SERVICES FOR TECHNICAL FILES
The ATEX Directive places requirements on the storage of manufacturers technical files. A technical file is made up of all the documentation necessary to back up a manufacturers declaration of conformity with specified criteria in accordance with the ATEX Directive.
Storage of Technical Files
In the case of both modules "Type Examination" and "Internal Control of Production", the ATEX Directive specifies that the manufacturer shall keep the technical files for a period of not less than 10 years after the last item was manufactured. The same would apply to the notified body.
A method for charging for this service has been agreed by the European Group of Notified Bodies appointed under ATEX, based on encouraging the manufacturer to advise the body when production of a particular item has ceased.
Baseefa charges are based on the following:-
Files created as part of Type Examination - free for 10 years.
Files transferred from EECS or other Notified Bodies - free for 10 years
Files where Baseefa is responsible for the production phase - free for 10 years after the issue of the last QA Notification of Verification certificate.
Files where Baseefa had no part in the preparation of the file, and no part in the production phase - initial fee on standard scale to cover 10 years retention.
Files where Baseefa has no continuing involvement - a renewal charge every 3 years to retain the file for the following 10 years.
Receipt of "Internal Control of Production" Files
It is a mandatory requirement in the ATEX Directive that Technical Files created as part of the "Internal Control Production" module for Category 2 and Category M2 non-electrical equipment are depsoited with a Notified Body and that the Notified Body should acknowledge receipt of the file. We provide a formal receipt which confirms that the file has been deposited and that we have not looked at it. You may send us supplementary information to add to the file but you may not remove it from our premises, since to allow you to do so would defeat the object of the independant retention. it will be treated confidentially and only copied to those who have a statutory right of access, such as the European Commission.
Technical File Review
When requested, we will review the content of any technical file deposited with us on a purely optional and voluntary basis. We will confirm the issue of a formal "Review Receipt" that, in our opinion, the file, as passed to us, contains appropriate data to substantiate a Declaration of Conformity to the Directive. In doing so, we will not take responsibility for the veracity of the information in the file, but confirm that the way the information is presented allows a conclusion that the equipment is compliant.
Should you prefer (or your customer require), we can, of course, proceed with full Type Examination on a voluntary basis.
For further information please see the attached article, Role of the Technical File, written by Ron Sinclair of Baseefa.
