DNVGL.com uses cookies to give you the best possible experience on our site. By browsing the site
you agree to our use of cookies. You can click “Close” to remove this message. For more information
please visit our cookie information page.
Close
Our IECEx Certification Body and ATEX Notified Body services are issued by our joint-
venture entity DNV Nemko Presafe AS in Oslo, Norway.
https://www.dnvgl.com/services/quality-assurance-for-manufacturers-of-hazardous-area-equipment-qan-qar--82903 1/4
3/30/2018 Quality Assurance for Manufacturers of Hazardous Area Equipment (QAN & QAR) - Business Assurance - DNV GL
ATEX equipment manufacturers must comply with the appropriate Annex(es) of the ATEX
Directive (IV, V, VI, VII or IX) depending on zone designation of the equipment, if the
product(s) are mass produced or a fixed number of units are manufactured, and if ISO
9001 certification is in place. If the manufacturer already holds a valid ISO 9001 certificate,
the process is a little simpler as many of the fundamental requirements for ISO 9001 and
EN 80079-34 overlap.
The manufacturing site is audited, including other sites involved in the product
manufacturing. This normally covers a review of records and an examination of the design
specification of the equipment, including a verification of the tests carried out and the
product documentation to be provided. The next step is for the manufacturer to submit a
copy of its quality system documentation to verify that all necessary requirements for the
product are met.
A date for an initial assessment visit will be agreed upon at a time when any related
product certification work is at a suitable stage. It is important to think of the audit as a
positive process where improvement opportunities can be identified. Remember that
both a valid ATEX QAN and a valid ATEX product certificate are required before the
product can be placed on the EU market. Keep in mind that the total process may take
some time from the initial phase to completion.
The non-conformities raised during the audit are discussed in the closing meeting, the
manufacturer is given a deadline to present corrective actions related to any findings
raised. When all non-conformities are confirmed closed, the Notified Body will issue the
Quality Assurance Notification, which is valid for 3 years.
A surveillance audit will take place within 18 months. A re-assessment audit in order to
renew the ATEX QAN will take place 2-3 months prior to the expiry of the existing
certificate. If the manufacturer does not have an ISO 9001 certificate in place, the
surveillance audit needs to be done within 12 months.
https://www.dnvgl.com/services/quality-assurance-for-manufacturers-of-hazardous-area-equipment-qan-qar--82903 2/4
3/30/2018 Quality Assurance for Manufacturers of Hazardous Area Equipment (QAN & QAR) - Business Assurance - DNV GL
For IECEx this is called a Quality Assessment Report (QAR). The manufacturer must ensure
compliance with all requirements in IEC 80079-34 and have an ISO 9001 compliant
Quality Management System. However, as for ATEX QAN, an ISO 9001 certificate is not a
mandatory requirement, but is recommended as it does simplify the process. As for an
ATEX QAN, the IECEx QAR is issued with a three-year validity and published
on www.iecex.com.
A surveillance audit will take place within 18 months, or within 12 months if there is no ISO
9001 certification in place, with a re-assessment in order to renew the IECEx QAR 2-3
months prior to the expiry of the existing. If the manufacturer is applying for, or holds both
an ATEX QAN and an IECEx QAR, both schemes will be audited and maintained jointly.
The IECEx QAR audit scheme does not differ much from the ATEX QAN audit scheme. It is
recommended that manufacturers consider the benefits of a combined IECEx and ATEX
audit as a time- and cost effective option. Please contact us for more information about
this.
IECEx – The IEC System for Certification to Standards relating to Equipment for use in
Explosive Atmospheres
Common Standards:
https://www.dnvgl.com/services/quality-assurance-for-manufacturers-of-hazardous-area-equipment-qan-qar--82903 3/4
3/30/2018 Quality Assurance for Manufacturers of Hazardous Area Equipment (QAN & QAR) - Business Assurance - DNV GL
ISO 80079-34 - Explosive atmospheres – Part 34: Application of quality systems for
equipment manufacture
ISO 14001 - Environmental management systems -- Requirements with guidance for use
https://www.dnvgl.com/services/quality-assurance-for-manufacturers-of-hazardous-area-equipment-qan-qar--82903 4/4