In most cases, to enable the issue of an ATEX product certificate, the manufacturer must also hold a valid Quality Assurance Notification (QAN).
Typically we only test a small sample of products as part of any approval. The Quality Assurance Notification is therefore involved with the continued monitoring of systems and processes in relation to those Ex products. It involves periodic audit of the manufacturing process by a qualified auditor.
Certain exclusions apply as not all conformity routes mandate a quality assurance requirement. For more information, please contact us.
ATEX Quality Assurance Notification (QAN)
The manufacturer must comply with the appropriate Annex(es) of the Directive (IV, V, VI, VII or IX) applicable dependent upon designation of the equipment (zone), whether they are mass produced or built in a batch.
The audit of the manufacturing location (and possibly any other sites that are involved with the manufacture of the product) typically covers a review of records and a check of the design specification of the equipment. A surveillance audit then takes place approximately every 18 months, (12 months if ISO 9001 certification is not held) with a new ATEX QAN certificate issued every 3 years.
Since the implementation of ATEX in 2003, we have helped hundreds of clients maintain this requirement in order that they can continue to make ATEX approved products. We can also look to combine a QAN audit with other audit actions if possible.