ATEX Directive Quality Assurance Notification QAN/QAR
Presafe provides Quality Assurance Notification (QAN) according to the ATEX Directive and Quality Assurance Report (QAR) according to IECEx requirements.
- To be permitted to sell ATEX products on the European market, manufacturers must obtain a Quality Assurance Notification (QAN) issued by a Notified Body.
- Similarly to the ATEX QAN scheme, before IECEx certification of a product can be finalized, it is required that a Certification Body issues a Quality Assurance Report (QAR) to the manufacturer.
ATEX Quality Assurance Notification (QAN)
As well as an EC-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 somewhat simpler. Many of the requirements for ISO 9001 and EN 80079-34 overlap, wherefore the actual audit scheme can be somewhat simplified. The Notified Body will require a copy of the ISO 9001 certificate for their records.
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. Presafe can provide a requirements checklist and information, in advance of an audit, on what documents that need to be provided for the process. If changes to the documentation are needed, we will contact you to discuss.
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, Presafe will issue the Quality Assurance Notification, which is valid for 3 years.
A surveillance audit will take place within 18 months with a re-assessment in order to renew the ATEX QAN 2-3 months prior to the expiry of the existing. 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. 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.