Quality Assurance for Manufacturers of Hazardous Area Equipment (QAN & QAR)
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We can offer our clients the convenience of combining QAN & QAR certification with common management systems frameworks, such as ISO 9001, ISO 14001 and OHSAS 18001.
DNV certifies manufacturers’ quality systems in compliance with the requirements of the ATEX Directive and the IECEx Scheme. This is known as a Quality Assurance Notification (QAN) under ATEX and a Quality Assurance Report (QAR) under the IECEx Scheme.
Depending on the applicable conformity assessment route that a manufacturer has chosen for their products approval they will usually find that it is necessary to obtain a QAN from a Notified Body to be able to place ATEX products on the market.
Our IECEx Certification Body and ATEX Notified Body services are issued by DNV Presafe AS in Oslo, Norway.
ATEX Quality Assurance Notification (QAN)
As well as an EU-type examination certificate, it is a mandatory requirement for ATEX equipment manufacturers to have a Quality Assurance Notification for Category 1 and Category 2 products. The Quality Assurance Notification is the continued monitoring of systems and processes in relation to those products in accordance with EN 80079-34.
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.
It is advisable for a manufacturer due to undergo an ATEX audit to refer to EN 80079-34 and make any necessary changes to implement EN 80079-34 requirements into its existing system. We are happy to provide our clients a requirements checklist and information, in advance of an audit, on what documents will need to be provided for the process.
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.
IECEx Quality Assessment Report (QAR)
It is also a mandatory requirement for manufacturers of IECEx certified equipment to have a documented quality assurance system in place for their products.
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.
Combined Assessment (QAN, QAR & QMS)
As one of the world’s leading certification bodies specialising in quality and management systems certification, we can offer our clients the convenience of combining QAN & QAR certification with common management systems frameworks, such as ISO 9001, ISO 14001 and OHSAS 18001.
Please contact us to discuss your combined quality assurance certification needs.
Relevant Directives / Schemes:
ATEX Directive – 2014/34/EU (which replaces the original ATEX Directive 94/9/EC)
IECEx – The IEC System for Certification to Standards relating to Equipment for use in Explosive Atmospheres
ISO 80079-34 - Explosive atmospheres – Part 34: Application of quality systems for equipment manufacture
ISO 9001 - Quality management systems – Requirements
ISO 14001 - Environmental management systems -- Requirements with guidance for use
OHSAS 18001 - Occupational Health and Safety Management