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: 29-Aug-2018
• ICS: 03.120.01 - Quality in general
• ICS: 29.260.20 - Electrical apparatus for explosive atmospheres
• Technical Committee: SC 31M - Non-electrical equipment and protective systems for explosive atmospheres
• Drafting Committee: MT 80079-34 - TC 31/SC 31M/MT 80079-34
• Current Stage: PPUB - Publication issued
• Start Date: 30-Aug-2018
• Completion Date: 24-Aug-2018

Relations

• Revises: ISO/IEC 80079-34:2011 - Explosive atmospheres - Part 34: Application of quality systems for equipment manufacture
• Effective Date: 05-Sep-2023

Overview

ISO/IEC 80079-34:2018 is an international standard published by the International Electrotechnical Commission (IEC) that specifies the requirements for quality management systems (QMS) tailored for the manufacture of Ex Products-equipment intended for use in explosive atmospheres. This standard emphasizes establishing and maintaining a QMS that ensures Ex Products meet strict safety and performance criteria in alignment with their certification requirements. ISO/IEC 80079-34:2018 complements ISO 9001:2015 by focusing on the unique manufacturing challenges of Ex Products and ensuring compliance with explosive atmospheres standards.

This second edition replaces the 2011 version and aligns clause numbering to ISO 9001:2015 while maintaining the original objectives with minor technical revisions. It provides manufacturers with a structured framework to control risks, support operational excellence, and uphold safety in hazardous environments where explosive gases, dust, or vapors are present.

Key Topics

ISO/IEC 80079-34:2018 covers the following essential areas of quality management specific to Ex Product manufacturing:

• Context of the Organization
  Identifying internal and external issues and understanding the needs of interested parties critical to producing compliant Ex Products.

• Leadership and Commitment
  Assigning clear roles, responsibilities, and authorities to ensure leadership drives a safety-focused quality culture with customer focus.

• Planning
  Addressing risks and opportunities related to Ex Product manufacture and setting measurable quality objectives to promote continual improvement.

• Support and Resources
  Managing human, infrastructural, and environmental resources effectively to maintain product quality and safety.

• Operational Control
  Comprehensive documentation and monitoring of processes including design and development, external provider control, production, preservation, traceability, and post-delivery activities.

• Performance Evaluation
  Monitoring and measuring product conformity, customer satisfaction, internal audits, and management reviews to validate the effectiveness of the QMS.

• Improvement
  Implementing corrective actions and continual improvement strategies based on performance data and nonconformity analyses.

• Specific Guidance for Ex Protection Types (Annex A)
  Providing detailed information related to types of protection such as flameproof enclosures (Ex d), intrinsic safety (Ex i), increased safety (Ex e), pressurized equipment (Ex p), encapsulation (Ex m), and others.

Applications

ISO/IEC 80079-34:2018 is vital for manufacturers engaged in:

• Ex Product Manufacturing
  Ensuring that equipment designed for operation in explosive atmospheres complies with rigorous safety standards.

• Quality Management Systems for Hazardous Area Equipment
  Integrating risk management and quality assurance practices tailored for potentially explosive environments.

• Certification Readiness and Compliance
  Facilitating alignment with certification processes by establishing traceability, control of materials, and documentation necessary for validated production.

• Risk Mitigation in Explosive Atmospheres
  Minimizing product failures that could lead to hazardous incidents in industries such as oil and gas, chemical processing, mining, and manufacturing sectors handling flammable substances.

• Supply Chain and External Provider Control
  Managing outsourced components or services to ensure they meet the quality requisites specific to Ex Products.

Related Standards

ISO/IEC 80079-34:2018 should be used in conjunction with other relevant standards to ensure comprehensive safety and compliance in explosive atmospheres:

• ISO 9001:2015 - General principles and requirements for Quality Management Systems
• IEC 60079 series - Standards concerning equipment and protective systems for explosive atmospheres, including:
  • IEC 60079-1 (Flameproof enclosures)
  • IEC 60079-11 (Intrinsic safety)
  • IEC 60079-2 (Pressurized equipment)
  • IEC 60079-7 (Increased safety)
  • IEC 60079-18 (Encapsulation)

By integrating ISO/IEC 80079-34:2018 with these standards, manufacturers achieve a robust compliance framework that addresses both quality management and the specialized technical requirements of Ex Product safety.

---

Keywords: ISO/IEC 80079-34:2018, Ex Product manufacture, quality management systems, explosive atmospheres, IEC standards, ISO 9001:2015, hazardous area equipment, product certification, risk management, Ex protection types, manufacturing compliance.

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
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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

– 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

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

– 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

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

– 6 – ISO/IEC 80079-34:2018 © IEC 2018
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. 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 subcommittee 31M: Non-
electrical equipment and protective systems for explosive atmospheres of IEC technical
committee 31: Equipment for explosive atmospheres.
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.

In order to help the reader, the text of the applicable sections of ISO 9001:2015 is reproduced
in a rectangular box. Where clauses are referenced within a rectangular box these refer to
ISO 9001:2015.
The text of this International standard is based on the following documents:
FDIS Report on voting
31M/130/FDIS 31M/135/RVD
Full information on the voting for the approval of this International Standard can be found in
the report on voting indicated in the above table.
This document has been drafted in accordance with the ISO/IEC Directives, Part 2.
A list of all parts of 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 document will remain unchanged until the
stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to
the specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
– 8 – ISO/IEC 80079-34:2018 © IEC 2018
INTRODUCTION
This part of ISO/IEC 80079 specifies requirements for a quality management system that can
be used by an organization for the manufacture of Ex Products.
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 document is intended to cover both electrical and non-electrical
equipment, protective systems, safety devices, Ex Components and their combinations. The
detailed content (e.g. annexes) is currently focused on the established documents.
Quality requirements are an integral part of most certification schemes and as such this
document has been prepared with the IECEx system requirements in mind, is intended to
support ATEX Directive requirements for quality management system and can be applied in
other national or regional certification schemes that relate to the manufacture of Ex Products.
In Annex D there is a correlation matrix regarding ISO/IEC 80079-34:2011 to
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 9001:2015 and which provide equivalent results, the
minimum requirements are given in this document.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their
content constitutes requirements 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 9000, Quality management systems – Fundamentals and vocabulary
ISO 9001:2015, 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, 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 17000.

– 10 – ISO/IEC 80079-34:2018 © IEC 2018
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 9001:2015. 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
3.10
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
3.11
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.
3.12
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).
4 Context of the organization
4.1 Understanding the organization and its context
The organization shall determine external and internal issues that are relevant to its
purpose and its strategic direction and that affect its ability to achieve the intended result(s)
of its quality management system.
The organization shall monitor and review information about these external and internal
issues.
NOTE 1 Issues can include positive and negative factors or conditions for consideration.
NOTE 2 Understanding the external context can be facilitated by considering issues arising from legal,
technological, competitive, market, cultural, social and economic environments, whether international, national,
regional or local.
NOTE 3 Understanding the internal context can be facilitated by considering issues related to values, culture,
knowledge and performance of the organization.

4.1 of ISO 9001:2015 applies with the following addition:
In regard to this document, the context of the organization is to ensure that any Ex Product is
in accordance with its certificate and technical documentation.

– 12 – ISO/IEC 80079-34:2018 © IEC 2018
4.2 Understanding the needs and expectations of interested parties
Due to their effect or potential effect on the organization’s ability to consistently provide
products and services that meet customer and applicable statutory and regulatory
requirements, the organization shall determine:
a) the interested parties that are relevant to the quality management system;
b) the requirements of these interested parties that are relevant to the quality management
system.
The organization shall monitor and review information about these interested parties and
their relevant requirements.
4.2 of ISO 9001:2015 applies.
4.3 Determining the scope of the quality management system
The organization shall determine the boundaries and applicability of the quality
management system to establish its scope.
When determining this scope, the organization shall consider:
a) the external and internal issues referred to in 4.1;
b) the requirements of relevant interested parties referred to in 4.2;
c) the products and services of the organization.
The organization shall apply all the requirements of this International Standard if they are
applicable within the determined scope of its quality management system.
The scope of the organization’s quality management system shall be available and be
maintained as documented information. The scope shall state the types of products and
services covered, and provide justification for any requirement of this International
Standard that the organization determines is not applicable to the scope of its quality
management system.
Conformity to this International Standard may only be claimed if the requirements
determined as not being applicable do not affect the organization’s ability or responsibility
to ensure the conformity of its products and services and the enhancement of customer
satisfaction.
4.3 of ISO 9001:2015 applies.
4.4 Quality management system and its processes
4.4.1 The organization shall establish, implement, maintain and continually improve a
quality management system, including the processes needed and their interactions, in
accordance with the requirements of this International Standard.
The organization shall determine the processes needed for the quality management syste
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