ConformEx takes responsibility for all activities outsourced to the external testing labs and external companies performing presentation and marketing tasks on behalf of ConformEx.
ConformEx does not outsource QAN audits or product evaluation to a consultant, as this poses an unacceptable threat to the impartiality of ConformEx. This does not apply to individuals contracted as QAN auditors or product evaluators (Point No.5 of M-M-03)
Except above policy, generally ConformEx does not outsource QAN audits or product evaluation to another external body or firm.
ConformEx does not own an internal lab, therefore testing activities are outsourced wholly to external testing labs, but only accredited ones according to ISO/IEC 17025:2017 by ILAC signatory accreditation bodies.
Non-accredited testing labs
according to the below requirements
6.2.2.2 of ISO/IEC 17065:2017; and
Point 4.4 of annex III of directive 2014/34/EU
In below special cases, the obligatory for having accreditation for external testing lab including client laboratory, maybe excluded.
when an accredited Ex testing lab does not exist in the country or area where the client located; and
transportation testing sample(s) to the external partner testing labs is non-feasible and very difficult
In such cases, ConformEx shall perform conducts audit and approval on management system of the non-accredited lab according to ISO/IEC 17025 requirements by using the relevant audit checklist (F-S-129).
Such above decsribed audits are outsources to one of the accredited associated testing labs of ConformEx or one of the personnel of them who is competent for the requirements and internal audit of ISO/IEC 17025.
If the final result of the above-mentioned audit is in a way cause a positive decision is taken for qualifying the non-accredited lab, a contract for providing Ex testing service by associated non-accredited lab (F-S-130) is concluded between ConformEx and the lab.
In addition, on-site witness during testing operations, shall be performed by one of the product evaluators who have been already appointed by ConformEx.
The result of auditing and approval of the non-accredited labs is recorded in F-S-129 and when a non-accredited lab is approved for providing testing service, the name and relevant information is recorded in the list of associated non-accredited testing labs (F-S-131).
For the results of witnessing on tests, the non-accredited testing lab is required to consider in the template of its issued test report, a specific part for recording the relevant witness result by witnessor (product evaluator assigned by ConformEx) for each test, next to each section in the test report, where the results of the same test are recorded.
For the non-accredited labs which do not belong the client (manufacturer) lab and are considered as independent lab, continuation the qualification status for annual surveillances, maybe agreed between ConformEx and the lab.
But for the non-accredited labs which belong to the manufacturer which is client of ConformEx for ATEX certification, maintaining qualification of the lab (for the purpose of maintaining validity or re-issuing the ATEX certificate) depends on the need to periodic repeating the required tests according to the requirement of the applied ATEX certification module.
2- Market development and marketing
ConformEx may outsource only its presentation and marketing activities to the legal entities and real persons, located outside Italy that could be committed to be in compliance with
