Nemko Scheme requirements

 

PRODUCT TESTING, INSPECTION AND CERTIFICATION 

 

S E R V I C E   D E S C R I P T I O N 

 

 

Introduction 

 

Nemko’s provision of testing, certification, market access, and other independent third party Conformity Assessment Services (“the Services”) to Customer are governed by these Nemko Scheme Requirements (“the Requirements”). The Requirements supplement the requirements set out in the agreed test or certification scheme or standard (“the Schemes”), set out basic expectations to Customer and include provisions that are deemed necessary for Nemko to comply with applicable accreditation or scheme requirements and to safeguard Nemko’s integrity, impartiality and independence.  

All references to Nemko shall be understood as references to the Nemko Group Legal entity which is party to the service agreement with Customer (“the Agreement”).  

Nemko and Customer are hereinafter referred to as Party in singular and Parties in plural. 

 

The Services 

Nemko shall provide the Services in accordance with the agreed Scheme. Unless otherwise agreed in the Agreement with explicit reference to this provision, Nemko’s quotations are based on a successful conformity assessment – ie that the Product or system are found to meet the applicable requirements. Any circumstances that require mitigation or repeat testing/examination will trigger additional costs which shall be covered on a time and materials basis based on standard hourly rates unless otherwise agreed. 

Unless otherwise explicitly agreed between the Parties, all agreed or estimated progress plan(s) for the provision of the Services are based upon the assumption that Customer provides the necessary Materials, information and accesses in a timely and structured manner. In case of Customer’s delay, the progress plan or estimate will as a minimum be extended correspondingly. Nemko reserves the right to further extensions, taking into account other assignments which collide with the Services due to the delays. 

 Unless it is explicitly agreed as part of the Services that Nemko shall identify discrepancies, errors, inconsistencies or omissions in the Materials. Customer is responsible for all aspects of the Materials, including the Product. Nemko is entitled to rely on the accuracy and completeness of the Materials in the performance of the Services. 

 Nemko does not undertake any fitness for purpose obligations. Neither does Nemko make any representation or warranty that the outcome of the Services is that the Product is actually and eventually deemed to meet the requirements set out in the Schemes. In case the conclusion of the agreed process and assessment is that the requirements in the applicable Schemes are not met, certificates will not be issued. Customer may then if deemed relevant, order further testing and assessment as additional work. Nemko’s conclusion and a brief explanation may be provided in a report, if requested by Customer. 

 International Approval or market access support work is undertaken on a best effort basis. Nemko is not in a position to undertake an obligation of result, and reserves the right to stop the project in case of unacceptable risk for Nemko or its personnel, or in case of integrity challenges.  

 Nemko’s certification decisions are based on documentation established by Nemko itself or by other conformity assessment bodies, in accordance with the requirements set out in the applicable Schemes.  

 Customer shall familiarize itself with any draft or final gap-analysis, report, attestation, certificate, training materials or other agreed deliverable (“Deliverable”) issued within a reasonable time after completion of the corresponding part of the Services.  

 The testing or certification of a Product do not release Customer from its responsibility for the compliant design, production, marketing, sale, labelling, distribution, transport, use or other aspects of the Product and its commercialization. Neither does the testing or certification directly or indirectly represent or imply a transfer from Customer to Nemko of the risks or liabilities arising from or in connection with the design, manufacture, distribution, use or other aspects of the Product and its commercialization. 

 Unless otherwise instructed by the Applicant, as defined in the relevant quote, solely the Applicant shall have access to the project documentation, deliverables and results.

 

 Issuance, use and maintenance of certificates and other Deliverables 

 Upon completion of the Services, Nemko may at its own discretion issue a Certificate, attestation, report or other Deliverable to the Customer, provided Nemko finds that there is satisfactory evidence of conformity with the applicable requirements, and provided that fees and licenses are paid by the Customer in accordance with the Agreement.  

 Payment of all dues, including regular licenses, is a condition for the issuance and maintenance of all Certificates and reports.  

 Subject to payments being made by Customer in accordance with the Agreement, Customer shall have the right to use valid Certificates with pertaining product marks and labelling in standard size and design as provided by Nemko for the purposes for which such Deliverables are generally intended and used, including on letters, documents and other promotional material, in accordance with the applicable requirements.  

 The Deliverables, including certificates, attestations and reports, shall solely be used in connection with products that are manufactured in total conformity with the tested or certified design.  

 Customer shall not adjust or alter the Deliverables in any manner whatsoever, including, but not limited to, by translating the document. 

 In case of misleading use of Deliverables or marks, or other breach of the applicable requirements for the maintenance and use of the Deliverables and marks, Nemko may at its own discretion decide to take unilateral corrective actions, including suspension or withdrawal of Deliverables, publication of the transgression and complaint to relevant authorities. Customer shall immediately implement such corrective actions, regardless of whether they are disputed or not. 

 

 Customer’s reporting throughout validity period of a certificate 

 Customer shall without undue delay report to Nemko all facts and circumstances which may reasonably affect the assumptions for issuance or validity of the Certificate. Customer shall inform Nemko of all quality cases, changes to the quality management systems, modifications of the production processes, customer complaints, manufacturing problems, identified deficiencies in the Products, major incidents, changes of key personnel, any proposed product alteration etc, which concern the Products covered by the certifications, insofar they may be relevant for the validity of the Deliverable concerned. Nemko may verify that the Customer has taken relevant corrective actions for the recorded complaints in conjunction with routine or extraordinary audits or inspections, as permitted under the applicable Scheme.  

 The Customer is obliged to ensure that a record of all complaints made known to it relating to compliance with the Schemes and subsequent actions taken with respect to such complaints, as well as of any deficiencies found in Products that affect compliance with the applicable Schemes, is maintained by all parties to the manufacture of the Product. The records shall be available for inspection by Nemko representatives at all times. 
 

Customer shall immediately notify Nemko in writing if Customer discovers or has grounds to suspect that the Product has subsequent to certification been found to be potentially hazardous, or that it has been or may have been the cause of personal injury or property damage. In cases where the results of examination by an agency other than Nemko were relied upon by Nemko for certification of the Product, Customer shall notify Nemko if Customer subsequently discovers said results to be invalid. 

 Upon learning, from any source, that any Products covered by a certificate did not comply with the applicable Schemes at the time that such Products left Customer’s control, Customer shall immediately notify Nemko. Further, the Customer shall promptly, at its own expense, take all reasonable or mandatory steps to rework, recall, remove the certification mark from, or destroy, all such Products, notwithstanding that such Products may have been delivered to or are being held on behalf of a wholesaler, dealer, retailer or consumer, or that title to such individual Product has passed from Customer. Customer’s obligations shall be limited to using its best efforts, in good faith, to secure the voluntary return or destruction of such Products or the voluntary removal of the certification mark by such distributor, wholesaler, dealer, retailer or consumer. 

 Customer shall upon request provide Nemko with a new test report or a sample of a certified product for the purpose of re-examination and testing in case there are substantiated grounds to believe that the product does not meet the applicable Schemes, or in case there is in Nemko’s sole discretion a need to verify that the product remains in accordance with the certified design. The documented costs of this shall under any circumstances be covered by Customer on a time and materials basis, applying standard hourly rates. 

 Customer shall take necessary action in case of any non-conformities, observations, improvement opportunities and noteworthy efforts reported by Nemko in connection with onsite visits.  

 The certificate may only be transferred from Customer to another legal entity if (i) Customer documents that the transfer of the certificate does not imply any changes in the product, the production or other assumptions which form the basis for Nemko’s issuance of the certificate, and (ii) that the other legal entity signs a certification agreement with Nemko. 
 

Audits and inspections 

 Customer shall ensure that all mandatory audits and inspection requirements are complied with. 

 In cases where the maintenance of a valid certificate or other Deliverables depends on specific requirements, as described by the applicable Scheme, Nemko may at its sole discretion carry out or have carried out unscheduled visits of Customer and its production sites when in Nemko’s sole discretion it is determined necessary to verify that the conditions for maintaining the Deliverable concerned are met. Customer shall upon request provide immediate unrestricted access to all sites, suppliers, personnel, devices, documentation and other assets as requested by Nemko, to Nemko and any representatives of the relevant accreditation or governmental body, to the extent required by the scheme concerned.  

 

Suspension or withdrawal 

Nemko may at its sole discretion suspend or withdraw the certificate if in Nemko’s view the requirements for maintenance of the certificate are not met, or in case Customer does not pay any applicable annual license/subscription fee.  

 The decision to suspend or withdraw shall be in writing and shall outline the factual basis for the action taken. 

 Nemko shall provide Customer with a reasonable notice in advance in case it is contemplated to suspend the certificate due to delayed payment of the applicable fees.   

 If a Deliverable is suspended or withdrawn, the Customer shall not use, make available or refer to the Deliverable, regardless of whether the basis for suspension or withdrawal is contested or appealed or not. Further, the Customer shall ensure that all other active use of the Deliverable, regardless of technological platform, shall cease with immediate effect.  

 

Appeals against grant, suspension or withdrawal of certification 

 Nemko’s decisions to grant, suspend or withdraw certification may, to the extent required by the applicable accreditation, be appealed by Customer to Nemko’s Appeal Committee in writing within 3 weeks from the time the Customer has received Nemko’s written decision. The appeal shall be submitted to the Nemko Party concerned.  

 Developments of applicable Schemes and industry practices 

 Customer shall maintain updated knowledge of all applicable Schemes and relevant industry practices, when relevant under the applicable requirements. 

  Unless explicitly agreed in writing, and regardless of anything to the contrary in Schemes concerned, the Agreement does not imply any obligation or duty of care for Nemko to inform the Customer of developments in the applicable standards or industry practices taking place after the issuance of the Deliverables. However, when required in the applicable Schemes, Nemko will provide information on a best effort basis. 
        

Marking, labelling and advertising 

 When a certificate is issued, the Customer is granted a non-exclusive, non-transferrable, non-assignable license to represent the Product as certified by Nemko and to use the assigned certification mark, if any, in the manner set forth in the associated certification documents. The Product shall be represented as certified only if it is marked as set forth in the Scheme concerned. 

 Labels shall not contain the Scheme certification mark without the prior knowledge and written general or specific consent of Nemko. 

 Customer’s authorization to use the Scheme certification mark may be withdrawn by Nemko for failure to comply with any part of the Agreement. In such case, for Products in production and in stock, Nemko may require removal of the Scheme certification mark or label, or require that the product be made to comply with Nemko’s requirements. For products already shipped, Nemko may require recall of the Product concerned for either removal of the certification mark or label, or for reworking of the Product so that the Product is made to comply with the applicable requirements. 

 Customer shall be entitled to use appropriate references to Nemko or the text set out in the certification documents, in communication media such as advertising or promotional material solely in connection with the specific Products that bear the Scheme certification mark, provided that in the sole discretion of Nemko the materials comply with the requirements of Nemko and the certification scheme concerned. Materials shall in no way use the product certification issued by Nemko to create an impression as to the nature of Nemko’s findings, coverages or Service that is misleading, or otherwise may bring Nemko into disrepute.  

 Upon suspension, withdrawal or termination of certification, regardless of reason, and regardless of whether there are pending disputes between Nemko and the Customer, the Customer shall forthwith cease the use of any certification marks, certificates and labels.