Applies to: Ex and hazardous-area equipment manufacturers
What Is ISO 80079 and Why It Matters?
ISO/IEC 80079-34 specifies quality management system requirements for manufacturers of equipment intended for use in explosive atmospheres (Ex equipment). It supports compliance with ATEX and IECEx certification schemes by ensuring consistent production of explosion-protected equipment. The standard focuses on production control, traceability, verification, and ongoing conformity with certified designs. It ensures that equipment continues to meet the safety requirements defined in type examination certificates. Compliance is essential for maintaining certification validity and for legal market access in hazardous-area industries.
How Can We Help?
Compliance with ISO/IEC 80079-34 is highly technical and closely scrutinized by certification bodies. Any weakness in production control, documentation, or change management can jeopardize your ATEX or IECEx certification. We build a robust and audit-ready quality system specifically aligned with explosion protection requirements. Our experts integrate certified design control, production verification, supplier oversight, and change management into a structured compliance framework. We prepare you thoroughly for surveillance audits and ensure ongoing conformity with notified body expectations. With our guidance, a complex and high-risk certification requirement becomes a controlled, secure, and sustainable compliance system.
FAQ
ISO/IEC 80079-34 — frequently asked questions
It is not a standalone legal requirement, but it is effectively mandatory for manufacturers of Ex (explosion-protected) equipment seeking ATEX or IECEx certification. Certification bodies require compliance as proof of a controlled manufacturing quality system.
ISO/IEC 80079-34 defines quality system requirements for manufacturing equipment intended for explosive atmospheres. It ensures consistent production of Ex-certified products and supports compliance with ATEX Directive and IECEx Scheme requirements.
- Manufacturers of explosion-protected electrical equipment
- Non-electrical Ex equipment manufacturers
- Component manufacturers used in hazardous areas
- OEMs supplying ATEX/IECEx markets
Key documented elements include:
- Quality manual aligned with Ex product control
- Product verification and routine test procedures
- Control of critical Ex components
- Traceability records
- Change management procedures
- Competence and training records
- Calibration and inspection records
Time depends on product complexity and current QMS maturity.
Exact cost varies based on size, scope, readiness, and Notified Body audit fees. A professional gap analysis significantly reduces wasted cost and audit risk.
Maintenance requires:
- Strict control of Ex-critical processes
- Ongoing inspections and tests
- Internal audits
- Management reviews
- Change control discipline
Certification bodies conduct annual surveillance audits.
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ISO/IEC 80079-34
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