IECEx OD 314-2
Edition 2.0

2018-10IECEx
OPERATIONAL DOCUMENT

IEC System for Certification to Standards relating to Equipment for use
in Explosive Atmospheres (IECEx System)
IECEx Certified Service Facilities Scheme –Part 2: Selection of Ex equipment and design of Ex installations

IECEx OD 314-2:2018(E)

Quality Management System requirements for IECEx Service Facilities providing
selection of Ex equipment and design of Ex installations related services

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IECEx OD 314-2
Edition 2.0

2018-10IECEx
OPERATIONAL DOCUMENT
IEC System for Certification to Standards relating to Equipment for use
in Explosive Atmospheres (IECEx System)
IECEx Certified Service Facilities Scheme –Part 2: Selection of Ex equipment and design of Ex installations
Quality Management System requirements for IECEx Service Facilities providing
selection of Ex equipment and design of Ex installations related services

INTERNATIONAL
ELECTROTECHNICALCOMMISSION

PRICE CODE

ZZ

–2–

IECEx OD 314-2 © IEC:2018(E)

CONTENTSCONTENTS ............................................................................................................................ 2
FOREWORD ........................................................................................................................... 3
INTRODUCTION ..................................................................................................................... 4
1

General ............................................................................................................................ 6

2

Definitions ........................................................................................................................ 6

3

Application ....................................................................................................................... 6
3.1

4

Documentation requirements ................................................................................... 7
General ....................................................................................................... 7
Records ....................................................................................................... 7
3.2 Management responsibility ...................................................................................... 7
3.3 Resource management ............................................................................................ 8
3.4 Product realization .................................................................................................. 8
3.5 Measurement, analysis and improvement ................................................................ 8
Planning ...................................................................................................... 8
Customer satisfaction .................................................................................. 9Internal audit ............................................................................................... 9
Monitoring and measurement of processes .................................................. 9
Monitoring and measurement of product ...................................................... 9
Analysis of data ......................................................................................... 10
Improvement ............................................................................................. 10
Corrective action ....................................................................................... 10
Preventive action ....................................................................................... 10
Preliminary requirements for ExCB assessment of Ex Service Facilities ......................... 10

5

Preliminary review (optional) .......................................................................................... 106

ExCB auditor expertise ................................................................................................... 10

7

On-site assessment ........................................................................................................ 10

8

Process assessment by ExCBs ...................................................................................... 10
8.1
8.2
8.3
8.4
8.5

Compliance with IEC 60079-14 .............................................................................. 11
Use of subcontractors ........................................................................................... 11
Assessment of competence for operatives and responsible persons ...................... 11
Records ................................................................................................................ 12
Conditions for selection of Ex equipment and design of Ex installations
completion ............................................................................................................. 12
Annex A Selection of Ex equipment or design of Ex installations service report issued
by Ex Service Facilities .................................................................................................. 13
A.1
A.2

General ................................................................................................................. 13
Content of selection of Ex equipment or design of Ex installations service
provision report form ............................................................................................. 13

IECEx OD 314-2 © IEC:2018(E)–3–INTERNATIONAL ELECTROTECHNICAL COMMISSION____________
IECEx Operational Document OD 314-2
IECEx Certified Service Facilities Scheme –Part 2: Selection of Ex equipment and design of Ex installations
Quality Management System requirements for
IECEx Service Facilities providing selection of Ex equipment anddesign of Ex installations related services
FOREWORD
This Operational Document IECEx OD 314-2 - Quality Management System requirements for
the Certified Service Facilities Scheme – Part 2: Selection of Ex equipment and design of Ex
installations (“IECEx 03-2 Scheme) specifies a mechanism for organizations that provide
selection of Ex equipment and design of Ex installations related services meeting therequirements of IEC 60079-14 the ability to obtain IECEx Certification under the IECEx System.
A listing of currently approved ExCBs is maintained on the IECEx website: www.iecex.com.
Document History
Date

Summary

2013-03

This original issue Edition 1.0 of IECEx OD 314-2 supersedes
IECEx OD 014 Version 2.0 in part and represents the application of a newnumbering system.

2018-10

This Edition 2.0 was approved for publication by the 2018 ExMC Meeting
via ExMC Decision 2018/52 and supersedes Edition 1.0 of IECEx OD 3142 upon publication

Address:
IECEx Secretariat
Australia Square
Level 33, 264 George Street
Sydney NSW 2000
Australia
Contact Details:
Tel: +61 2 4628 4690
E-mail: chris.agius@iecex.com
http://www.iecex.com

–4–

IECEx OD 314-2 © IEC:2018(E)

INTRODUCTION
This Operational Document is supplementary to the Operational manuals and procedures
operated by IECEx Certification Bodies (ExCBs), approved by the IECEx Management
Committee to issue IECEx Certificates of Conformity to Ex Service Facilities providing selectionof Ex equipment and design of Ex installation services, according to IEC 60079-14.
The IECEx Certified Service Facilities Scheme is modelled on the IECEx Certificate ofConformity Scheme, which is an ISO Type 5 Certification System.
The purpose of this Operational Document is to ensure that each ExCB, accepted by ExMC for
the purposes of issuing IECEx Certified Service Facility Certificates, processes applications
from Ex equipment selection and Ex installations design Service Facilities with the same
approach and technical or management requirements, known as certifying the IECEx way.
For selection of Ex equipment and design of Ex installations, a certified Ex Service Facility
should be capable of selecting equipment and designing an installation of any Ex type ofprotection. Ex competent personnel for a particular type of protection may need to be engaged
for a particular application where such personnel are not permanently employed by the service
facility .
The preparation of this IECEx Operational Document has been done so with the aim ofalignment with various ISO or IEC International Standards, ISO Guides, and IECEx Rules ofProcedures, including but not limited to the following:
NOTE Although this IECEx Operational Document makes reference to IEC 60079-14 and IEC 60079-17, it is also
relevant in determining ability to work with other international, national or regional requirements of a similar nature,such as IEC 61892-7 - Mobile and fixed offshore units – electrical installations – Part 7: Hazardous areas.

IECEx 03-0, IECEx Certified Service Facilities Scheme – Part 0: General Rules of Procedure
IECEx 03-2, IECEx Certified Service Facilities Scheme – Part 2: Selection of Ex equipment anddesign of Ex installations – Rules of Procedure
IEC 60079-14, Explosive atmospheres – Part 14: Electrical installations design, selection anderection
IEC 60079 Series as relevant or as referenced from IEC 60079-14, for example IEC 60079 –Parts 10-1, 10-2, 13, 19, 26, 28, 29-1, 29-4, 30-1, 30-2, 32-1, 43 or 46
ISO/IEC 17000, Conformity assessment – Vocabulary and general principles
ISO/IEC 17011, Conformity assessment – General requirements for accreditation bodies
accrediting conformity assessment bodies
ISO/IEC 17020, Conformity assessment – Requirements for the operation of various types ofbodies performing inspection
ISO/IEC 17021-1, Conformity assessment – Requirements for bodies providing audit andcertification of management systems – Part 1: Requirements
ISO/IEC 17065, Conformity assessment – Requirements for bodies certifying products,
processes and services
ISO 19011, Guidelines for auditing management systems
ISO Guide 27, Guidelines for corrective action to be taken by a certification body in the eventof misuse of its mark of conformity
ISO Guide 28, Conformity assessment – Guidance on a third-party certification system forproducts

IECEx OD 314-2 © IEC:2018(E)–5–ISO/IEC Guide 53, Conformity assessment – Guidance on the use of an organization's quality
management system in product certification
This IECEx OD 314-2 often refers to IECEx OD 025, Guidelines on the management ofassessment and surveillance programs for the assessment of manufacturer’s quality system, in
accordance with the IECEx Scheme.
Although this Scheme relates to Service Facilities, many of the elements of IECEx OD 025 areapplicable, as such this Operational Document is applicable at a number of steps in thisprocedure.

–6–

IECEx OD 314-2 © IEC:2018(E)

Quality Management System requirements for
IECEx Service Facilities providing selection of Ex equipment anddesign of Ex installations services
1

GeneralThis Operational Document sets out the Quality Management System (QMS) requirements thatan Ex Service Facility shall conform to in order to gain and maintain IECEx Certification as an
IECEx Certified Service Facility, involved in selection of Ex equipment and design of Ex
installations.
It also sets out the requirements for IECEx Certification Bodies (ExCBs), approved by the IECEx
Management Committee to issue IECEx Certificates of Conformity to Service Facilities
concerning the assessment of Service Facilities for their compliance to these requirements.
These requirements also form the basis of surveillance of IECEx Certified Service Facilities by
ExCBs.
While certification of the Quality Management System (QMS) to relevant standards is not arequirement of the IECEx Scheme, a Service Facility with a QMS may find it benefits in assistingthem to meet the requirements of this Operational Document.
In using ISO 9001 as the basis for this Operational Document, the following requirements
replace, add to or are more specific than those required by ISO 9001. The clause referencesused in this Operational Document have been adopted from ISO 9001:2008.
NOTE Requirements set forth in ISO 9001:2015 and ISO/IEC 80079-34 are under consideration by IECEx ExMC andExSFC.

2

Definitions

2.1
Ex Service facility
see IECEx 03-2
NOTE 1 Ex Service Facility is a term used by IECEx and in the context of this IECEx OD 314-2 shall apply to anorganization that carries out or controls selection of Ex equipment or design of Ex installations, according to IEC
60079-14.
NOTE 2 An Ex Service Facility may have restrictions on the type of Ex equipment, Ex types of protection, ratingsand size which will be covered by their limitation of scope.

2.2
Ex equipment
see IECEx 02

3

Application

This IECEx Operational Document shall be applied by ExCBs, approved by the IECEx
Management Committee to issue IECEx Service Facility Certificates.
The Quality Management System (QMS) requirements below are based on the relevant
requirements of ISO 9001 as amended or added to.

IECEx OD 314-2 © IEC:2018(E)–7–

ExCBs shall manage their quality management system auditing, for the IECEx Certified Service
Facility Program using IECEx OD 025 as a basis, which covers:•

Audit planning•

Auditor competence•

Duration for surveillance audits•

Audit reporting•

OthersOn-going certification maintenance by the ExCB issuing the IECEx Service Facility Certificate
shall consist of the following:a) Annual surveillance: On-site surveillance audits at the location(s) where the Certified Ex
Service Facility manages their service activities shall be conducted at not more than
12 monthly intervals, for which a FAR shall be issued in accordance with IECEx OD 313-2;andb) Re-assessment: Conducted as part of every third annual surveillance audit and shall
include the full review of a Service Facility’s documented procedures.
3.1
3.1.1

Documentation requirements
GeneralThe Ex Service Facility shall develop a process plan to establish verification of the selection of
Ex equipment and design of Ex installations processes to the requirements of IEC 60079-14,
other relevant parts of the 60079 series. E.g. 60079-13 and 60079-43 and other relevant
standards which may not be part of the IEC 60079 series as applicable to the design e.g.
lightning protection and electromagnetic radiation.
All selection of Ex equipment and design of Ex installations performed by the Ex Service Facility
require documented procedures and or work instructions and shall be defined in their scope of
IECEx Certified Service Facility Certification.
During the surveillance audits, ExCBs are required to assess identified changes.
NOTE

3.1.2

National regulations may require certain records to be kept for a minimum period from the date of delivery.

Records

The following requirements are additional to those of ISO 9001, Clause 4.2.4:
Records must be kept of Ex equipment that is selected and Ex installations that are designedin accordance with the requirements of this IECEx OD 314-2 and IEC 60079-14.
Also, records must be kept of Ex equipment that is selected and Ex installations that aredesigned, even after being selected or designed, do not comply with the requirements of thisIECEx OD 314-2 and IEC 60079-14.
As a minimum, records shall be kept for 10 years.
3.2

Management responsibility

The following requirements are additional to those of ISO 9001, Clause 5:
The senior management shall establish a mechanism to ensure that there is at least one person
appointed to deputize when necessary for the management representative in matters relating
to the scope of work covered by the IECEx Certificate of Conformity for the Ex Service Facility.

–8–

IECEx OD 314-2 © IEC:2018(E)The responsibilities and authorities of the management representative and any deputies shallbe documented. The ExCB shall be notified of any changes to the personnel appointed as the
Responsible Person, according to IEC 60079-14.
NOTE: The term “Management Representative” in ISO 9001 is equivalent to the term “Responsible Person” inIEC 60079-14.

3.3

Resource management

The following requirements are additional to those of ISO 9001, Clause 6:
The Ex Service Facility shall provide for training of all personnel performing activities affecting
the selection of Ex equipment and design of Ex installations process. Ex competent persons
performing assigned tasks shall be qualified on the basis of appropriate education, training orexperience, as defined in IEC 60079-14. Appropriate training and continuing education records
shall be maintained.
Ex Competent Persons, including responsible persons and operatives (designers), shallmaintain their competence, with ExCBs required to verify the currency of the competence of Ex
competent persons as part of the on-going surveillance of the Ex Service Facility.
The Ex Service Facility shall establish and maintain a Competence Management System that
includes the evaluation of personnel for compliance with the requirements of IEC 60079-14 forresponsible persons and operatives. The Competence Management System shall cover thescope of work undertaken by the Ex Service Facility and geographic application relating to enduser sites.
NOTE 1 Attention is drawn to the requirements that may be applicable relating to different geographic locations anddifferent external influences.
NOTE 2 Evidence of competence can be provided by having personnel certified to the applicable Unit ofCompetency Ex 009 (Design electrical installations in or associated with explosive atmospheres) of Operational
Document IECEx OD 504 (Specification for Units of Competence Assessment Outcomes).

3.4

Product realization

The following requirements are additional to those of ISO 9001, Clause 7:
The Ex Service Facility shall establish specific procedures or work instructions for selection of
Ex equipment and design of Ex installations. These procedures or work instructions shallconsider each process covered under the scope of the IECEx Service Facility Certificate to therequirements of IEC 60079-14 in accordance with the parameters listed below:•

Type of Ex service offered;•

Verification of designs;•

Details and evidence of Ex competence for responsible persons and operatives, nominatedas Ex Competent Persons;•Details and evidence of other operatives or specialists required to contribute to the design.
E.g lightning protection, earthing, corrosion or materials specialists; and.

•Sub-contractor activities, if any.

3.5

Measurement, analysis and improvement

The following requirements are additional to those of ISO 9001, Clause 8.
3.5.1

Planning

Clause 8.1 of ISO 9001 applies with the following exceptions:IECEx OD 314-2 © IEC:2018(E)–9–Improvements are not within the scope of this IECEx OD 314-2 Operational Document. They
may be made at the discretion of the Ex Service Facility, but the provisions of 3.2 shall apply
at all times.
3.5.2

Customer satisfaction

Clause 8.2.1 of ISO 9001 is replaced by the following requirement:
For the purpose of this Operational Document, ‘customer satisfaction’ is in relation to the Ex
Service Facilities compliance with the relevant requirements of IEC 60079-14. However
additional measures of customer satisfaction according to ISO 9001 are encouraged.
3.5.3

Internal audit

Clause 8.2.2 of ISO 9001 and the following applies:
The audit program shall address the effectiveness of the elements of the Quality Management
System (QMS) as described in this document to ensure that the selection of Ex equipment anddesign of Ex installations processes are in accordance with IEC 60079-14. The period between
audits should normally not exceed 12 months.
3.5.4

Monitoring and measurement of processes

Clause 8.2.3 of ISO 9001 applies.
Where a selection of Ex equipment or design of Ex installations process can affect the integrity,
safety or functionality of an Ex type of protection or an Ex equipment, that specific process shallbe measured or monitored and documentary evidence shall be maintained to demonstratecompliance with required parameters.
3.5.5

Monitoring and measurement of product

The following requirement is additional to those of ISO 9001, Clause 8.2.4:
Where tests are required, they shall be performed as specified in IEC 60079-14 with nosampling techniques being permitted, according to IEC 60079-14 provisions and requirements.
The Ex Service Facility shall have an established process for verification of design which is
independent of the personnel who carried out the design. Control of non-conforming product
The following requirements are additional to those of ISO 9001, Clause 8.3:
The Ex Service Facility shall take action, appropriate to the degree of significance, associatedwith selection of Ex equipment or design of Ex installations, which has been found following Ex
installation or Ex initial inspection to be non-conforming.
For all non-conforming selection of Ex equipment or design of Ex installations, the Ex Service
Facility shall maintain records of:•

Identification of the selection of Ex equipment or Ex installation design;•

The customer who received the Ex installation design;•

The action taken to inform the organization responsible for the selection of Ex equipment or
Ex installation design;•

The action taken to implement corrective and preventative action;•

Actions and communications taken with a relevant regulator (whenever applicable).

– 10 –
3.5.6

IECEx OD 314-2 © IEC:2018(E)Analysis of data

Clause 8.4 of ISO 9001 applies.
3.5.7

Improvement

Clause 8.5.1 of ISO 9001 applies.
3.5.8

Corrective action

Clause 8.5.2 of ISO 9001 applies.
3.5.9

Preventive action

Clause 8.5.3 of ISO 9001 applies.

4

Preliminary requirements for ExCB assessment of Ex Service Facilities

As a pre-requisite, it shall be established that the Ex Service Facility satisfies the requirementsof IEC 60079-14 in terms of adequate facilities, equipment and competent personnel to performthe scope of work to be covered by the IECEx Certified Service Facility Certificate.

5Preliminary review (optional)

Prior to an on-site assessment, at the location(s) where the Certified Ex Service Facility
manages their service activities, a preliminary review may be conducted by the ExCB, where
requested by the Applicant Service Facility. This preliminary review may also serve as a “gapanalysis”. Such activity is usually conducted on a fee for service basis.

6

ExCB auditor expertise

The ExCB’s audit of the location(s) where the Certified Ex Service Facility manages their service
activities shall be performed by person or persons that have an expertise comparable to thescope of application of the Ex Service Facility, including Quality Management Systems (QMS).

7

On-site assessment

The on-site assessment at the location(s) where the Certified Ex Service Facility manages theirservice activities will be conducted by an ExCB to verify compliance with IEC 60079-14 and the
IECEx Scheme requirements, e.g. this IECEx OD 314-2.
In addition to the general requirements of the IECEx Scheme, the IECEx Service Facility
Certificate will be issued subject to the conditions specified on the rules governing this Scheme
and based on satisfactory assessment by the ExCB.
Refer to Operational Document IECEx OD 313-2 for further details.

8

Process assessment by ExCBs

This Section identifies the critical areas that ExCBs shall have included in the assessment andsurveillance of Ex Service Facilities seeking to obtain and maintain IECEx Service Facility
Certification.

IECEx OD 314-2 © IEC:2018(E)8.1– 11 –

Compliance with IEC 60079-14

ExCBs shall assess the Ex Service Facility’s procedures and processes for compliance to beable to meet the relevant requirements to the IEC 60079-14.
This shall include assessment of the Ex Service Facility’s selection of Ex equipment or designof Ex installations plans and work procedures for compliance with IEC 60079-14 and verificationthat such selection of Ex equipment or design of Ex installations plans and work procedures
clearly define the method for verification and for pass/fail and acceptance criteria.
8.2

Use of subcontractors

ExCBs shall assess the method of control the Ex Service Facility maintains over any
subcontractor used to perform part of the selection of Ex equipment or design of Ex installations
process, including testing and calibration activities.
The Ex Service Facility agrees to arrange for the ExCB to evaluate relevant documentation andto arrange a visit to any subcontractor that the ExCB deems warranted. Subcontractors
conducting operations that have the potential to impact on compliance with IEC 60079-14 shallbe subject to audit by the ExCB.
Subcontracting by Ex Service Facilities shall be clearly defined in agreements between the
ExCB and the Service Facility and the ExCB and the Subcontractor or, by delegation of the
ExCB, directly between the Ex Service Facility and the Subcontractor.
The scope of activity is an integral part of such agreements as well as evidence of competenceof the Subcontractor (e.g. certificates, initial and annual audits by the ExCB). The overall
responsibility remains in any case with the ExCB which certified the Service Facility.
Agreements mentioned above shall be registered by the IECEx secretariat.
Subcontracting activities shall be used on a limited basis, mainly in cases where theinvestments for such activities are rather high and volume for such work at the Ex Service
Facility rather low.
Subcontracting activities related to the main scope of selection of Ex equipment and design of
Ex installations, indicated in the IECEx Certificate, is not allowed.
8.3

Assessment of competence for operatives and responsible persons

The ExCB shall evaluate the Ex Service Facility’s mechanism for verification of current
competence of the ExSF nominated Ex Competent Persons, including the responsible person
and operatives. Responsible persons and operatives and shall satisfy the competence
requirements of IEC 60079-14.
For Ex Competent Persons having a Certificate of Personnel Competencies (CoPC) according
to IECEx OD 504, Unit of Competence Ex 009 (Design electrical installations in or associatedwith explosive atmospheres), or having any other evidence of appropriate assessment anddemonstration of Competencies based on IEC 60079-14, the ExCB shall verify that the certified
or assessed scope of Ex activities covers the actual activities within the Ex Service Facility.
Those qualifying as Ex Competent Persons shall be identified in the Ex Service Facility’s
documented system, along with their scope of activity.
An Ex Service facility certificate remains valid only while the Competent Persons listed in thefacility’s documented system, operating as the “Responsible Person” remains engaged in theactivity.

– 12 –

IECEx OD 314-2 © IEC:2018(E)Any change that may impact on the Ex Service Facility complying with IECEx Scheme
requirements, e.g. change of “Personnel” is required to be notified to the ExCB immediately.
It should be noted that the status of an Ex Competent Person is directly linked to the Ex Service
Facility and is therefore not transferable between service facilities without assessment by an
ExCB.
Replacement of Ex operatives or responsible Competent Person(s) shall have the evidence of
their Ex competence verified by the ExCB.
8.4

Records

Results of the selection of Ex equipment or design of Ex installations conducted by the Ex
Service Facility shall be recorded by use of appropriate means that ensure:•

Legibility;•

Traceability of verification; and•Stored to enable retrieval in accordance with 3.1.2 above.

8.5

Conditions for selection of Ex equipment and design of Ex installations completion

Ex Service Facilities processes and procedures shall comply with the following, concerning
selection of Ex equipment and design of Ex installations completion.
Selection of Ex equipment and design of Ex installations shall be considered complete once acomplying selection of Ex equipment and design of Ex installations report is issued to show
conformance with IEC 60079-14 by the Responsible Person of the Ex Service Facility.
___________

IECEx OD 314-2 © IEC:2018(E)– 13 –

Annex A
Selection of Ex equipment or design of Ex installations service reportissued by Ex Service Facilities
A.1

GeneralThis Annex A specifies the minimum content of an Ex Service Report to be prepared, recorded
and retained in accordance with their QMS procedures by an organisation certified under the
IECEx 03-2 Scheme to provide selection of Ex equipment or design of Ex installations services
according to the requirements of IEC 60079-14 and the organisations accepted Scope.
This Ex Service Report shall be prepared following the provision of all Ex services relevant to
the organisation’s operation as an IECEx Certified Service Facility.
Selection of Ex equipment or design of Ex installations service reports shall be reported taking
into account aspects related to Ex equipment, Ex installation and environment (external
influences), as required by IEC 60079-14.
A copy of the Ex Service Report, which may be an electronic copy, shall be provided to andapproved by the management of the site, system, installation or equipment receiving the Ex
service provided.

A.2

Content of selection of Ex equipment or design of Ex installations service
provision report form

The Ex Service Report shall contain all relevant details of at least the following content
elements:•

Name of IECEx Certified Service Facility Organisation;•

The identifier of the IECEx Certificate held by this organisation as an IECEx Certified
Service Facility;•

Name and contact details of personnel from the IECEx certified selection of Ex equipment
or design of Ex installations Service Facility that provided the services;•

The name and address of the recipient of the Ex service provided;•

The date that the selection of Ex equipment or design of Ex installations service wasprovided;•

Ex Report reference number, to be traced in the user verification dossier;•Reference to IEC 60079-14 for selection of Ex equipment or design of Ex installations
services;•

A brief description of the site, system, Ex equipment or Ex assembly applicable to theselection of Ex equipment or design of Ex installations service provided;•

Copies of photographs, measurements and any other relevant artefacts regarding theselection of Ex equipment or design of Ex installations services provided; and•List and description of any findings, resolutions, actions taken or actions required related
to selection of Ex equipment or design of Ex installations services provided, signed by Ex
Service Facility Responsible Person, approved and signed by the Ex installation user or
responsible person.