Quality Assurance for Manufacturers of Hazardous Area Equipment (QAN & QAR)
Depending upon which jurisdiction products are to be used in, equipment for use in hazardous areas may need to be certified by a notified body according to the EU ATEX Directive or the IECEx requirements.
A manufacturer’s quality system need to be certified 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.
As well as an EU-type examination certificate, it is a mandatory requirement for ATEX equipment manufacturers to have a QAN for Category 1 and Category 2 products. The QAN 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.
It is also a mandatory requirement for manufacturers of IECEx certified equipment to have a documented quality assurance system in place for their products.
To be given a 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.
Both product certification and quality assurance verification will be needed to place products on the market in many parts of the world.
There can be cost and time savings by combining QAN & QAR certification with common management systems frameworks, such as ISO 9001, ISO 14001 and OHSAS 18001.
Related Directives, schemes and standards
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.
As one of the world’s leading certification bodies specializing in quality and management systems certification, we can offer our clients the convenience of combining QAN & QAR certification with common management systems frameworks. Our IECEx Certification Body and ATEX Notified Body services are issued by DNV Product Assurance AS in Oslo, Norway.
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.
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, DNV will issue the QAN or QAR, 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 or IECEx QAR 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. If the manufacturer is applying for, or holds both an ATEX QAN and an IECEx QAR, both schemes will be audited and maintained jointly.