BS EN ISO/IEC 80079-34:2020 – TC
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Tracked Changes. Explosive atmospheres – Application of quality systems for ex product manufacture
Published By | Publication Date | Number of Pages |
BSI | 2020 | 196 |
ISO/IEC 80079-34:2018 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 9001:2015 and which provide equivalent results, the minimum requirements are given in this document. This second edition cancels and replaces the first edition, published in 2011, and constitutes a full technical revision. The significant changes with respect to the previous edition should be considered as minor technical revisions. However, the clause numbering in regard to the previous edition has changed in order to be in line with ISO 9001:2015. The normal “Table of Significant Changes” has not been included for this reason. This publication is published as a double logo standard. This standard should be read in conjunction with ISO 9001:2015
PDF Catalog
PDF Pages | PDF Title |
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1 | compares BS EN ISO/IEC 80079‑34:2020 |
2 | TRACKED CHANGES Text example 1 — indicates added text (in green) |
3 | BS EN ISO/IEC 80079‑34:2020 — Tracked Changes |
8 | Annex ZB (informative) ZB.1 Introduction ZB.2 Non-electrical equipment (EN 13463-1) ZB.2.1 General ZB.2.2 Non-metallic parts |
9 | ZB.2.3 Casing and external parts ZB.2.4 Earthing and equipotential bonding of conductive parts ZB.2.5 Light transmitting parts ZB.2.6 Ingress protection (IP) ZB.2.7 Completed products |
10 | ZB.5.1 General ZB.5.2 Metal-based material ZB.5.3 Machining ZB.5.4 Cemented joints and potted assemblies |
11 | ZB.5.5 Assembling ZB.5.6 Routine tests ZB.5.7 Power transmission systems ZB.6.1 General ZB.6.2 Ignition protection system ZB.6.3 Installation |
12 | ZB.6.4 Tests ZB.8.1 General ZB.8.2 Protective liquid |
13 | ZB.8.3 Casing ZB.8.4 Measuring or indicating devices |
18 | ZB.12.2 Explosion resistant equipment (EN 14460) |
24 | B) Information about the background of ‘Major technical changes’ |
25 | Annex ZZ (informative) |
26 | Annex ZD (informative) |
27 | EN 1834 (all parts), Reciprocating internal combustion engines — Safety requirements for design and construction of engines for use in potentially explosive atmospheres EN 13463-22), Non-electrical equipment for use in potentially explosive atmospheres — Part 2: Protection by flow restricting enclosure ‘fr’ |
28 | EN 14491, Dust explosion venting protective systems EN 14986, Design of fans working in potentially explosive atmospheres EN 24003, Permeable sintered metal materials — Determination of bubble test pore size (ISO 4003:1977) |
29 | EN ISO 2738, Sintered metal materials, excluding hardmetals — Permeable sintered metal materials — Determination of density, oil content and open porosity EN ISO/IEC 17021-1, Conformity assessment — Requirements for bodies providing audit and certification of management systems — Part 1: Requirements EN ISO 80079-36, Explosive atmospheres — Part 36: Non-electrical equipment for explosive atmospheres — Basic method and requirements |
34 | INTERNATIONAL ELECTROTECHNICAL COMMISSION FOREWORD |
36 | INTRODUCTION |
37 | EXPLOSIVE ATMOSPHERES – 1 Scope 2 Normative references 3 Terms and definitions 3.1 |
38 | 3.2 3.33.1 3.83.6 |
39 | 3.14 3.153.12 4.1 General requirements |
40 | 4.2 Documentation requirements 4.2.1 General 4.2.2 Quality manual 4 Context of the organization |
42 | 5 Leadership |
44 | 6 Planning |
46 | 7 Support |
51 | 4.2.3 Control of documents |
52 | 4.2.4 Control of records 5 Management responsibility 5.1 Management commitment 5.2 Customer focus 5.3 Quality policy |
53 | 5.4 Planning 5.4.1 Quality objectives 5.4.2 Quality management system planning 5.5 Responsibility, authority and communication 5.5.1 Responsibility and authority 5.5.2 Management representative Subclause 5.5.2 of ISO 9001:2008 applies. 5.5.3 Internal communication Subclause 5.5.3 of ISO 9001:2008 applies. 5.6 Management review 5.6.1 General |
54 | 5.6.2 Review input 5.6.3 Review output 6 Resource management 6.1 Provision of resources 6.2 Human resources 6.2.1 General 6.2.2 Competence, training and awareness 6.3 Infrastructure 6.4 Work environment 7 Product realization 7.1 Planning of product realization Subclause 7.1 of ISO 9001:2008 applies. NOTE Examples are given in Annexes A and B. |
55 | 7.2 Customer-related processes 7.2.1 Determination of requirements related to the product Subclause 7.2.1 of ISO 9001:2008 applies. 7.2.2 Review of requirements related to the product 7.3 Design and development 7.3.1 Design and development planning 7.3.2 Design and development inputs 7.3.3 Design and development outputs 7.3.4 Design and development review 7.3.5 Design and development verification Subclause 7.3.5 of ISO 9001:2008 is not within the scope of this standard. 7.3.6 Design and development validation Subclause 7.3.6 of ISO 9001:2008 is not within the scope of this standard. 7.3.7 Control of design and development changes Subclause 7.3.7 of ISO 9001:2008 applies with the following addition: The person identified in 5.5.1 a) shall approve any changes that could compromise Ex compliance. |
56 | 8 Operation |
61 | 7.4 Purchasing 7.4.1 Purchasing process |
64 | 7.4.3 Verification of purchased product |
66 | 7.5.2 Validation of processes for production and service provision |
67 | 7.6 Control of monitoring and measuring equipment |
68 | 8 Measurement, analysis and improvement 8.1 General 8.2 Monitoring and measurement 8.2.1 Customer satisfaction 8.2.2 Internal audit 8.2.3 Monitoring and measurement of processes |
72 | 8.5 Improvement 8.5.1 Continual improvement Subclause 8.5.1 of ISO 9001:2008 applies 8.5.2 Corrective action Subclause 8.5.2 of ISO 9001:2008 applies. 8.5.3 Preventive action Subclause 8.5.3 of ISO 9001:2008 applies 9 Performance evaluation |
76 | 10 Improvement |
78 | Annex A (informative) A.1 GeneralOverview A.2 Enclosures – General remarkGeneral A.3 Ex d-flameproof – Flameproof enclosures covered by IEC 60079-1 |
81 | A.4 Ex i – intrinsic safety covered by IEC 60079-11 |
83 | A.5 Ex e – Increased safety and nA – Non sparkingcovered by IEC 60079-7 |
84 | A.6 Ex p – Pressurized equipment covered by IEC 60079-2 |
85 | A.7 Ex m – Encapsulation covered by IEC 60079-18 |
86 | A.8 Ex o – OilLiquid immersion covered by IEC 60079-6 A.9 Ex q – Powder filling covered by IEC 60079-5 |
87 | A.10 Equipment covered by IEC 60079-15 |
88 | A.10A.11 Ex t – Dust ignition protection by enclosure covered by IEC 60079-31 |
89 | A.12 Ex op – Optical radiation covered by IEC 60079-28 A.11A.13 Gas detectors covered by IEC 60079-29 |
90 | A.14 Ex h – Non-electrical Equipment covered by ISO 80079-36 |
93 | A.12A.18 Flame arresters covered by ISO 16852 |
95 | Annex B (informative) B.1 GeneralOverview B.2 Verification guidance B.3 Tests |
96 | B.4 Test examples |
97 | B.5 Purchase information B.6 Pre-tested components B.7 Measurement and monitoring |
98 | Annex C (informative) C.1 External Provider’s Declaration of Conformity |
99 | C.2 Additional Supporting information C.3 Responsibility of the Organization |
100 | C.4 Example of an External Provider’s Declaration of Conformity |
101 | Annex D (informative) ISO/IEC 80079-34:2011 to ISO/IEC 80079-34 Edition 2 Correlation Matrix |
104 | Bibliography |
106 | undefined |
111 | Annex ZA (normative)Normative references to international publications and the corresponding European publications |
112 | Annex ZB (informative)Information relevant to equipment and protective systems according to standards harmonized under Directive 2014/34/EU ZB.1 Introduction ZB.2 Non-electrical equipment (EN 134631) ZB.3 Protection by flow restricting enclosure “fr” (EN 134632) ZB.4 Protection by flameproof enclosure “d” (EN 134633) ZB.5 Protection by constructional safety “c” (EN 134635) ZB.6 Protection by control of ignition sources “b” (EN 134636) ZB.7 Protection by pressurised enclosures “p” (EN 134637) |
113 | ZB.8 Protection by liquid immersion “k” (EN 13463-8) ZB.9 Fans (EN 14986) ZB.9.1 General ZB.9.2 Material ZB.9.3 Assembled equipment and protective systems ZB.9.4 Routine tests |
114 | ZB.10 Petrol dispensers (EN 136171) ZB.10.1 General ZB.10.2 Electrical installation ZB.10.3 Information for safe operation ZB.10.4 Assembly groups ZB.10.5 Assembling |
115 | ZB.10.6 Monitoring equipment ZB.10.7 Electrostatic discharge capacity ZB.10.8 Routine tests ZB.11 Electrostatic spraying equipment ZB.11.1 General |
116 | ZB.11.2 Electrical assembly |
117 | ZB.11.3 Mechanical assembly ZB.11.4 Tests |
118 | ZB.12 Protective systems ZB.12.1 General ZB.12.2 Explosion resistant equipment (EN 14460) ZB.12.3 Explosion venting devices (EN 14797) |
119 | ZB.12.4 Explosion isolation systems (EN 15089) |
120 | ZB.12.5 Flameless explosion venting devices (EN 16009) ZB.12.6 Explosion diverters (EN 16020) |
121 | ZB.12.7 Explosion isolation flap valves (EN 16447) |
122 | Annex ZC (informative)Significant changes between these European Annexes and the European Annexes of EN ISO/IEC 8007934:2011 |
124 | Annex ZD (informative)Relationship between this European Standard and the essential requirements of 2014/34/EU [2014 OJ L96] aimed to be covered |
128 | English CONTENTS |
132 | FOREWORD |
134 | INTRODUCTION |
135 | 1 Scope 2 Normative references 3 Terms and definitions |
137 | 4 Context of the organization 4.1 Understanding the organization and its context |
138 | 4.2 Understanding the needs and expectations of interested parties 4.3 Determining the scope of the quality management system |
139 | 4.4 Quality management system and its processes |
140 | 5 Leadership 5.1 Leadership and commitment 5.1.1 General 5.1.2 Customer focus |
141 | 5.2 Policy 5.2.1 Establishing the quality policy 5.2.2 Communicating the quality policy 5.3 Organizational roles, responsibilities and authorities |
142 | 6 Planning 6.1 Actions to address risks and opportunities |
143 | 6.2 Quality objectives and planning to achieve them 6.3 Planning of changes |
144 | 7 Support 7.1 Resources 7.1.1 General 7.1.2 People 7.1.3 Infrastructure 7.1.4 Environment for the operation of processes |
145 | 7.1.5 Monitoring and measuring resources |
146 | 7.1.6 Organizational knowledge 7.2 Competence |
147 | 7.3 Awareness 7.4 Communication |
148 | 7.5 Documented information 7.5.1 General 7.5.2 Creating and updating |
149 | 7.5.3 Control of documented Information |
151 | 8 Operation 8.1 Operational planning and control 8.2 Requirements for products and services 8.2.1 Customer communication |
152 | 8.2.2 Determining the requirements for products and services 8.2.3 Review of the requirements for products and services |
153 | 8.2.4 Changes to requirements for products and services 8.3 Design and development of products and services 8.3.1 General 8.3.2 Design and development planning |
154 | 8.3.3 Design and development Inputs 8.3.4 Design and development controls |
155 | 8.3.5 Design and development outputs 8.3.6 Design and development changes |
156 | 8.4 Control of externally provided processes, products and services 8.4.1 General |
157 | 8.4.2 Type and extent of control |
159 | 8.4.3 Information for external providers |
160 | 8.5 Production and service provision 8.5.1 Control of production and service provision 8.5.2 Identification and traceability |
161 | 8.5.3 Property belonging to customers or external providers 8.5.4 Preservation 8.5.5 Post-delivery activities |
162 | 8.5.6 Control of changes 8.6 Release of products and services |
163 | 8.7 Control of nonconforming outputs |
164 | 9 Performance evaluation 9.1 Monitoring, measurement, analysis and evaluation 9.1.1 General 9.1.2 Customer satisfaction 9.1.3 Analysis and evaluation |
165 | 9.2 Internal audit 9.3 Management review 9.3.1 General |
166 | 9.3.2 Management review inputs 9.3.3 Management review outputs |
167 | 10 Improvement 10.1 General 10.2 Nonconformity and corrective action |
168 | 10.3 Continual improvement |
169 | Annex A (informative)Information relevant to particular Types of Protection and specific Ex Products A.1 Overview A.2 General A.3 Ex d – Flameproof enclosures covered by IEC 60079-1 A.3.1 Verification A.3.2 Castings |
170 | A.3.3 Machining A.3.4 Cemented joints and potted assemblies A.3.5 Routine overpressure testing |
171 | A.3.6 Flanged joints A.3.7 Elements, with non-measurable paths, of breathing and draining devices |
172 | A.4 Ex i – intrinsic safety covered by IEC 60079-11 A.4.1 Components for intrinsically safe products A.4.2 Printed circuit boards (PCB) Table A.1 – Component features requiring compatibility |
173 | A.4.3 Sub-assemblies and assemblies A.4.4 Enclosures for Group III or reduced spacing |
174 | A.4.5 Routine verifications and tests A.4.6 Intrinsically safe circuits and assemblies incorporated in Ex equipment of other types of protection A.5 Ex e – Increased safety covered by IEC 60079-7 A.5.1 Ingress protection (IP) A.5.2 Internal wiring and contact integrity A.5.3 Rotating machines |
175 | A.5.4 Windings A.5.5 Terminal boxes A.5.6 Cable Glands, terminals and other accessories A.5.7 Routine verifications and tests A.6 Ex p – Pressurized equipment covered by IEC 60079-2 A.6.1 Ingress protection (IP) A.6.2 Components and manufacturing process |
176 | A.6.3 Components, constructional characteristics A.6.4 Routine verifications and tests A.7 Ex m – Encapsulation covered by IEC 60079-18 A.7.1 Production documentation A.7.2 Routine verifications and tests A.8 Ex o – Liquid immersion covered by IEC 60079-6 A.8.1 Material control |
177 | A.8.2 Filling A.8.3 Ingress protection A.8.4 Routine verifications and tests A.9 Ex q – Powder filling covered by IEC 60079-5 A.9.1 Material control A.9.2 Filling A.9.3 Ingress protection (IP) A.9.4 Routine verifications and tests |
178 | A.10 Equipment covered by IEC 60079-15 A.10.1 General requirements A.10.2 Ex nA – Non sparking equipment A.10.3 Ex nC – Sealed devices A.10.4 Ex nR – Restricted Breathing |
179 | A.11 Ex t – Dust ignition protection by enclosure covered by IEC 60079-31 A.11.1 Casting A.11.2 Enclosure parts A.11.3 Gaskets A.11.4 Protection devices A.11.5 Cemented and cast enclosure parts |
180 | A.11.6 Ingress protection (IP) A.11.7 Routine verifications and tests A.12 Ex op – Optical radiation covered by IEC 60079-28 A.13 Gas detectors covered by IEC 60079-29 |
181 | A.14 Ex h – Non-electrical Equipment covered by ISO 80079-36 A.14.1 General A.14.2 Non-metallic parts A.14.3 Casing and external parts A.14.4 Earthing and equipotential bonding of conductive parts A.14.5 Light transmitting parts |
182 | A.14.6 Ingress protection (IP) A.15 Non Electrical Equipment protected by constructional safety “c”covered by ISO 80079-37 A.15.1 General A.15.2 Metal-based material A.15.3 Machining A.15.4 Cemented joints and potted assemblies |
183 | A.15.5 Assembling A.15.6 Routine tests A.15.7 Power transmission systems A.16 Non-electrical equipment protected by control of ignition sources “b” covered by ISO 80079-37 A.16.1 General A.16.2 Ignition protection system A.16.3 Assembling |
184 | A.16.4 Routine verifications and tests A.17 Non-electrical equipment protected by liquid immersion “k” covered by ISO 80079-37 A.17.1 General A.17.2 Protective liquid A.17.3 Casing A.17.4 Measuring or indicating devices A.18 Flame arresters covered by ISO 16852 |
186 | Annex B (informative) Verification criteria for elements with non-measurable paths used as an integral part of a Type of Protection B.1 Overview B.2 Verification guidance B.3 Tests |
187 | B.4 Test examples B.4.1 General B.4.2 Example 1 (pore size) B.4.3 Example 2 (density) |
188 | B.5 Purchase information B.6 Pre-tested components B.7 Measurement and monitoring |
189 | Annex C (informative)External Provider’s Declaration of Conformity C.1 External Provider’s Declaration of Conformity |
190 | C.2 Additional Supporting information C.3 Responsibility of the Organization |
191 | C.4 Example of an External Provider’s Declaration of Conformity |
192 | Annex D (informative)ISO/IEC 80079-34:2011 to ISO/IEC 80079-34 Edition 2Correlation Matrix |
195 | Bibliography |