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
requirements of M-M-03 (Limitations , Observations & most important forbidden activities);
requirements of ConformEx outsourcing procedure (P-S-22) and
requirements of contract with the marketing service providers (F-S-04).
ConformEx does not outsource application review, contract making and certification decision making to external bodies, companies and persons.
3- Foreign Representatives for Outsourced Product Evaluation and ATEX Quality System Auditing Activities
The granting of representation for product evaluation and quality system auditing services is reserved exclusively for companies based outside Italy.
An applicant for a foreign representative for evaluation and auditing services, must be a legal entity.
Prior to the drafting of a cooperation agreement, the representative must prepare a precise and comprehensive risk assessment report, covering all risks related to impartiality and conflicts of interest and reflecting the representative's actual circumstances at the time of the application for obtaining representation, and submit it to ConformEx, along with appropriate, defined mitigation actions of risks, for ConformEx's approval.
If the representative use of any shared resources with a consultancy firm, they must provide a complete list of such resources to ConformEx and include this information in their risk assessment report, so that any prohibitions regarding the use of specific shared resources, in accordance with ConformEx and ACCREDIA requirements, to be clarified.
The representative must facilitate the ConformEx assessor's on-site visit by ensuring the availability of suitable infrastructure and qualified personnel, and by demonstrating that the applicable requirements of ISO/IEC 17065, ACCREDIA, and the ATEX directive are fulfilled.
ConformEx does not outsource product evaluation and quality system auditing activities to an organization where its legal registered activities, organizational relationships, shared resources or other circumstances create an unacceptable impartiality or conflict-of-interest risk that cannot be effectively eliminated or adequately controlled.
The activities of competence assessment and the appointment of product evaluators and quality system auditors cannot be outsourced and must be carried out by ConformEx itself.
ConformEx must communicate directly with the product evaluators and quality system auditors, introduced by the representative regarding the collection of documents, the conducting of interviews, the administration of theoretical or practical examinations, and other matters related to competence assessment and appointment.
In a project base manner, throughout all stages of the assessment or audit, such as assignment of evaluator and/ or auditor, committing to impartiality, preparing and approving the product assessment or quality system audit plan, exchanging assessment or audit reports, etc., there must be direct communication and contact between the product evaluator and/or quality system auditor and ConformEx.
Where laboratory testing is required as part of an outsourced product evaluation project, the qualification and approval of the proposed laboratory shall be performed directly by ConformEx, and the laboratory shall be subject to the applicable ConformEx requirements for outsourced testing activities. Subsequently a direct partnership agreement must be concluded between ConformEx and the local laboratory.
The quotation for certification services must be communicated directly from ConformEx to the client, and a signed copy must be obtained directly from the client. However, the project price and other financial terms may be excluded from said quotation and instead addressed in a local agreement between the representative and the client, covering only financial matters, which would serve as an annex to the ConformEx quotation.
The agreement with the local partner laboratory covers technical aspects and testing process requirements; additionally, testing costs and payment terms for each project are specified in the partner laboratory's quotation which is communicated to the representative (and a copy to ConformEx), and payment may be made by the representative.
The processes for reviewing evaluation and audit results, as well as decision-making regarding certification and the issuance and registration of certificates, cannot be outsourced and must be performed exclusively by ConformEx itself.
According to part 3 of article 23 of the directive 2014/34/EU, outsourcing of evaluation and auditing activities are subject to the client's prior agreement and does not transfer ConformEx's responsibility or certification authority to the representative or the relevant evaluators and auditors.
ConformEx retains full responsibility for the outsourced activities and exclusive authority for final approval of the assessment/audit plan and test laboratory, final review of the certification file, certification decision, and issuance and registration of the certificate.
According to the requirements of part 1 of article 23 of the directive 2014/34/EU, assessment result and approval by notified body (ConformEx) on qualification of the representative, must be informed to relevant ATEX notifying authority, which is Ministero delle Imprese e Made-in-Italy.
The representative shall comply with ConformEx requirements for confidentiality, information security, controlled access and data protection. access to certification, evaluation and audit information shall be limited to personnel authorized for the relevant project, including where premises, personnel or IT resources are shared with affiliated organizations.
All complaints and appeals raised from local parties and relating to outsourced evaluation or auditing activities, the performance of assigned evaluators or auditors, the representative, or ConformEx shall be promptly referred to ConformEx and handled in accordance with the applicable ConformEx procedures. The representative shall not independently investigate, decide upon or close such complaints or appeals unless specifically authorized by ConformEx for a defined supporting activity.
ConformEx monitors periodically the performance and continued compliance of the foreign representative and the relevant assigned evaluators and auditors. continued authorization shall be subject to satisfactory technical performance, maintenance of competence, compliance with impartiality and confidentiality requirements, and fulfilment of applicable ConformEx procedures and contractual requirements.
