review documented information

Remove outdated information and update documents that no longer reflect actual processes.

8. Implement changes

Ensure employees understand and follow revised arrangements.

9. Conduct an internal audit

Test whether the revised QMS is working in practice.

10. Conduct management review

Management should evaluate QMS performance and decide on required actions.

11. Address nonconformities

Correct identified weaknesses and verify corrective-action effectiveness.

12. Prepare for certification or transition

Confirm readiness with the certification body and establish the appropriate audit route.


ISO 9001:2026 Gap Analysis

A gap analysis provides a practical way to compare the current QMS with ISO 9001:2026.

A useful gap assessment can review:

QMS Area Review Question
Context Does our context still reflect the current business?
Interested parties Are relevant requirements identified?
Leadership Is management visibly accountable for QMS performance?
Quality culture Do employees understand the importance of quality?
Risks Are risks and opportunities properly identified and addressed?
Objectives Are quality objectives relevant and measurable?
Competence Are employees competent for assigned responsibilities?
Documentation Is documented information current and useful?
Operations Are operational processes controlled?
Suppliers Are external providers appropriately controlled?
Customer requirements Are requirements reviewed before commitments are made?
Monitoring Are meaningful performance measures available?
Internal audit Does auditing evaluate actual QMS performance?
Management review Does management use QMS information for decisions?
Improvement Are recurring problems investigated and addressed?

The result should be a practical action plan rather than simply a list of clauses.


ISO 9001:2015 to ISO 9001:2026 Transition

Organizations already certified to ISO 9001:2015 should review their transition requirements with their certification body.

ISO/TC 176 has published transition guidance stating that accreditation bodies are to be ready to assess ISO 9001:2026 by 31 March 2027. Accredited certification bodies have transition-related submission requirements by 30 June 2027, with accreditation-body transition decisions scheduled by 30 September 2027. From 31 March 2028, new and initial accredited certifications may only be issued to ISO 9001:2026. Organizations currently certified to ISO 9001:2015 have until 30 September 2029 to complete their transition.

Transition may take place through:

  • A scheduled surveillance audit
  • A recertification audit
  • A separate transition audit

The applicable arrangements should be confirmed directly with the certification body because the audit route and timing can depend on the organization's certification cycle.


ISO 9001:2026 Transition Timeline

The published transition milestones can be summarized as follows:

16 September 2026
ISO 9001:2026 published.

31 March 2027
Accreditation bodies are to be ready to assess certification bodies against the revised standard.

30 June 2027
Accredited certification bodies are required to submit their transition declaration and supporting information.

30 September 2027
Accreditation-body transition decisions are scheduled to be completed.

31 March 2028
New and initial accredited certifications may only be issued to ISO 9001:2026.

30 September 2029
Existing ISO 9001:2015 certificates must have completed transition.

Organizations should use these dates for planning rather than waiting until the end of the transition period.


Does an ISO 9001:2015 QMS Need to Be Completely Rebuilt?

Generally, organizations should not assume that a complete rebuild is necessary.

ISO describes ISO 9001:2026 as building on the established ISO 9001 framework.

An organization with a mature QMS may already have many of the processes needed for the revised standard.

The transition exercise should therefore identify:

  • What already works
  • What needs clarification
  • What needs updating
  • What evidence needs strengthening
  • What employees need to understand
  • What processes require additional control
  • What documented information is outdated

This approach can make transition more manageable and reduce unnecessary documentation.


ISO 9001:2026 Documentation Requirements

One of the common mistakes during ISO implementation is creating documentation simply because an organization believes every requirement needs a separate procedure.

The better approach is to determine what documented information is necessary for the organization to operate effectively and demonstrate conformity.

Depending on the business, this can include:

  • Quality policy
  • Quality objectives
  • Process information
  • Procedures
  • Work instructions
  • Forms
  • Records
  • Inspection results
  • Training records
  • Supplier evaluations
  • Internal audit reports
  • Management review records
  • Corrective-action records
  • Customer-related records

Documentation should reflect how the organization actually works.

A document that nobody follows is unlikely to strengthen the QMS.


ISO 9001:2026 Certification Preparation

Organizations preparing for certification should consider the entire certification cycle rather than focusing only on the final audit.

A practical preparation process includes:

Define the scope

Identify exactly what the certification covers.

Understand requirements

Review ISO 9001:2026 against the organization's activities.

Conduct a gap analysis

Identify missing or weak areas.

Implement the QMS

Make sure the processes operate in practice.

Train employees

Personnel should understand the processes relevant to their roles.

Conduct an internal audit

Evaluate conformity and effectiveness.

Complete management review

Ensure management has reviewed QMS performance.

Close significant gaps

Address nonconformities and improvement actions.

Prepare for certification audit

Make the relevant evidence available to the audit team.


ISO 9001:2026 Audit Preparation

A certification audit is not simply an examination of documents.

Auditors can look at whether the QMS is implemented and effective within the agreed certification scope.

Organizations should therefore be prepared to demonstrate:

  • How customer requirements are identified
  • How processes are controlled
  • How employees are made competent
  • How suppliers are controlled
  • How risks and opportunities are addressed
  • How quality objectives are monitored
  • How customer satisfaction is evaluated
  • How internal audits are conducted
  • How management reviews performance
  • How nonconformities are handled
  • How continual improvement is demonstrated

Evidence should correspond to the organization's actual activities.


ISO 9001:2026 for Small Businesses and SMEs

ISO 9001:2026 is not limited to large corporations.

Small and medium-sized businesses can implement a QMS appropriate to their size, complexity and operations.

A small organization may have:

  • Fewer employees
  • Fewer processes
  • One location
  • A smaller supplier network
  • Simpler documentation
  • Direct management involvement

That does not mean it cannot operate an effective QMS.

The important point is that the management system should be appropriate to the organization.

A small engineering company should not create a management system simply because a multinational company uses similar paperwork.


ISO 9001:2026 for Manufacturing Companies

Manufacturing organizations may use ISO 9001:2026 to structure processes covering:

  • Production planning
  • Purchasing
  • Supplier control
  • Incoming inspection
  • Production controls
  • Equipment
  • Calibration
  • Product identification
  • Traceability
  • Final inspection
  • Nonconforming products
  • Customer complaints
  • Corrective action
  • Performance monitoring

The actual controls should be based on the organization's products, processes and customer requirements.


ISO 9001:2026 for Construction and Engineering Companies

Construction and engineering organizations can apply ISO 9001:2026 to areas such as:

  • Project planning
  • Contract review
  • Design management
  • Procurement
  • Subcontractor controls
  • Material inspection
  • Site activities
  • Document control
  • Technical approvals
  • Nonconforming work
  • Project handover
  • Customer communication
  • Corrective action

The QMS should connect with the organization's project-management processes rather than operate as a separate paperwork system.


ISO 9001:2026 for IT and Service Companies

ISO 9001:2026 also applies to service organizations.

IT companies, software businesses, consultants, logistics providers, healthcare organizations and professional service firms can establish processes around:

  • Customer requirements
  • Service delivery
  • Competence
  • Service performance
  • Supplier management
  • Customer feedback
  • Complaints
  • Corrective action
  • Process monitoring
  • Continual improvement

The evidence used to demonstrate conformity will naturally differ from a manufacturing company.


ISO 9001:2026 and Customer Requirements

Customer focus remains central to ISO 9001.

Organizations should understand:

  • What the customer has requested
  • What the contract requires
  • What statutory or regulatory requirements apply
  • Whether the organization can fulfil the requirements
  • How changes will be controlled
  • How customer feedback will be handled

This is especially important when businesses accept projects with complex specifications or multiple contractual requirements.


ISO 9001:2026 and Supplier Management

External providers can have a significant effect on quality.

Supplier controls should therefore reflect the importance and risk associated with the purchased product, service or outsourced process.

A critical supplier may require more detailed evaluation and performance monitoring than a low-risk supplier.

Useful supplier performance indicators can include:

  • Delivery performance
  • Product conformity
  • Response time
  • Complaint frequency
  • Corrective-action performance
  • Reliability
  • Technical capability

ISO 9001:2026 and Continual Improvement

Continual improvement is not limited to correcting audit findings.

Organizations can use:

  • Customer feedback
  • Audit results
  • Process data
  • Complaint trends
  • Supplier performance
  • Employee suggestions
  • Management review
  • Risk information
  • Operational results

to identify improvement opportunities.

The strongest QMS is one that provides management with useful information for improving the business.


Common ISO 9001:2026 Implementation Mistakes

Organizations preparing for ISO 9001:2026 should avoid several common problems.

Treating the revision as a paperwork exercise

Updating documents without changing ineffective processes does not create a stronger QMS.

Assuming everything has changed

The 2026 edition builds on the existing ISO 9001 framework. A complete rebuild may not be necessary.

Ignoring leadership

Quality should not be treated as the responsibility of one quality manager.

Creating generic risk registers

Risk information should relate to real organizational processes.

Using meaningless KPIs

Measurements should provide useful information about process and QMS performance.

Ignoring employees

People operating the processes need to understand relevant changes.

Waiting until the transition deadline

Organizations that begin reviewing their QMS early have more time to identify and correct weaknesses.

Focusing only on certification

The certificate is evidence of conformity within an agreed scope. The QMS itself should support the organization's actual operations.


How to Start ISO 9001:2026 Implementation

If your organization already has ISO 9001:2015 certification, start by reviewing the current QMS against ISO 9001:2026.

If you are starting from the beginning, establish the QMS around your actual business processes.

A useful starting checklist is:

  • Identify the certification scope
  • Understand the organization's context
  • Identify relevant interested parties
  • Review customer requirements
  • Establish quality objectives
  • Identify risks and opportunities
  • Map key processes
  • Define responsibilities
  • Determine competence requirements
  • Control documented information
  • Establish operational controls
  • Evaluate suppliers
  • Monitor performance
  • Conduct internal audits
  • Conduct management review
  • Implement corrective action
  • Establish continual improvement
  • Prepare for certification

ISO 9001:2026 Certification by Country

Organizations looking for country-specific certification information can use the relevant SCS Certification guides below.

These pages focus primarily on certification requirements, certification scope, audit arrangements, commercial requirements, locations and quotation-related information rather than replacing the technical clause-by-clause guidance in this article.

UAE

ISO 9001:2026 Certification in UAE – A Practical Guide for Businesses

For organizations operating in Dubai, Abu Dhabi, Sharjah, Ajman, Umm Al Quwain, Ras Al Khaimah and Fujairah, the appropriate certification scope should reflect the organization's actual activities and locations.

Saudi Arabia

ISO 9001:2026 Certification in Saudi Arabia – Get Certified with SCS

The Saudi Arabia guide addresses certification scope, audit requirements, certification cost considerations and business requirements.

Oman

ISO 9001:2026 Certification in Oman – Get Certified with SCS

The Oman guide covers certification considerations for businesses in locations including Muscat, Sohar, Salalah, Nizwa, Sur and Duqm.

Qatar

ISO 9001:2026 Certification in Qatar – Get Certified with SCS

The Qatar guide addresses certification scope and requirements for businesses operating in Doha, Al Rayyan, Al Wakrah, Lusail, Al Khor, Mesaieed and Ras Laffan.

Kuwait

ISO 9001:2026 Certification in Kuwait – Get Certified with SCS

The Kuwait guide focuses on certification scope, cost, timelines, business requirements and transition considerations.

Bahrain

ISO 9001:2026 Certification in Bahrain – Get Certified with SCS

The Bahrain guide focuses on certification for customer, tender, supplier and business requirements.

India

ISO 9001:2026 Certification in India – Get Certified with SCS

The India guide covers certification for organizations across manufacturing, textiles, transport, energy, engineering, construction, healthcare, pharmaceuticals, IT, logistics and other sectors.

Malaysia

ISO 9001:2026 Certification in Malaysia – Get Certified with SCS

The Malaysia guide addresses certification requirements, scope, cost, timelines, industries and locations.

United Kingdom

ISO 9001:2026 Certification in UK – A Practical Guide for Businesses

The UK guide covers certification and transition considerations across England, Scotland, Wales and Northern Ireland.


ISO 9001:2026 Certification and Commercial Requirements

ISO 9001 certification can be relevant when a business is responding to:

  • Customer qualification requirements
  • Supplier registration
  • Contractor requirements
  • Tender conditions
  • Procurement requirements
  • International supply-chain requirements
  • Internal quality-management objectives

However, certification does not automatically guarantee contract awards, tender success or customer approval.

The exact requirement should always be checked against the relevant tender, contract, customer or supplier-registration documentation.

This distinction is important because certification demonstrates conformity of the QMS within its agreed scope; it does not replace the commercial or technical qualifications of a supplier.


ISO 9001:2026 Certification Process

A typical certification route can include:

Initial enquiry

The organization provides information about its activities, locations, workforce and proposed scope.

Certification scope review

The activities and locations to be covered are established.

Application and quotation

The certification requirements and audit arrangements are determined.

Stage 1 audit

The certification body's audit team reviews relevant aspects of the management system and readiness.

Stage 2 audit

The QMS is assessed for implementation and conformity against the applicable requirements.

Corrective action

Where nonconformities are identified, the organization addresses them according to the applicable certification process.

Certification decision

Following satisfactory completion of the certification process, certification can be issued within the agreed scope.

The exact audit arrangements depend on factors such as organization size, complexity, locations, scope and applicable certification requirements.


How ISO 9001:2026 Can Support Business Improvement

A well-implemented QMS can provide a structured way to manage quality throughout an organization.

Potential areas of improvement include:

  • More consistent processes
  • Better customer requirement management
  • Improved supplier control
  • Fewer recurring problems
  • Better use of performance information
  • Clearer responsibilities
  • Improved customer satisfaction
  • More structured corrective action
  • Better management visibility
  • Stronger continual improvement

The value comes from how the QMS is used.

A certificate on its own does not create an effective quality system.


ISO 9001:2026: What Organizations Should Do Now

The publication of ISO 9001:2026 marks the beginning of a transition period rather than a reason to immediately replace every existing QMS document.

Organizations should begin with a structured review.

For existing ISO 9001:2015 certificate holders, the immediate priorities are:

  1. Obtain and review the ISO 9001:2026 requirements.
  2. Understand the differences relevant to the organization.
  3. Conduct a gap assessment.
  4. Review leadership and quality-culture arrangements.
  5. Review risks and opportunities.
  6. Check organizational context.
  7. Review operational controls.
  8. Update relevant documented information.
  9. Communicate changes to employees.
  10. Conduct an internal audit.
  11. Complete management review.
  12. Discuss the transition route with the certification body.

For new applicants, the starting point is different: establish a QMS that reflects the current ISO 9001:2026 requirements and the organization's actual business processes.


ISO 9001:2026: Final Considerations

ISO 9001:2026 is an important update to the world's most widely used Quality Management System standard, but its foundation remains familiar.

The biggest practical mistake would be to treat the revision as either completely insignificant or as a requirement to rebuild the entire organization.

A better approach is to understand the changes, examine the existing QMS and identify where improvements are genuinely required.

Clauses 4 through 10 continue to provide the core structure:

Clause 4 — Context of the Organization
Understand the environment in which the QMS operates.

Clause 5 — Leadership
Ensure management ownership, accountability and quality culture.

Clause 6 — Planning
Address quality objectives, risks and opportunities.

Clause 7 — Support
Provide the resources, competence, awareness, communication and information needed by the QMS.

Clause 8 — Operation
Control the processes used to deliver products and services.

Clause 9 — Performance Evaluation
Measure, audit and review QMS performance.

Clause 10 — Improvement
Address nonconformities and continually improve the management system.

The ISO 9001:2026 transition should therefore be treated as an opportunity to make the QMS clearer, more relevant and more closely connected to how the business actually operates.

Organizations should also confirm the applicable certification and transition requirements directly with their certification body, particularly where certification is needed for a tender, customer approval, supplier qualification or contractual requirement.

Authoritative References

ISO 9001:2026 — Quality Management Systems — Requirements
https://www.iso.org/standard/9001.html

ISO/TC 176 — ISO 9001:2026 Release and Transition Guidance
https://committee.iso.org/sites/tc176/home/news/content-left-area/news-and-updates/news.html

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Frequently Asked Questions

ISO 9001:2026 is the current edition of the international Quality Management System standard. It gives organizations a practical framework for consistently meeting customer and applicable requirements while improving the way their processes work.
ISO 9001:2026 was published on 16 September 2026 and replaces ISO 9001:2015 as the current edition.
Yes. ISO 9001:2026 is currently the latest edition. Organizations seeking a new certification should plan against this edition, while existing ISO 9001:2015 certificate holders should plan their transition.
The revision puts more attention on leadership, quality culture, ethical behaviour, business strategy, risks and opportunities, people and awareness. It also introduces a new Annex A to explain important concepts and the intent behind requirements.
No. The basic management-system framework remains familiar. An organization with a working ISO 9001:2015 QMS should first identify what has changed and what needs strengthening instead of assuming everything has to be rebuilt.
The 2026 edition keeps the established QMS structure but gives clearer attention to areas such as leadership, quality culture, strategic alignment, risks and opportunities, people awareness and supporting guidance. The process approach and continual improvement remain important.
The familiar quality management principles remain relevant, including customer focus, leadership, engagement of people, the process approach, improvement, evidence-based decision-making and relationship management.
Yes. Clauses 4 through 10 remain the main requirement sections of the QMS, covering context, leadership, planning, support, operation, performance evaluation and improvement.
The main requirements are in Clauses 4 to 10. Clause 4 deals with context, Clause 5 with leadership, Clause 6 with planning, Clause 7 with support, Clause 8 with operation, Clause 9 with performance evaluation and Clause 10 with improvement.
Clause 4 asks an organization to understand the environment in which its QMS operates. That includes relevant internal and external issues, interested parties and the scope of the management system.
Look at the factors that can genuinely affect the QMS: business conditions, customers, suppliers, technology, regulations, organizational structure and other relevant internal or external matters. The review should reflect the business as it operates today.
Not necessarily. The organization needs to understand and determine its context, but that does not mean every point must sit in a standalone document. Existing QMS information can provide suitable evidence where appropriate.
Context should influence decisions about risks, objectives, resources and processes. If the business changes significantly, the QMS may need to change with it.
They are people or organizations relevant to the QMS and its intended results. Depending on the business, this could include customers, regulators, employees, owners, suppliers, partners and other relevant groups.
Clause 5 focuses on leadership, customer focus, the quality policy, responsibilities and accountability. The 2026 edition places additional attention on leadership, quality culture and ethical behaviour.
Quality culture is reflected in how people actually approach quality at work. It shows up in management decisions, employee awareness, problem solving, accountability and the willingness to prevent problems rather than simply react to them.
The revision reinforces that quality is a management responsibility, not something that can be left entirely to the quality department. Leaders need to provide direction, resources, accountability and visible support for the QMS.
Ethical behaviour receives greater emphasis in the revised approach to quality culture. Organizations should consider how leadership, employee awareness and responsible decision-making support the effectiveness of the QMS.
Clause 6 is about planning. It covers risks and opportunities, quality objectives and the actions needed to address them.
The revised standard provides clearer treatment of risks and opportunities. The practical aim is to help organizations make better decisions instead of treating risk management as a paperwork exercise.
No specific document called a “risk register” is automatically required. What matters is having an effective way to identify and address relevant risks and opportunities, with suitable documented information where needed.
They should relate to real situations that can affect QMS results. For example, dependence on one supplier, changing customer needs, equipment problems or a new market opportunity can lead to actions within relevant processes.
Quality objectives are intended results that help the organization manage and improve QMS performance. Depending on the business, they might relate to complaints, delivery, defects, customer satisfaction, suppliers or process efficiency.
No. Quality objectives can focus on customers, products, services, processes, suppliers or operational performance. They should be useful to the organization rather than created simply because a KPI is expected.
Clause 7 covers the support needed to make the QMS work. It includes resources, competence, awareness, communication, documented information, infrastructure, monitoring resources and organizational knowledge.
Employees need to understand more than their individual tasks. Organizations should consider whether people understand how their work contributes to quality, the QMS and the organization's quality culture.
Not automatically. Training should be based on the competence needed for particular work. Where a person already has the necessary competence, additional training may not be the appropriate response.
It is the knowledge the organization needs to operate its processes and achieve conformity. It may come from technical experience, lessons learned, customer requirements, regulations, process know-how or experienced employees.
Not simply because the standard has been revised. The emphasis should be on having the documented information needed to run the QMS effectively and demonstrate conformity, rather than producing paperwork with little practical value.
Clause 8 covers the operational side of the QMS. It includes operational planning and control, customer requirements, design and development where applicable, external providers, production and service provision, release, and nonconforming outputs.
Clause 8 is where the management system meets day-to-day operations. It deals with how requirements are understood, work is controlled, suppliers are managed and products or services are delivered.
Clause 8.1 deals with operational planning and control. The organization needs to plan and control the processes required to meet product and service requirements.
Clause 8.2 deals with requirements for products and services. It includes customer communication, determining requirements, reviewing commitments and managing changes to customer requirements.
Clause 8.3 concerns design and development where it applies to the organization's products or services. The controls can include planning, inputs, reviews, verification, validation, outputs and design changes.
No. Its applicability depends on what the organization actually does. A company developing its own products may need detailed design controls, while a business with no applicable design activity may have a different situation.
Clause 8.4 deals with externally provided processes, products and services. Supplier selection, evaluation, purchasing controls, outsourced processes and supplier performance can all fall within this area.
Clause 8.5 concerns production and service provision under controlled conditions. Depending on the organization, this can involve work instructions, equipment, process parameters, identification, traceability, preservation and post-delivery activities.
Clause 8.6 is concerned with the release of products and services. The organization should have appropriate evidence that the applicable requirements have been met before release.
Clause 8.7 addresses nonconforming outputs. The organization needs a sensible method for identifying and controlling products or services that do not meet requirements.
That depends on the company's existing controls and the results of its gap assessment. Manufacturing organizations should review areas such as production planning, supplier controls, inspection, release, traceability and nonconforming products.
Service companies can apply Clause 8 to areas such as service planning, customer requirements, delivery, outsourced activities, monitoring, completion and the handling of service-related nonconformities.
Yes. Clause 8 is broad enough to support a specialist article covering its subclauses and operational requirements in much greater depth. The current guide should remain the overall 2026 changes and requirements resource.
Clause 9 focuses on performance evaluation. It covers monitoring and measurement, analysis and evaluation, customer satisfaction, internal audits and management review.
Use measures that tell management something useful about the business. Depending on the organization, that could mean monitoring complaints, defects, delivery, supplier performance, customer feedback, process results or corrective actions.
It is the organization's understanding of how customers view the extent to which their requirements and expectations have been met. The evidence can come from several sources, not just a formal survey.
No. Surveys are only one option. Complaints, customer meetings, reviews, repeat business, returns and other relevant feedback can also provide useful information.
An internal audit is a planned evaluation of the QMS to determine whether applicable requirements are being met and whether the system is properly implemented and maintained.
Not necessarily. A process-based audit can often give a clearer picture of how the QMS actually works. The audit programme should reflect the organization's processes, requirements, risks and priorities.
Management review gives top management a structured opportunity to look at QMS performance and decide whether action is needed. It should be based on relevant information rather than becoming a routine meeting with little follow-up.
Clause 10 deals with improvement. It includes nonconformity, corrective action and continual improvement of the Quality Management System.
Correction fixes the immediate problem. Corrective action goes further by addressing why the problem happened and considering what needs to change to reduce the chance of it happening again.
Yes. Continual improvement remains an important part of the QMS. Organizations can use audits, customer feedback, performance data, nonconformities and other information to identify useful improvements.
Annex A provides additional explanation around terminology, concepts and the intent of ISO 9001:2026 requirements. It is intended to help organizations understand and apply the standard more consistently.
Annex A is explanatory material intended to clarify concepts and intent. Organizations should distinguish that guidance from the actual requirements when assessing conformity.
It can be useful when a requirement seems open to different interpretations. Rather than treating the QMS as a checklist, Annex A can help management and QMS personnel understand what the requirement is trying to achieve.
Yes. The process approach remains important. Organizations should understand how processes interact, what inputs and outputs they have, who is responsible and how their performance is controlled.
Yes. Risk-based thinking remains part of the standard, with the 2026 edition providing clearer treatment of risks and opportunities.
Very much so. Customer requirements remain central to the QMS, from reviewing what the customer needs through delivery, feedback, complaints and improvement.
Yes. The 2026 edition carries forward the climate-change consideration introduced through the 2024 amendment to ISO 9001:2015. Organizations should consider whether climate change is relevant to their context.
No automatic standalone programme is required. The organization should determine whether climate change is relevant to its context and respond in a way that makes sense for its circumstances.
It is a structured comparison between an organization's existing QMS and the requirements applicable to ISO 9001:2026. The result should show where the organization is already prepared and where work remains.
Ideally, it should come early in the transition or implementation process. Knowing the gaps first makes it easier to prioritize changes instead of rewriting documents unnecessarily.
Yes. An existing QMS can be assessed against the 2026 edition and updated where necessary. In many cases, a substantial amount of the existing system can remain useful.
No. The transition is an assessment and improvement exercise, not necessarily a complete restart. Existing effective processes should be retained where they continue to meet the applicable requirements.
No. Review them first. A procedure that is accurate, effective and still suitable does not need to be rewritten merely because the standard has a new edition.
Start with the revised requirements, carry out a gap assessment, decide what needs changing, update affected processes and information, brief employees, conduct an internal audit, complete management review and coordinate the transition assessment with the certification body.
ISO/TC 176 states that existing ISO 9001:2015 certified organizations have until 30 September 2029 to complete the transition. It is better to plan around the organization's audit cycle than wait for the final date.
Existing certificates can remain within the applicable transition arrangements. The exact timing and conditions should be confirmed with the organization's certification body.
Yes. Transition can take place during a scheduled surveillance or recertification audit, or through a separate transition audit, subject to the certification arrangements that apply.
Yes, where the certification body's arrangements allow it. Organizations should discuss the timing before the audit so the appropriate transition arrangements can be made.
From 31 March 2028, new and initial accredited certifications may only be issued to ISO 9001:2026 under the published transition arrangements.
There is little advantage in waiting. Starting with a gap assessment gives the organization time to understand the changes, make improvements, run an internal audit and address findings before the transition assessment.
Early preparation gives the organization more breathing room. It also allows the revised standard to be treated as an opportunity to improve the QMS rather than as a deadline-driven document exercise.
The evidence will depend on the organization's scope and processes. It may include updated QMS information, process records, objectives, risk and opportunity information, internal audits, management review, employee awareness and operational records.
No. There is no automatic need for a standalone transition manual. The organization needs appropriate information and evidence to operate and demonstrate conformity of its QMS.
Review it rather than changing it automatically. If the organization's context, strategic direction or understanding of quality has changed, an update may be appropriate.
Not necessarily. Existing objectives should be checked for relevance and effectiveness. Change them when business priorities, QMS performance or other relevant circumstances justify doing so.
No. A quality manual can still be useful to an organization, but ISO 9001:2026 does not make a particular manual structure the centre of the QMS.
Yes. This is a good opportunity to remove duplicate information, outdated procedures and documents that no longer reflect how work is actually done, while keeping the information needed for effective control.
Keep the system proportionate to the business. A small company does not need to copy the documentation structure of a multinational organization. Its QMS should be clear, workable and suited to its actual operations.
It can support controls for production planning, purchasing, suppliers, inspection, testing, traceability, release, nonconforming products and improvement. The exact application depends on the company's products and processes.
Construction businesses can use the QMS to control contract review, project planning, procurement, subcontractors, design where applicable, material inspection, site activities, document control, nonconforming work and handover.
Engineering organizations can apply it to customer requirements, technical reviews, design and development where applicable, project controls, competence, suppliers, verification, service delivery and corrective action.
IT companies can use the QMS for customer requirements, service or software delivery, competence, suppliers, customer communication, service performance, complaints, corrective action and continual improvement.
The same principles can be adapted to service work. Relevant processes may include enquiry handling, contract review, service planning, delivery, monitoring, customer feedback, supplier control and improvement.
Yes. A startup can build its QMS around the processes it actually needs. Starting with clear responsibilities and sensible controls can be more useful than creating a large documentation system from day one.
No. An organization can implement the standard without certification. Third-party certification becomes relevant when the organization chooses it or when a customer, tender, contract or other requirement calls for certification.
Implementation is the work of establishing and operating the QMS. Certification is the independent assessment of that system by a certification body within an agreed scope and under the applicable certification process.
Yes. Some organizations use ISO 9001 as an internal framework for improving consistency, customer focus and process control without pursuing third-party certification.
No certificate can guarantee that every product or service will always be free from problems. Certification demonstrates that the organization's QMS has been assessed against applicable requirements within its defined scope.
No. The QMS requires attention to customer requirements and customer perceptions, but certification itself is not a guarantee of a particular customer's experience.
Yes, where a customer asks suppliers to hold ISO 9001 certification, having an appropriate certificate can help meet that particular qualification requirement. The customer's own conditions should always be checked.
It can where ISO 9001 certification is listed as a tender requirement or qualification condition. Certification alone, however, does not guarantee that a tender will be won.
Check the certification body's relevant scope, accreditation where required, audit process, geographical coverage and whether its certification will satisfy the customer's or tendering organization's specific requirements.
SCS can discuss certification scope, audit considerations, transition arrangements and the certification process. The organization itself remains responsible for establishing and operating its QMS.
SCS can discuss the applicable certification and transition process with organizations seeking certification or transition. Existing certificate holders should also coordinate with the certification body responsible for their current certificate.
A useful plan can cover the requirements review, gap assessment, process changes, responsibilities, documented information, employee awareness, internal audit, management review, corrective action and certification or transition arrangements.
There is no universal timetable. The effort depends on factors such as company size, process complexity, locations, scope, existing QMS maturity and the amount of work identified during the gap assessment.
Start with the real gaps. Reuse processes that already work, avoid unnecessary documentation, give responsibilities to the right people and address the areas with the greatest effect on QMS performance first.
Avoid treating the revision as a document exercise, copying generic procedures, overlooking employee awareness, keeping disconnected risk information, choosing meaningless KPIs or leaving internal auditing until immediately before certification.
Explain what is changing in their own work, not just what has changed in the standard. Update relevant instructions, clarify responsibilities and give practical examples that employees can relate to.
Management should understand the significant changes, review QMS performance, confirm responsibilities, provide resources and demonstrate active support. Transition works better when it is treated as a business responsibility rather than a quality-department project.
Keep what works and assess it against the 2026 requirements. There is no reason to change a useful process simply because the edition number has changed.
Use the transition as a chance to address those weaknesses properly. The organization should deal with both the revised requirements and the underlying process problems that may already be affecting QMS performance.
It gives organizations a framework for using information from audits, customer feedback, process performance, nonconformities, risks and opportunities to decide where improvement is worthwhile.
Yes. Its management-system structure can support integration with other ISO systems where that approach suits the organization. Common activities such as leadership, planning, auditing and management review can often be coordinated.
Yes. Organizations can combine compatible processes into an integrated management system. Each standard's specific requirements still need to be addressed, but duplicate management activities can often be reduced.
Start with the standard and the existing QMS side by side. Once the organization knows which requirements affect its current system, it can decide what needs to change instead of making assumptions.
ISO and ISO/TC 176 are the key authoritative sources. ISO provides information about the 2026 edition, while ISO/TC 176 provides transition information and related implementation milestones.
ISO/TC 176 states that organizations currently certified to ISO 9001:2015 have until 30 September 2029 to complete their transition to ISO 9001:2026. Planning early is preferable to waiting until the deadline.