ISO/IEC 80079-34:2018

Overview

ISO/IEC 80079-34:2018 - Explosive atmospheres - Part 34: Application of quality management systems for Ex Product manufacture - specifies particular requirements and information for establishing and maintaining a quality management system (QMS) for the manufacture of Ex (explosion-protected) products in accordance with their certificates. This 2018 second edition replaces the 2011 edition, aligns clause numbering with ISO 9001:2015, and is intended to be read in conjunction with ISO 9001:2015. The standard is published as a double-logo ISO/IEC document and focuses on achieving product safety, compliance and consistent manufacturing for equipment used in explosive atmospheres.

Key Topics and Requirements

ISO/IEC 80079-34:2018 adapts general QMS principles to the specific hazards and production controls needed for Ex Products. Major topical areas include:

• QMS structure and context: understanding organization, interested parties and scope specific to Ex product manufacture.
• Leadership and policy: management commitment, quality policy and defined responsibilities for Ex compliance.
• Risk and planning: actions to address risks and opportunities related to explosive-atmosphere product safety.
• Support and resources: competence, infrastructure, monitoring and organizational knowledge required for Ex manufacture.
• Operational control: production controls, design and development, control of externally provided processes and supplier management, identification and traceability, preservation and release of products.
• Verification and testing: routine verifications and type-specific checks (see informative Annex A covering common Types of Protection such as Ex d, Ex i, Ex e, Ex p, Ex m).
• Performance evaluation and improvement: monitoring, internal audit, management review and corrective action processes tailored to Ex product requirements.
• Documented information: control of quality records and documented processes supporting certification and conformity.

Applications and Who Uses It

ISO/IEC 80079-34:2018 is used by:

• Manufacturers of Ex equipment and protective systems seeking to demonstrate consistent production in line with certification.
• Quality managers and compliance engineers implementing QMS controls specific to explosive atmospheres.
• Certification bodies and notified/certifying organizations assessing manufacturer compliance with Ex product requirements.
• Suppliers and contract manufacturers involved in parts, PCB, enclosures, castings and assembly where Ex conformity is critical. Practical applications include setting up production controls, supplier qualification, traceability, routine testing, and preparing for conformity assessment to IEC 60079 series requirements.

Related Standards

• ISO 9001:2015 - Quality management systems (to be read in conjunction)
• IEC 60079 series (e.g., IEC 60079-1, -2, -7, -11, -18) - Type-specific construction and testing requirements for Ex protection

Keywords: ISO/IEC 80079-34:2018, explosive atmospheres, Ex product manufacture, quality management system, ISO 9001:2015, IEC 60079.