ISO 9001

Overview

The requirements standard for a quality management system, and the most widely used certification standard in the world. ISO 9001:2026, the sixth edition, was published on 16 September 2026 and replaces ISO 9001:2015; certified organizations have a transition period to move to it.

ISO 9001:2026, Quality management systems — Requirements, is the sixth edition of the standard, published on 16 September 2026. It replaces ISO 9001:2015 and is the only standard in the ISO 9000 family that organizations certify against. It sets out what a quality management system (QMS) must contain, without prescribing how any particular organization should design its processes, and applies to organizations of any size and in any sector, including manufacturers, service providers, public bodies and not-for-profits.

The standard follows the harmonized structure used across ISO management system standards, so its auditable content sits in Clauses 4 to 10: context of the organization (4), leadership (5), planning (6), support (7), operation (8), performance evaluation (9) and improvement (10). Clauses 1 to 3 cover scope, normative references and terms, with the terms taken from ISO 9000:2026, which was revised ahead of it. This shared structure is what makes ISO 9001 straightforward to integrate with ISO 14001, ISO 45001, ISO/IEC 27001 and other management system standards.

The revision is evolutionary rather than a rewrite. The process approach, risk-based thinking and the Plan-Do-Check-Act cycle all carry over from the 2015 edition, and so does the freedom organizations have over the form and extent of their documented information. The main changes are:

• Quality culture and ethical behaviour. Top management must promote a quality culture and ethical behaviour as part of leadership and commitment (Clause 5.1), and people doing work under the organization's control must be aware of them (Clause 7.3).
• Risks and opportunities separated. Clause 6.1 is split into sub-clauses that treat risks and opportunities as distinct things, each with its own actions, rather than a single combined requirement.
• Planning of changes. The requirements for planning changes to the QMS are strengthened so that changes are carried out without losing the system's ability to achieve its intended results.
• Climate change. The climate action wording added to Clauses 4.1 and 4.2 by Amendment 1:2024 is now part of the base text: the organization determines whether climate change is a relevant issue, and interested parties can have climate-related requirements.
• Annex A guidance. For the first time the standard carries an informative annex explaining its structure, terminology and requirements. It adds no requirements but is useful when interpreting clauses.

Operational requirements in Clause 8 continue to cover planning and control of operations, requirements for products and services, design and development (which can be excluded where not applicable), control of externally provided processes, products and services, production and service provision, release of products and services, and control of nonconforming outputs.

Certification is carried out by third-party certification bodies, normally accredited under an IAF-recognised national accreditation body. The usual route is a two-stage initial audit: Stage 1 reviews readiness, scope, documented information and the internal audit and management review evidence; Stage 2 assesses implementation and effectiveness across the scope. Certificates are typically issued for a three-year cycle with surveillance audits in between and a recertification audit at the end. Organizations that do not want certification can still use ISO 9001 as an internal framework or make a self-declaration of conformity.

Transition from ISO 9001:2015. Existing ISO 9001:2015 certificates stay valid during the transition period, which is expected to be three years from publication; the International Accreditation Forum and national accreditation bodies set the confirmed arrangements. Certification bodies must themselves be accredited to the new edition before they can issue ISO 9001:2026 certificates. A practical transition starts with a gap analysis against the published text, then updates to leadership commitments and awareness on quality culture and ethics, the risk and opportunity analysis, change planning, and the internal audit programme, followed by a transition audit, usually combined with a surveillance or recertification visit.

Purpose

To specify the requirements for a quality management system where 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 through effective application of the system and continual improvement.

Key Benefits

• Provides a recognised, auditable framework for controlling quality across all processes
• Certification is widely accepted by customers, regulators and tender processes worldwide
• Clarifies responsibilities, process ownership and the criteria used to judge acceptable work
• Embeds risk-based thinking into planning rather than relying on after-the-fact corrective action
• Creates a consistent basis for internal audit, management review and continual improvement
• Aligns structurally with ISO 14001, ISO 45001 and ISO/IEC 27001 for integrated management systems
• Provides a common language for supplier and customer quality expectations
• Supports consistent onboarding and training through documented process criteria

Key Requirements

• Determine the context of the organization, including whether climate change is a relevant issue, and the needs and expectations of interested parties (Clause 4)
• Define the scope of the QMS and the processes needed, with their sequence and interaction
• Demonstrate top management leadership and commitment, including a quality policy, assigned roles, and promoting a quality culture and ethical behaviour (Clause 5)
• Determine risks and opportunities separately and plan actions to address each; set quality objectives and plan changes to the QMS (Clause 6)
• Provide resources, ensure competence and awareness (including of quality culture and ethical behaviour), manage communication and documented information (Clause 7)
• Plan and control operations, including requirements review, design and development where applicable (Clause 8)
• Control externally provided processes, products and services, including suppliers and outsourced work
• Control production and service provision, including identification, traceability and property belonging to others
• Control nonconforming outputs and record the actions taken
• Monitor, measure, analyse and evaluate performance, including customer satisfaction (Clause 9)
• Conduct internal audits at planned intervals and management reviews at planned intervals
• Act on nonconformities with correction and corrective action, and continually improve the QMS (Clause 10)

Who Needs This Standard?

Organizations of any size or sector that need a recognised quality management framework — manufacturers, engineering and construction firms, service providers, laboratories, healthcare and education providers, public sector bodies, and suppliers whose customers or tender processes require certification. It is also the base standard for sector schemes such as IATF 16949 (automotive) and AS9100 (aerospace), and a common contractual requirement in supply chains.

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