Key takeaways
Short answer: ISO 22400 is a manufacturing operations KPI standard — it defines OEE, MTBF, MTTR, throughput, and 30+ other indicators with precise formulas. ISO 9001 is a quality management system standard — it specifies how an organization documents processes, manages quality, and continuously improves. They are complementary. ISO 22400 standardizes the KPI definitions that ISO 9001's monitoring and improvement clauses require. See also OEE and ISO 22400.
ISO 22400 is "Automation systems and integration — Key performance indicators (KPIs) for manufacturing operations management." Parts include:
The KPIs cover production (OEE, throughput, allocation efficiency), quality (scrap rate, rework rate, FPY), maintenance (MTBF, MTTR, MTTF), and inventory.
For each KPI: precise formula, required inputs, time-state model.
ISO 9001:2015 is the quality management system standard. Key clauses:
9001 is process- and document-oriented. It specifies what the organization must have in place, not the specific metrics.
ISO 9001 requires monitoring and measurement (clause 9.1) but does not specify which metrics. ISO 22400 provides the metrics with standardized definitions.
A plant using ISO 22400-aligned OEE provides the measurement that ISO 9001's clause 9.1 requires, with auditable definitions.
Most plants pursue ISO 9001 first because:
ISO 22400 alignment usually follows as part of OEE implementation:
Define your OEE, MTBF, MTTR, etc. using ISO 22400 formulas. Document the time-state model. Use standardized terminology. Maintain auditability of inputs.
No certification body for 22400, but auditors increasingly expect it.
Almost never directly. The main misalignment is when a plant uses non-22400 OEE formulas; ISO 9001 audits find the inconsistency and flag it.
Aligning the OEE definitions resolves the misalignment.
All of these benefit from ISO 22400-aligned KPIs as evidence.
1. Treating ISO 22400 as a certification. It is not. Alignment is the right framing.
2. Treating ISO 9001 as a documentation exercise. Documents without operations behind them fail audit.
3. Using non-22400 formulas in a 9001 environment. Auditors increasingly flag this.
4. Pursuing 22400 alignment without 9001 foundation. The standards build on each other.
A modern OEE platform provides ISO 22400-aligned formulas with documented time-state models, supports ISO 9001 audit requirements with trail and trend reporting, and integrates with QMS for CAPA workflow.
Fabrico's OEE module supports ISO 22400-aligned formulas, ISO 9001-friendly audit trail and trend reporting, and CAPA workflow integration.
See how Fabrico captures this automatically — explore OEE for manufacturing or book a demo.
No. It is a definition standard; you align with it but do not certify against it.
No. But most plants pursuing 22400 alignment have 9001 in place.
IATF builds on 9001 with automotive specifics. Uses ISO 22400-aligned KPIs as evidence.
Yes, in part. Quality KPIs (scrap rate, FPY) are included.
Usually 9001 first, then 22400 alignment as OEE matures.
Login
Blog
