ISO 9001:2026 — Quality management systems — Requirements
ISO lists ISO 9001:2026 as the published sixth edition and ISO 9001:2015 as withdrawn. Organization-specific certification transition timing must come from the applicable certification cycle and responsible certification body.
What the authority record establishes
ISO lists ISO 9001:2026 as the published sixth edition and ISO 9001:2015 as withdrawn. Organization-specific certification transition timing must come from the applicable certification cycle and responsible certification body.
Not law by itself; may become contractually, scheme, or regulator relevant through adoption
The exact official title, issuing body, jurisdiction, version or application record, and linked source define the scope of this page. Readers should not transfer the authority's status to a commercial product or infer transaction-, patient-, system-, site-, or organization-specific applicability from this summary.
Why it matters to this market
Teams need edition-aware requirement mappings, controlled transition work, and historical evidence that does not silently relabel records created under the 2015 edition.
Affected operating stages
- Standards Monitoring
- Gap Analysis
- Transition Planning
- Document And Process Change
- Training
- Audit Planning
Capabilities to examine
Controlled Documents And Workforce Qualification
Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for controlled documents and workforce qualification.
Audit Planning And Findings
Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for audit planning and findings.
Change Control And Configuration Traceability
Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for change control and configuration traceability.
Quality Risk Management
Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for quality risk management.
Quality Cost, KPI, And Management Review
Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for quality cost, KPI, and management review.
Affected buyer audiences
- quality-system owners
- certification-program participants
- auditors
- QMS providers
Implementation questions
- Which entities, products, populations, transactions, systems, sites, or jurisdictions are actually within scope?
- What is binding, what is guidance, and what is a technical or consensus standard?
- Which publication, adoption, effective, application, transition, and enforcement dates differ?
- Who owns legal, clinical, quality, regulatory, policy, or operational interpretation?
- How will a source revision affect open work and historical decisions?
Interpretation boundary
The official record establishes edition identity, publication date, and lifecycle status. It does not certify an organization, interpret the standard text, or establish one universal certification-transition deadline.