Rules & Regulation-ATEX
Rules & regulations for ATEX certification
I-O-18 Rev: 02
1. SUBJECT MATTER
This general regulation for conformity assessment pursuant to the ISO/IEC 17065 , EU ATEX directive (2014/34/EU) and normative references such as EN 60079 standard series for which Nobel Certification Italia (hereafter named “NOBEL CERT”) operates as a product certification body (PCB) as well as EU notified body for certification of equipment and protective systems intended for use in potentially explosive atmospheres according to conformity assessment modules which has been described as annexes of EU ATEX directive (2014/34/EU), as described below, is adopted and approved by NOBEL CERT, and is applicable to NOBEL CERT and the applicant of the conformity assessment service (the "client"), except for the cases that the mentioned parties expressly agree on the exceptions to this Regulation.
Each exception will be valid only if previously agreed in writing between NOBEL CERT and the client (the Parties). In the case that one or more of the articles were to prove null or ineffectual for any reason, the nullity or ineffectualness will not be extended to other requirements of this NOBEL CERT Regulation.
Within this Regulation, the applicable conditions to the Certification Contract stipulated between the Parties for the certification services are also defined, taking as essential elements of this regulations:
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by the CLIENT side, the acceptance of the pertinent NOBEL CERT quotation, the presentation of the application and the acceptance of the applicable NOBEL CERT Regulation;
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by NOBEL CERT side, the order confirmation, once the documentation has been received from the CLIENT.
The CLIENT entrusts NOBEL CERT with the relevant Service to issue the pertinent documents attesting conformity of product, according to one of the conformity assessment modules indicated as annexes of EU directive 2014/34/EU including below certification schemes which the ownership of the relevant issued certificates belongs to NOBEL CERT under ACCREDIA accreditation.
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MODULE B: EU-TYPE EXAMINATION (annex III of ATEX directive)
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MODULE D: CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE PRODUCTION PROCES (annex IV of ATEX directive)
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MODULE E: CONFORMITY TO TYPE BASED ON PRODUCT QUALITY ASSURANCE (annex VII of ATEX directive)
Note: Rules and Regulations for issuing product and production quality assurance notification (module D and E) and a special rules and regulation (I-O-14), has been developed for audits and certification for ATEX QAN.
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MODULE G: CONFORMITY BASED ON UNIT VERIFICATION (annex IX of ATEX directive)
Note: a policy for unit verification certification (module G) has been defined.
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in the case of equipment relevant to groups and categories indicated in point (ii) of section (b) of clause No.1 of article No.13 of ATEX directive, issuance acknowledge receipt of the technical documentation provided for in Annex VIII, point 2 of ATEX directive.
Note: a policy for issuing technical file acknowledge receipt or A.R (subpart ii of part b of paragraph 1 of article No.13 of ATEX directive), has been defined.
Note: any exclusion, nullity or ineffectualness regarding this regulation, shall be indicated in the “Exclusive Contract for each ATEX certification module” or by the particular rules, regulations or policy defined for the modules D, E, G and subpart ii of part b of paragraph 1 of article No.13 of ATEX directive. furthermore, they cannot be in conflict with determined requirements by above-mentioned norms and references, relevant to NOBEL CERT certification scope which are basis of product certification activities.
Upon conclusion of product conformity assessment tasks, in case of positive outcome of verification activity and making positive decision for certification, NOBEL CERT issues the CLIENT with one of the above-mentioned certificates. In the case of a negative result, NOBEL CERT issues the CLIENT with the specific communication describing the non-conformities found, to be resolved by the in compliance with the specified deadlines in the relevant sections of this regulations.
In case of failure on solving the non-conformities in the specified deadlines, NOBEL CERT issues to the CLIENT a communication with the negative result, requires the CLIENT to pay for the activity carried out up to that point and informs the Competent Authorities of this negative outcome in the manner provided by them.
In the case of an explicit request by the CLIENT, NOBEL CERT also sends the relevant Evaluation / Test Reports to the client.
2. GENERAL TERMS AND CONDITIONS
2.1. Attaining the certification
Issuance ATEX certificate, and its maintenance, where applicable, depend on:
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the availability of the CLIENT to submit its produced product sample/s and itself to the ordinary, supplementary and documental assessments within the timeframe envisaged and indicated by NOBEL CERT;
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the positive result of the aforementioned conformity assessment activities, performed by NOBEL CERT;
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the payment of the amounts due, on any basis, to NOBEL CERT (including the activities of issuing and the variation/re-issue of the certificates).
2.2. Samples
If required, the samples must reach the laboratory indicated by NOBEL CERT accompanied by the documents needed by NOBEL CERT testing lab procedures. All the transport expenses are borne by the CLIENT. It is the responsibility of the CLIENT to collect the samples at the end of the tests.
Any resulted material from testing, will be immediately disposed of by NOBEL CERT.
All explosion proof tests are considered as destructive and therefore after the tests are completed, NOBEL CERT is not responsible for returning the samples to the customer in the same form and condition as they were delivered to NOBEL CERT.
The client shall prepare the testing sample/s according to the quantity and the technical specifications which NOBEL CERT requires.
2.3. Verification personnel and resource for testing
NOBEL CERT assigns the verification activities including technical documentation review and product evaluation to personnel including NOBEL CERT employees or to those who have a collaboration relationship with NOBEL CERT, or employee of companies with which NOBEL CERT has signed a collaboration contract in possession of the specific expertise and preventively qualified according to specific procedures, in accordance with the applicable accreditation provisions.
The testing activities are outsourced to the accredited associated laboratories.
2.4. Confidentiality
All the documents relating to the assessment activity (documentation, recordings, communications, assessment reports, etc.) are considered confidential, without prejudice to what is provided for by legislative provisions and/or by the provisions of the ACCREDIA and competent authorities.
Note: any information about the client obtained from sources other than the client (e.g. from the complainant or from regulators) is treated by NOBEL CERT as confidential.
Access to and consultation of the documents relating to the activities in hand is reserved to NOBEL CERT personnel involved in the conformity assessment process.
In the event that this information must be communicated or disclosed due to legislative or accreditation provisions, NOBEL CERT will give communication of this to the CLIENT, unless for the cases that prohibited by law.
Documents are property of the CLIENT, when acquired by NOBEL CERT in relation to the subject matter of this regulation, will be maintained by NOBEL CERT for at least 10 years from issuance date of certificate, unless stricter specific rules apply.
The client accepts the data processing procedures required by law and allows the inclusion of its company name in the list of NOBEL CERT references.
2.5. Impartiality
NOBEL CERT, in its capacity as PCB and EU notified body, is required to guarantee impartiality during all the conformity assessment activities; in this respect, NOBEL CERT avails of a process to assess and manage the risks of impartiality.
All prohibited tasks regarding impartiality are described in M-M-03 (Limitations , Observations & most important forbidden activities)
2.6. NOBEL CERT Ethics Code and Legislative Decree 231 of 8 June 2001
NOBEL CERT has adopted an Ethics Code pursuant to Legislative Decree 231 of 8 June 2001 on the liability of legal persons, of companies and of associations, including those are individuals. Consequently, in conducting business with NOBEL CERT, the CLIENT is required to view the mentioned decree and behave in a manner that is based on the highest ethical standards.
By signing the Certification Contract, the CLIENT declares to have viewed, to be familiar with the content of the NOBEL CERT Ethics Code and to have accepted its content.
The CLIENT also declares to be familiar with the provisions set out in Legislative Decree 231/01, to undertake to respect the NOBEL CERT Ethics Code and to fulfil its contractual obligations in accordance with an appropriate manner to avoid the occurrence of relevant behavior according to Legislative Decree 231/01.
In particular, failure of the CLIENT to observe any one of the provisions of the Ethics Code will imply a serious breach of the obligations of this regulation and legitimate NOBEL CERT to terminate this with immediate effect, pursuant to article 1456 of the Civil Code.
To this end, NOBEL CERT must communicate to the CLIENT, by registered letter with notification of receipt, or other modality valid for all purposes and effects of law, the motivated intention to avail of the termination clause.
Furthermore, The CLIENT behavior which results in the initiation of judicial proceedings to ascertain its relevance according to Leg. Dec. 231/01, of which NOBEL CERT has become familiar with in any way, will legitimate the latter to withdraw from the Contract of certification for just cause.
2.7. Accreditation and Authorization of NOBEL CERT as PCB
2.7.1. Obligation related to accreditation
In the activity subject matter of this NOBEL CERT Regulation, NOBEL CERT operates as a qualified as product certification body for European Directive 2014/34/EU and notified to the European Commission to implement the tasks related to the application of conformity assessment procedures of products, processes and services established Community Directives particularly for EU ATEX directive, on behalf of economic operators, with competence, transparency, neutrality, independence.
In particular, within the scope of the European Directives for which the Authorization/qualification by the Competent Authority is granted on the basis of the accreditation issued by ACCREDIA, according to the international standard UNI CEI EN ISO/IEC 17065, NOBEL CERT must operate in conformity to this standardand and to the specific provisions issued by ACCREDIA, applying the relevant reference documents, which are considered to be specifically referred to.
NOBEL CERT is also required, according to ACCREDIA RG-01, to communicate the information and validity status of the certificates issued (e.g. certificates issued, limited, suspended and revoked) to the below parties:
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ACCREDIA;
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competent authorities and
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the relevant third parties including the chambers of commerce, research institutes, CRIF, CERVED, ANAC, ENEA, IAF, ISTAT, credit institutes and so on.
Accreditation bodies and competent Authorities also have the right to carry out audits at the following premises: of NOBEL CERT and/or of its The CLIENTs and/or of Suppliers/critical Subcontractors of its The CLIENTs in order to verify the work of NOBEL CERT within the scope of the accredited certification schemes.
Note: updated information on the accreditation status of NOBEL CERT is available on the page of Accreditation.
2.7.2. Suspension, renunciation, revocation of accreditation and/or qualification of NOBEL CERT
In case the accreditation and/or qualification required to NOBEL CERT to operate as PCB for the specific Directive 2014/34/EU is suspended or revoked or in case of renunciation NOBEL CERT will inform the CLIENT of this, as well as support it in the possible transfer to other PCB.
Except in cases of fraud and gross negligence, NOBEL CERT is in no way responsible for any damage caused to the CLIENT by the suspension, renunciation, limitation of extension or revocation of accreditation and/or qualification; in such cases, the CLIENT has the right to renounce to the certification issued by NOBEL CERT, without prior notice and without additional charges.
2.7.3. Subcontract
Upon notice to the CLIENT, NOBEL CERT reserves itself the possibility to subcontract part of the certification Service requested to third parties, for example performing tests at external laboratories. The CLIENT will be informed of the detail of the outsourced activities as well as of the references of the subcontractor, has the right to refuse this outsourcing for justified reasons, within five (5) working days from the communication date.
NOBEL CERT is anyway fully responsible for every outsourced activity and retains the responsibility for issuing, maintaining, extending, limiting, suspending or withdrawing the ATEX Certification.
NOBEL CERT guarantees that the subject to which the subcontract is entrusted is competent and conforms to the applicable regulatory provisions and is not involved in the design and manufacture of the product, so as not to compromise impartiality as set out in par. 2.5 above.
2.8. Force majeure
In all emergency cases where the parties are deprived of their authority, in such a way as to cause the non-implementation of the operations under this contract (such as earthquakes, floods, unforeseen events and any other unforeseen factors that make it impossible to access the site the work will be done), the performance of the exclusive contract subject will be postponed to another date with the agreement of the parties.
3. CONFORMITY ASSESSMENT PROCESS
3.1. Presentation of the Request
The CLIENT has the right to request a quotation in advance, in which NOBEL CERT gives a detailed description of the activities carried out in its capacity as PCB and of the relevant Price applied.
The quotation will include the following information:
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description of the certification Service;
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references to this Rules & Regulation of certification;
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the manner in which the Service is provided;
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amount due, according to NOBEL CERT Price analysis
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invoicing and payment terms
In case of acceptance of the quotation, the CLIENT is required to send NOBEL CERT:
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approval on quotation;
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acceptance of “Specific contract for evaluation and certification of explosion proof product for EU type examination” (A-M-10) , this Rules & Regulation of certification, by the Legal Representative, or its Attorney, or adequately delegated person;
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any purchase order, if required by The CLIENT
EU ATEX Directive already specifies the relevant conformity assessment procedures. for the applicable requirements, including the documentation requested and rights and duties of the CLIENT, refer to the Directive 2014/34/EU and to the Special NOBEL CERT Requirements specified in this regulation.
The request to access to the certification Service is presented by the Manufacturer (the CLIENT) and occurs by presentation of a specific Request to NOBEL CERT, containing the recorded information in online application form which is available on NOBEL CERT website containing the following minimum information:
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general information about the CLIENT (company name, name, address, legal status, etc.);
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description of the product to certify and the relevant production site;
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applicable Directive (2014/34/EU) and assessment procedure envisaged and/or chosen by the CLIENT;
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declaration which shows that the same request has not been presented to any other PCB;
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documentation to assess the conformity of the product to the applicable requirements requested by the applicable Directive.
There is a confirmation for agreement with this rule and regulation in application form.
The Manufacturer is allowed to appoint a person or company (excluding consultancies) to act as its agent to assist him in all phases of the certification process, but the request, the contract documents and all the other documentation must be signed by the Manufacturer. The client must represent an evidence relevant to delegation of power to NOBEL CERT.
The Request must be presented in a distinct manner for each type of product, or rather for each representative sample of a specific production. The type may also include product variants, as long as these do not imply different types of risk with regard to the essential requirements of ATEX Directive. The product variants must be indicated in an attachment to the request.
If the CLIENT has already obtained one or more ATEX Certificates from another PCB and requests NOBEL CERT to take over as new PCB for the surveillance activities, the CLIENT itself is required to provide NOBEL CERT with a copy of these ATEX certificates.
Acceptance by NOBEL CERT of the Request presented by the CLIENT depends on the positive result of the review of the request (application review result) itself by the competent NOBEL CERT personnel; then the Contract of certification is executed by NOBEL CERT.
This is followed by the planning phase of the activity by NOBEL CERT, with communication to the CLIENT the ways of the service provision.
NOBEL CERT does not guarantee in any way the positive result of the verification activity and, consequently, the issuance of the relevant ATEX certificate.
in cases which the client has urgent need and obligated for announcement the status of the certification progress to relevant interested parties, it may request NOBEL CERT to issue a statement for certification progress.
Note: statement of certification progress shall not announce in any way that the certification has been done and only shall include the progress of product testing and evaluation of technical documentation.
In the case in which subsequent Requests are presented for types similar to others already covered by EU type examination certificate or for variations to types already covered by EU type examination certificate, it is up to NOBEL CERT to judge, at its own discretion, if the documentation provided and the tests to which the product must be subjected can be reduced, as well as the extent of this reduction.
NOBEL CERT reserves the right to recognize documents issued by other certification bodies, namely certificates, declarations of conformity, test reports, reports attesting the conformity of the products.
If the product for which ATEX certification is requested has already been issued with a relevant NOBEL CERT voluntary certificate, NOBEL CERT reserves the right to define criteria of possible reduction of the tests according to the suitability of the tests and verification activities already carried out in a voluntary scope by NOBEL CERT.
3.2. EU type examination
3.2.1 Requested documentation
The technical documentation shall make it possible to assess the product’s conformity with the applicable requirements of normative references and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the product. The technical documentation shall contain at least the following elements:
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a general description of the product,
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the design, method of manufacture and operation of the product including a general description of the product,
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conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,
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descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the product,
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a list of the normative references and standards applied in full or in part the references of which have been published in the Official Journal of the European Union or IECEx standards on relevant website and, where those normative references have not been applied, descriptions of the solutions adopted to meet the essential health and safety requirements of this EU ATEX Directive, including a list of other relevant technical specifications applied. In the event of partly applied harmonized standards, the technical documentation shall specify the parts which have been applied,
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results of design calculations made, analysis and examinations carried out, etc., and
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test reports,
This documentation must be provided in Italian or English language; any other language is accepted only if this has been envisaged in the quotation phase.
for more details, please see I-O-20 (Guideline for preparation product technical file for ATEX certification)
3.2.2. Verification of Technical File
NOBEL CERT verifies that the Technical File complies to the applicable requirements of ATEX directive and applied normative references and standards relevant to the product.
If the Technical File examination ends with positive result, certification process continues to the following stages. If, instead, Technical File examination shows non-conformities with reference to requirements of ATEX directive and applied standard/s, or part of the documentation received results to be lacking or incomplete, NOBEL CERT informs in writing the Manufacturer and waits for resolution of non-conformities / integration of the same documentation.
Non-conformities related to documentation are classified in the following way:
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Major Non-conformity: evidence of non-conformity with reference to applicable normative reference and standard and/or lack of one of documents requested in technical file. Manufacturer must integrate the documentation before the beginning the product evaluation process;
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Minor Non-Conformity: requested documentation is available but is clearly incomplete or inconsistent to allow a complete product evaluation. Minor non-conformities are allowed to be solved during the process of evaluation and therefore the evaluation and verification activities are not required to be postponed.
Manufacturer has a three (3) months deadline to send to NOBEL CERT the missing documents, referred to major non-conformities. Otherwise, NOBEL CERT keeps the right to stop the evaluation process and ask the payment of all the activity carried out.
3.2.3. Verification of the product:
If the outcome of the assessment of the Technical Documentation is positive, NOBEL CERT carries out or arranges for the necessary examinations, checks and tests to be carried out following tasks:
3.2.3.1. examining the technical documentation, verifying that the specimen(s) have been manufactured in conformity with the technical documentation, and identifying the elements which have been designed in accordance with the applicable provisions of the relevant standards, as well as the elements which have been designed in accordance with other relevant technical specifications;
3.2.3.2. carry out appropriate examinations and tests, or have them carried out, to check whether, where the manufacturer has chosen to apply the solutions in the relevant standards, these have been applied correctly;
3.2.3.3. carry out appropriate examinations and tests, or have them carried out, to check whether, where the solutions in the relevant standards have not been applied, the solutions adopted by the manufacturer applying other relevant technical specifications.
Note: if the relevant accreditation body (ACCREDIA) requires to be present during any task of product verification to witness the activities, NOBEL CERT and the client are responsibile to agree with accreditation body's personnel and provide the appropriate conditions for an effective presence and without prior notice to the premises of the client, otherwise certification may not be issued or it may be suspended or withdrawn if such failure to meet obligations is persistent, unless for justified reasons.
3.2.4. Tests and controls
NOBEL CERT, if necessary, draws up a specific test protocol and communicates to the CLIENT the number of samples of the representative type of production envisaged which must be provided free of charge for the conformity test. NOBEL CERT can request other samples of the same type if necessary to carry out the test programme.
Prior to sending product sample/s by the client , sufficient number of photos , if needed video , datasheet and other technical information as needed must be sent by the CLIENT to NOBEL CERT till a control is done about conformity of the selected sample/s with the required type specification as well as checking conformity of the required preparation work (e.g. drilling on sample) on the sample/s which has been already requested by NOBEL CERT .NOBEL CERT agrees with the Customer on the location where the examinations and tests shall be performed.
At the end of the examinations and tests, NOBEL CERT draws up an assessment report listing the steps taken in accordance with 3.2.3.1 , 3.2.3.2 , 3.2.3.3 and the task of “agreeing with the manufacturer on a location where the examinations and tests will be carried out.” and the results thereof.
Without prejudice to its obligations towards the authorities, NOBEL CERT shall make the entire contents of the report, or part of it, public only with the agreement of the Customer.
3.2.5. Result of assessment
If the assessment has a positive result, the process will continue with the phase of Review and Final Decision (see par. 3.2.7 under) and, in case of positive decision, with the issue of an EU Type Examination certificate according to following provisions:
Where the type meets the requirements of the standards that apply to the product concerned, NOBEL CERT shall issue an EU-type examination certificate to the manufacturer. That certificate shall contain the name and address of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity and the necessary data for identification of the approved type. The EU-type examination certificate may have one or more annexes attached Whatever the outcome of the examination, NOBEL CERT keeps a copy of the documentation relating to the project, of the other documents attached to the application and of the results of the tests and checks carried out.
NOBEL CERT reserves the right to ask the manufacturer to keep the tested samples, or parts thereof, duly marked or sealed, at its premises.
In case of negative result, the two following situations may present:
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NOBEL CERT appointed personnel requests or carries out supplementary tests/verification activities. The costs to carry out the supplementary activities are understood as payable by the CLIENT and communicated through an appropriate quotation, according to the NOBEL CERT Price list in force or performed price analysis calculation; the process continues with the performance of supplementary tests/verification activities;
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situations have been identified for which the product cannot in any way be considered as conforming to the requirements of the applicable standard or it has not been not manufactured according to the Technical File and consequently it is not considered possible to proceed with the issue of the EU type Examination certificate. NOBEL CERT communicates the negative conclusion of the certification process to the CLIENT, requests payment for the activity carried out to this point and communicates such negative conclusion to the Competent authority , in the ways requested by the Competent Authorities.
3.2.6. Review and final decision on the issue of the Certification
The decision on the issuance of the all types of ATEX Certificates is taken NOBEL CERT decision making group,including NOBEL CERT managing director with at least one Ex decision making expert who is assigned among all apointed product evaluators and different from the evaluator/s who has been involved in evluation process of the relevant Ex product.
All the documentation relating to the conformity assessment activities carried out are analyzed by decision maker by assisting the technical expert which, based on the results contained in the aforesaid documentation, as well as any other relevant information, decides whether or not to issue the EU type examination Certificate. If the Certification is denied, NOBEL CERT communicates this decision in writing to the CLIENT, indicating the reasons.
In the event of an EU type examination Certification is not issued, NOBEL CERT shall inform the Competent Authorities of this negative outcome.
If the Certification is granted, NOBEL CERT issues the EU Type Examination or other type of ATEX Certificate (according to the certification module) to the Customer, which contains the following items:
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name and address of the manufacturer,
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the conclusions of the examination
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the conditions (if any) for its validity
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the necessary data for identification of the approved type
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one or more annexes attached Whatever the outcome of the examination
The EU-type examination certificate and its annexes shall contain all relevant information to allow the conformity of manufactured products with the examined type to be evaluated and to allow for in-service control.
NOBEL CERT keeps a copy of the documentation relating to the project, of the other documents attached to the application and of the results of the tests and checks carried out.
Regardless of whether it is issued at the same time as or after the OEM certificate, the certificate issued in the name of the OBL Manufacturer will have the same expiry date as the OEM Manufacturer's certificate.
If needed, During the period of validity of the certification, NOBEL CERT keeps a constant update on technological progress (defined as "state of the art") in order to verify whether the certified Type may cease to comply with the applicable requirements of the ATEX directive and product harmonized standards or specifications. If technological progress has a substantial impact on the conformity of the certified type, NOBEL CERT shall inform the customer.
3.2.7. Validity of EU type examination certificates and renewal
Upon occurring one of below situations, the EU type examination certificates, will no longer be valid:
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withdrawal of certified harmonized standard/s or normative reference or specification or EU directive;
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the modifications on certified product announced by the client and affects product conformity with the certification requirements as detected by NOBEL CERT
The costs for the renewal activities are intended to be borne by the Customer and communicated by means of an economic quotation.
The renewal activity shall include the detailed examination of the technical documentation of the type, considering:
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the current state of the art (technological progress) of the specific product;
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the standards which may be revised from initial certification period;
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the verification of the representative sample;
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if necessary, the repetition of the tests and checks on the product in relation to the result of the evaluation of the technical documentation.
4. OBLIGATIONS OF THE CLIENT
4.1. General Obligations of the CLIENT
The CLIENT is committed to:
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Prepare and make available to NOBEL CERT the required Documentation for the purposes of the relevant conformity assessment procedure.
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To inform NOBEL CERT the name and contact information of consultancy (person or company), if the client has enjoyed consultancy service to develop its product or production process.
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OBL Manufacturer agrees not to make any technical or documentary changes to the products supplied by OEM Manufacturer.
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ensure that the samples of certified product placed on the market bear the type identification number, batch, series, or any other element allowing their identification; ensure that, on the same samples, the Manufacturer's name, their trade name or registered trade mark and the postal address to which the Manufacturer can be contacted are indicated; ensure that the contact information is easily understandable for the end user and other interested parties relevant to certified product.
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ensure that the certified product put on the market is accompanied by appropriate instructions on safety, as provided by the applicable standard; ensure that these instructions are clear, understandable, intelligible, and written in an appropriate language to be easily understood by the final user;
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keep the conformity of the products which are subject to certification, with the requirements of the applicable regulations and / or stated in the relevant certificate; inform NOBEL CERT of any program of modification on certified product (both in terms of design changes and the characteristics of the product); in the group of changes, should be considered, as applicable, even those arising from changes in the harmonized standards and other technical specifications with reference to which conformity is declared;
Following applying any change by client that may affect the certificatrion, the below tasks must be done by NOBEL CERT and the client accepts to cooperate with NOBEL CERT for them.
1- giving notice of the change and deadline for implementation of necessary actions;
2- evaluating of implemented modifications; and
3- if necessary, performance of re-evaluation , review, decision making and reissuance of the certificate as per need.
4- payment of the relevant fees for above services to NOBEL CERT.
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keep the technical documentation and any approvals /certifications applicable for a period of at least 10 years from the date that the certificated product was placed on the market;
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where deemed necessary with regard to the risks associated to the certified product, in order to protect the health and safety of consumers, carry out a random test on a sample of certified product made available on the market;
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to inform received complaints regarding to the certified product to NOBEL CERT and to examine complaints related to the certified product; examine samples of certified product found not compliant; examine the recalls and / or withdrawals from the market, as related to the certified product;
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keep a record of such complaints, of such non-conformities and of such recalls / withdrawals from the market, as well as of the relative corrective actions; where required by NOBEL CERT, provide evidence of their management;
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If certified products placed on the market are considered or there is a good reason to believe that certified products placed on the market do not comply with the standards under which they have been certified, immediately take the necessary corrective actions to make them compliant, to withdraw or recall them; furthermore, where the product placed on the market presents a risk, immediately inform the relevant competent Authority and consumers in which the certified product in question has been placed on market, providing them with the details of non-conformities and related corrective action taken; in front of a request coming from a competent Authority or consumer, provide to such Authority/consumer with all the information and documentation, in paper or electronic format, as needed to demonstrate compliance of the certified product to the applicable standard; they shall be in an easily comprehensible language for such Authority; cooperate with that Authority, on the basis of its request, for any action taken to eliminate the risks presented by certified products placed on the market;
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do not make any statement or advertisement about their certification in a way they may be considered as misleading or unauthorized, or inconsistent with the field of application of the same certification, and not use their certification so as to bring discredit to NOBEL CERT;
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fulfill the requirements contained in the Regulations for the Use of NOBEL CERT certification Marks, as applicable;
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Interrupt the use of advertising material containing references to the certification, in case the same has been suspended, revoked or has expired;
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Reproduce in their entirety the certification documents, in case copies of them are provided to third parties;
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Return to NOBEL CERT the obtained original Certification, if any, in case it decides to transfer to another Body.
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if needed, to pay travel expenses of product evaluator personnel, which is announced by NOBEL CERT.
4.2. safety at work – obligation of notice
The CLIENT, according to the legislation in force on safety and accident prevention at work, undertakes to provide NOBEL CERT personnel and any accompanying persons with a full and detailed notice on the specific existing risks in the environment in which they will work.
If NOBEL CERT product assessors need to be present at the customer's place, The CLIENT also undertakes to promote, through its own person empowered for that purpose, the cooperation and coordination to implement the measures and actions of protection and prevention from risks at work, which affect the work activities of the product evaluators appointed by NOBEL CERT and of any accompanying persons, and which require the protection of workers and of all other subjects who work or in any case are present in the same work environment and according to any specific existing risks, will provide NOBEL CERT personnel and any accompanying persons with the appropriate personal protection equipment and will put in place any protection to allow the activities to be carried out in total safety.
The obligations of article 4, apply generally to the OEM, including OBL Manufacturers. A contractual agreement must be in force between the OEM and the associated OBL manufacturers, including the link between the OEM's products and OBL's products.
Manufacturer OBL (Own Brand Labelling): A natural or legal person who owns a product which has been designed and manufactured by another third-party Manufacturer, and markets it under his own name or trademark.
OEM (Original Equipment Manufacturer): a company that manufactures and sells products or parts of a product that their buyer, another company, sells to its own customers while putting the products under its own branding.
5. FINANCIAL TERMS AND CONDITIONS
5.1. Amounts due to issue and maintain the certification
The amounts due for the certification and if needed maintenance activities, where specified, together with the relevant payment conditions, are indicated in the Quotation as accepted by the CLIENT; this Quotation is set according to the fees indicated in the NOBEL CERT Price analysis in force and on the basis of the information provided by the CLIENT in the application form and attached product information.
The CLIENT is required to correctly communicate all the information requested during the application and prior to price analysis phase, in order to issue a Quotation without fault, as well as update NOBEL CERT on any modifications;
If occurs, on the basis of the product modified data prior to signing certification contract and even after it, NOBEL CERT assesses if it is necessary to review of the financial terms and conditions agreed and revising quotation or not.
For any new service which has been required after contract conclusion, which is not specifically set out in the Quotation, as well as any absence of the same, the amounts are indicated by a new price analysis will be applied.
5.2. Payment of fees due
Upon conclusion of the Service, NOBEL CERT issues and present to the CLIENT the EU type examination certificate, product test and evaluation reports, only on condition that all the fees due to NOBEL CERT have beenalready paid.
In case of failure to pay the fees, or in the event of non-fulfilment of the Certification Contract by the CLIENT, NOBEL CERT has the right to interrupt the Services at any moment, until the CLIENT has paid and/or remedied to its non-fulfilment.
6. SUSPENSION, REVOCATION OR RENUNCIATION OF THE CERTIFICATION
6.1. Renunciation of certification
If the CLIENT wishes to renounce to certification issued by NOBEL CERT, it must make a written request for this. This communication automatically cancels the relevant surveillance activity if conducted by NOBEL CERT; in this case the client must do the followings:
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stop attaching the certification mark and, in any case, making reference to NOBEL CERT as PCB;
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communicate within a term no longer than fifteen (15) days from the renunciation date, the stock in the production sites and warehouses of the products which show reference to NOBEL CERT as PCB
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use up said products in own production sites or warehouses within the term, following the expiry date, which will be indicated by NOBEL CERT.
It is understood that, following the renunciation, the CLIENT must in any case guarantee to NOBEL CERT, within 6 months of the renunciation, the possibility of carrying out an audit at the production sites and warehouses, if needed by NOBEL CERT, in order to gather the necessary evidence in relation to stocks and products placed on the market. Any costs and expenses of such possible audit shall be borne by the CLIENT.
NOBEL CERT cancels the issued Ex product type certificates, as per informing the competent Authorities for renunciation, in the ways requested by Competent Authorities.
Following the withdrawal of an OEM certificate, the revocation measure will also be applied to the derived certifications relating to associated OBL Manufacturers.
It is understood that in the case of waiver by the OEM, the OEM retains full responsibility for managing its contractual obligations with associated OBL Manufacturers, releasing NOBEL CERT from any liability related to such contractual obligations.
Following the waiver, NOBEL CERT will be relieved of the obligation to inform the Customer of any technological progress and to carry out any further investigations concerning the certified products.
6.2. Suspension of surveillance activities and/or of the validity of Certification
6.2.1 Motivations to suspend certification
The EU Type Certificates may be suspended by NOBEL CERT following non-compliance by the Customer in the following cases:
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failure of the Customer's business;
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failure to communicate changes to the organizational structure within the terms provided for in article 4.1 (last paragraph);
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non-payment of the amounts due to NOBEL CERT;
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non-fulfilment of the Customer's obligations under article 4 above;
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failure to take corrective action;
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alerts from the market, after assessing their seriousness;
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refusal by the Customer to carry out further investigations and/or take appropriate measures in relation to the evolution of technological progress communicated by NOBEL CERT.
The validity of the EU Type Certificate issued by NOBEL CERT to an OBL Manufacturer is automatically suspended if the relevant OEM Manufacturer's certificate is suspended.
It is understood that, in the event of suspension by the OEM, the OEM retains full responsibility for managing its contractual obligations with the associated OBL Manufacturers, releasing NOBEL CERT from any liability related to such contractual obligations.
In particular cases (e.g. a report from the market of proven seriousness) a suspension that primarily concerns an OBL Manufacturer can be automatically extended also to the relevant OEM, as well as to any other associated OBL.
6.2.2 Communication of suspension
The suspension of the certification and any restoration of it are communicated to the CLIENT. The communication shows the reason for the suspension and expiry dates by which the CLIENT must implement the corrective actions requested. The CLIENT has five (5) days in which to communicate to NOBEL CERT of having taken charge of the provision, adaptation to requirements, implementation times, which must not be longer than six (6) months, and any other useful information on the solution of the findings disputed. The communication must occur in written form. The suspension will consider the principle of proportionality.
6.2.3 Consequences of suspension
Following the suspension, the CLIENT must interrupt the use of the Certificate and abstain from publicizing them until the end of the suspension period. The suspension implies the impossibility of attaching the certification mark and the consequent impossibility to put the related products on the market, starting from the suspension date.
NOBEL CERT shall suspend the Certification issued and inform the competent Authorities of the suspension in the manner provided by the competent Authorities.
In the most serious cases, NOBEL CERT reserves the right to request the CLIENT to recall products from the market, including those stocked in warehouses.
The expenses borne by NOBEL CERT to carry out any verification activities or activities caused by suspension are paid by the CLIENT.
The CLIENT is in any case required to pay the amounts to restore and maintain the certification.
6.2.4 Restoring certification
The suspension can be cancelled only when the CLIENT has satisfactorily resolved the Non-Conformities found or in the case in which the situation which gave way to the suspension has been resolved.
Before proceeding to restore the certification, NOBEL CERT can carry out further verification activities to ascertain the actual resolution of the issues previously found; all the expenses for these additional verification activities are borne by the CLIENT.
6.2.5 Duration of suspension period
The suspension cannot exceed six (6) months, if the suspension is not cancelled within this period of time, the certificate is revoked.
6.3 Revocation of certification
6.3.1 Motivations for revocation
The EU Type Examination issued can be revoked by NOBEL CERT in case of:
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failure to remove the causes of suspension within the period indicated by NOBEL CERT;
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Serious breach of the Customer's obligations;
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fraudulent or unlawful use of the Certificate;
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adoption of significant changes made to the product by the Customer, without the prior involvement of NOBEL CERT;
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non-payment of the amounts due, for any reason, to NOBEL CERT. In this case, before proceeding to revoke the certificate, NOBEL CERT shall send the Customer a communication entitled "notice of revocation"; fifteen (15) days after this communication has been sent, without the Customer having paid the amounts due, the certificate shall be revoked. During this period of notice, all the verification activities are suspended, as in the case of suspension;
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bankruptcy or cessation of business of the Customer;
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failure to adapt the product and the technical documentation in relation to the technological progress evidenced by the revision of the Standards / Technical Specifications.
6.3.2 Consequences for revocation
In case of revocation of the Ex product type examination certificate, the Customer is obliged to perform or paying attention to the followings:
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stop to affix the certification mark on products referable to the revoked Certification and, consequently, cease marketing it;
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refrain from advertising and using the withdrawn Certifications, removing any NOBEL CERT references from the products and documentation in use;
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pay the balance of all amounts due to NOBEL CERT.
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The revocation of the Ex product type examination automatically involves the cancellation of the relative surveillance activity, if carried out by NOBEL CERT.
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In the presence of OEM and associated OBL manufacturers, a revocation order affecting an OEM also results in a revocation for associated OBL.
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It is understood that in the event of withdrawal by the OEM, the OEM retains full responsibility for managing its contractual obligations with associated OBL Manufacturers, releasing NOBEL CERT from any liability related to such contractual obligations.
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NOBEL CERT communicates the revocation measure to the competent authorities in the manner established by the competent authorities.
The conditions that will cause the certificate is terminated, suspended, withdrawan or scope reduced and the actions that NOBEL CERT will take after the occurrence of the mentioned situations, are described in the procedure of P-O-13.
7. LEGISLATIVE, LEGAL AND REGULAMENTARY VARIATIONS
7.1. Modifications to the legislative provisions and/or reference laws
If important variations affecting the validity of the issued EU type examination Certificate, are introduced in the legislative provisions (ATEX directive) or in the relevant EU harmonized standards, which provide the presumption of conformity to the requirements of the specific product standards, NOBEL CERT will give communication of this to the CLIENT.
The client will have the right to adapt its products, within the indicated terms, or renounce the certification.
In case the CLIENT intends to adapt to the new provisions, NOBEL CERT will be entitled to repeat the tests and verification activities on the products assessment, as also to request new documentation. The expenses for said activities will be charged to the CLIENT, according to a new quotation.
7.2. Modifications to the Regulation and/or to the General and Special requirements
In the case in which the requirements applicable to the certification activity, contained in standards (e.g. ISO /IEC 17065) and/or in other specific documents (e.g. applicable accreditation rules), are subject to variations, NOBEL CERT can update the procedure described above to transpose the new provisions.
NOBEL CERT also reserves the right to make modifications and integrations to this NOBEL CERT Regulation without the preventive agreement of the CLIENT; in this case, NOBEL CERT will communicate the change of the Regulation by a notice to the CLIENTs and/or through publication on its website.
7.3. Supplementary assessments following modifications
Any costs for documental assessment activities and/or assessment activities at the place of work, deriving from modifications to laws or to regulations above are borne by the CLIENT.
8. LIMITS TO CERTIFICATION AND RESPONSIBILITY
8.1. Liability of The CLIENT – to Hold Harmless
The CLIENT undertakes to comply with and maintaining compliance with mandatory requirements, such as laws, regulations, etc., of an international, national or local level, with particular regard to the products inside the scope of certification.
The issue and maintenance of the certification do not constitute attestation or guarantee by NOBEL CERT of conformity to the compulsory requirements that weigh on the CLIENT and, in general, of the legislative conformity of the latter.
Therefore, the CLIENT is - and remains - the only responsible party towards himself and towards third parties of the correct activity and conformity of the same, and of its products/services, to the applicable standards as well as to the expectations of the CLIENTs and third parties in general.
The CLIENT also undertakes to hold harmless NOBEL CERT and its employees, assistants and collaborators against any complaint, action and/or claim of third parties connected with activities performed by NOBEL CERT according to this Regulation.
8.2. NOBEL CERT Breach – Limits of responsibility
NOBEL CERT can be held responsible by the CLIENT only for damages following willful misconduct or gross negligence.
8.3. Forfeiture clause
Any complaint or claim for damages against NOBEL CERT must be brought by the CLIENT, on pain of forfeiture, within and no later than one (1) year from the event which has given way to the claim or to the complaint.
9. Obligations of NOBEL CERT
(a) NOBEL CERT shall make publicly available information about the status of EU type examination certification that it has granted the certified product and relevant organization. The information shall be updated regularly. The information shall include the following:
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Name and location of the certified client
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Certified product and type/s
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Certification standard
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Dates of granting certification and expiry date as applicable
(b) NOBEL CERT shall give due notice of any changes to its requirements for product certification including those are relevant to product standards, management system for product certification and local rules and regulations relevant to the product applied for certification.
It shall take into account the views expressed by interested parties before deciding on the precise form and the effective date of the changes.
Following a decision on, and publication of the changed requirements, NOBEL CERT shall verify that each certified client carries out necessary adjustments.
Following changing any requirement relevant to certificatrion such as NOBEL CERT, ATEX directive , relevant harmonized standards and the other relevant normative references, the below tasks must be done by NOBEL CERT and the client accepts to cooperate with NOBEL CERT for them.
1- giving notice of the change and deadline for implementation of necessary actions;
2- evaluating of implemented modifications; and
3- if necessary, performance of re-evaluation , review, decision making and reissuance of the certificate as per need.
c) NOBEL CERT shall ensure that the Product Certification to all clients is provided independently, impartially and in a non-discriminatory manner.
The policies and procedures under which NOBEL CERT operates the certification services are non-discriminatory and are administered in a non-discriminatory manner.
d) Appeals: Client shall appeal to NOBEL CERT mainly, in respect of the following,
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Non acceptance of client’s application for product certification and
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Granting, suspending, withdrawing or denying of product certification
