How to use this glossary
Start with the term you need. Each entry gives a plain-language definition, then points to related terms and practical guides.
- Use the A–Z index to jump directly to a term.
- Follow related links when you need implementation context.
- Confirm developing ISO 9001:2026 requirements against official sources before acting.
Accreditation
The formal recognition by an authoritative body that a certification body is competent to carry out specific conformity assessment tasks. Accreditation bodies — such as UKAS (UK), DAkkS (Germany), ANAB (USA), and IAF members worldwide — assess certification bodies against ISO/IEC 17021-1. Accreditation is distinct from certification: organisations are certified, while certification bodies are accredited.
Audit
A systematic, independent, and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled. ISO 9001:2026 requires both internal audits (Clause 9.2) and accepts external audits from certification bodies. Audits may be first-party (internal), second-party (customer or interested party), or third-party (independent certification body).
Audit Programme
A set of one or more audits planned for a specific time frame and directed towards a specific purpose. Under ISO 9001:2026 Clause 9.2, organisations must establish, implement, and maintain an audit programme that considers the importance of the processes concerned, changes affecting the organisation, and the results of previous audits. The programme must define frequency, methods, responsibilities, planning requirements, and reporting.
Awareness
The state of knowing and understanding one's role in relation to the quality management system. ISO 9001:2026 Clause 7.3 requires that persons doing work under the organisation's control are aware of the quality policy, relevant quality objectives, their contribution to the effectiveness of the QMS (including the benefits of improved performance), and the implications of not conforming with QMS requirements. The 2026 revision expands awareness requirements to include understanding of the organisation's quality culture.
Certification
The process by which an accredited third-party certification body provides written assurance (a certificate) that a product, process, service, or management system conforms to specified requirements. ISO 9001:2026 certification demonstrates that an organisation's quality management system meets all requirements of the standard. Certificates are typically valid for three years, subject to annual surveillance audits.
Certification Audit
The formal audit conducted by an accredited certification body to assess whether an organisation's quality management system meets all requirements of ISO 9001:2026. A certification audit typically consists of two stages: Stage 1 (documentation review and readiness assessment) and Stage 2 (on-site audit of system implementation and effectiveness). Successful completion results in the award of an ISO 9001:2026 certificate.
Certification Body (CB)
An independent third-party organisation accredited to assess and certify management systems against international standards such as ISO 9001:2026. Certification bodies must themselves be accredited by a national accreditation body that is a member of the International Accreditation Forum (IAF). Major global certification bodies include Bureau Veritas, SGS, TÜV, DNV, and BSI.
Climate Change (Clause 4.1)
One of the three substantive new requirements in ISO 9001:2026. Clause 4.1 now explicitly requires organisations to determine whether climate change is a relevant external issue when establishing the context of the organisation. This does not require organisations to implement environmental management — that remains the domain of ISO 14001 — but it does require a documented determination of relevance and, where relevant, consideration of climate-related risks and opportunities.
Competence
The ability to apply knowledge and skills to achieve intended results. ISO 9001:2026 Clause 7.2 requires organisations to determine the necessary competence of persons doing work that affects quality performance, ensure those persons are competent (through education, training, or experience), take actions to acquire necessary competence, and retain documented information as evidence. Competence requirements must be reviewed when roles change or new processes are introduced.
Conformity
The fulfilment of a requirement. In the context of ISO 9001:2026, conformity means that a product, service, process, or management system meets all applicable specified requirements. The opposite of conformity is nonconformity. Organisations must monitor and measure conformity of products and services (Clause 8.6) and address nonconformities when they occur (Clause 10.2).
Context of the Organisation
The combination of internal and external issues that are relevant to an organisation's purpose and strategic direction, and that affect its ability to achieve the intended results of its quality management system. Clause 4.1 of ISO 9001:2026 requires organisations to determine these issues and monitor and review information about them. In the 2026 revision, climate change has been explicitly added as an external issue to consider.
Continual Improvement
A recurring activity to enhance performance. ISO 9001:2026 Clause 10.3 requires organisations to continually improve the suitability, adequacy, and effectiveness of the quality management system. Improvement can be achieved through the use of audit results, analysis of data, management review outputs, and corrective actions. The 2026 revision consolidates improvement requirements under a single clause, replacing the separate 'improvement' and 'nonconformity and corrective action' structure of earlier revisions.
Corrective Action
Action taken to eliminate the cause of a nonconformity and prevent recurrence. ISO 9001:2026 Clause 10.2 requires organisations to react to nonconformities, evaluate the need for corrective action, implement any action needed, review the effectiveness of that action, and update risks and opportunities if necessary. Corrective action is reactive — it addresses root causes of problems that have already occurred — and is distinct from preventive action, which addresses potential problems.
Customer Focus
One of the seven quality management principles underlying ISO 9001:2026. The primary focus of quality management is to meet customer requirements and strive to exceed customer expectations. ISO 9001:2026 requires organisations to determine customer requirements (Clause 8.2), monitor customer perceptions (Clause 9.1.2), and ensure that customer focus is promoted throughout the organisation by top management (Clause 5.1.2).
Customer Satisfaction
The customer's perception of the degree to which the customer's expectations have been fulfilled. ISO 9001:2026 Clause 9.1.2 requires organisations to monitor customers' perceptions of the degree to which their needs and expectations have been fulfilled. Methods for obtaining this information include customer surveys, customer feedback on delivered products and services, meetings with customers, and analysis of market share.
Documented Information
Information required to be controlled and maintained by an organisation and the medium on which it is contained. ISO 9001:2026 uses the single term 'documented information' to cover what earlier versions called 'documents' and 'records'. Documented information can be in any format and media, and from any source. Clause 7.5 requires organisations to create, update, and control documented information.
Effectiveness
The extent to which planned activities are realised and planned results achieved. ISO 9001:2026 requires organisations to evaluate the effectiveness of the quality management system through internal audits (Clause 9.2), management review (Clause 9.3), and analysis and evaluation of data (Clause 9.1.3). Top management must review the continuing suitability, adequacy, and effectiveness of the QMS at planned intervals.
Ethical Behaviour (Clause 5.1.1)
One of the three substantive new requirements in ISO 9001:2026. Clause 5.1.1 now explicitly requires top management to demonstrate leadership and commitment by promoting ethical behaviour throughout the organisation. This reflects growing recognition that quality culture and organisational integrity are foundational to effective quality management. The requirement does not prescribe a specific code of ethics but requires that ethical behaviour be actively promoted, not merely assumed.
Gap Analysis
A structured assessment comparing an organisation's current quality management system against the requirements of ISO 9001:2026 to identify areas where the system does not yet meet the new standard's requirements. A gap analysis is the recommended first step in any ISO 9001:2026 transition project. It identifies which clauses are already compliant, which require minor updates, and which require significant new work.
IAF (International Accreditation Forum)
The world association of conformity assessment accreditation bodies and other bodies interested in conformity assessment in the fields of management systems, products, services, personnel, and other similar programmes of conformity assessment. The IAF coordinates the transition timelines for ISO management system standards, including ISO 9001:2026. IAF Mandatory Document MD 26 governs the transition from ISO 9001:2015 to ISO 9001:2026.
Interested Parties (Stakeholders)
Persons or organisations that can affect, be affected by, or perceive themselves to be affected by a decision or activity. ISO 9001:2026 Clause 4.2 requires organisations to determine relevant interested parties and their relevant requirements. Typical interested parties include customers, employees, suppliers, regulators, shareholders, and the communities in which the organisation operates. Climate change considerations introduced in the 2026 revision may expand the scope of relevant interested parties.
Internal Audit
A first-party audit conducted by the organisation itself, or on its behalf, for management review and other internal purposes. ISO 9001:2026 Clause 9.2 requires organisations to conduct internal audits at planned intervals to provide information on whether the QMS conforms to the organisation's own requirements and to ISO 9001:2026, and is effectively implemented and maintained. Internal auditors must be objective and impartial, meaning they cannot audit their own work.
Leadership
One of the seven quality management principles and a dedicated clause (Clause 5) in ISO 9001:2026. Leaders at all levels establish unity of purpose and create conditions in which people are engaged in achieving the organisation's quality objectives. The 2026 revision strengthens leadership requirements by explicitly requiring top management to promote ethical behaviour (Clause 5.1.1) and quality culture, not merely to demonstrate commitment.
Management Review
A formal review by top management of the organisation's quality management system at planned intervals to ensure its continuing suitability, adequacy, effectiveness, and alignment with the strategic direction of the organisation. ISO 9001:2026 Clause 9.3 specifies the inputs required for management review (including quality policy, objectives, audit results, customer satisfaction, and nonconformities) and the outputs that must be documented.
Nonconformity
The non-fulfilment of a requirement. A nonconformity may relate to a product, service, process, or the quality management system itself. ISO 9001:2026 Clause 10.2 requires organisations to react to nonconformities by taking action to control and correct them, deal with the consequences, and investigate root causes to prevent recurrence. Nonconformities identified during audits must be documented and tracked to closure.
Opportunities
Circumstances that have the potential to lead to a positive outcome for the quality management system or the organisation. ISO 9001:2026 Clause 6.1 requires organisations to determine not only risks but also opportunities — situations where the organisation can improve performance, increase customer satisfaction, or gain competitive advantage. Opportunities arising from climate change considerations (Clause 4.1) are a new area of focus in the 2026 revision.
PDCA Cycle (Plan-Do-Check-Act)
A four-stage iterative management method used for the control and continual improvement of processes and products. The entire structure of ISO 9001:2026 is built on the PDCA model: Plan (Clauses 4–6: context, leadership, planning), Do (Clauses 7–8: support and operation), Check (Clause 9: performance evaluation), and Act (Clause 10: improvement). The PDCA cycle is also applied at the individual process level within the quality management system.
Preventive Action
Action taken to eliminate the cause of a potential nonconformity or other undesirable potential situation before it occurs. In ISO 9001:2026, preventive action is addressed through the risk-based thinking requirements of Clause 6.1 rather than as a separate clause. Organisations are required to determine risks and opportunities and plan actions to address them — this is the modern equivalent of the formal preventive action procedure required by ISO 9001:2008.
Process Approach
One of the seven quality management principles. The process approach involves the systematic management of processes and their interactions to achieve intended results. ISO 9001:2026 requires organisations to determine the processes needed for the QMS, their sequence and interaction, the criteria and methods needed to ensure effective operation and control, and the responsibilities and authorities for these processes. The process approach underpins the entire structure of ISO 9001:2026.
Quality Culture
The shared values, beliefs, and behaviours within an organisation that support the achievement of quality objectives and customer satisfaction. ISO 9001:2026 Clause 5.1.1 explicitly requires top management to promote a quality culture — a new requirement not present in ISO 9001:2015. Quality culture goes beyond compliance with documented procedures; it reflects the degree to which quality thinking is embedded in everyday decision-making at all levels of the organisation.
Quality Management Principles
The seven foundational principles on which ISO 9001:2026 is based, as defined in ISO 9000:2015: (1) Customer focus, (2) Leadership, (3) Engagement of people, (4) Process approach, (5) Improvement, (6) Evidence-based decision making, and (7) Relationship management. These principles are not requirements of the standard but provide the conceptual foundation for understanding why the requirements are structured as they are.
Quality Management System (QMS)
A formalised system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. A QMS helps organisations coordinate and direct activities to meet customer and regulatory requirements and improve their effectiveness and efficiency on a continuous basis. ISO 9001:2026 specifies the requirements for a QMS when an organisation needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements.
Quality Objectives
Specific, measurable goals established by an organisation consistent with its quality policy and used to drive improvement in quality performance. ISO 9001:2026 Clause 6.2 requires quality objectives to be consistent with the quality policy, measurable, take into account applicable requirements, be relevant to conformity of products and services and enhancement of customer satisfaction, be monitored, be communicated, and be updated as appropriate. Objectives must be documented.
Quality Policy
A formal statement from top management of an organisation's intentions and direction with respect to quality. ISO 9001:2026 Clause 5.2 requires the quality policy to be appropriate to the purpose and context of the organisation, provide a framework for setting quality objectives, include a commitment to satisfy applicable requirements, and include a commitment to continual improvement of the QMS. The quality policy must be documented, communicated within the organisation, and available to interested parties.
Records
Documented information that provides evidence of activities performed or results achieved. In ISO 9001:2026, records are a subset of documented information that must be retained (rather than merely maintained). Examples include calibration records, training records, internal audit reports, management review minutes, and records of nonconformities and corrective actions. The standard specifies minimum retention requirements for certain records.
Risk-Based Thinking
An approach to quality management that considers risk throughout the planning and implementation of the quality management system. ISO 9001:2026 Clause 6.1 requires organisations to determine the risks and opportunities that need to be addressed to give assurance that the QMS can achieve its intended results, enhance desirable effects, prevent or reduce undesirable effects, and achieve improvement. The 2026 revision restructures Clause 6.1 to make risk-based thinking requirements clearer and more actionable.
Root Cause Analysis
A structured method for identifying the underlying cause of a nonconformity or problem, rather than addressing only its symptoms. ISO 9001:2026 Clause 10.2 requires organisations to evaluate the need for corrective action to eliminate the causes of nonconformities, in order to prevent recurrence or occurrence elsewhere. Common root cause analysis tools include the 5-Why technique, fishbone (Ishikawa) diagrams, and fault tree analysis.
Scope of the QMS
The boundaries and applicability of the quality management system. ISO 9001:2026 Clause 4.3 requires organisations to determine the boundaries and applicability of the QMS to establish its scope. The scope must be documented and must state the types of products and services covered, and provide justification for any requirement of the standard that the organisation determines is not applicable. The scope must be available and maintained as documented information.
Supplier (External Provider)
An organisation or person that provides a product or service. ISO 9001:2026 uses the term 'external provider' to cover all types of suppliers, including those providing outsourced processes, products, or services. Clause 8.4 requires organisations to control externally provided processes, products, and services, and to determine and apply criteria for the evaluation, selection, monitoring of performance, and re-evaluation of external providers.
Surveillance Audit
An audit conducted by a certification body between recertification audits to verify that a certified organisation continues to comply with the requirements of the standard. Surveillance audits are typically conducted annually and cover a subset of the QMS requirements. Failure to maintain compliance during a surveillance audit may result in suspension or withdrawal of certification.
Top Management
A person or group of people who directs and controls an organisation at the highest level. ISO 9001:2026 places significant responsibility on top management, requiring them to demonstrate leadership and commitment (Clause 5.1), establish the quality policy (Clause 5.2), assign organisational roles, responsibilities, and authorities (Clause 5.3), and — new in the 2026 revision — promote quality culture and ethical behaviour (Clause 5.1.1).
Transition Audit
A special audit conducted by a certification body to upgrade an existing ISO 9001:2015 certificate to ISO 9001:2026. Transition audits assess whether the organisation has addressed the new and changed requirements of the 2026 revision, particularly the three substantive changes in Clauses 4.1, 5.1.1, and 6.1. The IAF has established a three-year transition window from the September 16, 2026 publication date, with all certificates required to be transitioned by September 2029.
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