ISO 9001:2026 Quality management systems — Requirements
- ClassificationCategoryQuality ManagementDomainQuality & SafetyFramework FamilyISO Management Systems
- Regulatory ContextTypeStandardLegal InstrumentStandardSectorCross-SectorIndustryCross-Industry
- Region / PublisherRegionGlobalRegion DetailInternationalPublisherInternational Organization for Standardization (ISO), ISO/TC 176/SC 2
- VersioningVersionISO 9001:2026 (sixth edition)Effective DateSeptember 16, 2026 (publication date); transition of ISO 9001:2015 certificates by September 30, 2029Issue DateSeptember 16, 2026 (sixth edition; replaces ISO 9001:2015 and Amendment 1:2024)
- AdoptionAdoption ModelCertificationImplementation ComplexityMedium
- Official ReferenceOpen Link in New TabSource
License included / downloadable: No
ISO 9001:2026 is a copyrighted ISO standard sold by ISO and by national standards bodies; its text is not included with the platform.
Framework text is licensed by its publisher and is included only where stated above.
- ISO 9001:2026 specifies requirements for a quality management system that consistently provides products and services meeting customer and regulatory requirements.
- ISO/TC 176/SC 2 published the sixth edition on September 16, 2026, replacing ISO 9001:2015, which is withdrawn.
- Certificates to the 2015 edition transition by September 30, 2029.
- The sixth edition adds quality culture and ethical behavior, separates risks from opportunities, and strengthens the management of change.
- ISO describes it as the only ISO 9000 family standard that can be certified to, with more than one million certificates in 189 countries.
Overview
ISO 9001:2026, Quality management systems — Requirements, is the international standard that specifies requirements for a quality management system (QMS) when an organization needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements and aims to enhance customer satisfaction (Clause 1). The International Organization for Standardization (ISO) published the sixth edition on September 16, 2026 through ISO/TC 176/SC 2, replacing ISO 9001:2015 and its Amendment 1:2024, both of which ISO lists as withdrawn. It applies to any organization, regardless of type, size, or the products and services it provides.
ISO describes ISO 9001 as the only standard in the ISO 9000 family that can be certified to, though certification is not mandatory, and reports more than one million certificates in 189 countries. The requirements sit in Clauses 4 to 10 and rest on the seven quality management principles of ISO 9000, the process approach, the Plan-Do-Check-Act cycle, and risk-based and opportunity-based thinking (Introduction 0.2 and 0.3). Clause 3 now carries a limited set of core management system terms; ISO 9000 remains the normative reference for quality terms.
The sixth edition adds quality culture and ethical behavior to the requirements, separates risks from opportunities (Clauses 6.1.1 to 6.1.3), strengthens the management of change, revises informative Annex A and removes Annex B (Foreword). Under the transition guidance on the ISO/TC 176 page, organizations certified to ISO 9001:2015 have until September 30, 2029 to complete their transition, and from March 31, 2028 new and initial accredited certifications may only be issued to ISO 9001:2026.
Why does it matter?
The Introduction calls establishing and implementing a QMS a strategic decision that supports improved performance, enhances customer satisfaction and provides a foundation for sustained success and sustainable development initiatives (Introduction 0.1). ISO 9001:2026 sets the requirements that make that system auditable.
Key benefits include:
- Consistent products and services
The QMS is aimed at consistently providing products and services that meet customer and applicable statutory and regulatory requirements (Introduction 0.1), backed by controls on production and service provision, release and nonconforming outputs (Clauses 8.5 to 8.7).
- Customer focus that is measured
Customer focus is a requirement of leadership (Clause 5.1.2), and customer satisfaction is monitored and measured (Clause 9.1.2).
- Risks and opportunities handled separately
The organization determines risks and opportunities (Clause 6.1.1) and plans separate actions to address risks (6.1.2) and opportunities (6.1.3).
- Quality culture and ethical behavior
The sixth edition addresses quality culture and ethical behavior within the requirements, particularly for leadership, awareness and the environment for the operation of processes (Foreword; Clauses 5.1, 7.1.4 and 7.3).
- A recognized basis for certification
Customers and tenders often ask for certification, which ISO describes as not mandatory but open only for ISO 9001 within the ISO 9000 family.
How does it work?
ISO 9001:2026 uses the same clause structure as other ISO management system standards. Clauses 1 to 3 give the scope, normative references and terms; Clauses 4 to 10 hold the requirements; informative Annex A clarifies the structure, terminology and clauses without adding requirements. For guidance on applying all clauses, the standard points to ISO 9002.
Implementation follows the clauses: determine the context, interested parties and scope of the QMS (4.1 to 4.3) and the processes and their interactions (4.4); set the quality policy and assign roles (5.2 and 5.3); determine risks and opportunities, set quality objectives and plan changes (6.1 to 6.3); provide the people, infrastructure, environment, monitoring resources and organizational knowledge the processes need (7.1.2 to 7.1.6); then plan and control operations (8.1 to 8.7).
The system is then evaluated and improved: monitoring, measurement, analysis and evaluation, including customer satisfaction (9.1.1 to 9.1.3), internal audit (9.2), management review (9.3), continual improvement (10.1) and nonconformity and corrective action (10.2). An organization moving from the 2015 edition compares its QMS with the changes listed in the Foreword and with Annex A.
Key Elements
- Context of the organization (Clause 4)
Understanding the organization and its context (4.1), the needs and expectations of interested parties (4.2), the scope of the QMS (4.3) and the QMS and its processes (4.4). Amendment 1:2024, now incorporated, adds the question of whether climate change is a relevant issue.
- Leadership (Clause 5)
Leadership and commitment (5.1.1), customer focus (5.1.2), the quality policy (5.2) and roles, responsibilities and authorities (5.3), where quality culture and ethical behavior are now addressed.
- Planning (Clause 6)
Determining risks and opportunities (6.1.1), actions to address risks (6.1.2) and opportunities (6.1.3), quality objectives (6.2) and planning of changes (6.3).
- Support (Clause 7)
Resources: people, infrastructure, environment for the operation of processes, monitoring and measuring resources and organizational knowledge (7.1.2 to 7.1.6), competence (7.2), awareness (7.3), communication (7.4) and documented information (7.5).
- Operation (Clause 8)
Operational planning (8.1), requirements for products and services (8.2), design and development (8.3), externally provided processes, products and services (8.4), production and service provision (8.5), release (8.6) and control of nonconforming outputs (8.7).
- Performance evaluation (Clause 9)
Monitoring and measurement, customer satisfaction and analysis and evaluation (9.1), internal audit (9.2) and management review (9.3).
- Improvement (Clause 10)
Continual improvement (10.1) and nonconformity and corrective action (10.2).
- Annex A (informative)
Clarification of structure, terminology and clauses, revised in the sixth edition to explain the intent of the requirements without adding any.
What does it cover?
ISO 9001:2026 is applicable to any organization, regardless of its type or size, or the products and services it provides, and all of its requirements are generic (Clause 1). The terms product and service apply only to products and services intended for, or required by, a customer (Clause 1, Note 1). ISO also lists sector standards based on ISO 9001, including ISO 13485 for medical devices, ISO 22163 for railways, ISO 29001 for petroleum, petrochemical and natural gas, and ISO/IEC/IEEE 90003 for computer software.
What are its objectives?
The Introduction names four potential benefits of implementing a QMS based on these requirements (0.1), which are the objectives of the standard:
Consistently provide products and services that meet customer and applicable statutory and regulatory requirements.
Facilitate opportunities to enhance customer satisfaction.
Address risks and opportunities associated with the organization's context and objectives.
Demonstrate conformity to QMS requirements, to internal and external parties.
Apply the process approach, PDCA and risk-based and opportunity-based thinking in how the QMS is built.
Framework in Context
ISO/TC 176/SC 2 prepared the sixth edition in collaboration with CEN under the Vienna Agreement; CEN approved it as EN ISO 9001:2026 on August 10, 2026, and CEN members must give it national standard status by March 2027. The Foreword lists six main changes: core ISO management system terms in Clause 3, quality culture and ethical behavior, separate treatment of risks and opportunities, stronger management of change, a revised informative Annex A and the removal of Annex B. The standard applies the harmonized approach (0.4), so it aligns with the other management system standards a company may run.
Common Framework Mappings
ISO 9001:2026 is commonly mapped to the quality, management system and sector standards below so that an organization can share governance, document control, audit and corrective action processes across an integrated system.
Mapped frameworks include:
ISO 13485:2016
IATF 16949:2016
ISO/IEC 20000-1
ISO 22301
ISO 27001:2022
ISO 42001
ISO 31000:2018
CMMI v3.0
GAMP 5
ISO 14971:2019
ISO 9000:2015
ISO 9004:2018
ISO 14001:2015
ISO 45001:2018
AS9100D
ISO 19011:2018
How SmartSuite Supports ISO 9001:2026
SmartSuite provides the system for managing controls, evidence, mappings, assessments, and reporting.
Use Compliance Management, Internal Audit Management, Enterprise Risk Management and Third Party Risk Management to hold the clause requirements, processes, risks and opportunities, external providers, audits and corrective actions that Clauses 4 to 10 call for.
Clause Library
Hold Clauses 4 to 10 and Annex A as structured requirements linked to the processes, documents and controls that satisfy each one.
Process Owners and Change Control
Assign owners to QMS processes and record planned changes to the QMS and their outcomes (Clauses 4.4 and 6.3).
Documented Information
Keep documents and records with owners, approvals and an audit trail (Clause 7.5).
Internal Audits and Corrective Action
Plan audits, record findings and take nonconformities through root cause and corrective action to closure (Clauses 9.2 and 10.2).
External Providers and Risk Planning
Evaluate external providers and track risks and opportunities, each with its own actions and owners (Clauses 6.1 and 8.4).
Quality Performance Reporting
Report customer satisfaction, quality objective results, open findings and management review inputs to leadership (Clauses 9.1.2, 9.1.3 and 9.3).
Related frameworks
ISO 13485:2016 specifies quality management system requirements for organizations in the medical device life-cycle and is the basis of the FDA's QMSR and the EU harmonized standard.
IATF 16949:2016 is the IATF's automotive quality management standard, used with ISO 9001:2015 and certified only by IATF-recognized certification bodies.
ISO/IEC 20000-1:2018 specifies requirements for a service management system covering planning, design, transition, delivery and improvement of services, certifiable by audit.
ISO 22301:2019 specifies requirements for a business continuity management system to protect against, prepare for, respond to and recover from disruptions.
ISO/IEC 27001:2022 specifies requirements for an information security management system: Clauses 4 to 10, risk treatment, the Statement of Applicability and 93 Annex A controls.
ISO/IEC 42001:2023 is the first AI management system standard: requirements for an AIMS in clauses 4 to 10, with Annex A reference controls and Annex B guidance.
Frequently Asked Questions For ISO 9001:2026
Put this framework to work in SmartSuite
Manage controls, risks, evidence, and audits in one platform designed for modern governance, risk, and compliance.