ISO IEC 80079-34 pdf download

ISO IEC 80079-34 pdf download.EXPLOSIVE ATMOSPHERES – Part 34: Application of quality management systems for Ex Product manufacture
1 Scope
This document specifies particular requirements and information for establishing and maintaining a quality management system to manufacture Ex Products in accordance with the certificates. While it does not preclude the use of other quality management systems that are compatible with the objectives of ISO 9001 :201 5 and which provide equivalent results, the minimum requirements are given in this document.
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 1 7000.3.2 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 :201 5. 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 3.1 0 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 3.1 1 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. 3.1 2 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).