Explosive Atmospheres

EXPLOSIVE ATMOSPHERES –

Application of quality systems

for equipment manufacture

1 Scope

This part of ISO/IEC 80079 specifies particular requirements and information for establishing

and maintaining a quality system to manufacture Ex equipment including protective systems

in accordance with the Ex certificate.

It does not preclude the use of other quality systems that are compatible with the objectives of

ISO 9001:2008 and which provide equivalent results.

2 Normative references

The following referenced documents are indispensable for the application of this document.

For dated references, only the edition cited applies. For undated references, the latest edition

of the referenced document (including any amendments) applies.

IEC 60050-426, International Electrotechnical Vocabulary – Part 426: Equipment for explosive

atmospheres

IEC 60079-0, Explosive atmospheres – Part 0: Equipment – General requirements

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

General requirements

ISO 9000:2005, Quality management systems – Fundamentals and vocabulary

ISO 9001:2008, Quality management systems – Requirements

3 Terms and definitions

For the purposes of this document, the terms and definitions given in IEC 60050-426,

IEC 60079-0 and ISO 9000:2005, as well as the following definitions, apply.

3.1

Ex component

part of Ex equipment or a module (other than an Ex cable gland), marked with the symbol “U”,

which is not intended to be used alone and requires additional consideration when

incorporated into Ex equipment or systems for use in explosive atmospheres

NOTE This definition is identical to that of IEC 60079-0, except that the term “electrical” has been replaced by

“Ex” to allow a broader application of the definition.

3.2

Ex equipment

machines, apparatus, fixed or mobile devices, control components and instrumentation

thereof and detection or prevention systems which, separately or jointly, are intended for the

generation, transfer, storage, measurement, control and conversion of energy for the

processing of material and which are capable of causing an explosion through their own

potential sources of ignition

– 8 – 80079-34/FDIS IEC

NOTE This definition includes “equipment” as defined by IEC 60079-0.

3.3

Ex certificate

document that assures the conformity of a product with specified requirements for explosive

atmospheres

NOTE 1 The certificate may be either the supplier’s declaration of conformity or the purchaser’s recognition of

conformity or certification (as a result of action by a third party) as defined in the ISO/IEC 17000 series.

NOTE 2 This is equivalent to the term “certificate” as defined by IEC 60079-0.

3.4

manufacturer

organization, situated at a stated location or locations, that carries out or controls such stages

in the manufacture, assessment, handling and storage of a product that enables it to accept

responsibility for continued compliance of the product with the relevant requirements and

undertakes all obligations in that connection

NOTE The term "manufacturer" is used instead of "organization" as used in ISO 9001:2008. For the purposes of

this standard they are interchangeable.

3.5

contract

requirements forming an agreement between a manufacturer and a customer and transmitted

by any appropriate means

3.6

customer complaint

reported written or verbal allegation made by a customer which concerns the identity, quality,

durability, safety, security, conformity or performance of any equipment or protective system

or component as defined in the Ex certificate

3.7

product

Ex equipment, protective systems, safety devices, Ex components and their combinations, as

well as software and service as defined in 3.4.2 of ISO 9000:2005

3.8

protective systems

design units which are intended to halt incipient explosions immediately and/or to limit the

effective range of explosion flames and explosion pressures

NOTE Protective systems may be integrated into equipment or separately placed on the market for use as

autonomous systems.

3.9

safety devices

devices intended for use inside or outside explosive atmospheres but required for or

contributing to the safe functioning of equipment and protective systems with respect to the

risks of explosion

3.10

schedule drawing

drawing or document listed in the Ex certificate and/or test report

3.11

related drawing

drawing or document not listed in the Ex certificate but linked to the schedule drawing, and

used for example, for detailed manufacture of component parts

80079-34/FDIS IEC – 9 –

3.12

technical documentation

documentation that enables the conformity of the product with the requirements of the

standard(s) to be assessed

NOTE 1 This may include schedule drawings when a certification body is involved.

NOTE 2 It covers the design, manufacture and operation of the product and contain:

– a general description;

– design and manufacturing drawings and layouts of components, sub-assemblies, circuits, etc.;

– descriptions and explanations necessary for the understanding of drawings and layouts and the operation of

the product;

– a list of the standards referred to in the Ex certificate, applied in full or in part, and descriptions of the

solutions adopted to meet the requirements of the Standards;

– results of design calculations made, examinations carried out, etc.;

– test reports.

3.13

manufacturer’s documentation

documents required by a manufacturer but not subject to assessment by body responsible for

verification when making an application for a test report or an Ex certificate

EXAMPLE Manufacturing instructions, related drawings, data sheets and sales literature.

3.14

type of protection

specific measures applied to Ex equipment to avoid ignition of a surrounding explosive

atmosphere

NOTE This definition is identical to that of IEC 60079-0, except that the term “electrical” has been replaced by

“Ex’ to allow a broader application of the definition.

3.15

body responsible for verification

body which conducts documentation review and periodical audit as appropriate

NOTE The body may be either a manufacturer, purchaser, third party or a certification body.

4 Quality management system

4.1 General requirements

Subclause 4.1 of ISO 9001:2008 applies, with the following addition:

The quality system shall ensure that the product conforms to the type described in the Ex

certificate and the technical documentation.

4.2 Documentation requirements

4.2.1 General

Subclause 4.2.1 of ISO 9001:2008 applies.

4.2.2 Quality manual

Subclause 4.2.2 of ISO 9001:2008 applies.

4.2.3 Control of documents

Subclause 4.2.3 of ISO 9001:2008 applies, with the following addition:

– 10 – 80079-34/FDIS IEC

a) technical documentation and manufacturer’s documentation shall be controlled,

b) documented procedures shall ensure that information contained within manufacturer’s

documentations is compatible with the technical documentation. The manufacturer shall

not initially approve or subsequently amend related drawings unless they are in

compliance with the schedule drawings,

c) the quality system shall ensure that no factor (type, characteristic, position etc.) defined

within the Ex certificate and technical documentation (e.g. schedule drawings) is modified,

d) there shall be a documented system that refers all related drawings to the relevant

schedule drawings,

e) where there are common schedule drawings associated with more than one Ex certificate,

there shall be a documented system to ensure simultaneous supplementary action in the

event of an amendment to such drawings,

NOTE 1 Some manufacturers use common components with common drawing numbers on more than one

product. Some of these products may have different persons responsible for them. Therefore, if one product with a

common component and drawing number is revised to meet a need, and if the necessary supplementary certificate

is obtained, there needs to be a system for ensuring that any other certificates that call up such components are

also subject to supplementary certification. This is in order to avoid such products not being in compliance with

their technical documentation. The system should identify the component drawing version, and this version

shouldn’t be modified by anybody other than the person(s) responsible for the equipment.

f) where a manufacturer also has drawings for equipment not intended for use in explosive

atmospheres, the manufacturer shall have a system that enables both the related

drawings and schedule drawings to be clearly identified,

NOTE 2 The following examples indicate some methods of achieving this:

the use of visual markers;

the use of a unique series of drawing numbers, e.g. all drawings concerning a certified equipment have an Ex

prefix to the drawing number.

g) the manufacturer shall document who is responsible for the quality system of each Ex

certificate.

NOTE 3 In some certification schemes, the body responsible for the quality system associated with each Ex

certificate may be different from the body that issued the Ex certificate and therefore needs to be clearly identified.

h) where technical documentation or manufacturer’s documentation are passed to a third

party, they shall be provided in a way that is not misleading,

i) the manufacturer shall have a documented process to annually check the validity of all Ex

related certificates, standards, regulations and other external specifications.

4.2.4 Control of records

Subclause 4.2.4 of ISO 9001:2008 applies, with the following addition:

The manufacturer shall retain adequate quality records to demonstrate conformity of the

product and satisfy national regulation and legislation.

NOTE In the absence of specific national regulations and legislation, it is suggested that a minimum of 10 years

period be applied.

As a minimum, the list of documents requiring control and retention, as far as applicable, shall

be:

– those arising from regulatory requirements;

– customer order;

– contract review;

– training records;

– inspection and test data (per batch);

– calibration data;

– sub-contractor evaluation;

80079-34/FDIS IEC – 11 –

– delivery data (customer, delivery date and quantity, including serial numbers where

available).

5 Management responsibility

5.1 Management commitment

Subclause 5.1 of ISO 9001:2008 applies.

5.2 Customer focus

Subclause 5.2 of ISO 9001:2008 applies.

5.3 Quality policy

Subclause 5.3 of ISO 9001:2008 applies.

5.4 Planning

5.4.1 Quality objectives

Subclause 5.4.1 of ISO 9001:2008 applies.

5.4.2 Quality management system planning

Subclause 5.4.2 of ISO 9001:2008 applies, with the following addition:

All the elements, requirements and provisions adopted by the manufacturer in order to ensure

compliance of the product with its Ex certificate and technical documentation shall be

documented in a systematic and orderly manner in the form of written policies, procedures

and instructions. The quality system documentation shall permit a consistent interpretation of

quality programs, plans, manuals and records.

5.5 Responsibility, authority and communication

5.5.1 Responsibility and authority

Subclause 5.5.1 of ISO 9001:2008 applies, with the following addition:

Responsibilities and authority for the following shall be defined:

a) the effective coordination of activities with respect to equipment intended for use in

explosive atmospheres;

b) the liaison with the issuer of the Ex certificate (when not issued by the manufacturer) with

respect to any proposed change to the design defined in the Ex certificate and the

technical documentation;

c) the liaison with the body responsible for the verification of the quality system with respect

to intended updating of the quality system;

NOTE 1 It is not practicable for the manufacturer to inform the body responsible for the verification of the quality

system each time the quality system is updated. It is only practicable to inform them of "substantial" updating of the

quality system relevant to the type of protection. Similarly, it is not practicable to specify in general terms what

types of updating are or are not "substantial". It is therefore recommended that the manufacturer should inform the

body responsible for the verification of the quality system on any update of the quality system having

consequences on product compliance.

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

e) the authorization of concessions (see 8.3 j));

f) the customers’ information of any applicable specific conditions of use and any schedules

of limitations;

– 12 – 80079-34/FDIS IEC

NOTE 2 Certificate numbers with a suffix X contain specific conditions of use. Component certificates numbers,

with a suffix U may contain schedules of limitations.

NOTE 3 For each Ex certificate, it is recommended that an authorized person(s) is (are) appointed who should

have responsibility and authority for the above activities so providing an unambiguous focal point within the

manufacturer.

g) the reviewing of Ex certificate and technical documentation and identifying any changes

that effect product compliance with the certificate.

5.5.2 Management representative

Subclause 5.5.2 of ISO 9001:2008 applies.

5.5.3 Internal communication

Subclause 5.5.3 of ISO 9001:2008 applies.

5.6 Management review

5.6.1 General

Subclause 5.6.1 of ISO 9001:2008 applies, with the following addition:

a) the maximum intervals between reviews should normally be 12 months and shall not

exceed 14 months;

b) top management shall chair the review;

c) the person(s) responsible for the activities as detailed in 5.5.1 shall participate in the

review.

5.6.2 Review input

Subclause 5.6.2 of ISO 9001:2008 applies with the following addition:

The review shall include the overall effectiveness of the quality management system with

respect to equipment intended for use in explosive atmospheres.

NOTE Results of audits should include both internal audits and those conducted by other parties (e.g. a body

responsible for the verification of the quality system, if one is involved).

5.6.3 Review output

Subclause 5.6.3 of ISO 9001:2008 applies.

6 Resource management

6.1 Provision of resources

Subclause 6.1 of ISO 9001:2008 applies.

6.2 Human resources

6.2.1 General

Subclause 6.2.1 of ISO 9001:2008 applies.

6.2.2 Competence, training and awareness

Subclause 6.2.2 of ISO 9001:2008 applies, with the following addition:

80079-34/FDIS IEC – 13 –

The manufacturer shall ensure that all persons having an impact on Ex compliance receive

appropriate training.

EXAMPLE People having impact may include those concerned with manufacturing, inspecting, testing, sales,

marketing, supply management, calibration and control services and other services.

6.3 Infrastructure

Subclause 6.3 of ISO 9001:2008 applies.

6.4 Work environment

Subclause 6.4 of ISO 9001:2008 applies.

7 Product realization

7.1 Planning of product realization

Subclause 7.1 of ISO 9001:2008 applies.

NOTE Examples are given in Annexes A and B.

7.2 Customer-related processes

7.2.1 Determination of requirements related to the product

Subclause 7.2.1 of ISO 9001:2008 applies.

7.2.2 Review of requirements related to the product

Subclause 7.2.2 of ISO 9001:2008 applies with the following addition:

The review shall ensure that any stated customer requirement is compatible with the Ex

certificate e.g. equipment group, temperature class, type of protection, EPL and ambient

temperature range.

NOTE In some situations, such as internet sales, a formal review may be impractical.. In such the information

made available to the customer and the order acknowledgement should include as a minimum the Ex marking

7.2.3 Customer communication

Subclause 7.2.3 of ISO 9001:2008 applies.

7.3 Design and development

7.3.1 Design and development planning

Subclause 7.3.1 of ISO 9001:2008 is not within the scope of this standard.

7.3.2 Design and development inputs

Subclause 7.3.2 of ISO 9001:2008 is not within the scope of this standard.

7.3.3 Design and development outputs

Subclause 7.3.3 of ISO 9001:2008 is not within the scope of this standard.

7.3.4 Design and development review

Subclause 7.3.4 of ISO 9001:2008 is not within the scope of this standard.

– 14 – 80079-34/FDIS IEC

7.3.5 Design and development verification

Subclause 7.3.5 of ISO 9001:2008 is not within the scope of this standard.

7.3.6 Design and development validation

Subclause 7.3.6 of ISO 9001:2008 is not within the scope of this standard.

7.3.7 Control of design and development changes

Subclause 7.3.7 of ISO 9001:2008 applies with the following addition:

The person identified in 5.5.1 a) shall approve any changes that could compromise Ex

compliance.

7.4 Purchasing

7.4.1 Purchasing process

Subclause 7.4.1 of ISO 9001:2008 applies, with the following addition:

a) while manufacture, testing and final inspection may be sub-contracted, the responsibility

for ensuring conformance with the Ex certificate shall not be sub-contracted;

b) suppliers that provide a product, process or service that can affect the product's

compliance with the Ex certificate, shall only be selected after an evaluation has

demonstrated that they have the capability of ensuring compliance with all specified

requirements:

1) documented objective evidence that the supplier can provide a product, process or

service that is fit for its purpose shall be made by one or more of the following

methods:

– the supplier has an acceptable Ex quality system,

NOTE 1 A quality system in accordance with this standard is generally acceptable.

– the supplier has a quality system certificate in accordance to the appropriate

standard and with an acceptable scope,

NOTE 2 A certificate issued by an accredited body which can demonstrate that it operates in compliance

with ISO/IEC 17021 is generally acceptable; depending on the nature of the product, process, or service,

a quality system in accordance with ISO 9001:2008 may not be sufficient.

– a documented site assessment to ensure that all relevant controls are available,

documented, understood and effective.

NOTE 3 The evaluation should take the following into account:

– criticality of the product, process or service;

– degree of difficulty, or variability in the manufacturing process;

– location of the supplier and hence the effectiveness of communications;

– whether the supplier, in turn, sub-contracts the product, process or service.

2) suppliers providing calibration services (including verification on measuring devices by

comparison with calibrated equipment) shall be evaluated on their ability to meet

stated requirements, in addition to 7.6;

3) where the features affecting the type of protection cannot be verified at a later stage,

e.g. encapsulated intrinsically safe circuits, then the product, process or service shall

only be accepted by one of the following methods:

– the manufacturer can demonstrate that the control process implemented by the

subcontractor ensures Ex compliance,

– the body responsible for the verification of the quality system performs periodic

audits at the sub-contractors.

c) suppliers not used for a period exceeding one year shall be re-evaluated in accordance

with 7.4.1 b) prior to the placing of a contract or a purchase order;

80079-34/FDIS IEC – 15 –

d) requirements b) and c) are not mandatory for products, processes or services where the

manufacturer verifies conformance in accordance with 7.4.3;

e) the ongoing ability of the supplier to provide conforming product, process or service shall

be reviewed at periods not exceeding one year;

NOTE 4 "Review" is a process by which the manufacturer demonstrates the ongoing suitability of their suppliers,

e.g. receiving inspection report analysis.

NOTE 5 The terms "re-evaluation" and "review" have different meaning and should not be confused.

f) the manufacturer shall facilitate an arrangement whereby the body responsible for the

verification of the Ex quality system may also verify aspects of any supplier’s operation

that affects the type of protection.

7.4.2 Purchasing information

Subclause 7.4.2 of ISO 9001:2008 applies, with the following addition:

a) the purchasing documents shall clearly describe the specific requirements pertaining to

subcontracted product set out in the Ex certificate and the technical documentation (e.g.

for process control, testing or inspection);

b) for items where conformance cannot be verified after manufacture (e.g. encapsulated

intrinsically safe circuits), the purchasing information shall set out the specific quality

procedures, resources and sequence of activities relevant to the particular item;

c) the manufacturer shall define the method by which documents, e.g. technical

specifications, stated in a particular purchase order remain traceable to the order;

d) where the manufacturer does not provide such documents with subsequent orders, then

the manufacturer shall have procedures for ensuring that suppliers have current copies of

documents and that their integrity be maintained.

7.4.3 Verification of purchased product

Subclause 7.4.3 of ISO 9001:2008 applies, with the following addition:

a) for purchased products that can compromise the type of protection the manufacturer shall

determine and implement verification arrangements which demonstrate the product’s

compliance with the Ex certificate, taking into account the nature of the product and the

nature of the supplier;

b) when deciding what type of verification is required for a particular purchased product, the

manufacturer shall consider the nature of the purchased product, the supplier and how

critical it is to the type of protection.

NOTE In considering whether the supplier should carry out the verification, the manufacturer should take into

account the results of the evaluation carried out under 7.4.1. The decision should reflect the competence of

the supplier, including whether they have a quality system that covers the activity, the resources, e.g.

equipment, and personnel with sufficient skill and experience to do the job. This latter point is particularly

significant when judgement is required, such as when inspecting a flameproof casting. When the manufacturer

elects to have the supplier carry out tests or inspections relevant to the type of protection, the product should

be supplied with a declaration of conformity according to ISO/IEC 17050-1 that confirms it has been done.

c) where the supplier has been evaluated, and documented objective evidence has been

obtained to demonstrate that the supplier is fully capable of producing and verifying the

product or service, no further verification of the product or service is required, provided a

declaration of conformity according to ISO/IEC 17050-1 is supplied with each batch or

product;

d) where the Ex certificate specifies routine tests or inspections, these shall be carried out

on each product. They may be carried out by either the supplier or the manufacturer.

When carried out by the supplier, this shall be specified on the purchasing documents,

e.g. by a quality plan, and confirmed by the supplier, e.g. by a declaration of conformity

according to ISO/IEC 17050-1 including test results, if required;

e) where verification of a purchased product cannot be carried out after manufacture, e.g.

the internal parts of encapsulated intrinsically safe circuits, then the product shall only be

accepted if supplied with a declaration of conformity according to ISO/IEC 17050-1. This

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