Maintain traceability from approved explosion-protected product documentation through components, production batches and release.
Scope and use
ISO/IEC 80079-34:2018 sets quality-system requirements for manufacturing Ex products and references ISO 9001:2015. A quality system does not replace explosion-protection design, type testing or product certification.
Key requirements
- Identify the certified product scope, approved drawings, critical components, manufacturing sites and controlled suppliers.
- Control design or component changes, purchasing, production, inspection, nonconformities and release so that manufactured products remain consistent with approved documentation.
Implementation outline
- Identify the certified product scope, approved drawings, critical components, manufacturing sites and controlled suppliers.
- Control design or component changes, purchasing, production, inspection, nonconformities and release so that manufactured products remain consistent with approved documentation.
- Keep traceable records and define how potentially affected products or batches are assessed when a deviation or change occurs.
- Map certification and production records; control supplier and process changes; sample a batch from receipt through release; review corrective action and audit evidence.