ISO/IEC 80079-34:2011

ISO/IEC 80079-34
Edition 1.0 2011-04
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE


Explosive atmospheres –
Part 34: Application of quality systems for equipment manufacture

Atmosphères explosives –
Partie 34: Application des systèmes de qualité pour la fabrication d’équipements


ISO/IEC 80079-34:2011

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ISO/IEC 80079-34
Edition 1.0 2011-04
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE


Explosive atmospheres –
Part 34: Application of quality systems for equipment manufacture

Atmosphères explosives –
Partie 34: Application des systèmes de qualité pour la fabrication d’équipements

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
V
CODE PRIX


ICS 03.120.01; 29.260.20 ISBN 978-2-88912-459-6

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– 2 – 80079-34  IEC:2011
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
1 Scope . 7
2 Normative references . 7
3 Terms and definitions . 7
4 Quality management system . 9
4.1 General requirements . 9
4.2 Documentation requirements . 9
4.2.1 General . 9
4.2.2 Quality manual . 9
4.2.3 Control of documents . 9
4.2.4 Control of records . 10
5 Management responsibility . 11
5.1 Management commitment . 11
5.2 Customer focus . 11
5.3 Quality policy . 11
5.4 Planning . 11
5.4.1 Quality objectives . 11
5.4.2 Quality management system planning. 11
5.5 Responsibility, authority and communication . 11
5.5.1 Responsibility and authority . 11
5.5.2 Management representative . 12
5.5.3 Internal communication . 12
5.6 Management review . 12
5.6.1 General . 12
5.6.2 Review input . 12
5.6.3 Review output . 12
6 Resource management . 12
6.1 Provision of resources . 12
6.2 Human resources . 12
6.2.1 General . 12
6.2.2 Competence, training and awareness . 12
6.3 Infrastructure . 13
6.4 Work environment . 13
7 Product realization . 13
7.1 Planning of product realization . 13
7.2 Customer-related processes . 13
7.2.1 Determination of requirements related to the product . 13
7.2.2 Review of requirements related to the product . 13
7.2.3 Customer communication . 13
7.3 Design and development . 13
7.3.1 Design and development planning . 13
7.3.2 Design and development inputs . 13
7.3.3 Design and development outputs . 13
7.3.4 Design and development review . 13
7.3.5 Design and development verification . 14

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80079-34  IEC:2011 – 3 –
7.3.6 Design and development validation . 14
7.3.7 Control of design and development changes . 14
7.4 Purchasing . 14
7.4.1 Purchasing process . 14
7.4.2 Purchasing information . 15
7.4.3 Verification of purchased product . 15
7.5 Production and service provision . 16
7.5.1 Control of production and service provision . 16
7.5.2 Validation of processes for production and service provision . 16
7.5.3 Identification and traceability . 16
7.5.4 Customer property . 16
7.5.5 Preservation of product . 17
7.6 Control of monitoring and measuring equipment . 17
8 Measurement, analysis and improvement . 17
8.1 General . 17
8.2 Monitoring and measurement . 17
8.2.1 Customer satisfaction . 17
8.2.2 Internal audit . 17
8.2.3 Monitoring and measurement of processes . 18
8.2.4 Monitoring and measurement of product . 18
8.3 Control of nonconforming product . 18
8.4 Analysis of data . 19
8.5 Improvement . 19
8.5.1 Continual improvement . 19
8.5.2 Corrective action . 19
8.5.3 Preventive action . 19
Annex A (informative) Information relevant to particular types of protection and
specific products . 20
Annex B (informative) Verification criteria for elements with non-measurable paths
used as an integral part of a type of protection . 29
Bibliography . 32

Table A.1 – Component/feature compatibility . 22

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INTERNATIONAL ELECTROTECHNICAL COMMISSION
_____________

EXPLOSIVE ATMOSPHERES –

Part 34: Application of quality systems
for equipment 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. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International Standard ISO/IEC 80079-34 has been prepared by IEC subcommittee 31M: Non-
electrical equipment and protective systems for explosive atmospheres, of IEC 31: Equipment
for explosive atmospheres.
This publication is published as a double logo standard.
This standard should be read in conjunction with ISO 9001:2008.

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80079-34  IEC:2011 – 5 –
The text of this particular standard is based on the following documents:
FDIS Report on voting
31M/45/FDIS 31M/48/RVD

Full information on the voting for the approval of this particular standard can be found in the
report on voting indicated in the above table. In ISO, the standard has been approved
because there were no negative votes out of the eleven votes cast.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
A list of all parts in the IEC 60079 series, under the general title Explosive atmospheres, as
well as the ISO/IEC 80079 series, can be found on the IEC website.
The committee has decided that the contents of this publication will remain unchanged until
the stability date indicated on the IEC web site under "http://webstore.iec.ch" in the data
related to the specific publication. At this date, the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.

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– 6 – 80079-34  IEC:2011
INTRODUCTION
This International Standard specifies requirements for a quality system that can be used by an
organization for the production of equipment and protective systems for explosive
atmosphere.
It can also be used by third parties, including certification bodies, to assess the organization’s
ability to meet conformity assessments system requirements and/or regulatory requirements.
The application of this standard is intended to cover both electrical and non-electrical
equipment and protective systems. The detailed content (e.g. annexes) is currently more
focused on the established equipment standards for electrical equipment, However, IEC sub-
committee 31M has recently been formed with the responsibility for the development of
standards for non-electrical equipment. It is anticipated that, where appropriate, these
standards, or requirements related to them, will be referenced within this standard in the
future.
Manufacturer’s quality requirements are an integral part of most certification schemes and as
such this Standard has been prepared with the IECEx equipment certification scheme
requirements in mind, is intended to support the ATEX scheme requirements for a
manufacturer’s quality system and can be applied in other national or regional certifications
schemes that relate to the manufacture of explosion-protected equipment.

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80079-34  IEC:2011 – 7 –
EXPLOSIVE ATMOSPHERES –

Part 34: Application of quality systems
for equipment manufacture



1 Scope
This part of ISO/IEC 80079 specifies particular requirements and information for establishing
and maintaining a quality system to manufacture Ex equipment including protective systems
in accordance with the Ex certificate.
It does not preclude the use of other quality systems that are compatible with the objectives of
ISO 9001:2008 and which provide equivalent results.
2 Normative references
The following referenced documents are indispensable for the application 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/IEC 17050-1, Conformity assessment – Supplier's declaration of conformity – Part 1:
General requirements
ISO 9000:2005, Quality management systems – Fundamentals and vocabulary
ISO 9001:2008, 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 and ISO 9000:2005, as well as the following definitions, apply.
3.1
Ex Component
part of Ex equipment or a module (other than an Ex cable gland), marked with the symbol “U”,
which is not intended to be used alone and requires additional consideration when
incorporated into Ex equipment or systems for use in explosive atmospheres
NOTE This definition is identical to that of IEC 60079-0, except that the term “electrical” has been replaced by
“Ex” to allow a broader application of the definition.
3.2
Ex Equipment
machines, apparatus, fixed or mobile devices, control components and instrumentation
thereof and detection or prevention systems which, separately or jointly, are intended for the
generation, transfer, storage, measurement, control and conversion of energy for the
processing of material and which are capable of causing an explosion through their own
potential sources of ignition

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NOTE This definition includes “equipment” as defined by IEC 60079-0.
3.3
Ex certificate
document that assures the conformity of a product with specified requirements for explosive
atmospheres
NOTE 1 The certificate may be 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 the ISO/IEC 17000 series.
NOTE 2 This is equivalent to the term “certificate” as defined by IEC 60079-0.
3.4
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 The term "manufacturer" is used instead of "organization" as used in ISO 9001:2008. For the purposes of
this standard they are interchangeable.
3.5
contract
requirements forming an agreement between a manufacturer and a customer and transmitted
by any appropriate means
3.6
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 Ex certificate
3.7
product
Ex equipment, protective systems, safety devices, Ex Components and their combinations, as
well as software and service as defined in 3.4.2 of ISO 9000:2005
3.8
protective systems
design units which are intended to halt incipient explosions immediately and/or to limit the
effective range of explosion flames and explosion pressures
NOTE Protective systems may be integrated into equipment or separately placed on the market for use as
autonomous systems.
3.9
safety devices
devices 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
3.10
schedule drawing
drawing or document listed in the Ex certificate and/or test report
3.11
related drawing
drawing or document not listed in the Ex certificate but linked to the schedule drawing, and
used for example, for detailed manufacture of component parts

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80079-34  IEC:2011 – 9 –
3.12
technical documentation
documentation that enables the conformity of the product with the requirements of the
standard(s) to be assessed
NOTE 1 This may include schedule drawings when a certification body is involved.
NOTE 2 It covers the design, manufacture and operation of the product and 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 Ex 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, etc.;
– test reports.
3.13
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 an Ex certificate
EXAMPLE Manufacturing instructions, related drawings, data sheets and sales literature.
3.14
Type of Protection
specific measures applied to Ex equipment to avoid ignition of a surrounding explosive
atmosphere
NOTE This definition is identical to that of IEC 60079-0, except that the term “electrical” has been replaced by
“Ex’ to allow a broader application of the definition.
3.15
body responsible for verification
body which conducts documentation review and periodical audit as appropriate
NOTE The body may be either a manufacturer, purchaser, third party or a certification body.
4 Quality management system
4.1 General requirements
Subclause 4.1 of ISO 9001:2008 applies, with the following addition:
The quality system shall ensure that the product conforms to the type described in the Ex
certificate and the technical documentation.
4.2 Documentation requirements
4.2.1 General
Subclause 4.2.1 of ISO 9001:2008 applies.
4.2.2 Quality manual
Subclause 4.2.2 of ISO 9001:2008 applies.
4.2.3 Control of documents
Subclause 4.2.3 of ISO 9001:2008 applies, with the following addition:

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a) technical documentation and manufacturer’s documentation shall be controlled,
b) documented procedures shall ensure that information contained within manufacturer’s
documentations is compatible with the technical documentation. The manufacturer shall
not initially approve or subsequently amend related drawings unless they are in
compliance with the schedule drawings,
c) the quality system shall ensure that no factor (type, characteristic, position etc.) defined
within the Ex certificate and technical documentation (e.g. schedule drawings) is modified,
d) there shall be a documented system that refers all related drawings to the relevant
schedule drawings,
e) where there are common schedule drawings associated with more than one Ex certificate,
there shall be a documented system to ensure simultaneous supplementary action in the
event of an amendment to such drawings,
NOTE 1 Some manufacturers use common components with common drawing numbers on more than one
product. Some of these products may have different persons responsible for them. Therefore, if one product with a
common component and drawing number is revised to meet a need, and if the necessary supplementary certificate
is obtained, there needs to be a system for ensuring that any other certificates that call up such components are
also subject to supplementary certification. This is in order to avoid such products not being in compliance with
their technical documentation. The system should identify the component drawing version, and this version
shouldn’t be modified by anybody other than the person(s) responsible for the equipment.
f) where a manufacturer also has drawings for equipment not intended for use in explosive
atmospheres, the manufacturer shall have a system that enables both the related
drawings and schedule drawings to be clearly identified,
NOTE 2 The following examples indicate some methods of achieving this:
• the use of visual markers;
• the use of a unique series of drawing numbers, e.g. all drawings concerning a certified equipment have an Ex
prefix to the drawing number.
g) the manufacturer shall document who is responsible for the quality system of each Ex
certificate.
NOTE 3 In some certification schemes, the body responsible for the quality system associated with each Ex
certificate may be different from the body that issued the Ex certificate and therefore needs to be clearly identified.
h) where technical documentation or manufacturer’s documentation are passed to a third
party, they shall be p
...