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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
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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

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PDF Pages PDF Title
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
BS EN ISO/IEC 80079-34:2020 - TC
$216.05