ATEX QAN & IECEx QAR
It is a mandatory requirement for manufacturers of Ex equipment to have a Quality assurance notification for their Ex products as well as a product conformity certificate (i.e. ATEX, IECEx). The Quality Assurance notification is the continued monitoring of systems and processes in relation to those Ex products. (Certain exclusions apply - please contact Sira for more details).
You must have both in place (certificate and quality assurance) before putting your Ex equipment on the market.
ATEX Quality Assurance (QAN)
It is not enough to just gain product compliance for your equipment (unless your equipment falls under the exclusions as mentioned above). As Sira only test a small sample of your products during assessment, there also needs to be a system in place to continually monitor your quality procedures and processes, design specifications and records to ensure that you are constantly manufacturing and supplying equipment in accordance with your certification parameters.
For ATEX certification, this is called a Quality Assurance Notification (QAN)
The manufacturer must comply with the appropriate Annex(es) of the Directive (IV, V, VI, VII or IX) applicable dependant upon designation of your equipment (zone), whether you plan mass production or build a fixed number of units, and whether you maintain an ISO9001 compliant Quality Management System.
This will involve an audit of your site (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.
The ATEX Quality Assurance is a mandatory requirement. A surveillance audit (typically one day) will take place approximately every 18 months, (12 months if ISO9001 certification is not held) with a new ATEX QAN certificate issued every 3 years.
Sira can offer this service at the outset of an ATEX project by offering a fixed price quotation. We can arrange for the QAN to be completed when the product is certified compliant to ATEX, ensuring you can declare full compliance to the directive and bring your product to market in as short a lead-time as possible.
IECEx Quality Assessment Report (QAR)
It is also a legal requirement for manufacturers of IECEx equipment to have the relevant quality assurance in place for their products.
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 ISO9001 compliant Quality Management System.
An audit (typically one day) will take place annually (under the terms of the IECEx rules) and Sira are equipped to conduct this, ensuring that you can declare full compliance to the directive and bring your product to market in as short a lead-time as possible. If the manufacturer holds an accredited ISO 9001 certificate from a certification body that holds a national accreditation (e.g UKAS, RAB, ANAB) and are a signatory of the IAF MLA, then the frequency of the audit may be changed to eighteen month periods.
Sira can also offer training and technical advice on the requirements and responsibilities of Quality Assurance. For more information, please see our Preliminary QA Assessment Section, or contact Sira for more details.
Where possible, Sira will combine any audit actions (as well as offering a combined ISO9001 and QA audit facility) which can cut costs and timescales dramatically. For more information please contact Sira.
To obtain a formal quotation for Quality Assurance, please fill in the relevant sections of the request for quotation form, a copy of which can be downloaded by clicking here
For more information concerning Sira’s Quality Assurance services, please contact Sira by emailing firstname.lastname@example.org
or tel +44 (0) 1244 670 900