Understanding ISO 80079-34
Scope of ISO 80079-34
The main objective of ISO 80079-34 is to provide manufacturers of Ex equipment with a systematic approach to ensuring that their products comply with the essential safety requirements. The standard outlines the requirements for establishing and implementing a quality management system (QMS) for Ex equipment manufacture. This QMS is critical in assuring the safety and reliability of the equipment used in explosive atmospheres.
The standard encompasses various stages of the manufacturing process, including design, production, assembly, testing, and documentation. It covers all Ex equipment, regardless of the industry or the type of explosive substance it is intended to handle. ISO 80079-34 sets the foundation for quality management principles to be applied throughout the product lifecycle, ensuring consistency and reliability.
Significance of ISO 80079-34
Key Requirements of ISO 80079-34
- Quality Management System: Manufacturers must establish and maintain a QMS that aligns with ISO 9001, the internationally recognized standard for general quality management.
- Risk Assessment: A comprehensive risk assessment must be conducted to identify potential hazards and assess their potential impact on the Ex equipment.
- Documentation: The standard mandates thorough documentation throughout the entire product lifecycle, including design specifications, manufacturing processes, test procedures, and records.
- Competency of Personnel: Manufacturers must ensure that their personnel involved in the design, production, and testing of Ex equipment are competent and adequately trained.
- Verification and Validation: The standard requires manufacturers to conduct rigorous verification and validation processes to ensure that the Ex equipment meets all specified requirements.
- Non-Conformance Management: A system for managing non-conformities and corrective actions must be established to address any deviations from the standard’s requirements.
Benefits of Complying with ISO 80079-34
- Enhanced Safety: Compliance with ISO 80079-34 ensures that Ex equipment is designed and manufactured to withstand explosive atmospheres safely, minimizing the risk of accidents and protecting personnel and assets.
- Global Market Access: Many countries and industries mandate compliance with ISO 80079-34 for Ex equipment. By adhering to the standard, manufacturers can access a broader market and increase their competitiveness.
- Improved Reputation: Companies that comply with the standard demonstrate their commitment to safety and quality, which enhances their reputation among customers and stakeholders.
- Risk Mitigation: Rigorous risk assessments and controls implemented as part of the QMS help manufacturers identify potential hazards and mitigate risks effectively.
1. Scope
2. Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
IEC 60050-426, International Electrotechnical Vocabulary — Part 426: Equipment for explosive atmospheres
IEC 60079-0, Explosive atmospheres — Part 0: Equipment — General requirements
ISO 9000, Quality management systems — Fundamentals and vocabulary
ISO 9001:2015, Quality management systems — Requirements
3. Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60050-426, IEC 60079-0, ISO 9000 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
3.1 certificate
document that conveys the assurance of the conformity of a product, process, system, person, or organization with specified requirements
Note 1 to entry: This is equivalent to the term “certificate” defined in IEC 60079-0.
Note 2 to entry: The certificate is either the supplier’s declaration of conformity or the purchaser’s recognition of conformity or certification (as a result of action by a third party) as defined in ISO/IEC 17000.
3.2 manufacturer
organization, situated at a stated location or locations, that carries out or controls such stages in the manufacture, assessment, handling and storage of a product that enables it to accept responsibility for continued compliance of the product with the relevant requirements and undertakes all obligations in that connection
Note 1 to entry: The term “manufacturer” is used instead of “organization” as used in ISO 9001:2015. For the purposes of this document they are interchangeable.
3.3 contract
requirements forming an agreement between different parties and transmitted by any appropriate means
3.4 customer complaint
reported, written or verbal allegation made by a customer which concerns the identity, quality, durability, safety, security, conformity or performance of any equipment or protective system or component as defined in the certificate
3.5 Ex Product
Ex Equipment, protective system, safety device, Ex Component and their combination, as well as software and services
3.6 protective system
device other than components of equipment which are intended to halt incipient explosions immediately and/or to limit the effective range of an explosion
Note 1 to entry: Protective systems can be integrated into equipment or separately released for use as autonomous systems.
3.7 safety device
device intended for use inside or outside explosive atmospheres but required for or contributing to the safe functioning of equipment and protective systems with respect to the risks of explosion
3.8 schedule drawing
drawing or document listed in the certificate or test report
3.9 related drawing
drawing or document not listed in the certificate but linked to the schedule drawing, and used for example, for detailed manufacture or purchase of component parts
3.10 technical documentation
documentation that enables the conformity of the product with the requirements of the standard(s) to be assessed
Note 1 to entry: This includes schedule drawings
Note 2 to entry: It covers the design, manufacture and operation of the product and can contain:
— a general description;
— design and manufacturing drawings and layouts of components, sub-assemblies, circuits, etc.;
— descriptions and explanations necessary for the understanding of drawings and layouts and the operation of the product;
— a list of the standards referred to in the certificate, applied in full or in part, and descriptions of the solutions adopted to meet the requirements of the standards;
— results of design calculations made, examinations carried out, risk assessment etc.;
— test reports.
Note 3 to entry: For Non-electrical equipment, this includes the “Formal Ignition hazard identification and assessment” referred to in ISO 80079-36
3.11 manufacturer’s documentation
documents required by a manufacturer but not subject to assessment by body responsible for verification when making an application for a test report or a certificate
Note 1 to entry: For example, manufacturing instructions, related drawings, data sheets and sales literature.
Note 2 to entry: The manufacturer’s documentation can be either in paper form or electronic form.
3.12 body responsible for verification
body which conducts documentation review and periodical audit as appropriate
Note 1 to entry: The body can be a manufacturer (first party), purchaser (second party), or a Certification body (third party).
