- Before Ex products can be placed on the European market, a Quality Assurance Notification (QAN) must be issued by a Notified Body. This can either be a Product QAN (A:IV) or a Production QAN (A:VII)
- Before an IECEx Certificate can be issued, a Certification Body must issue a Quality Assurance Report (QAR). This is similar to the ATEX QAN scheme
ATEX Quality Assurance (QAN)
As well as an EC-type examination certificate, it is a mandatory requirement for manufacturers of ATEX equipment to have a Quality Assurance Notification for their 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 13980.
The manufacturer of ATEX equipment must comply with the appropriate Annex(es) of the Directive (IV, V, VI, VII or IX) applicable depending upon zone designation of the equipment, whether the product(s) are mass produced or a fixed number of units are fabricated, and whether or not ISO 9001 certification is held. If the manufacturer already has a valid ISO 9001 certificate, the process is somewhat simpler, as many of the requirements of ISO 9001 and EN 13980 overlap, and thus the actual audit scheme may be somewhat simplified. The Notified Body will require a copy of the ISO 9001 certificate for their records.
The manufacturer’s site is audited (and possibly any other sites that are involved with the manufacture of the product) and typically covers a review of records and a check of the design specification of the equipment, as well as a verification of the tests carried out and documentation to be provided with the product.
The next step is for you to send a copy of your Quality System documentation so we can check that it includes the necessary requirements for the products concerned. Please note:
It is advisable for a manufacturer due to undergo an ATEX audit to refer to EN 13980 and make any necessary changes to implement its requirements in your system. Nemko can provide a requirement checklist to help you do this and will inform you in advance what documents that we need to see. These can be sent in advance of the audit. If changes to the documentation are required, we will contact you to discuss this.
We will agree on a date for an initial assessment visit 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 opportunities for improvement can be identified. Remember that both a valid ATEX QAN and a valid product ATEX certificate are required before the product can be placed on the EU market. Have 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, Nemko will issue the Quality Assurance Notification, with a 3 year validity.
A surveillance audit will take place within 18 months, (12 months if ISO 9001 certification is not held) with a re-assessment in order to renew the ATEX QAN 2-3 months prior to the expiry of the existing.
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 all zone designated equipment.
For IECEx this is called a Quality Assessment Report (QAR)
The manufacturer must ensure compliance with the full requirements of IECEx operational document OD/005 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 – on www.iecex.com - , with a 3 year validity.
A surveillance audit will take place within 18 months, (12 months if ISO 9001 certification is not held) 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 is the proprietor of 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 and therefore manufacturers should consider the benefits of a combined IECEx and ATEX audit. This would be a very time and cost effective option, please contact Nemko for enquiries.
Please phone or send us your request in the form below, and we will contact you as soon as possible. Let us know your purpose and we will find the right person to call you back.