ISO/IEC 80079-34:2018

Explosive atmospheres — Part 34: Application of quality management systems for Ex Product manufacture

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

Atmosphères explosives — Partie 34: Application de systèmes de management de la qualité pour la fabrication des produits Ex

ISO/IEC 80079-34:2018 spécifie des exigences particulières et des informations destinées à établir et à maintenir un système de management de la qualité afin de fabriquer des produits Ex, conformément aux certificats existants. Même s’il n'est pas incompatible avec l'utilisation d'autres systèmes de management de la qualité conciliables avec les objectifs de l'ISO 9001:2015 et donnant des résultats équivalents, le présent document indique les exigences minimales. Cette deuxième édition annule et remplace la première édition, parue en 2011. Cette édition constitue une révision technique complète. Il convient de considérer que les modifications importantes apportées à l’édition précédente donnent lieu à une révision technique mineure. Toutefois, la numérotation des articles a été modifiée par rapport à l’édition précédente afin d’être conforme à l’ISO 9001:2015. C’est la raison pour laquelle, l’habituel « Tableau des modifications majeures » n’est pas inclus. Cette publication est publiée en tant que norme à double logo. Il convient d’utiliser la présente norme conjointement avec l'ISO 9001:2015.

General Information

• Status: Published
• Publication Date: 03-Sep-2018
• ICS: 29.260.20 - Electrical apparatus for explosive atmospheres
• Technical Committee: ISO/TMBG - Technical Management Board - groups
• Drafting Committee: ISO/TMBG - Technical Management Board - groups
• Parallel Committee: IEC/SC 31M - Non-electrical equipment and protective systems for explosive atmospheres
• Current Stage: 6060 - International Standard published
• Due Date: 11-Dec-2018
• Completion Date: 04-Sep-2018

Relations

• Revises: ISO/IEC 80079-34:2011 - Explosive atmospheres — Part 34: Application of quality systems for equipment manufacture
• Effective Date: 05-Dec-2015
• Consolidated By: ISO 24034:2020 - Welding consumables — Solid wire electrodes, solid wires and rods for fusion welding of titanium and titanium alloys — Classification
• Effective Date: 06-Jun-2022

Standards Content (Sample)

ISO/IEC 80079-34
Edition 2.0 2018-08
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Explosive atmospheres –
Part 34: Application of quality management systems for Ex Product manufacture

Atmosphères explosives –
Partie 34: Application de systèmes de management de la qualité pour la
fabrication des produits Ex


ISO/IEC 80079-34:2018-08(en-fr)

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ISO/IEC 80079-34


Edition 2.0 2018-08




INTERNATIONAL



STANDARD




NORME



INTERNATIONALE











Explosive atmospheres –

Part 34: Application of quality management systems for Ex Product manufacture




Atmosphères explosives –

Partie 34: Application de systèmes de management de la qualité pour la

fabrication des produits Ex















INTERNATIONAL

ELECTROTECHNICAL

COMMISSION


COMMISSION

ELECTROTECHNIQUE


INTERNATIONALE




ICS 03.120.01; 29.260.20 ISBN 978-2-8322-6024-1




Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

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– 2 – ISO/IEC 80079-34:2018 © IEC 2018
CONTENTS
FOREWORD . 6
INTRODUCTION . 8
1 Scope . 9
2 Normative references . 9
3 Terms and definitions . 9
4 Context of the organization . 11
4.1 Understanding the organization and its context . 11
4.2 Understanding the needs and expectations of interested parties . 12
4.3 Determining the scope of the quality management system . 12
4.4 Quality management system and its processes . 13
5 Leadership . 14
5.1 Leadership and commitment . 14
5.1.1 General . 14
5.1.2 Customer focus . 14
5.2 Policy . 15
5.2.1 Establishing the quality policy . 15
5.2.2 Communicating the quality policy . 15
5.3 Organizational roles, responsibilities and authorities . 15
6 Planning . 16
6.1 Actions to address risks and opportunities . 16
6.2 Quality objectives and planning to achieve them . 17
6.3 Planning of changes . 17
7 Support . 18
7.1 Resources . 18
7.1.1 General . 18
7.1.2 People . 18
7.1.3 Infrastructure . 18
7.1.4 Environment for the operation of processes . 18
7.1.5 Monitoring and measuring resources . 19
7.1.6 Organizational knowledge . 20
7.2 Competence . 20
7.3 Awareness . 21
7.4 Communication . 21
7.5 Documented information . 22
7.5.1 General . 22
7.5.2 Creating and updating . 22
7.5.3 Control of documented Information . 23
8 Operation . 25
8.1 Operational planning and control . 25
8.2 Requirements for products and services . 25
8.2.1 Customer communication . 25
8.2.2 Determining the requirements for products and services . 26
8.2.3 Review of the requirements for products and services . 26
8.2.4 Changes to requirements for products and services . 27
8.3 Design and development of products and services . 27
8.3.1 General . 27

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ISO/IEC 80079-34:2018 © IEC 2018 – 3 –
8.3.2 Design and development planning . 27
8.3.3 Design and development Inputs . 28
8.3.4 Design and development controls . 28
8.3.5 Design and development outputs . 29
8.3.6 Design and development changes . 29
8.4 Control of externally provided processes, products and services . 30
8.4.1 General . 30
8.4.2 Type and extent of control . 31
8.4.3 Information for external providers . 33
8.5 Production and service provision . 34
8.5.1 Control of production and service provision . 34
8.5.2 Identification and traceability . 34
8.5.3 Property belonging to customers or external providers . 35
8.5.4 Preservation . 35
8.5.5 Post-delivery activities . 35
8.5.6 Control of changes . 36
8.6 Release of products and services . 36
8.7 Control of nonconforming outputs . 37
9 Performance evaluation . 38
9.1 Monitoring, measurement, analysis and evaluation . 38
9.1.1 General . 38
9.1.2 Customer satisfaction . 38
9.1.3 Analysis and evaluation . 38
9.2 Internal audit . 39
9.3 Management review . 39
9.3.1 General . 39
9.3.2 Management review inputs . 40
9.3.3 Management review outputs . 40
10 Improvement . 41
10.1 General . 41
10.2 Nonconformity and corrective action . 41
10.3 Continual improvement . 42
Annex A (informative) Information relevant to particular Types of Protection and
specific Ex Products . 43
A.1 Overview. 43
A.2 General . 43
A.3 Ex d – Flameproof enclosures covered by IEC 60079-1 . 43
A.3.1 Verification . 43
A.3.2 Castings . 43
A.3.3 Machining . 44
A.3.4 Cemented joints and potted assemblies . 44
A.3.5 Routine overpressure testing . 44
A.3.6 Flanged joints . 45
A.3.7 Elements, with non-measurable paths, of breathing and draining
devices . 45
A.4 Ex i – intrinsic safety covered by IEC 60079-11 . 46
A.4.1 Components for intrinsically safe products . 46
A.4.2 Printed circuit boards (PCB) . 46
A.4.3 Sub-assemblies and assemblies . 47

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– 4 – ISO/IEC 80079-34:2018 © IEC 2018
A.4.4 Enclosures for Group III or reduced spacing . 47
A.4.5 Routine verifications and tests . 48
A.4.6 Intrinsically safe circuits and assemblies incorporated in Ex equipment
of other types of protection . 48
A.5 Ex e – Increased safety covered by IEC 60079-7 . 48
A.5.1 Ingress protection (IP) . 48
A.5.2 Internal wiring and contact integrity . 48
A.5.3 Rotating machines . 48
A.5.4 Windings . 49
A.5.5 Terminal boxes . 49
A.5.6 Cable Glands, terminals and other accessories . 49
A.5.7 Routine verifications and tests . 49
A.6 Ex p – Pressurized equipment covered by IEC 60079-2 . 49
A.6.1 Ingress protection (IP) . 49
A.6.2 Components and manufacturing process . 49
A.6.3 Components, constructional characteristics . 50
A.6.4 Routine verifications and tests . 50
A.7 Ex m – Encapsulation covered by IEC 60079-18 . 50
A.7.1 Production documentation . 50
A.7.2 Routine verifications and tests . 50
A.8 Ex o – Liquid immersion covered by IEC 60079-6 . 50
A.8.1 Material control . 50
A.8.2 Filling . 51
A.8.3 Ingress protection . 51
A.8.4 Routine verifications and tests . 51
A.9 Ex q – Powder filling covered by IEC 60079-5 . 51
A.9.1 Material control . 51
A.9.2 Filling . 51
A.9.3 Ingress protection (IP) . 51
A.9.4 Routine verifications and tests . 51
A.10 Equipment covered by IEC 60079-15 . 52
A.10.1 General requirements . 52
A.10.2 Ex nA – Non sparking equipment . 52
A.10.3 Ex nC – Sealed devices . 52
A.10.4 Ex nR – Restricted Breathing . 52
A.11 Ex t – Dust ignition protection by enclosure covered by IEC 60079-31 . 53
A.11.1 Casting . 53
A.11.2 Enclosure parts . 53
A.11.3 Gaskets . 53
A.11.4 Protection devices . 53
A.11.5 Cemented and cast enclosure parts . 53
A.11.6 Ingress protection (IP) . 54
A.11.7 Routine verifications and tests . 54
A.12 Ex op – Optical radiation covered by IEC 60079-28 . 54
A.13 Gas detectors covered by IEC 60079-29 . 54
A.14 Ex h – Non-electrical Equipment covered by ISO 80079-36 . 55
A.14.1 General . 55
A.14.2 Non-metallic parts . 55
A.14.3 Casing and external parts . 55

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ISO/IEC 80079-34:2018 © IEC 2018 – 5 –
A.14.4 Earthing and equipotential bonding of conductive parts . 55
A.14.5 Light transmitting parts . 55
A.14.6 Ingress protection (IP) . 56
A.15 Non Electrical Equipment protected by constructional safety “c” covered by
ISO 80079-37 . 56
A.15.1 General . 56
A.15.2 Metal-based material . 56
A.15.3 Machining . 56
A.15.4 Cemented joints and potted assemblies . 56
A.15.5 Assembling . 57
A.15.6 Routine tests . 57
A.15.7 Power transmission systems . 57
A.16 Non-electrical equipment protected by control of ignition sources “b” covered
by ISO 80079-37 . 57
A.16.1 General . 57
A.16.2 Ignition protection system . 57
A.16.3 Assembling . 57
A.16.4 Routine verifications and tests . 58
A.17 Non-electrical equipment protected by liquid immersion “k” covered by
ISO 80079-37 . 58
A.17.1 General . 58
A.17.2 Protective liquid . 58
A.17.3 Casing . 58
A.17.4 Measuring or indicating devices . 58
A.18 Flame arresters covered by ISO 16852 . 58
Annex B (informative)  Verification criteria for elements with non-measurable paths
used as an integral part of a Type of Protection . 60
B.1 Overview. 60
B.2 Verification guidance . 60
B.3 Tests . 60
B.4 Test examples . 61
B.4.1 General . 61
B.4.2 Example 1 (pore size) . 61
B.4.3 Example 2 (density) . 61
B.5 Purchase information . 62
B.6 Pre-tested components . 62
B.7 Measurement and monitoring . 62
Annex C (informative) External Provider's Declaration of Conformity . 63
C.1 External Provider's Declaration of Conformity . 63
C.2 Additional Supporting information . 64
C.3 Responsibility of the Organization . 64
C.4 Example of an External Provider's Declaration of Conformity . 65
Annex D (informative) ISO/IEC 80079-34:2011 to ISO/IEC 80079-34 Edition 2

Correlation Matrix . 66
Bibliography . 69

Table A.1 – Component features requiring compatibility . 46

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INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________

EXPLOSIVE ATMOSPHERES –

Part 34: Application of quality management systems
for Ex Product manufacture

FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. Internation
...