Copyright © 2025 International Electrotechnical Commission, IEC. All rights reserved. It is permitted to download this electronic file, to make a copy and to print out the content for the sole purpose of preparing National Committee positions. You may not copy or "mirror" the file or printed version of the document, or any part of it, for any other purpose without permission in writing from IEC.	31M/261/CDV
	COMMITTEE DRAFT FOR VOTE (CDV)
	Project number:
	ISO/IEC 80079-34 ED3
	Date of circulation:		Closing date for voting:
	2025-06-27		2025-09-19
	Supersedes documents:
	31M/225/CD, 31M/242A/CC
IEC SC 31M : Non-electrical equipment and protective systems for explosive atmospheres
Secretariat:		Secretary:
Germany		Mrs Anke Sachtleben
Of interest to the following committees:		Horizontal function(s):
TC 31,SC 31G,SC 31J
Aspects concerned:
Safety
Submitted for CENELEC parallel voting		Not submitted for CENELEC parallel voting
This document is still under study and subject to change. It should not be used for reference purposes. Recipients of this document are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to provide supporting documentation. Recipients of this document are invited to submit, with their comments, notification of any relevant “In Some Countries” clauses to be included should this proposal proceed. Recipients are reminded that the CDV stage is the final stage for submitting ISC clauses. (see ac/22/2007 or new guidance doc).
Title:
Explosive atmospheres - Part 34: Application of quality management systems for Ex Product manufacture
proposed stability date: 2026
Note from TC/SC officers:
Submitted for parallel voting in CEN For further information regarding the procedures of IEC/SC 31M see IEC/TC 31 Good Working Practice Annex G

CONTENTS

FOREWORD 7

INTRODUCTION 12

1 Scope 13

2 Normative references 13

3 Terms and definitions 13

4 Context of the organization 16

4.1 Understanding the organization and its context 16

4.2 Understanding the needs and expectations of interested parties 16

4.3 Determining the scope of the quality management system 16

4.4 Quality management system and its processes 17

5 Leadership 17

5.1 Leadership and commitment 17

5.1.1 General 17

5.1.2 Customer focus 18

5.2 Policy 18

5.2.1 Establishing the quality policy 18

5.2.2 Communicating the quality policy 18

5.3 Organizational roles, responsibilities and authorities 19

6 Planning 20

6.1 Actions to address risks and opportunities 20

6.2 Quality objectives and planning to achieve them 20

6.3 Planning of changes 21

7 Support 21

7.1 Resources 21

7.1.1 General 21

7.1.2 People 21

7.1.3 Infrastructure 21

7.1.4 Environment for the operation of processes 22

7.1.5 Monitoring and measuring resources 22

7.1.6 Organizational knowledge 23

7.2 Competence 23

7.3 Awareness 24

7.4 Communication 24

7.5 Documented information 24

7.5.1 General 24

7.5.2 Creating and updating 25

7.5.3 Control of documented Information 25

8 Operation 27

8.1 Operational planning and control 27

8.2 Requirements for products and services 27

8.2.1 Customer communication 27

8.2.2 Determining the requirements for products and services 28

8.2.3 Review of the requirements for products and services 28

8.2.4 Changes to requirements for products and services 28

8.3 Design and development of products and services 29

8.3.1 General 29

8.3.2 Design and development planning 29

8.3.3 Design and development Inputs 29

8.3.4 Design and development controls 30

8.3.5 Design and development outputs 30

8.3.6 Design and development changes 30

8.4 Control of externally provided processes, products and services 31

8.4.1 General 31

8.4.2 Type and extent of control 31

8.4.3 Information for external providers 32

8.5 Production and service provision 32

8.5.1 Control of production and service provision 32

8.5.2 Identification and traceability 33

8.5.3 Property belonging to customers or external providers 33

8.5.4 Preservation 33

8.5.5 Post-delivery activities 34

8.5.6 Control of changes 34

8.6 Release of products and services 34

8.7 Control of nonconforming outputs 35

9 Performance evaluation 36

9.1 Monitoring, measurement, analysis and evaluation 36

9.1.1 General 36

9.1.2 Customer satisfaction 36

9.1.3 Analysis and evaluation 36

9.2 Internal audit 37

9.3 Management review 38

9.3.1 General 38

9.3.2 Management review inputs 38

9.3.3 Management review outputs 38

10 Improvement 39

10.1 General 39

10.2 Nonconformity and corrective action 39

10.3 Continual improvement 39

Annex A (informative) Information relevant to particular Types of Protection and specific Ex Products 40

A.1 Introduction 40

A.2 General 40

A.3 Ex d – Flameproof enclosures covered by IEC 60079-1 40

A.3.1 Verification 40

A.3.2 Castings 41

A.3.3 Machining 41

A.3.4 Cemented joints and potted assemblies 41

A.3.5 Routine overpressure testing 41

A.3.6 Flanged joints 43

A.3.7 Elements, with non-measurable paths, of breathing and draining devices 43

A.4 Ex i – intrinsic safety covered by IEC 60079-11 43

A.4.1 Components for intrinsically safe apparatus and associated apparatus 43

A.4.2 Printed circuit boards (PCBs) 44

A.4.3 Conformal coating and encapsulation 45

A.4.4 Sub-assemblies and assemblies 46

A.4.5 Enclosures for Group IIIC or reduced spacing 46

A.4.6 Routine verifications and tests 46

A.4.7 Intrinsically safe circuits and assemblies incorporated in Ex equipment of other Types of Protection 47

A.4.8 Cells and batteries 47

A.4.9 Parameters of loosely specified components 47

A.5 Ex e – Increased safety covered by IEC 60079-7 47

A.5.1 Degree of protection (IP Code) 47

A.5.2 Internal wiring and contact integrity 47

A.5.3 Rotating machines 47

A.5.4 Windings 48

A.5.5 Terminal boxes 48

A.5.6 Cable Glands, terminals and other accessories 48

A.5.7 Routine verifications and tests 48

A.6 Ex p – Pressurized equipment covered by IEC 60079-2 48

A.6.1 Degree of protection (IP Code) 48

A.6.2 Components and manufacturing process 48

A.6.3 Components, constructional characteristics 49

A.6.4 Routine verifications and tests 49

A.7 Ex m – Encapsulation covered by IEC 60079-18 49

A.7.1 Production documentation 49

A.7.2 Routine verifications and tests 49

A.8 Ex o – Liquid immersion covered by IEC 60079-6 50

A.8.1 Material control 50

A.8.2 Filling 50

A.8.3 Degree of protection (IP Code) 50

A.8.4 Routine verifications and tests 50

A.9 Ex q – Powder filling covered by IEC 60079-5 50

A.9.1 Material control 50

A.9.2 Filling 50

A.9.3 Degree of protection (IP Code) 50

A.9.4 Routine verifications and tests 50

A.10 Equipment covered by IEC 60079-15 51

A.10.1 General requirements 51

A.10.2 Ex nA – Non sparking equipment 51

A.10.3 Ex nC– Sealed devices 51

A.10.4 Ex nR– Restricted Breathing 51

A.11 Ex t – Dust ignition protection by enclosure covered by IEC 60079-31 52

A.11.1 Casting 52

A.11.2 Enclosure parts 52

A.11.3 Gaskets 52

A.11.4 Protection devices 52

A.11.5 Cemented and cast enclosure parts 52

A.11.6 Degree of protection (IP Code) 53

A.11.7 Routine verifications and tests 53

A.12 Ex op – Optical radiation covered by IEC 60079-28 53

A.13 Gas detectors covered by IEC 60079-29 series 53

A.14 Ex h – Non-electrical Equipment covered by ISO 80079-36 54

A.14.1 General 54

A.14.2 Non-metallic parts 54

A.14.3 Casing and external parts 54

A.14.4 Earthing and equipotential bonding of conductive parts 54

A.14.5 Light transmitting parts 54

A.14.6 Degree of protection (IP Code)) 55

A.15 Non Electrical Equipment protected by constructional safety “c” covered by ISO 80079-37 55

A.15.1 General 55

A.15.2 Metal-based material 55

A.15.3 Machining 55

A.15.4 Cemented joints and potted assemblies 55

A.15.5 Assembling 56

A.15.6 Routine tests 56

A.15.7 Power transmission systems 56

A.16 Non-electrical equipment protected by control of ignition sources “b” covered by ISO 80079-37 56

A.16.1 General 56

A.16.2 Ignition protection system 56

A.16.3 Assembling 56

A.16.4 Routine verifications and tests 57

A.17 Non-electrical equipment protected by liquid immersion “k” covered by ISO 80079-37 57

A.17.1 General 57

A.17.2 Protective liquid 57

A.17.3 Casing 57

A.17.4 Measuring or indicating devices 57

A.18 Flame arresters covered by ISO/IEC 80079-49 58

A.19 Equipment assemblies covered by IEC 60079-46 58

A.19.1 General 58

A.19.2 Limited-scope restrictions 58

A.19.3 Mounting and interconnection of items 58

A.19.4 Routine verifications and tests 58

A.19.5 Incorporation of Ex Equipment 59

A.19.6 Competencies 59

A.19.7 Design and production of equipment assemblies 59

A.19.8 Ignition hazard assessment 59

Annex B (informative) Verification criteria for elements with non-measurable paths used as an integral part of a Type of Protection 60

B.1 Introduction 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 63

C.3 Example of an external provider's declaration of conformity 65

Annex D (informative) Guidance for the application of this document to the different types of organization 66

Annex E (normative) Type and control of externally provided products, processes and services 68

E.1 Types of products, processes or services 68

E.2 External provider selection and evaluation 68

E.2.1 General 68

E.2.2 Evaluation of external providers of level A 69

E.2.3 Evaluation of external providers of level B 69

E.2.4 Evaluation of external providers of level C 69

E.3 Ongoing evaluation of external providers 69

E.4 Verification of products, processes or services 70

Bibliography 71

Table A.1 – Component specifications that might require consideration 42

Table D.1 – Applicability of this document 65

Table E.1 – Minimum required external provider evaluation level 67

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 ISO/IEC subcommittee 31M: Non-electrical equipment and protective systems for explosive atmospheres of IEC technical committee 31: Equipment for explosive atmospheres.

This third edition cancels and replaces the second edition, published in 2018, and constitutes a technical revision.

This edition includes the following significant technical changes with respect to the previous edition:

Users of this document are advised that interpretation sheets clarifying the interpretation of this document can be published. Interpretation sheets are available from the IEC webstore and can be found in the “history” tab of the page for each document.

The significant changes with respect to ISO/IEC 80079-34 are listed below.

NOTE The technical changes referred include the significant technical changes in the revised standard but is not an exhaustive list of all modifications from the previous version.

Changes in a standard classified as ‘minor and editorial changes’ refer to changes regarding the previous standard, which modify requirements in an editorial or a minor technical way. In addition, changes of the wording to clarify technical requirements without any technical change are classified as ‘minor and editorial changes’.

A reduction in the level of an existing requirement is also classified as a ‘minor and editorial change’.

Changes in a standard classified as ‘extension’ refers to changes regarding the previous standard, which add new or modify existing technical requirements, in a way that new options are given, but without increasing requirements for equipment that was fully compliant with the previous standard. These ‘extensions’ will therefore not have to be considered for products in conformity with the preceding edition.

Changes in a standard classified as ‘major technical change’ refer to changes regarding the previous standard, which add new or increase the level of existing technical requirements, in a way that a product in conformity with the previous standard will not always be able to fulfil the requirements given in the standard. ‘Major technical changes’ have to be considered for products in conformity with the previous edition.

B) Information about the background of Changes

C1 The requirements surrounding the type and control of externally provided products, processes and services have been reworded to better suit the needs of different organizations. In particular the concept of three different types of raw materials (custom, non-custom and general parts) have been introduced including minimum external provider evaluation levels. The evaluation levels are based on whether the verification is performed by the organization itself or whether it is performed by the external provider regardless if done via sub-contracting or because it is no longer possible at a later time.

C2 The concept of how to handle nonconforming Ex Products that have been deemed unsafe and have been released for use has been introduced. In particular the information flow to certificate issuers, customers and so forth has been clarified.

C3 Edition 3.0 of ISO/IEC 80079-34 splits the organization into five sub-organizations commonly encountered in the industry. The document has been updated to reflect and address the needs of the different organizations and Annex D has been drafted to facilitate the extent of auditing at each organizational level. It is however paramount that Annex D serves as guidance and the context of the organization is determined for each individual organization.

C4 The definition of the term technical documentation had significant overlap with the definition of the term schedule drawing. The terms and definitions were aligned with IEC 60079-0, which resulted in the deletion of the term. The document has been updated to reflect the new term.

C5 The definition of the term manufacturer’s documentation had significant overlap with the definition of the term related drawing. The terms and definitions were aligned with IEC 60079-0, which resulted in the deletion of the term. The document has been updated to reflect the new term.

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:

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. In ISO, the standard has been approved by XXX P members out of YYY having cast a vote.

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 web site 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.

A bilingual version of this publication may be issued at a later date.

The National Committees are requested to note that for this document the stability date is XXXX.

this text is included for the information of the national committees and will be deleted at the publication stage.

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 (for example 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 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.

EXPLOSIVE ATMOSPHERES –

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

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.

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 (IEV) - 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

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: The certificate is either the supplier’s declaration of conformity (1^st party declaration) or the purchaser’s recognition of conformity (2^nd party acceptance) or certification (3rd party attestation). Declaration, acceptance and certification are defined in ISO/IEC 17000.

[SOURCE: IEC 60050-426:2020, 426-04-23]

3.2

Ex Product certificate

certificate for an Ex Product

3.3

organization

3.3.1

manufacturer

organization, situated at a stated location, that controls such stages in the manufacturing process, assessment, handling and storage of an Ex Product that enables it to accept responsibility for continued compliance of the Ex Product with the relevant requirements and undertakes all obligations in that connection

3.3.2

manufacturing location

facility, under control of or under contract with a manufacturer, that may be a site of the manufacturer or an external provider that carries out manufacturing, handling, storage, or other activities, up to and including releasing the Ex Product for use, bearing the Ex Product certificate number

3.3.3

production site

facility that may be either a facility of the manufacturer or an external provider that is subject to the application of this document, that does not release the Ex Product for use, but carries out manufacturing, handling, storage, or other activities related to the Ex Product, or parts of the Ex Product, under the control of, or under contract with, a manufacturing location

3.3.4

local assembler

site of the manufacturer or agent of the manufacturer where final assembly of the Ex Product is performed in accordance with the definition authorized by the manufacturer

3.3.5

trade agent

organization that is presenting themselves to the market as the manufacturer, has a contract with the original Ex Product certificate holder and assumes full responsibility as manufacturer for each product that is sold under their name.

Note 1 to entry: A trade agent is usually distributor of the certified product who would like that the product be under their name and without information of the original equipment manufacturer OEM on the product.

3.4

contract

requirements forming an agreement between different parties and transmitted by any appropriate means

3.5

customer complaint

reported, written or verbal allegation made by a customer which concerns the identity, quality, durability, safety, security, conformity or performance of any Ex Product as defined in the Ex Product certificate

3.6

Ex Product

Ex Equipment, protective system, safety device, Ex Component and their combination, as well as software and services

3.7

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  to entry: Protective systems can be integrated into equipment or separately released for use as autonomous systems.

3.8

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

3.9

schedule drawing

DEPRECATED: technical documentation

drawing or document listed in the certificate or test report that enables the conformity of the product with the requirements of the standard(s) to be assessed

[SOURCE: IEC 60050-426:2020, 426-04-43]

3.10

related drawing

drawing or document not listed in the certificate or test report but linked to the schedule drawing, and used for example, for detailed manufacture or purchase of component parts

3.11

body responsible for verification

body which conducts documentation review and periodical audit as appropriate

Note  to entry: The body can be a manufacturer (first party), purchaser (second party), or a Certification body (third party).

[SOURCE: IEC 60050-426:2020, 426-04-44]

3.12

risk

effect of uncertainty on objectives

Note 1 to entry: An effect is a deviation from the expected. It can be positive, negative or both, and can address, create or result in opportunities and threats. The concept of “Risk-based thinking” is explained in A.4 of ISO 9001:2015

Note 2 to entry: Objectives can have different aspects and categories, and can be applied at different levels.

Note 3 to entry: Risk is usually expressed in terms of risk sources, potential events, their consequences and their likelihood.

Note 4 to entry: This definition differs from that specified in IEC 60050 and hence the rest of the IEC 60079 and ISO/IEC 80079 series of standards.

[SOURCE: ISO 31000:2018, 3.1, modified — Note 1 to entry and Note 3 to entry have been modified, Note 4 to entry has been added]

3.13

external provider’s declaration of conformity

document issued by an external provider confirming that the products, processes or services are as requested

NOTE 1 to entry: The external provider’s declaration of conformity can take the form of a declaration, certificate or compliance statement.

NOTE 2 to entry: Annex C provides guidance for external provider’s declarations of conformity

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 or part of the Ex Product is in accordance with its Ex Product certificate and schedule drawings.

The organization shall determine the extent of control for manufacturing locations, production sites and local assemblers.

The applicability of the requirements of this standard shall be determined by the type of organization (manufacturer, manufacturing location, production site, local assembler or trade agent) and their role in ensuring that Ex Product released for use is compatible with the schedule drawings.

NOTE Annex D provides guidance for the applicability of this standard to the different types of organization.

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.

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.

4.4.1 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 system and their application throughout the organization, and shall:

a) determine the inputs required and the outputs expected from these processes;

b) determine the sequence and interaction of these processes;

c) determine and apply the criteria and methods (including monitoring, measurements and related performance indicators) needed to ensure the effective operation and control of these processes;

d) determine the resources needed for these processes and ensure their availability;

e) assign the responsibilities and authorities for these processes;

f) address the risks and opportunities as determined in accordance with the requirements of 6.1;

g) evaluate these processes and implement any changes needed to ensure that these processes achieve their intended results;

h) improve the processes and the quality management system.

4.4.2 To the extent necessary, the organization shall:

a) maintain documented information to support the operation of its processes;

b) retain documented information to have confidence that the processes are being carried out as planned.

4.4 of ISO 9001:2015 applies with the following addition:

The quality management system shall ensure that the Ex Product or part of the Ex Product conforms to the type described in the Ex Product certificate and schedule drawings.

Top management shall demonstrate leadership and commitment with respect to the quality management system by:

a) taking accountability for the effectiveness of the quality management system;

b) ensuring that the quality policy and quality objectives are established for the quality management system and are compatible with the context and strategic direction of the organization;

c) ensuring the integration of the quality management system requirements into the organization’s business processes;

d) promoting the use of the process approach and risk-based thinking;

e) ensuring that the resources needed for the quality management system are available;

f) communicating the importance of effective quality management and of conforming to the quality management system requirements;

g) ensuring that the quality management system achieves its intended results;

h) engaging, directing and supporting persons to contribute to the effectiveness of the quality management system;

i) promoting improvement;

j) supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility.

NOTE Reference to “business” in this International Standard can be interpreted broadly to mean those activities that are core to the purposes of the organization’s existence, whether the organization is public, private, for profit or not for profit.

5.1.1 of ISO 9001:2015 applies.

Top management shall demonstrate leadership and commitment with respect to customer focus by ensuring that:

a) customer and applicable statutory and regulatory requirements are determined, understood and consistently met;

b) the risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed;

c) the focus on enhancing customer satisfaction is maintained.

5.1.2 of ISO 9001:2015 applies.

Top management shall establish, implement and maintain a quality policy that:

a) is appropriate to the purpose and context of the organization and supports its strategic direction;

b) provides a framework for setting quality objectives;

c) includes a commitment to satisfy applicable requirements;

d) includes a commitment to continual improvement of the quality management system.

5.2.1 of ISO 9001:2015 applies.

The quality policy shall:

a) be available and be maintained as documented information;

b) be communicated, understood and applied within the organization;

c) be available to relevant interested parties, as appropriate.

5.2.2 of ISO 9001:2015 applies.

Top management shall ensure that the responsibilities and authorities for relevant roles are assigned, communicated and understood within the organization.

Top management shall assign the responsibility and authority for:

a) ensuring that the quality management system conforms to the requirements of this International Standard;

b) ensuring that the processes are delivering their intended outputs;

c) reporting on the performance of the quality management system and on opportunities for improvement (see 10.1), in particular to top management;

d) ensuring the promotion of customer focus throughout the organization;

e) ensuring that the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.

5.3 of ISO 9001:2015 applies with the following additions:

Ex authorized person(s) shall be appointed with defined and documented responsibilities and authority to ensure the following requirements are met:

a) the effective coordination of activities with respect to Ex Products;

b) the liaison with the issuer of the Ex Product certificate (when not issued by the manufacturer) with respect to any proposed change to the design defined in the Ex Product certificate and schedule drawings;

c) the liaison with the body responsible for the verification of the quality management system with respect to intended updates of the quality management system;

NOTE 1 It is not practicable for the manufacturer to inform the body responsible for the verification of the quality management system each time the quality management system is updated. It is only practicable to inform them of "substantial" updates to the quality management system relevant to the Type of Protection. Similarly, it is not practicable to specify in general terms what types of updates are or are not "substantial". It is therefore normal that the manufacturer informs the body responsible for the verification of the quality management system on any update of the quality management system having consequences on Ex Products compliance. The change of an Ex authorized person is considered a “substantial” change.

d) the authorization of initial approval and changes to related drawings, where appropriate;

e) the authorization of concessions (see 8.7e));

f) the accuracy of relevant information regarding Ex Product given to the customer for any sales literature and installation instructions (which shall include applicable Specific Conditions of Use and any Schedule of Limitations);

NOTE 2 Ex Equipment Certificate numbers with a suffix “X” contain Specific Conditions of Use. Ex Component certificates numbers, with a suffix “U” contain a Schedule of Limitations.

g) the effective coordination of manufacturing processes related to Ex Products including those at production sites and externally provided products, services and processes detailed in 8.4;

In the case of a manufacturer with multiple manufacturing locations an Ex authorized person with relevant responsibilities shall be appointed for each manufacturing location. One Ex authorized person may be appointed as responsible for multiple manufacturing locations.

NOTE 3 The appointed Ex authorized person(s) for the manufacturing location can take responsibility for the production site(s) and the local assembler(s) who perform the final assembly.

6.1.1 When planning for the quality management system, the organization shall consider the issues referred to in 4.1 and the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed to:

a) give assurance that the quality management system can achieve its intended result(s);

b) enhance desirable effects;

c) prevent, or reduce, undesired effects;

d) achieve improvement.

6.1.2 The organization shall plan:

a) actions to address these risks and opportunities;

b) how to:

1) integrate and implement the actions into its quality management system processes (see 4.4);

2) evaluate the effectiveness of these actions.

Actions taken to address risks and opportunities shall be proportionate to the potential impact on the conformity of products and services.

NOTE 1 Options to address risks can include avoiding risk, taking risk in order to pursue an opportunity, eliminating the risk source, changing the likelihood or consequences, sharing the risk, or retaining risk by informed decision.

NOTE 2 Opportunities can lead to the adoption of new practices, launching new products, opening new markets, addressing new customers, building partnerships, using new technology and other desirable and viable possibilities to address the organization’s or its customers’ needs.

6.1 of ISO 9001:2015 applies.

6.2.1 The organization shall establish quality objectives at relevant functions, levels and processes needed for the quality management system.

The quality objectives shall:

a) be consistent with the quality policy;

b) be measurable;

c) take into account applicable requirements;

d) be relevant to conformity of products and services and to enhancement of customer satisfaction;

e) be monitored;

f) be communicated;

g) be updated as appropriate.

The organization shall maintain documented information on the quality objectives.

6.2.2 When planning how to achieve its quality objectives, the organization shall determine:

a) what will be done;

b) what resources will be required;

c) who will be responsible;

d) when it will be completed;

e) how the results will be evaluated.

6.2 of ISO 9001:2015 applies.

When the organization determines the need for changes to the quality management system, the changes shall be carried out in a planned manner (see 4.4).

The organization shall consider:

a) the purpose of the changes and their potential consequences;

b) the integrity of the quality management system;

c) the availability of resources;

d) the allocation or reallocation of responsibilities and authorities.

6.3 of ISO 9001:2015 applies with the following addition:

The Ex authorized person(s) identified in 5.3 shall be involved in the approval process of any modification or change to the quality management system that could affect Ex Product compliance.

The organization shall determine and provide the resources needed for the establishment, implementation, maintenance and continual improvement of the quality management system.

The organization shall consider:

a) the capabilities of, and constraints on, existing internal resources;

b) what needs to be obtained from external providers.

7.1.1 of ISO 9001:2015 applies.

The organization shall determine and provide the persons necessary for the effective implementation of its quality management system and for the operation and control of its processes.

7.1.2 of ISO 9001:2015 applies.

The organization shall determine, provide and maintain the infrastructure necessary for the operation of its processes and to achieve conformity of products and services.

NOTE Infrastructure can include:

a) buildings and associated utilities;

b) equipment, including hardware and software;

c) transportation resources;

d) information and communication technology.

7.1.3 of ISO 9001:2015 applies.

The organization shall determine, provide and maintain the environment necessary for the operation of its processes and to achieve conformity of products and services.

NOTE A suitable environment can be a combination of human and physical factors, such as:

a) social (e.g. non-discriminatory, calm, non-confrontational);

b) psychological (e.g. stress-reducing, burnout prevention, emotionally protective);

c) physical (e.g. temperature, heat, humidity, light, airflow, hygiene, noise).

These factors can differ substantially depending on the products and services provided.

7.1.4 of ISO 9001:2015 applies.

7.1.5.1 General

The organization shall determine and provide the resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services to requirements.

The organization shall ensure that the resources provided:

a) are suitable for the specific type of monitoring and measurement activities being undertaken;

b) are maintained to ensure their continuing fitness for their purpose.

The organization shall retain appropriate documented information as evidence of fitness for purpose of the monitoring and measurement resources.

7.1.5.2 Measurement traceability

When measurement traceability is a requirement, or is considered by the organization to be an essential part of providing confidence in the validity of measurement results, measuring equipment shall be:

a) calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; when no such standards exist, the basis used for calibration or verification shall be retained as documented information;

b) identified in order to determine their status;

c) safeguarded from adjustments, damage or deterioration that would invalidate the calibration status and subsequent measurement results.

The organization shall determine if the validity of previous measurement results has been adversely affected when measuring equipment is found to be unfit for its intended purpose, and shall take appropriate action as necessary.

7.1.5 of ISO 9001:2015 applies with the following addition:

When monitoring or measuring is used to verify the conformity of Ex Products, the measuring equipment shall be calibrated and a valid calibration certificate shall exist.

Verification of measuring equipment against calibrated equipment is also permitted as long as it is suitably documented.

The calibration certificate shall meet one of the following requirements:

a) Where a calibration certificate bears the accreditation logo issued by an accredited calibration laboratory, the laboratory need not be subjected to further evaluation if it can demonstrate that it operates in compliance with an internationally recognized standard and is covered by a multilateral international agreement.

b) Where a calibration certificate does not bear the accreditation logo of a national accreditation authority, each calibration certificate shall include at least the following information:

 an unambiguous identification of the item calibrated;

 evidence that the measurements are traceable to international or national measurement standards;

 the method of calibration;

 a statement of compliance with any relevant specification;

 the calibration results;

 the uncertainty of measurement, where necessary;

 the environmental conditions, where relevant;

 the date of calibration;

 the signature of the person under whose authority the certificate was issued;

 the name and address of the issuing organization and the date of issue of the certificate;

 a unique identification of the calibration certificate.

c) Where a calibration certificate does not bear the accreditation logo of a national accreditation authority or does not contain the information listed in 7.1.5 b), the organization shall demonstrate a valid relationship to international or national measurement standards by other means, for example a documented site assessment.

The organization shall determine the knowledge necessary for the operation of its processes and to achieve conformity of products and services.

This knowledge shall be maintained and be made available to the extent necessary.

When addressing changing needs and trends, the organization shall consider its current knowledge and determine how to acquire or access any necessary additional knowledge and required updates.

NOTE 1 Organizational knowledge is knowledge specific to the organization; it is generally gained by experience. It is information that is used and shared to achieve the organization’s objectives.

NOTE 2 Organizational knowledge can be based on:

a) internal sources (e.g. intellectual property; knowledge gained from experience; lessons learned from failures and successful projects; capturing and sharing undocumented knowledge and experience; the results of improvements in processes, products and services);

b) external sources (e.g. standards; academia; conferences; gathering knowledge from customers or external providers).

7.1.6 of ISO 9001:2015 applies.

The organization shall:

a) determine the necessary competence of person(s) doing work under its control that affects the performance and effectiveness of the quality management system;

b) ensure that these persons are competent on the basis of appropriate education, training, or experience;

c) where applicable, take actions to acquire the necessary competence, and evaluate the effectiveness of the actions taken;

d) retain appropriate documented information as evidence of competence.

NOTE Applicable actions can include, for example, the provision of training to, the mentoring of, or the reassignment of currently employed persons; or the hiring or contracting of competent persons.

7.2 of ISO 9001:2015 applies with the following addition:

The organization shall have a documented process to identify and ensure that all persons having an impact on the compliance of Ex Products have the necessary competence.

NOTE 1 Parties who might have an impact on the compliance of Ex Products are the Ex authorized person(s), manufacturing, engineering, inspecting, testing, sales, marketing, supply management, calibration and quality control services and other services.

NOTE 2 Competence requirements of 7.2 also address the awareness of 7.3.

The organization shall ensure that persons doing work under the organization’s control are aware of:

a) the quality policy;

b) relevant quality objectives;

c) their contribution to the effectiveness of the quality management system, including the benefits of improved performance;

d) the implications of not conforming with the quality management system requirements.

7.3 of ISO 9001:2015 applies.

The organization shall determine the internal and external communications relevant to the quality management system, including:

a) on what it will communicate;

b) when to communicate;

c) with whom to communicate;

d) how to communicate;

e) who communicates.

7.4 of ISO 9001:2015 applies.

The organization’s quality management system shall include:

a) documented information required by this International Standard;

b) documented information determined by the organization as being necessary for the effectiveness of the quality management system.

NOTE The extent of documented information for a quality management system can differ from one organization to another due to:

— the size of organization and its type of activities, processes, products and services;

— the complexity of processes and their interactions;

— the competence of persons.

7.5.1 of ISO 9001:2015 applies with the following addition:

All requirements and provisions adopted by the organization to ensure compliance of Ex Products with their Ex Product certificate and schedule drawings, and to demonstrate compliance to this document, shall be appropriately documented in a systematic and orderly manner. This can be achieved in the form of manuals, policies, procedures, instructions, flowcharts, spread sheets, forms, or other appropriate means. The quality management system documentation shall permit a consistent interpretation of quality programs, plans, manuals and records.

When creating and updating documented information, the organization shall ensure appropriate:

a) identification and description (e.g. a title, date, author, or reference number);

b) format (e.g. language, software version, graphics) and media (e.g. paper, electronic);

c) review and approval for suitability and adequacy.

7.5.2 of ISO 9001:2015 applies.

7.5.3.1 Documented information required by the quality management system and by this International Standard shall be controlled to ensure:

a) it is available and suitable for use, where and when it is needed;

b) it is adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity).

7.5.3.2 For the control of documented information, the organization shall address the following activities, as applicable:

a) distribution, access, retrieval and use;

b) storage and preservation, including preservation of legibility;

c) control of changes (e.g. version control);

d) retention and disposition.

Documented information of external origin determined by the organization to be necessary for the planning and operation of the quality management system shall be identified as appropriate, and be controlled.

Documented information retained as evidence of conformity shall be protected from unintended alterations.

NOTE Access can imply a decision regarding the permission to view the documented information only, or the permission and authority to view and change the documented information.

7.5.3 of ISO 9001:2015 applies with the following addition:

a) schedule drawings and related drawings shall be controlled;

b) documented procedures shall ensure that information contained within related drawings is compatible with the Ex Product certificate and schedule drawings.

c) the organization shall not initially approve, subsequently amend, or apply related drawings unless they comply with the schedule drawings;

d) the quality management system shall ensure that any modification to the Ex Product (component type, characteristic, position etc.) is compatible within the Ex Product certificate and schedule drawings, or is otherwise permitted by the issuer of the Ex Product certificate;

e) there shall be a documented process that ensures reference of all related drawings to the relevant schedule drawings;

f) where there are common schedule drawings associated with more than one Ex Product 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 and then have more than one person responsible for the end products. A compliant QMS would assure that the change to the component for the one product is not implemented without approval from the responsible persons for all end-products that use that component.

g) where an organization also has drawings for products that are not Ex Products, the organization shall have a documented system that enables both the related drawings and schedule drawings to be clearly identified;

EXAMPLE 1 Some methods to achieve this are:

– the use of visual markers;

– the use of a unique series of drawing numbers, for example all drawings concerning a certified Ex Product have an Ex prefix to the drawing number;

– the use of a computerized relational database which generates parts list or bill of materials that identify critical assemblies and components critical to the Ex Product’s compliance

h) if the organization releases Ex Products for use, then it shall record the body responsible for the verification of their quality management system in relation to each Ex Product certificate;

NOTE 2 In some Certification Schemes, the body responsible for the verification of the quality management system associated with each Ex Product certificate can be different from the body that issued the Ex Product certificate.

i) the organization shall have a documented process to annually check the validity of all Ex related certificates, standards, regulations and other external specifications;

j) the organization shall retain adequate quality records to demonstrate conformity of the Ex Products or its parts for a minimum of 10 years after each Ex Product or its part has been released from the organization. Where applicable, records requiring retention include:

1) those arising from regulatory requirements;

2) documented information relating to quality;

3) responsibilities and authorities for Ex relevant roles assignment and communication within the organization;

4) customer order;

5) contract review;

6) training records;

7) design changes;

8) inspection and test data;

9) calibration data;

10) manufacturing traceability;

11) external provider evaluation;

12) external provider’s declaration of conformity;

13) delivery data (customer, delivery date and quantity, including serial numbers and product type and version identification where available);

EXAMPLE 2 The release from an organization can be from a production site to a manufacturing location or a release for use from a manufacturing location.

The organization shall plan, implement and control the processes (see 4.4) needed to meet the requirements for the provision of products and services, and to implement the actions determined in Clause 6, by:

a) determining the requirements for the products and services;

b) establishing criteria for:

1) the processes;

2) the acceptance of products and services;

c) determining the resources needed to achieve conformity to the product and service requirements;

d) implementing control of the processes in accordance with the criteria;

e) determining, maintaining and retaining documented information to the extent necessary:

1) to have confidence that the processes have been carried out as planned;

2) to demonstrate the conformity of products and services to their requirements.

The output of this planning shall be suitable for the organization’s operations.

The organization shall control planned changes and review the consequences of unintended changes, taking action to mitigate any adverse effects, as necessary.

The organization shall ensure that outsourced processes are controlled (see 8.4).

8.1 of ISO 9001:2015 applies with the following addition:

The control and acceptance of processes for Ex Products shall be evaluated to ensure full compliance with the requirements of the Ex Product certificate and schedule drawings. The information in Annex A and Annex B should be used as guidance to evaluate compliance to applicable Types of Protection or protection concept.

NOTE Annex A and Annex B are based on requirements found in the IEC 60079 and ISO/IEC 80079 series

Communication with customers shall include:

a) providing information relating to products and services;

b) handling enquiries, contracts or orders, including changes;

c) obtaining customer feedback relating to products and services, including customer complaints;

d) handling or controlling customer property;

e) establishing specific requirements for contingency actions, when relevant.

8.2.1 of ISO 9001:2015 applies.

When determining the requirements for the products and services to be offered to customers, the organization shall ensure that:

a) the requirements for the products and services are defined, including:

1) any applicable statutory and regulatory requirements;

2) those considered necessary by the organization;

b) the organization can meet the claims for the products and services it offers.

8.2.2 of ISO 9001:2015 applies.

8.2.3.1 The organization shall ensure that it has the ability to meet the requirements for products and services to be offered to customers. The organization shall conduct a review before committing to supply products and services to a customer, to include:

a) requirements specified by the customer, including the requirements for delivery and post-delivery activities;

b) requirements not stated by the customer, but necessary for the specified or intended use, when known;

c) requirements specified by the organization;

d) statutory and regulatory requirements applicable to the products and services;

e) contract or order requirements differing from those previously expressed.

The organization shall ensure that contract or order requirements differing from those previously defined are resolved.

The customer’s requirements shall be confirmed by the organization before acceptance, when the customer does not provide a documented statement of their requirements.

NOTE In some situations, such as internet sales, a formal review is impractical for each order. Instead, the review can cover relevant product information, such as catalogues.

8.2.3.2 The organization shall retain documented information, as applicable:

a) on the results of the review;

b) on any new requirements for the products and services.

8.2.3 of ISO 9001:2015 applies with the following addition:

Where there are stated customer requirements they shall be reviewed. The review shall ensure that the Ex Product to be released for use is compatible with any stated customer requirement, for example equipment group, temperature class, Type of Protection, Equipment Protection Level (EPL) and ambient temperature range.

Where there are no stated customer requirements, appropriate information shall be made available to the customer.

The organization shall ensure that relevant documented information is amended, and that relevant persons are made aware of the changed requirements, when the requirements for products and services are changed.

8.2.4 of ISO 9001:2015 applies with the following addition:

The Ex authorized person(s) identified in 5.3 shall ensure that there are documented procedures and controls to review and approve any changes that could affect Ex Product compliance.

EXAMPLE Changes to the related drawings, quality management system or marketing documents

The organization shall establish, implement and maintain a design and development process that is appropriate to ensure the subsequent provision of products and services.

8.3.1 of ISO 9001:2015 is not within the scope of this document.

In determining the stages and controls for design and development, the organization shall consider:

a) the nature, duration and complexity of the design and development activities;

b) the required process stages, including applicable design and development reviews;

c) the required design and development verification and validation activities;

d) the responsibilities and authorities involved in the design and development process;

e) the internal and external resource needs for the design and development of products and services;

f) the need to control interfaces between persons involved in the design and development process;

g) the need for involvement of customers and users in the design and development process;

h) the requirements for subsequent provision of products and services;

i) the level of control expected for the design and development process by customers and other relevant interested parties;

j) the documented information needed to demonstrate that design and development requirements have been met.

8.3.2 of ISO 9001:2015 is not within the scope of this document.

The organization shall determine the requirements essential for the specific types of products and services to be designed and developed. The organization shall consider:

a) functional and performance requirements;

b) information derived from previous similar design and development activities;

c) statutory and regulatory requirements;

d) standards or codes of practice that the organization has committed to implement;

e) potential consequences of failure due to the nature of the products and services.

Inputs shall be adequate for design and development purposes, complete and unambiguous.

Conflicting design and development inputs shall be resolved.

The organization shall retain documented information on design and development inputs.

8.3.3 of ISO 9001:2015 is not within the scope of this document.

The organization shall apply controls to the design and development process to ensure that:

a) the results to be achieved are defined;

b) reviews are conducted to evaluate the ability of the results of design and development to meet requirements;

c) verification activities are conducted to ensure that the design and development outputs meet the input requirements;

d) validation activities are conducted to ensure that the resulting products and services meet the requirements for the specified application or intended use;

e) any necessary actions are taken on problems determined during the reviews, or verification and validation activities;

f) documented information of these activities is retained.

NOTE Design and development reviews, verification and validation have distinct purposes. They can be conducted separately or in any combination, as is suitable for the products and services of the organization.

8.3.4 of ISO 9001:2015 is not within the scope of this document.

The organization shall ensure that design and development outputs:

a) meet the input requirements;

b) are adequate for the subsequent processes for the provision of products and services;

c) include or reference monitoring and measuring requirements, as appropriate, and acceptance criteria;

d) specify the characteristics of the products and services that are essential for their intended purpose and their safe and proper provision.

The organization shall retain documented information on design and development outputs.

8.3.5 of ISO 9001:2015 is not within the scope of this document.

The organization shall identify, review and control changes made during, or subsequent to, the design and development of products and services, to the extent necessary to ensure that there is no adverse impact on conformity to requirements.

The organization shall retain documented information on:

a) design and development changes;

b) the results of reviews;

c) the authorization of the changes;

d) the actions taken to prevent adverse impacts.

8.3.6 of ISO 9001:2015 applies with the following addition:

The Ex authorized person(s) identified in 5.3 shall be included in the approval process of any design and development modification or change that could affect Ex Product compliance.

EXAMPLE Changes to the related drawings, quality management system or marketing documents

The organization shall ensure that externally provided processes, products and services conform to requirements.

The organization shall determine the controls to be applied to externally provided processes, products and services when:

a) products and services from external providers are intended for incorporation into the organization’s own products and services;

b) products and services are provided directly to the customer(s) by external providers on behalf of the organization;

c) a process, or part of a process, is provided by an external provider as a result of a decision by the organization.

The organization shall determine and apply criteria for the evaluation, selection, monitoring of performance, and re-evaluation of external providers, based on their ability to provide processes or products and services in accordance with requirements. The organization shall retain documented information of these activities and any necessary actions arising from the evaluations.

8.4.1 of ISO 9001:2015 applies with the following addition:

While manufacture, test and final inspection may be outsourced to an external provider, the responsibility for ensuring conformance with the Ex Product certificate and the schedule drawings shall not be outsourced and remain with the manufacturer; receipt or acceptance of an external provider’s declaration of conformity does not absolve the manufacturer from this responsibility.

The organization shall ensure that externally provided processes, products and services do not adversely affect the organization’s ability to consistently deliver conforming products and services to its customers.

The organization shall:

a) ensure that externally provided processes remain within the control of its quality management system;

b) define both the controls that it intends to apply to an external provider and those it intends to apply to the resulting output;

c) take into consideration:

1) the potential impact of the externally provided processes, products and services on the organization’s ability to consistently meet customer and applicable statutory and regulatory requirements;

2) the effectiveness of the controls applied by the external provider;

d) determine the verification, or other activities, necessary to ensure that the externally provided processes, products and services meet requirements.

8.4.2 of ISO 9001:2015 applies with the following addition:

The type and extent of control and selection of external providers shall depend on the nature and type of product, processes or services provided by the external provider as specified in Annex E.

The organization shall ensure the adequacy of requirements prior to their communication to the external provider.

The organization shall communicate to external providers its requirements for:

a) the processes, products and services to be provided;

b) the approval of:

1) products and services;

2) methods, processes and equipment;

3) the release of products and services;

c) competence, including any required qualification of persons;

d) the external providers’ interactions with the organization;

e) control and monitoring of the external providers’ performance to be applied by the organization;

f) verification or validation activities that the organization, or its customer, intends to perform at the external providers’ premises.

8.4.3 of ISO 9001:2015 applies with the following addition:

a) the purchasing documents shall state the specific requirements pertaining to externally provided products, processes or services set out in the Ex Product certificate and schedule drawings taking into account the evaluation of the external provider in E.2;

EXAMPLE One method of describing the specific requirements in the purchasing documents is for the purchase order to include references to drawings, test procedures, instruction procedures or production parameters.

b) the organization shall define the method by which documents, such as technical specifications, stated in a particular purchase order remain traceable to the order;

c) where the organization does not provide such documents with subsequent orders, then the organization shall have documented procedures for ensuring that external providers have current copies of documents and that their integrity be maintained.

The organization shall implement production and service provision under controlled conditions.

Controlled conditions shall include, as applicable:

a) the availability of documented information that defines:

1) the characteristics of the products to be produced, the services to be provided, or the activities to be performed;

2) the results to be achieved;

b) the availability and use of suitable monitoring and measuring resources;

c) the implementation of monitoring and measurement activities at appropriate stages to verify that criteria for control of processes or outputs, and acceptance criteria for products and services, have been met;

d) the use of suitable infrastructure and environment for the operation of processes;

e) the appointment of competent persons, including any required qualification;

f) the validation, and periodic revalidation, of the ability to achieve planned results of the processes for production and service provision, where the resulting output cannot be verified by subsequent monitoring or measurement;

g) the implementation of actions to prevent human error;

h) the implementation of release, delivery and post-delivery activities.

8.5.1 of ISO 9001:2015 applies with the following addition:

The organization shall provide procedures, production equipment, working environments and inspection/testing facilities that together provide assurance with respect to the compliance of the Ex Product with its schedule drawings.

Where a process can affect the integrity of a Type of Protection, and where the resulting integrity cannot be verified after manufacture, for example the environmental conditions required for curing an encapsulant, that specific process shall be measured or monitored. Documented evidence shall be maintained to demonstrate compliance with required parameters. Annex A should be used as guidance to demonstrate compliance.

The organization shall use suitable means to identify outputs when it is necessary to ensure the conformity of products and services.

The organization shall identify the status of outputs with respect to monitoring and measurement requirements throughout production and service provision.

The organization shall control the unique identification of the outputs when traceability is a requirement, and shall retain the documented information necessary to enable traceability.

8.5.2 of ISO 9001:2015 applies with the following addition:

a) the organization shall establish and maintain procedures for product identification during all applicable stages of production, testing, final inspection and release for use;

b) traceability is required with respect to the final product and its significant parts. Traceability can be achieved using serial number, batch or by other appropriate methods.

NOTE Significant parts are, for example, a printed circuit board (PCB) and safety component of an intrinsically safe circuit, but not each electronic component on a PCB. The significant part is defined in the schedule drawings during the processes of the product assessment.

The organization shall exercise care with property belonging to customers or external providers while it is under the organization’s control or being used by the organization.

The organization shall identify, verify, protect and safeguard customers’ or external providers’ property provided for use or incorporation into the products and services.

When the property of a customer or external provider is lost, damaged or otherwise found to be unsuitable for use, the organization shall report this to the customer or external provider and retain documented information on what has occurred.

NOTE A customer’s or external provider’s property can include materials, components, tools and equipment, premises, intellectual property and personal data.

8.5.3 of ISO 9001:2015 applies with the following addition:

It is the responsibility of the manufacturer to verify the compatibility of a product supplied by a customer or an external provider with the requirements of the Ex Product certificate and schedule drawings.

The organization shall preserve the outputs during production and service provision, to the extent necessary to ensure conformity to requirements.

NOTE Preservation can include identification, handling, contamination control, packaging, storage, transmission or transportation, and protection.

8.5.4 of ISO 9001:2015 applies.

The organization shall meet requirements for post-delivery activities associated with the products and services.

In determining the extent of post-delivery activities that are required, the organization shall consider:

a) statutory and regulatory requirements;

b) the potential undesired consequences associated with its products and services;

c) the nature, use and intended lifetime of its products and services;

d) customer requirements;

e) customer feedback.

NOTE Post-delivery activities can include actions under warranty provisions, contractual obligations such as maintenance services, and supplementary services such as recycling or final disposal.

8.5.5 of ISO 9001:2015 applies.

The organization shall review and control changes for production or service provision, to the extent necessary to ensure continuing conformity with requirements.

The organization shall retain documented information describing the results of the review of changes, the person(s) authorizing the change, and any necessary actions arising from the review.

8.5.6 of ISO 9001:2015 applies with the following addition:

The Ex authorized person(s) identified in 5.3 shall be included in the approval process of changes that could affect Ex Product compliance.

EXAMPLE Changes to related drawings, quality management system or marketing documents

The organization shall implement planned arrangements, at appropriate stages, to verify that the product and service requirements have been met.

The release of products and services to the customer shall not proceed until the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority and, as applicable, by the customer.

The organization shall retain documented information on the release of products and services. The documented information shall include:

a) evidence of conformity with the acceptance criteria;

b) traceability to the person(s) authorizing the release.

8.6 of ISO 9001:2015 applies with the following addition:

Where routine tests are required by the Ex Product certificate and schedule drawings, these tests shall be performed as specified. Unless specifically permitted by the Ex Product certificate and schedule drawings, statistical methods shall not be used.

Ex Products shall only be released for use after final inspection and testing have been satisfactorily completed. Organizations that release Ex Products for use shall provide customers with instructions prepared in accordance with the relevant standards or statutory and regulatory requirements.

EXAMPLES Specific Conditions of Use, Schedule of Limitations, specific maintenance or repair instructions, particulars of possible misuse

8.7.1 The organization shall ensure that outputs that do not conform to their requirements are identified and controlled to prevent their unintended use or delivery.

The organization shall take appropriate action based on the nature of the nonconformity and its effect on the conformity of products and services. This shall also apply to nonconforming products and services detected after delivery of products, during or after the provision of services.

The organization shall deal with nonconforming outputs in one or more of the following ways:

a) correction;

b) segregation, containment, return or suspension of provision of products and services;

c) informing the customer;

d) obtaining authorization for acceptance under concession.

Conformity to the requirements shall be verified when nonconforming outputs are corrected.

8.7.2 The organization shall retain documented information that:

a) describes the nonconformity;

b) describes the actions taken;

c) describes any concessions obtained;

d) identifies the authority deciding the action in respect of the nonconformity.

8.7 of ISO 9001:2015 applies with the following addition:

a) the organization shall maintain a documented system, such that in the event of an Ex Product not conforming to the Ex Product certificate and schedule drawings, and having been supplied, then the organization’s customer can be identified;

b) the organization shall take action, appropriate to the degree of risk, where nonconforming Ex Product has been supplied to a customer. It is recommended that the organization liaise with the body responsible for the issue of the Ex Product certificate;

c) where the nonconforming Ex Product has been deemed unsafe by b) and has been released for use, then the following applies:

1) the organization shall, in writing, inform its customer and the body responsible for the verification of the quality management system and the issuer of the Ex Product certificate.

2) where the organization’s customer is not the user, the information to its customer shall include a request to pass the information on to the user, including a request to confirm that each user has been informed.

3) where the organization has not been able to verify that all users of unsafe nonconforming Ex Products have been informed then a notice shall be placed in appropriate information channels providing recommended action to be taken.

EXAMPLES Trade magazines, social media, internet publications, newspapers

d) for all nonconforming Ex Products that have been supplied to a customer, the organization shall maintain, for a minimum period of 10 years, records of:

1) serial numbers or identification of Ex Products supplied;

2) the customer who received the Ex Products;

3) the action taken to inform customers, the body responsible for the verification of the quality management system and the issuer of the Ex Product certificate in the case of unsafe nonconforming Ex Products;

4) the action taken to implement corrective action;

e) concessions for Ex Products that take the Ex Products outside the design as defined in the Ex Product certificate and schedule drawings are not permitted.

The organization shall determine:

a) what needs to be monitored and measured;

b) the methods for monitoring, measurement, analysis and evaluation needed to ensure valid results;

c) when the monitoring and measuring shall be performed;

d) when the results from monitoring and measurement shall be analysed and evaluated.

The organization shall evaluate the performance and the effectiveness of the quality management system.

The organization shall retain appropriate documented information as evidence of the results.

9.1.1 of ISO 9001:2015 applies.

The organization shall monitor customers’ perceptions of the degree to which their needs and expectations have been fulfilled. The organization shall determine the methods for obtaining, monitoring and reviewing this information.

NOTE Examples of monitoring customer perceptions can include customer surveys, customer feedback on delivered products and services, meetings with customers, market-share analysis, compliments, warranty claims and dealer reports.

9.1.2 of ISO 9001:2015 applies.

The organization shall analyze and evaluate appropriate data and information arising from monitoring and measurement.

The results of analysis shall be used to evaluate:

a) conformity of products and services;

b) the degree of customer satisfaction;

c) the performance and effectiveness of the quality management system;

d) if planning has been implemented effectively;

e) the effectiveness of actions taken to address risks and opportunities;

f) the performance of external providers;

g) the need for improvements to the quality management system.

NOTE Methods to analyse data can include statistical techniques.

9.1.3 of ISO 9001:2015 applies.

9.2.1 The organization shall conduct internal audits at planned intervals to provide information on whether the quality management system:

a) conforms to:

1) the organization’s own requirements for its quality management system;

2) the requirements of this International Standard;

b) is effectively implemented and maintained.

9.2.2 The organization shall:

a) plan, establish, implement and maintain an audit programme(s) including the frequency, methods, responsibilities, planning requirements and reporting, which shall take into consideration the importance of the processes concerned, changes affecting the organization, and the results of previous audits;

b) define the audit criteria and scope for each audit;

c) select auditors and conduct audits to ensure objectivity and the impartiality of the audit process;

d) ensure that the results of the audits are reported to relevant management;

e) take appropriate correction and corrective actions without undue delay;

f) retain documented information as evidence of the implementation of the audit programme and the audit results.

NOTE See ISO 19011 for guidance.

9.2 of ISO 9001:2015 applies with the following addition:

a) Each applicable element of the quality management system shall be audited annually with a maximum of 14 months in between corresponding audits, to assess the effectiveness of the quality management system to ensure that the Ex Product are in conformity with the Ex Product certificate and schedule drawings.

b) Effectiveness may be demonstrated with the use of a vertical product audit whereby an Ex Product awaiting dispatch is used to prove the system. In this case the auditor examines all aspects of the system associated with the production of that Ex Product from a certification viewpoint.

c) Checklists based on the requirements of this document should be used to assist with internal audits.

Organizations may employ either method or some other equivalent method.

Top management shall review the organization’s quality management system, at planned intervals, to ensure its continuing suitability, adequacy, effectiveness and alignment with the strategic direction of the organization.

9.3.1 of ISO 9001:2015 applies with the following addition:

a) the maximum intervals between reviews shall not exceed 14 months;

b) top management shall chair the review;

c) the Ex authorized person(s) responsible for the activities as detailed in 5.3 shall participate in the review.

d) the review shall include the overall effectiveness of the quality management system with respect to Ex Products, including results of internal and external audits.

NOTE Review of results of internal and external audits would provide evidence of the effectiveness of the quality management system.

The management review shall be planned and carried out taking into consideration:

a) the status of actions from previous management reviews;

b) changes in external and internal issues that are relevant to the quality management system;

c) information on the performance and effectiveness of the quality management system, including trends in:

1) customer satisfaction and feedback from relevant interested parties;

2) the extent to which quality objectives have been met;

3) process performance and conformity of products and services;

4) nonconformities and corrective actions;

5) monitoring and measurement results;

6) audit results;

7) the performance of external providers;

d) the adequacy of resources;

e) the effectiveness of actions taken to address risks and opportunities (see 6.1);

f) opportunities for improvement.

9.3.2 of ISO 9001:2015 applies.

The outputs of the management review shall include decisions and actions related to:

a) opportunities for improvement;

b) any need for changes to the quality management system;

c) resource needs.

The organization shall retain documented information as evidence of the results of management reviews.

9.3.3 of ISO 9001:2015 applies.

The organization shall determine and select opportunities for improvement and implement any necessary actions to meet customer requirements and enhance customer satisfaction.

These shall include:

a) improving products and services to meet requirements as well as to address future needs and expectations;

b) correcting, preventing or reducing undesired effects;

c) improving the performance and effectiveness of the quality management system.

NOTE Examples of improvement can include correction, corrective action, continual improvement, breakthrough change, innovation and re-organization.

10.1 of ISO 9001:2015 applies.

10.2.1 When a nonconformity occurs, including any arising from complaints, the organization shall:

a) react to the nonconformity and, as applicable:

1) take action to control and correct it;

2) deal with the consequences;

b) evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it does not recur or occur elsewhere, by:

1) reviewing and analysing the nonconformity;

2) determining the causes of the nonconformity;

3) determining if similar nonconformities exist, or could potentially occur;

c) implement any action needed;

d) review the effectiveness of any corrective action taken;

e) update risks and opportunities determined during planning, if necessary;

f) make changes to the quality management system, if necessary.

Corrective actions shall be appropriate to the effects of the nonconformities encountered.

10.2.2 The organization shall retain documented information as evidence of:

a) the nature of the nonconformities and any subsequent actions taken;

b) the results of any corrective action.

10.2 of ISO 9001:2015 applies.

The organization shall continually improve the suitability, adequacy and effectiveness of the quality management system.

The organization shall consider the results of analysis and evaluation, and the outputs from management review, to determine if there are needs or opportunities that shall be addressed as part of continual improvement.

10.3 of ISO 9001:2015 applies.

Annex A
(informative)

Information relevant to particular Types of Protection
and specific Ex Products

A.1 Introduction

This annex provides information on those aspects that the quality management system should address with respect to particular types of protection. It does not add to or otherwise change the requirements of this document.

This annex provides examples of how to meet the requirements of this document, recognizing that other methods which achieve the same objectives are equally acceptable; and draws attention to aspects of requirements that might not be readily apparent to those unfamiliar with quality management systems for Ex Products intended for use in explosive atmospheres.

NOTE Examples in this annex do not cover all Types of Protection, but give some advice and will be supplemented in the next edition.

A.2 General

Schedule drawings can provide conditions for the particular Type of Protection. All markings should be in accordance with the schedule drawings.

For enclosures and other components forming part of the enclosure and for fans, fan hoods and ventilation screens, the organization should verify the material composition for example by an external provider’s declaration of conformity, see Annex C).

Where temperature has an effect on a measurement, temperature variations should be addressed.

There should be documented procedures with defined acceptance criteria to demonstrate conformity for all routine and batch verifications and tests specified in the schedule drawings. The following should be recorded:

a) equipment used for test;

b) identification of the personnel carrying out the tests; and

c) results and dates of tests.

A.3 Ex d – Flameproof enclosures covered by IEC 60079-1

A.3.1 Verification

Verification consists of a visual inspection and/or measurement.

The measurement should be done with suitable measuring equipment. The persons doing this measurement should have the competence and knowledge of using this measuring equipment.

A.3.2 Castings

Castings should be subject to verification that demonstrates conformity, such as:

a) 100 % visual inspection should be done on each part;

b) wall thickness (including those parts not subject to machining);

c) flaws, inclusions, blow holes and porosity (by either a visual or test method depending upon the criticality).

NOTE 1 Verification is accomplished by 100 % visual inspection, or by another means deemed appropriate based on the ability of the organization to effectively control production.

NOTE 2 Recovery of castings is not currently addressed in IEC 60079-1.

Recovery of porous castings by impregnation methods, such as silicone is not permitted. In the event that a casting is recovered by welding it will become subject to the requirements applicable to welded enclosures, for example routine pressure testing.

A.3.3 Machining

Machining should be subject to verification by either 100 % inspection or statistical techniques as appropriate that demonstrates conformity, for example the following should be verified:

a) flatness of flanged flamepaths;

b) surface roughness of non-threaded flamepaths;

c) fit of all threaded flamepaths, for example threaded entries and threaded access covers;

d) depth of drilling and tapping of blind holes to ensure adequate residual wall thickness;

e) dimensional requirements of all flamepaths.

NOTE Suitable statistical techniques are used in ISO 2859-1, ISO 3951-1or equivalent standard.

A.3.4 Cemented joints and potted assemblies

Documented procedures should address the following, as applicable:

a) shelf life and storage conditions;

b) mixing;

c) surface preparation;

d) filling instructions, freedom from voids and temperature conditions;

e) minimum thickness

f) curing, which should include: curing period, any relevant environmental factors, provisions to ensure product is undisturbed during the curing period;

g) after curing, an inspection should be done

A.3.5 Routine overpressure testing

A.3.5.1 General

The purpose of the test is to check that the enclosure does not suffer damage or permanent deformation.

Leakage through cemented joints or potted assemblies would constitute a failure unless otherwise permitted by the issuer of the Ex Product certificate.

The test can be a single test conducted on a complete assembly, or a series of tests on each sub-assembly or component part. For the static routine overpressure test, it is sufficient to test the enclosure empty. The individual parts of a flameproof enclosure (for example, cover and base) can be tested separately. For enclosures that contain more than one discrete compartment, each compartment should be tested individually. The method used should ensure that the assembly, sub-assembly or component parts are subjected to representative stress patterns, for example actual fastening facilities are used. Clamping that affects the mechanical properties of the Type of Protection would invalidate the test results.

Due to safety considerations and difficulty in detecting leakage, hydraulic rather than pneumatic methods are recommended.

The test facility should have the capacity to maintain the required pressure during the test period. Leakage from flamepaths can be reduced by the use of gaskets or ‘O’ rings.

The pressure gauge should be calibrated, of suitable resolution and range, located such that it does not invalidate the test, for example due to pressure drop down pipelines.

The method of test should enable any leakage to be monitored during the test period.

The verification of the routine overpressure test should include verification of the product for visible damage or deformation, for example flange flamepaths are still within the dimensions shown in the schedule drawings.

A.3.5.2 Batch testing

Where permitted by the Ex Product certificate, the routine overpressure testing maybe replaced by a batch test according to the following criteria, based on ISO 2859-1;

a) For a production batch up to 100, a sampling of 8 should be tested at 1,5 times the reference pressure with no failures.

b) For a production batch from 101 to 1 000, a sampling of 32 should be tested at 1,5 times the reference pressure with no failures.

c) For a production batch from 1 001 up to 10 000, a sampling of 80 should be tested at 1,5 times the reference pressure with no failures.

d) Batches above 10 000 should be subdivided into smaller batches.

If there are any non-compliant test results, 100 % of all remaining samples in the batch should be tested at 1,5 times the reference pressure. Future batches should be routine tested at 1,5 times the reference pressure until confidence is established to reconsider batch testing.

NOTE Upon non-compliant test results, reconsideration of this batch testing approach is at the discretion of the party issuing the Ex Product certificate.

A.3.5.3 Welded construction

Where permitted by the Ex Product certificate, the routine overpressure testing may be verified by non-destructive inspection methods, for example,

a) radiographic inspection

b) ultrasonic inspection

c) magnetic particle inspection

d) liquid penetrant inspection

e) infrared thermography inspection

f) helium leakage inspection

NOTE 1 ISO standards exist for each of the above weld inspection methods.

NOTE 2 The inspection methods should be suitable for the type of imperfection to be tested. In certain circumstances a combination of inspection methods should be used.

A.3.6 Flanged joints

Flanged joints should be verified after final assembly to ensure the gap specified in the schedule drawings is not exceeded. If not practical, special measure should be taken during the production.

A.3.7 Elements, with non-measurable paths, of breathing and draining devices

For products containing elements like sintered metal, pressed metal wire or metal foam, see Annex B.

A.4 Ex i – intrinsic safety covered by IEC 60079-11

A.4.1 Components for intrinsically safe apparatus and associated apparatus

Production procedures should ensure that electronic components are compatible with the specifications provided in the schedule drawings.

The schedule drawings might specify absolute value limits and hence not specify a tolerance. In this case there should be a process to ensure that the nominal value as modified by the worst case tolerance is within the absolute limits specified.

Table A.1 provides a list of externally provided component types and their specifications that might appear in some form in the schedule drawings parts list and therefore require consideration (see A.4.2.2). Where a particular specification is not given for a component in the schedule drawings then that specification does not need to be considered for the component in question. In some cases it might be necessary to specify a particular manufacturer and part number (or part family), for example when parameters of loosely specified components have been determined by testing of samples, or when components with their own Ex component certification are used.

Table A.1 – Component specifications that might require consideration

A.4.2 Printed circuit boards (PCBs)

A.4.2.1 Unpopulated PCBs

Purchase documents submitted to the supplier for unpopulated (bare board) PCBs should specify the factors that together demonstrate conformity. These can include:

a) type and version;

b) PCB design files, for example Gerber files

c) copper thickness (usually expressed as weight per square foot) with tolerance, including plating of vias;

d) PCB overall thickness with tolerance;

e) PCB stack-up with tolerances where applicable; particular care should be taken where the prepreg thickness is used as a separation on which intrinsic safety depends;

f) material specification where relevant to intrinsic safety (normally the board material and solder resist material which are compatible with the CTI requirements).

Unpopulated PCBs should be accepted from their manufacturer with an external provider’s declaration of conformity (see Annex C) which declares compliance to the purchase documents.

There should be a documented verification procedure for received PCBs. Depending on the complexity of the circuit board and confidence in the capability of the PCB manufacturer, this might include:

1) a check that the PCB is the correct type and version as identified on the PCB (for example on an ident, solder resist or outer copper layer);

2) a simple visual check of the PCB outline and outer copper layer(s), (for example against transparencies, drawings or controlled inspection samples);

3) a check of the PCB thickness where this is relevant to intrinsic safety;

4) where there are small separations (for example for reduced separations at low voltages): regular micro analysis of creepage and solid insulation distances, and analysis of residual unintended copper;

It can normally be assumed that all PCBs in a single delivery will be identical. These checks are normally performed on delivery, though that can cause issues where PCBs are delivered vacuum sealed and are likely to be stored for some time before use.

A.4.2.2 Populated PCBAs

For PCBAs the manufacturer should maintain a list of components on which intrinsic safety depends (sometimes referred to as safety critical components) used in production (for example some resistors, fuses, transformers and Zener diodes) determined during the Ex Product assessment. A documented procedure should state the processes for verifying the parts and placement of the identified components on which intrinsic safety depends (see A.4.1). This can include one or more of the following methods:

a) a manual visual verification;

b) for surface mount components, by ensuring loading of the pick and place machines with the correct components, for example with a check of the component reel when it is loaded, every time it is re-loaded, and a final check at the end of the assembly run;

c) for surface mount components, by the use of a pick and place machine with a measuring function; in this case the calibration requirements of 7.1.5 apply;

d) by automatic test equipment (ATE) to verify critical component characteristics (although this is sometimes not sufficient where components are in parallel and cannot be individually verified);

e) by automatic optical inspection (AOI) that verifies component marking and orientation (for example the correct type and number of components in shunt semiconductor assembly).

Normally, unpopulated PCB manufacture is consistent enough to maintain separations during PCBA assembly, though in some cases tolerances for manually assembled PCBs might provide a risk that separations on which intrinsic safety depends might not be maintained. There should be a procedure to identify these separations, and the verification required, for example measurement on a sample basis that component position is inside the PCB pads.

Documented procedures should ensure that workmanship standards (for example IPC standards) are defined with respect to component mounting and soldering. This should include verification, for example 100 % manual visual inspection with the aid of an inspection microscope, or AOI that verifies component orientation and soldering.

A.4.3 Conformal coating and encapsulation

Where they are relevant to intrinsic safety, varnish, coatings, potting compounds and other encapsulation materials should be controlled with respect to the specification of material and effectiveness of the application.

Documented procedures should address the following:

a) shelf life and storage conditions;

b) mixing;

c) surface preparation;

d) the method of conformal coating to ensure an effective lasting unbroken seal;

e) filling instructions, freedom from voids and temperature conditions;

f) minimum thickness;

g) curing, which should include: curing period, any relevant environmental factors, provisions to ensure product is undisturbed during the curing period;

h) after curing, an inspection should be done;

The schedule drawings can require routine, batch verification or destructive testing of conformal coating or encapsulation.

A.4.4 Sub-assemblies and assemblies

There might be separate production documentation for different variations to the product design.

Documented procedures should ensure that segregation of related parts (for example terminals) and wiring/cabling is maintained and that specified colours, cross-sectional area, insulation thickness and labels (where appropriate) are fitted.

A.4.5 Enclosures for Group IIIC or reduced spacing

For apparatus that requires protection by enclosure for either reduced spacing or Group IIIC requirements, demonstration of the conformity of the enclosure with the schedule drawings should include the following;

a) depths of bore holes and tap holes;

b) dimensional requirements for those enclosure parts relevant for sealing effectiveness or mechanical stability;

c) insulating coatings and surface conditioning; material, layer thickness.

Documented procedures should ensure the following:

a) the gaskets correspond to the specification stated in the schedule drawings;

b) the sealing elements' effectiveness, for example by checking the sealing elements' correct fit. Sealing arrangements should be verified for compatibility with the product’s degree of protection (IP Code) rating.

If a gasket's correct fit becomes apparent only after assembly, the imprint could be visually examined, for example by the use of chalk.

A.4.6 Routine verifications and tests

In addition to A.2 batch and routine tests can include:

a) dielectric strength tests required for reduced separations on which intrinsic safety depends; where these are not practical on the manufactured circuit (for example because there is no galvanic isolation), representative test conductors included in the equipment design might be provided;

b) correct operation of safety barriers;

c) dielectric strength tests on isolating components such as transformers;

d) verification of encapsulation;

e) verification of component values or electrical parameters such as voltage or current.

A.4.7 Intrinsically safe circuits and assemblies incorporated in Ex equipment of other Types of Protection

Where Ex equipment incorporates intrinsically safe circuits or assemblies alongside other Types of Protection, adequate precautions must be taken to ensure that all requirements in the schedule drawings that relate to these other Types of Protection are met.

A.4.8 Cells and batteries

It is critical for intrinsic safety that the design, chemistry, construction and electrical ratings of these cells or batteries are unchanged from those originally tested.

One of the following means can be used to verify that the cells or batteries have not changed in a way that impairs intrinsic safety:

1) Use of a cell or battery which has an Ex Component certificate to IEC 60079‑11.

2) Obtaining an external provider’s declaration of conformity from the cell or battery manufacturer.

3) Establishing a documented system to be informed about changes by the cell or battery manufacturer

4) Periodic sample testing of representative cells to determine the properties of the cell or battery. The tests should be determined by the organization, but could be based on those in IEC 60079‑11, such as the 80 mΩ test from IEC 60079‑11.

NOTE The 80 mΩ test could be applied for a baseline and subsequent comparison for all Levels of Protection.

A.4.9 Parameters of loosely specified components

Where the “determination of parameters of loosely specified components” test of IEC 60079‑11 is applied, ongoing monitoring of the component and parameter might be needed to ensure compliance with the schedule drawings. The frequency of monitoring should be relative to the margin of safety on the critical parameter.

A.5 Ex e – Increased safety covered by IEC 60079-7

A.5.1 Degree of protection (IP Code)

Documented procedures should ensure that the following is verified:

a) weld continuity;

b) fitting of gaskets and seals;

c) continuity of moulded grooves and tongues;

d) application of cements including a visual inspection after curing.

A.5.2 Internal wiring and contact integrity

Documented procedures should ensure that the following are verified:

a) wiring is clamped as specified in the schedule drawings;

b) wiring is terminated as specified in the schedule drawings;

c) wires are as specified in the schedule drawings;

d) connections are tightened as specified in the schedule drawings;

e) creepage distances and clearances are as specified in the schedule drawings and have not been compromised.

A.5.3 Rotating machines

Documented procedures should ensure that the following are verified:

a) rotor end connections and fixing bars are as specified in the schedule drawings;

b) the fabrication process for die-cast rotors is as specified in the schedule drawings;

c) production controls are in place for:

– the air gap (rotor to stator) as specified in the schedule drawings;

– the fan clearance as specified in the schedule drawings;

– the bearing seal clearances as specified in the schedule drawings.

NOTE The schedule drawings might not specify a bearing seal clearance as not all Levels of Protection require a bearing seal clearance for all bearing seal designs.

A.5.4 Windings

Documented procedures should ensure that the following are verified:

a) wire and insulation system are as specified in the schedule drawings;

b) the impregnations process is as specified in the schedule drawings;

c) insulation materials are as specified in the schedule drawings;

d) mechanical securing of conductors are as specified in the schedule drawings;

e) type and mounting of protective devices, for example thermal cut-outs, are as specified in the schedule drawings.

A.5.5 Terminal boxes

Documented procedures should ensure that the following are verified:

a) terminals are as specified in the schedule drawings;

b) creepage distances and clearances as specified in the schedule drawings have not been compromised.

A.5.6 Cable Glands, terminals and other accessories

The dimensions specified in the schedule drawings should be confirmed on a statistical basis.

Where entry openings are secured by non-Ex temporary plugs, for example for transport only, additional information should be provided.

A.5.7 Routine verifications and tests

Procedures for all routine verifications and tests specified in the schedule drawings should be reviewed, along with the results of those verifications and tests.

A.6 Ex p – Pressurized equipment covered by IEC 60079-2

A.6.1 Degree of protection (IP Code)

Documented procedures should ensure that the following is verified:

a) weld continuity;

b) fitting of gaskets and seals;

c) continuity of moulded grooves and tongues;

d) application of cements including a visual inspection after curing.

A.6.2 Components and manufacturing process

The documented procedure should at least ensure the verification of assemblies with typical components as specified in the schedule drawings:

a) monitoring devices (and their location), for pressure, differential pressure, purging time, flow, temperature;

b) Ex Components and Ex Equipment;

c) enclosure, enclosure parts, materials of enclosure and enclosure parts and gaskets.

A.6.3 Components, constructional characteristics

The documented procedure should include the verification, the manufacturing processes and quality assurance technology for components and constructional characteristics relevant for safety as specified in the schedule drawings:

a) purging openings inside the pressurized enclosure or in the enclosure wall;

b) internal installations (components, partitions, enclosures);

c) installations into the enclosure wall (components, entries);

d) purging pipes, purge controller components (internal, external) should be verified with respect to their constructional specifications and the constructional characteristics.

A.6.4 Routine verifications and tests

In addition to A.2 typical tests include:

a) a functional test of the pressurized equipment;

b) a leakage test;

c) an infallible containment system test;

d) a containment system for a limited release system test.

A.7 Ex m – Encapsulation covered by IEC 60079-18

A.7.1 Production documentation

Thermal protection, for example thermal fuses, should be positioned according to and be of the type specified in the schedule drawings.

Documented procedures should address the following:

a) shelf life and storage conditions;

b) mixing;

c) surface preparation;

d) filling instructions, freedom from voids and temperature conditions;

e) minimum thickness;

f) curing, which should include: curing period, any relevant environmental factors, provision to ensure product is undisturbed during the curing period;

g) after curing, an inspection should be done;

A.7.2 Routine verifications and tests

In addition to A.2 typical tests include:

a) visual examination;

b) dielectric strength test.

A.8 Ex o – Liquid immersion covered by IEC 60079-6

A.8.1 Material control

All materials including filling liquid used should be of defined type.

A.8.2 Filling

Filling method and liquid level should be as stated in the schedule drawings. The process of filling and amount of liquid should be documented.

A.8.3 Degree of protection (IP Code)

Documented procedures should ensure that the following aspects are verified:

a) weld continuity;

b) fitting of gaskets and seals;

c) continuity of moulded grooves and tongues;

d) application of cements including a visual inspection after curing.

A.8.4 Routine verifications and tests

In addition to A.2 typical tests include:

a) reduced pressure test (sealed enclosures only);

b) overpressure test (sealed and unsealed enclosures).

A.9 Ex q – Powder filling covered by IEC 60079-5

A.9.1 Material control

The material should be of defined size and type as specified in the schedule drawings and verified as such by the organization.

Evidence should exist as to the flammability verification of enclosure materials and these materials should align with those specified in the schedule drawings.

A.9.2 Filling

Filling should be made without voids. Care is needed to ensure that voids are not created after filling by shaking down. The process for filling should be documented and the documentation should include verification criteria.

A.9.3 Degree of protection (IP Code)

Documented procedures should ensure that the following aspects are verified:

a) weld continuity;

b) fitting of gaskets and seals;

c) continuity of moulded grooves and tongues;

d) application of cements including a visual inspection after curing.

A.9.4 Routine verifications and tests

In addition to A.2 typical tests include:

a) pressure test;

b) dielectric strength test of filling material.

A.10 Equipment covered by IEC 60079-15

A.10.1 General requirements

A routine dielectric strength routine test needs to be performed for all devices and equipment in accordance with IEC 60079-15

A.10.2 Ex nA – Non sparking equipment

A.10.2.1 Circuit boards (PCBs)

Documented procedures should ensure that the following are verified:

a) the CTI, board and copper thickness of single and multi-layer boards are as specified in the schedule drawings and received external provider’s declaration of conformity;

b) populated PCBs are populated correctly and received external provider’s declaration of conformity, if applicable;

c) conformal coatings used to reduce spacing requirements are those specified in the schedule drawing by inspection or by an external provider’s declaration of conformity.

These verifications can be performed by inspection when it is possible or PCBs may be accepted with an external provider’s declaration of conformity (see Annex C). The declaration should state compliance to the purchase documents

A.10.2.2 Terminals and internal wiring

Documented procedures should ensure that the following are verified:

a) terminals are those specified in the schedule drawings;

b) creepage and clearance distances are as specified in schedule drawings;

c) wire is the type specified in the schedule drawings and that segregation (where required) is maintained.

A.10.3 Ex nC– Sealed devices

Documented methods should ensure the following examinations:

a) that creepage distances and clearances should be confirmed on a statistical basis.

b) the sealing requirements specified in the schedule drawings should be confirmed on a statistical basis.

A.10.4 Ex nR– Restricted Breathing

A.10.4.1 General requirements

Documented procedures should ensure that the following are verified:

a) creepage distances and clearances of integrated devices, as specified in the schedule drawings, are not affected;

b) the dimensions specified in the schedule drawings are confirmed (statistical method may be used only if permitted – see 8.6 ).

A.10.4.2 Cable glands

Documented methods should ensure that it is clearly distinguished in the schedule drawings which types of Cable Glands are associated with the enclosure forming a unit or being particularly matched and hence are subjected to the routine test of the enclosure.

A.10.4.3 Plunger actuators, shafts and axles

Documented methods should ensure that no lubricants or similar materials are used prior to the routine test.

A.10.4.4 Test equipment

Documented methods should ensure the correct assembling and function of test equipment.

A.10.4.5 Routine tests

There is no additional guidance in addition to A.2.

A.11 Ex t – Dust ignition protection by enclosure covered by IEC 60079-31

A.11.1 Casting

Castings should be subject to verification that demonstrates conformity with the schedule drawing, for example:

a) wall thickness (including the non-machinable parts);

b) cracks, inclusions, bubbles and porosity.

A.11.2 Enclosure parts

Enclosure parts should be subject to verification that demonstrates conformity with the schedule drawing, for example:

a) depths of bore holes and tap holes;

b) dimensional requirements for those enclosure parts relevant for sealing effectiveness or mechanical stability;

c) insulating coatings and surface conditioning; material, layer thickness.

A.11.3 Gaskets

Documented procedures should address the following:

a) the gaskets correspond to the quoted specification;

b) the sealing elements' effectiveness, for example by checking the sealing elements' correct fit.

If a gasket's correct fit becomes apparent only after assembly, the imprint could be visually examined, for example by use of adequate tools such as chalk.

A.11.4 Protection devices

Protection devices should be subject to verification that demonstrates conformity with the schedule drawings. Wherever protection devices, for example thermal safety devices, are specified in the Ex Product certificate, they should be verified according to type and placement.

A.11.5 Cemented and cast enclosure parts

Documented procedures should address the following:

a) shelf life and storage conditions;

b) mixing;

c) surface preparation;

d) filling instructions, freedom from voids and temperature conditions;

e) curing, which should include: curing period, any relevant environmental factors, provision to ensure product is undisturbed during the curing period;

f) after curing, an inspection should be done;

A.11.6 Degree of protection (IP Code)

Documented procedures should ensure that the following is verified:

a) weld continuity;

b) fitting of gaskets and seals;

c) continuity of moulded grooves and tongues;

d) application of cements including a visual inspection after curing.

A.11.7 Routine verifications and tests

In addition to A.2 typical tests include:

a) the visual inspection;

b) further verification and test requirements can result from the concepts of the dusts explosion protection standards. However, these can essentially be derived from the requirements for the Types of Protection listed so far.

A.12 Ex op – Optical radiation covered by IEC 60079-28

The following features should be verified for equipment containing source(s) of optical radiation. For components, this normally means verifying the marking on the components or packaging and may be achieved by using statistical techniques where appropriate:

a) optical source;

b) driver circuit;

c) Fibreoptic connectors;

d) Fibreoptic cable;

e) enclosure construction;

f) optical components, which have an impact on the safety relevant properties of the optical beam, for example lenses, filters, mirrors.

A.13 Gas detectors covered by IEC 60079-29 series

The manufacturer should confirm the regular operation of the measuring function by performing the following checks on each gas detector manufactured:

a) input and output functions, for example operation of displays, LEDs, alarms and push buttons;

b) sensitivity of the sensor;

c) software version.

In addition, the following checks should be performed on a sample basis:

1) response time;

2) linearity

3) response to other gases, if applicable;

4) long-term stability;

5) any other check that is considered necessary to confirm the measuring function complies with the relevant standards (for example, effects of temperature or humidity on sensors);

Where gas detectors utilize elements with non-measurable paths that are used as an integral part of a Type of Protection for example sinters, compliance should be verified in accordance with Annex B.

A.14 Ex h – Non-electrical Equipment covered by ISO 80079-36

A.14.1 General

The following safety aspects as specified in the schedule drawings should be realized by systematic production techniques and/or verifications and tests based on written procedures.

For protection concepts based on types of protection "d", "p" and "t", the safety aspects laid down in A.3, A.6 and A.11 may also apply.

A.14.2 Non-metallic parts

Non-metallic parts should be subject to verification that demonstrates conformity with the schedule drawings, for example:

a) material characteristics;

b) finish;

c) surface resistance;

d) surface area of non-conductive parts;

e) limitation of thickness;

f) measures for charge bonding (earthed frames).

A.14.3 Casing and external parts

Casing and external parts should be subject to verification that demonstrates conformity with the schedule drawings, for example:

a) material of the casing and content of light metals;

b) protection of removable parts against unintentional or inadvertent removal;

c) materials used for cementing including a visual inspection after curing.

A.14.4 Earthing and equipotential bonding of conductive parts

The following parts should be subject to verification that demonstrates conformity with the schedule drawings:

a) earthing terminal;

b) effective connection of conductive parts;

c) bonding cables.

A.14.5 Light transmitting parts

The following light transmitting parts should be subject to verification that demonstrates conformity with the schedule drawings, for example:

a) material;

b) integrity;

c) guards and protective covers.

A.14.6 Degree of protection (IP Code))

The following parts should be subject to verification that demonstrates conformity with the schedule drawings, for example:

a) weld continuity;

b) fitting of gaskets and seals;

c) continuity of moulded grooves and tongues;

d) after curing, an inspection should be done on each cemented part. Depending on the nature and repeatability of the cementing process and the cemented part, this could be for example use statistical techniques.

A.15 Non Electrical Equipment protected by constructional safety “c” covered by ISO 80079-37

A.15.1 General

Additional to the safety aspects for non-electrical equipment defined in A.14 the following safety aspects are relevant.

A.15.2 Metal-based material

The following parts should be subject to verification that demonstrates conformity with the schedule drawings, for example:

a) material name complies with the requirement;

b) material properties (composition with regard to corrosion, thermal conduction and mechanical sparks, mass fraction of aluminium, titanium, magnesium, zirconium, flammability);

c) cracks, inclusions, blow holes and porosity (either by a visual test or another suitable test method depending on exposure);

d) heat treatment, for example hardening, tempering;

e) dimensional accuracy including all parts without machining.

A.15.3 Machining

The following parts should be subject to verification that demonstrates conformity with the schedule drawings, for example:

a) compliance with tolerances for shape, position, concentricity, quality of finish;

b) dimensional accuracy of functional surfaces, for example tolerances for diameters; especially for indicator units pre-adjustment and correct polarity;

c) depth and configuration of cut-in to ensure the constructional intended stress concentration.

A.15.4 Cemented joints and potted assemblies

The following parts should be subject to verification that demonstrates conformity with the schedule drawings, for example:

a) shelf-life and storage of adhesives and casting compounds;

b) mixing procedure;

c) surface treatment (degreasing or equivalent measures are usually required immediately before the potting-process to ensure proper adhesion);

d) curing process, which should include: curing time, any relevant environmental factors and all provisions made to ensure that the curing process will proceed without disturbance;

e) after curing, 100 % visual inspection should be done on each potted assembly.

A.15.5 Assembling

The following parts should be subject to verification that demonstrates conformity with the schedule drawings, for example:

a) correct components and parts;

b) distances between moving parts or between fixed and moving parts;

c) equipotential bonding between subassemblies;

d) mechanical seals;

e) protective covers.

A.15.6 Routine tests

In addition to A.2, the following parts should be subject to verification that demonstrates conformity with the schedule drawings, for example:

a) sealing systems (fit, lubrication, initial tension, primary pressure);

b) dynamic vibrations, for example critical rotation speed, bearing at standstill or at transport;

c) functional test of the complete assembly (distance between rotor/stator modules, clamping, clearance, free room of motion).

A.15.7 Power transmission systems

The following parts should be subject to verification that demonstrates conformity with the schedule drawings, for example:

a) conditions of the lubrication;

b) belt tension;

c) equipotential bonding (especially couplings, belt drives, chain drives, gears, shafts).

A.16 Non-electrical equipment protected by control of ignition sources “b” covered by ISO 80079-37

A.16.1 General

Additional to the safety aspects for non-electrical equipment defined in A.14 the following safety aspects are relevant.

A.16.2 Ignition protection system

The following parts should be subject to verification that demonstrates conformity with the schedule drawings, for example:

a) selection of appropriate sensors, actuators and other relevant parts, for example temperature range;

b) indicating devices marked to indicate the maximum and minimum operating levels;

A.16.3 Assembling

The following parts should be subject to verification that demonstrates conformity with the schedule drawings, for example:

a) installation of sensors and actuators (fail safe characteristics, separate power supply);

b) connection installation of sensors;

c) position of sensors;

d) correct interfacing.

A.16.4 Routine verifications and tests

In addition to A.2, typically, the following routine verifications and tests should be done at the manufacturers’ site. If the ignition protection system is intended to be assembled during installation at the users’ site, the instructions should give specific guidance how to carry out these tests.

The following tests should be performed in order to demonstrate conformity with the schedule drawings, for example:

a) tests before initial operation or specification of these tests in the instructions;

b) functioning;

c) accuracy;

d) response behavior;

e) fail-safe;

f) interlocking of settings;

A.17 Non-electrical equipment protected by liquid immersion “k” covered by ISO 80079-37

A.17.1 General

Additional to the safety aspects for non-electrical equipment defined in A.14 the following safety aspects are relevant.

A.17.2 Protective liquid

The following features should be subject to verification that demonstrates conformity with the schedule drawings, for example:

a) type of liquid;

b) liquid level or flow rate or pressure (depending on the system).

A.17.3 Casing

The following items should be subject to verification that demonstrates conformity with the schedule drawings, for example:

a) leak tightness of the protective liquid closed loop;

b) protections against unintentional or inadvertent of fastenings;

c) measures against protective liquid impurity.

A.17.4 Measuring or indicating devices

The following features should be subject to verification that demonstrates conformity with the schedule drawings, for example:

a) dipstick;

b) marking of maximum/minimum criteria for the protective liquid level;

c) marking of maximum permissible angle of inclination.

A.18 Flame arresters covered by ISO/IEC 80079-49

Documented procedures should ensure that the following aspects are verified, if relevant:

a) gap width measurement on the enclosure, between cage and enclosure, on thread openings into the enclosure and between flame arrester and enclosure;

b) measurement of the triangle’s height, dimension or of the porosity of the flame arrester element;

c) pressure test of housing;

d) leak test of housing;

e) tests of welded joints;

f) flow measurement;

g) marking of the pipe connection facilities to be protected.

h) assurance of material properties;

i) determination of limits of use;

A.19 Equipment assemblies covered by IEC 60079-46

A.19.1 General

For items of the equipment assembly that are being produced by the assembly manufacturer, see the applicable section of this Annex related to the relevant Types of Protection.

A.19.2 Limited-scope restrictions

For items of the equipment assembly that are not being produced by the assembly manufacturer, the application of any restrictions limiting the scope of the quality assessment related to the Types of Protection should be verified. Examples of quality assessments that would involve limited-scope restrictions include

 a site that uses items of a given Type of Protection in manufacturing other equipment or assemblies, but that does not manufacture the items themselves, or

 a site that has no manufacturing, but does control other aspects of a given Type of Protection, such as the production, purchasing, supplier evaluation, incoming inspection, or other related functions.

A.19.3 Mounting and interconnection of items

The items of the equipment assembly should be verified as being electrically and mechanically installed in the assembly in accordance with schedule drawings. Examples of this include:

 Setting and functioning of protective devices and systems

 Securement and routing of interconnecting wiring systems

 Identification of equipment

 No obvious damage to items, including cables

 Mounting of non-electrical items aligned to avoid ignition sources

 Process equipment, such as piping, assembled to avoid leak sources

A.19.4 Routine verifications and tests

There is no additional guidance in addition to A.2.

A.19.5 Incorporation of Ex Equipment

It should be verified that any type of Ex Equipment is used within its specified Ex relevant parameters, for example ambient temperature range and equipment group.

The fulfilment of Specific Conditions of Use of any type of Ex Equipment should be verified in the context of the Equipment assembly.

Ex relevant parameters, for example torque values, and Specific Conditions of Use which have not been addressed should be relayed to the customer.

A.19.6 Competencies

When the schedule drawings allow for substitution of items used as part of the equipment assembly, verification that the documented process for training and competency should include item selection for all involved Types of Protection.

A.19.7 Design and production of equipment assemblies

Design and production of the equipment assembly should be verified as being in accordance with the applicable schedule drawings.

A.19.8 Ignition hazard assessment

Performance of an ignition hazard assessment on each equipment assembly design, and inclusion of this assessment in the documentation, should be verified. If there are any ignition hazards not mitigated in the equipment assembly, then compliance with the following should be verified

 the equipment assembly certificate number should include the "X" suffix in accordance with the marking requirements of IEC 60079-0 and the Specific Conditions of Use should be listed on the Ex Product certificate, and

 the documentation should provide guidance on the ignition hazards that could not be mitigated in the equipment assembly, and provide guidance on the mitigation measures to be implemented by the user.

Annex B
(informative)

Verification criteria for elements with non-measurable paths used
as an integral part of a Type of Protection

B.1 Introduction

Sintered material is used in many products, such as gas detectors and loudspeakers.

When the Ex Product certificate involves such components, then the design parameters for the component normally covers three factors:

a) maximum bubble test pore size;

b) minimum density;

c) component construction:

– for sintered metal and metal foam: material, diameter and thickness,

– for pressed metal wire: material, wire diameter and mesh size, element thickness.

Therefore, the purpose of this annex is not to add any technical requirements but to provide manufacturers with guidance as to how they can demonstrate that the actual components comply with the design requirements as detailed in the Ex Product certificate.

B.2 Verification guidance

Three options are available:

a) the manufacturer conducts the verification examination and tests;

b) the manufacturer conducts a pre-contract and follow-up periodic documented assessment of the component external provider and accepts sinters with an external provider's declaration of conformity;

c) the manufacturer accepts sinters with an external provider's declaration of conformity from a component manufacturer, who has an acceptable quality management system with an appropriate scope.

NOTE See 8.4 for control of external providers

B.3 Tests

The tests for all verification options should be performed in accordance with the requirements of the Ex Product certificate. Typical test requirements are given in ISO 4003 and ISO 2738.

The test may be conducted on a statistical basis if the sample size is not less than 5 % of the batch size. A single failure in the 5 % sample should result in another 5 % being tested; if a failure is detected in the second sample all sinters in the batch should be 100 % tested. Where tests to determine the maximum bubble test pore size and density are conducted on a sample basis, then the results should be calculated to establish the standard deviation (σ) for the sample batch,

i.e. σ_p is the maximum bubble test pore size standard deviation;

σ_D is the density standard deviation.

The maximum bubble test pore size should not be exceeded and the minimum density should remain equal to or greater than the value as stated in the Ex Product certificate when 3 σ is considered. Therefore, the mean value of the sample batch, plus 3 σ_p (for pore size) and minus 3 σ_D (for density) should not invalidate the requirements of the Ex Product certificate.

B.4 Test examples

B.4.1 General

The following examples for sintered metal are provided for guidance:

B.4.2 Example 1 (pore size)

Maximum permitted bubble test pore size as detailed in the

– Ex Product certificate = 150 µm

– mean value = 140 µm

– standard deviation (σ_p) = 2 µm

Therefore, maximum value = 140 µm + (2 x 3) µm = 146 µm (PASS).

If standard deviation (σ_p) = 5 µm, then maximum value = 140 µm + (5 x 3) µm = 155 µm (FAIL).

B.4.3 Example 2 (density)

Minimum permitted density as detailed in the

– Ex Product certificate = 5 g/cm³

– mean value = 5,3 g/cm³

– standard deviation (σ_D) = 0,05 g/cm³

Therefore, minimum value = 5,3 g/cm³ – (0,05 x 3) g/cm³ = 5,15 g/cm³ (PASS).

If standard deviation (σ_D) = 0,12, then minimum value = 5,3 g/cm³ – (0,12 x 3) g/cm³ = 4,94 g/cm³ (FAIL).

NOTE In some cases, the sinter is formed directly in a solid housing.

To establish the density value, the following formula is used:

substitute as follows:

where

ρW is the density of water;

m₁ is the housing only, weight in air;

m₂ is the housing only, weight in water;

m₃ is the housing and sinter (assembly), weight in air;

m₄ is the coated assembly, weight in air;

m₅ is the coated assembly, weight in water.

B.5 Purchase information

The manufacturer should ensure that the purchase documents include the following:

1. the component material specification detailed in the schedule drawings;

2. the dimensional requirements;

3. the maximum bubble test pore size and the standard called up in the schedule drawings for example ISO 4003;

4. the minimum density and the standard called up in schedule drawings for example ISO 2738.

B.6 Pre-tested components

Where the manufacturer does not conduct their own tests, the external provider's declaration of conformity, and should also include the following:

1. the manufactured batch size;

2. the sample size taken to establish the maximum bubble test pore size and the minimum density;

3. the number of components supplied;

4. the calculated maximum bubble test pore size and minimum density, for example the mean values and standard deviation should be stated.

B.7 Measurement and monitoring

Upon receipt of the components, the manufacturer should:

1. check the external provider's declaration of conformity against the requirements of B.5;

2. check the compatibility of the purchase order requirements with the external provider's declaration of conformity (if not testing on site and giving special attention to the stated bubble test pore size and density data to ensure that when taking the stated tolerance into account the specification is not exceeded;

3. conduct the tests (if testing on site);

4. conduct a statistical check on the overall size of the component, for example diameter and thickness.

Annex C
(informative)

External provider's declaration of conformity

C.1 External provider's declaration of conformity

The manufacturer should ensure that externally provided processes, products and services do not adversely affect the manufacturer’s ability to consistently deliver conforming products and services to its customers. This may be accomplished by requesting an external provider's declaration of conformity” which is intended to assure the compliance of the externally provided processes, products and services.

As applicable, the external provider's declaration of conformity should contain the following elements:

a) unique identification of the external provider's declaration of conformity;

b) the name and contact address of the issuer of the external provider's declaration of conformity;

c) the identification of the object of the external provider's declaration of conformity and any linking information:

1) Product description or description of a process;

2) Serial numbers, batch or lot identification, or an alternate means of traceability;

3) Manufacturer’s drawing or document number with revision status;

4) External provider’s drawing or document number with revision status (if different from manufacturer’s drawing);

5) Provider's work order number, internal tracking reference, or batch number, if applicable;

6) Purchase order number;

7) Quantity of processes, products and services conforming to the declaration;

8) Reference to documentation from the external provider outlining in detail all critical process parameters for the manufacturing of the provided part(s). For example, for a casting process, the temperatures, pressures, heating/cooling times etc.);

9) A recapitulation of all special processes or inspections required by the purchasing documents.

d) a statement confirming that no part of the external provider's production process has been subcontracted to third parties without the written consent of the manufacturer;

e) a statement of conformity in the following format; We (issuer name) do declare that the information provided in this external provider's declaration of conformity” is accurate and confirm that the processes, products and services supplied by (issuer name) comply in all respects with the Purchase order requirements;

f) the date and place of issue of the external provider's declaration of conformity;

g) the signature name and function of the authorized person(s) acting on behalf of the issuer;

NOTE 1 Seals or digital signatures can be a method of validation.

h) any limitation on the validity of the external provider's declaration of conformity.

NOTE 2 This annex is based on ISO/IEC 17050-1.

C.2 Additional Supporting information

Additional supporting information can be provided to relate the external provider's declaration of conformity to the conformity assessment results on which it is based, for example:

a) the name and address of any conformity assessment body involved, for example testing or calibration laboratory, inspection body, certification body;

b) reference to relevant conformity assessment reports, and the date of the reports;

c) reference to any management systems involved;

d) reference to the accreditation documents of conformity assessment bodies involved where the scope of accreditation is relevant to the external provider's declaration of conformity;

e) reference to the existence of associated supporting documentation;

f) additional information regarding certificates, registrations or marks that have been obtained;

g) other activities or programs of the conformity assessment body, for example membership in an agreement group.

References in the documentation to conformity assessment results should not misrepresent their applicability nor mislead the recipient of the external provider's declaration of conformity.

C.3 Example of an external provider's declaration of conformity

1) Document No. .........................................

2) Issuer: ..............................................................................................................................
.............................................................................................................................................
(Name and full address)

3) Object of the declaration: ...................................................................................................
…………………………………………………………………………………………………………………..
..................................., quantity.............................serial or batch number..............................

4) Manufacturers purchase order: ……………………..……………, dated …………………………..

5) Issuers work order: …………………………………………………, dated …………………………..

6) Declaration:

We <issuer name> herewith declare that the information provided in this external provider's declaration of conformity is accurate and confirm that the processes, products and services supplied by <issuer name> are in conformity to the requirements stated in the following documents:

Document No. Title Edition/Date of issue

………………… ………………………………………….. …………………………

………………… ………………………………………….. …………………………

………………… ………………………………………….. …………………………

7) Subcontracting:

We confirm that no part of the production of the object described above has been subcontracted to third parties without the written consent of the manufacturer.

8) Limits of the validity of this declaration: ……….…………………………………….……..

9) Additional information: ………………………………………………………………………….

………………………………………………………………………….

10) Signed for and on behalf of:

(Name, function) (Signature or equivalent authorized by the issuer)

.................................................

…………………………………..

11) Place and date of issue

……………………………………

Annex D
(informative)

Guidance for the application of this document to the different types of organization

Table D.1 provides guidance for the application of this document to the different types of organization. The requirements of ISO 9001 apply in all cases.

Table D.1 – Applicability of this document

Annex E
(normative)

Type and control of externally provided products, processes and services

E.1 Types of products, processes or services

For the purpose of this Annex;

1) Custom parts are products, processes or services that are made to order to the organization’s specification and that can affect the Ex Product’s compliance with the Ex Product certificate and schedule drawings including those where the features affecting the Type of Protection cannot be verified at a later stage.

EXAMPLE 1 Housings, printed circuit board assemblies, machining of flamepaths or injection moulding and castings, transformers

EXAMPLE 2 Products, processes or services which cannot be verified at a later stage are encapsulated intrinsically safe circuits, or cemented joints.

2) Non-custom parts are products, processes or services that are not made to order to the organization’s specification but can affect the Ex Product’s compliance with the Ex Product certificate and schedule drawings.

EXAMPLE 3 Components with datasheets such as resistors, fuses, non-metallic materials, calibration services, O-rings or Ex Products

3) General parts are products, processes or services that do not affect the Ex Product’s compliance with the Ex Product certificate and schedule drawings.

E.2 External provider selection and evaluation

E.2.1 General

External providers shall be classified in accordance to Table E.1. The classification shall be documented.

Table E.1 – Minimum required external provider evaluation level

The evaluation of the external provider shall be documented and take into account the nature and criticality of the product, process or service and the nature and competence of the external provider, the scope of their quality management system and where applicable the extent and type of verification and evaluation of features affecting the Type of Protection.

The evaluation of external providers for calibration services shall additionally be evaluated on their ability to meet stated requirements as well as the requirements of 7.1.5.

E.2.2 Evaluation of external providers of level A

External providers with an evaluation level A have no additional requirements to 8.4 of ISO 9001:2015.

E.2.3 Evaluation of external providers of level B

External providers with an evaluation level B shall be accepted by one of the following methods:

1) the external provider has an acceptable Ex quality management system according to this document assessed by an accredited body,

2) the external provider has a quality management system certificate in accordance with an appropriate standard and with an acceptable scope issued by a body accredited for said standard and scope.

NOTE A certificate for an ISO 9001 quality management system is acceptable

E.2.4 Evaluation of external providers of level C

External providers with an evaluation level C shall be selected after an evaluation has provided evidence that they have the capability of ensuring Ex compliance with all specified requirements.

Documented objective evidence that the external provider can provide product, process or service that is fit for purpose shall be obtained by one or more of the following methods:

1) the external provider has an acceptable Ex quality management system according to this document assessed by an accredited body,

2) the external provider has a quality management system certificate in accordance with an appropriate standard issued by an accredited body with a scope deemed acceptable by the organization. The organization shall document the justification for acceptance.

NOTE 1 A quality management system of the external provider in accordance with ISO 9001 might not be sufficient.

EXAMPLE A certificate for an ISO 3834 quality management system for external providers of welding services.

3) a documented site assessment to ensure that all relevant controls are available, documented, understood and effective. The evaluation should take the following into account:

a) criticality of the product, process or service;

b) degree of difficulty, or variability in the manufacturing process;

c) location of the external provider and hence the effectiveness of communications;

d) subcontracting by the external provider of the product, process or service;

e) required training or specialist skill or knowledge to carry out a verification.

4) the body responsible for the assessment of the quality management system performs periodic audits at the external provider.

NOTE 2 The verification by the body responsible for the assessment of the quality management system is an alternative means of external provider evaluation

E.3 Ongoing evaluation of external providers

External providers with an evaluation level A have no additional ongoing evaluation requirements to 8.4 of ISO 9001:2015.

When evaluating the ongoing ability of active external providers of level B and C the following shall apply:

1) They shall be reviewed at intervals not exceeding 14 months to demonstrate ongoing suitability and effectiveness to provide products, processes and services conforming to the Ex Product certificate and schedule drawings. Where the review has not been performed the external provider shall be re-evaluated to E.2 or deemed inactive.

EXAMPLE Receiving inspection report analysis, desktop or onsite assessment of external provider, detailed sample inspection.

2) The body responsible for the assessment of the Ex quality management system may verify aspects of any external provider’s operation that affects the Type of Protection. The organization shall facilitate such an arrangement.

E.4 Verification of products, processes or services

For all purchased processes, products and services that can compromise the Type of Protection, the organization shall ensure that arrangements which demonstrate the verification of the Ex Product’s compliance with the Ex Product certificate and schedule drawings have been determined and implemented. This determination or implementation may be carried out by the organization or the external provider.

EXAMPLE 1 Inspection of incoming products or verification of correct receipt for datasheet components.

Where routine tests, inspections or other verifications required by the Ex Product certificate and schedule drawings are carried out by the external provider, an external provider’s declaration of conformity shall be supplied for each batch or product. Results of routine tests, inspections or other verifications shall be retained by the organization or external provider for a minimum of 10 years.

Where products, processes or services are supplied from an external provider with an evaluation level C, an external provider’s declaration of conformity covering the necessary aspects for Ex compliance shall be supplied for each batch or product.

Where products, processes or services are supplied with an external provider’s declaration of conformity confirming the verification that has occurred for each batch or product no further verification is required.

Where products, processes or services are an Ex Product, then no further verification is required.

Where the compliance of the Ex Product with its schedule drawings is relative to the material, an external provider’s declaration of conformity, or a specific material analysis certificate, shall address material specific requirements and shall be supplied for each batch or product of custom parts.

EXAMPLE 2 Material properties of concern are flammability, CTI, RTI, or UV resistance, chemical composition, physical properties

The organization shall have a documented process to verify that the external provider’s declaration of conformity or the specific material analysis certificate covers the necessary aspects for Ex compliance.

Bibliography

ISO/IEC 17021 (all parts),Conformity assessment – Requirements for bodies providing audit and certification of management systems

ISO/IEC 17050-1,Conformity assessment -- Supplier's declaration of conformity -- Part 1: General requirements

IEC 60079 (all parts), Explosive atmospheres

ISO/IEC 80079-34:2011, Explosive atmospheres - Part 34: Application of quality systems for equipment manufacture

ISO 80079-36, Explosive atmospheres - Part 36: Non-electrical equipment for explosive atmospheres - Basic method and requirements

ISO 80079-37, Explosive atmospheres – Part 37: Non-electrical equipment for explosive atmospheres – Non-electrical type of protection constructional safety "c”, control of ignition source “b”, liquid immersion “k”

ISO/IEC 80079-49, Explosive atmospheres - Part 49: Flame arresters - Performance requirements, test methods and limits for use

ISO 2859-1, Sampling procedures for inspection by attributes – Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection

ISO 2738,Sintered metal materials, excluding hardmetals – Permeable sintered metal materials – Determination of density, oil content and open porosity

ISO 3951-1,Sampling procedures for inspection by variables – Part 1: Specification for single sampling plans indexed by acceptance quality limit (AQL) for lot-by-lot inspection for a single quality characteristic and a single AQL

ISO 4003,Permeable sintered metal materials – Determination of bubble test pore size

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