Nemko Scheme Requirements
PRODUCT TESTING, INSPECTION AND CERTIFICATION
Service description
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.
Additional scheme-specific requirements may apply.
Nemko Legal Terms
1. Confidentiality & release of information
a. Nemko shall apply market standard efforts to safeguard the confidentiality of any information it receives from the other Customer, Applicant or Customer’s representatives in connection with the provision of the Services.
b. Customer shall ensure that instructions are issued, when relevant directly from Applicant, to Nemko in case Customer requests that Nemko shall disclose information to any third parties. Third parties in this provision includes any other legal entities than Customer and Applicant, including but not limited to, any Customer’s and Applicant’s parent companies, affiliates, subsidiaries, shareholders or subcontractors. The instruction shall identify in detail which information shall be released.
c. Unless otherwise instructed by the Applicant, solely the Applicant shall have access to the project documentation, deliverables and results.
d. If Nemko is instructed to release information to a third party, the Customer shall hold Nemko harmless from any claims towards Nemko from the recipient party which exceed the limitation of liability provision included in the applicable terms and conditions, in case of full or partial reliance on the reports concerned. The obligations set out in this provision shall not apply to the extent the information is required to be disclosed by any relevant accreditation body or certification scheme owner, any competent court, governmental agency, or other relevant public authority in accordance with applicable law, court order or other public regulation.
e. In addition, information shall not be considered confidential to the extent it: (i) was known to the recipient prior to the information being disclosed by the other party, (ii) becomes known to the recipient through a third party without known confidentiality obligations towards Customer; (iii) is or becomes generally available in the public domain through no act or failure to act on the part of the recipient, or (iv) is in the professional discretion of Nemko as an independent conformity assessment body, necessary to issue a warning to the public regarding safety or use.
f. These confidentiality obligations shall survive the completion of the Services, termination of the Agreement or termination, suspension and withdrawal of certification, and remain in effect for as long as the relevant information can reasonably be deemed to be confidential information according to this Agreement
2. Intellectual Property
a. Customer warrants that it has the necessary authority to grant Nemko the right to use, amend, process and store all information provided and give Nemko access to all materials, documents, equipment, products and specifications for the purpose of the Services, regardless of format. Further, Customer warrants that it has acquired the necessary rights to use the standard(s) concerned from the relevant standardization body or other authorized source, and acknowledges that this constitutes an assumption for Nemko’s provision of the Services.
b. Each party shall remain the sole owner of any of its intellectual property and rights thereto existing prior to the date of the Agreement. In particular, Nemko shall remain the owner and hold all rights to the Nemko schemes, protocols, checklists as well as templates for attestations, certificates and reports.
c. Nemko shall hold all intellectual property rights to the reports and certificates issued to Customer under the Agreement, including the copyright.
d. Customer or Applicant, as relevant, shall hold a restricted, non-transferrable, global and royalty free license to use the valid reports, certificates, attestations, certification marks and labels in accordance with the applicable requirements.
e. Nemko shall be entitled to collect, store, process and use for conformity assessments as well as maintenance and updates of its schemes and systems, the know-how acquired in the course of the performance of the Services. In addition, Nemko shall be entitled to use materials received or generated under the Agreement in an anonymous and aggregated form, for its internal training and competence building related to the independent third party conformity assessment role, always subject to the confidentiality obligations set out in these Requirements.
f. Any reports or certificates shall only be made available in their entirety without altering the content, context or original language of the Deliverables.
3. Integrity and allocation of Nemko’s personnel
a. Appropriate personnel shall be appointed for the performance of the Services, in accordance with any applicable accreditation requirements. Unless otherwise agreed, substitute personnel may be assigned to the Services, at any time, and without extra cost and risk for Customer. Substitute personnel shall be suitably qualified and competent.
b. Nemko shall have the right to subcontract the Services under the Agreement fully or partially to any other duly qualified and competent companies in Nemko Group.
c. Nemko may, at own cost and risk, extend the team performing the Services with observers for purposes such as training, peer evaluations and mandatory supervision by accreditation bodies, scheme owners, notifying authorities and similar stakeholders in independent third party services.
d. Nemko shall be informed without undue delay of (i) any actual or potential Health, Safety and Environmental risk which Customer is aware of and which is reasonably relevant for the performance of the Services, and (ii) any of Customer’s implemented or planned measures against such risks that Customer requires Nemko’s personnel to adhere to.
e. Nemko’s personnel shall be given unrestricted, necessary access to the relevant sites in order to perform the Services. The right of Nemko to obtain free and unrestricted access shall not be conditional upon the execution by the representative or Nemko of any agreement, waiver or release which in any way affects the representative's or Nemko’s legal rights or the rights or obligations. Any such document executed in contravention of this provision shall be without force or effect.
f. Whenever Nemko’s performance of the Services involves visits on Customer’s controlled facility or site, the Customer is responsible for the adequacy, stability, safety and legal compliance of the Customer environment, including reasonable measures to mitigate or control relevant risks. Whenever Nemko personnel is present on Customer’s facilities or sites, they shall adhere to Customer’s reasonable HSE instructions provided in reasonable time before the visit. Nemko’s personnel, including also its subcontractors, may refuse to carry out any activity, or visit any area or site, if in their sole discretion they consider that relevant risks are unacceptable or not adequately addressed, contained or otherwise mitigated.
4. Risk distribution
a. Nemko shall not in any way be liable towards the Customer for any of the Customer’s consequential or indirect losses arising from or in connection with this Agreement or the performance of the Service, including but not limited to interruption of loss of use, business, contract or revenue, loss of goodwill, loss of profit or anticipated profit, loss of production, delayed market access, wasted overhead, cost of substitute equipment, recall costs, downtime costs, product liabilities or other special, punitive or other forms of indirect losses, howsoever they may arise, whether under contract, tor (including negligence), strict liability or otherwise.
b. Except in case of fraud, fraudulent misrepresentation, or other similar circumstances for which a Party may not lawfully limit its liability under this Agreement’s applicable law, the maximum cumulative liability or indemnification obligations of Nemko arising from or in connection with this Agreement, whether in contract, tort (including negligence) or strict liability shall be limited to three times the fee agreed for the Services concerned, or 100.000 USD, whichever is the lesser.
5. Force majeure
a. Neither party shall be in breach of the Agreement, nor liable for any failure or delay in performance hereunder if the cause of such failure or delay is attributable to events beyond reasonable control of the affected party, including but not limited to armed conflict terrorist attack, civil war, riots, toxic hazards, epidemics, pandemics, natural disasters, extreme weather, fire, explosion, failure of utility service, labour disputes, breakdown of infrastructures, including outages or disruptions in telecommunications systems and similar, cyber-attacks despite market standard preventive and mitigating actions having been taken, sanctions, or any public restrictions following any of the incidents above; or any other incidents beyond reasonable control (Force Majeure).
b. In the event of a force majeure occurrence, the affected party shall notify the other party without undue delay of the particulars of the situation. Either party shall be entitled to terminate the Agreement with immediate effect should the force majeure endure for more than 60 calendar days.
c. In case of unavailability of personnel due to force majeure events, the Parties shall use best efforts to identify a solution for audits to take place, including increased use of digital tools.
6. Law and jurisdiction
a. This quotation and the provision of the Services shall be governed and construed in accordance with the laws of the Nemko legal entity which issues the quotation, without regard to principles of conflicts of law.
b. Any dispute arising in relation to or as a consequence of this quotation or the Services concerned, which cannot be settled amicably through negotiations between the parties, shall be brought exclusively before the courts of this Nemko legal entity.
In particular, the following risk distribution provision shall be applicable:
• Nemko shall not in any way be liable towards the Customer for any of the Customer’s consequential or indirect losses arising from or in connection with the Agreement or the performance of the Service, loss of profit or anticipated profit, loss of production, delayed market access, wasted overhead, cost of substitute equipment, recall costs, downtime costs, product liabilities or other special, punitive or other forms of indirect losses, howsoever they may arise, whether under contract, tor (including negligence), strict liability or otherwise.
• Except in case of fraud, fraudulent misrepresentation, or other similar circumstances for which a Party may not lawfully limit its liability under the Agreement’s applicable law, the maximum cumulative liability of Nemko arising from or in connection with this Agreement, whether in contract, tort (including negligence) or strict liability shall be limited to three times the fee agreed for the Services concerned, or 100.000 USD, whichever is the lesser.
Pricing, Invoicing & Late Payment
1. Testing and/or evaluations will be scheduled upon receipt of signed quotation and product documentation including the populated Additional Project Information (API) and/or Equipment Under Test (EUT) form. Any prepayment must be received prior to commencement of any testing.
2. Products are required for testing. Products, including supporting equipment (documents, cables, adapters, etc) and software needed to put the equipment into proper test modes, must be received in reasonable time before the scheduled start date for the Services. Additional costs may incur if samples or documentation are delivered after the scheduled start date
3. All critical components shall have the appropriate agency certification marks consistent with the Services.
4. Lead times are non-binding and are provided under the assumption that all documentation and Products required have been provided.
5. Unless otherwise stated, the quotation assumes that the EUT and support system provided by the Customer do not require extraordinary electrical power, the use of pressurized air >100psi, extreme heat, toxic gases/chemicals, nor any hazardous/unstable materials.
6. The requested radio frequency ranges and application in all listed countries cannot be guaranteed unless a dedicated pre-investigation is ordered.
7. Unless otherwise agreed, all user manuals and product documentation shall be in English.
8. Unless otherwise explicitly stated in the quotation with reference to this provision, the following activities shall under any circumstances be deemed to represent additional services, which will be charged on a time and materials basis, or based upon a standard fee:
a. Re-testing or re-examination after the test covered by the initial test scope has failed
b. Unannounced/Unscheduled audits
c. Work associated with the closing of non-compliances identified during audits or inspections
d. Issuance of hard copy test reports rather than digital reports. In such case, a standard fee of 300 Euros per individual copy shall incur.
9. Nemko reserves the right to officially terminate the Agreement and the project after 60 days of inactivity and invoice for the work performed. When the Customer is ready to continue the project, a new quotation will be issued.
10. Nemko reserves the right to invoice line items as they are completed prior to overall project completion. Note that report items will also be invoiced when draft reports are issued and awaiting comments from client.
11. Market access may depend on testing, certification, inspection and agency services provided by third parties and needed for the purpose of market access in the countries concerned. Unless explicitly stated in the quotation, these services and the corresponding cost are not covered by this quotation. Market access may depend on separate agreements being signed between customer and these third parties.
12. The IA services are provided 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 substantiated unacceptable risk for Nemko or its personnel, or in case of integrity challenges.
13. The issuance and maintenance of a certificate, may be dependent on payment of an annual fee or license, as well as onsite inspections. The annual license fee for the year of the quotation will be calculated from the month when the certificate is granted. The estimated license fee is included in our prepayment invoice. If there is any difference between actual due annual license fee and the prepaid annual license fee, an invoice/credit will be issued upon completion of project.
14. Nemko reserves the right to invoice line items fully or partially as they are completed prior to overall project completion, or in case the project takes more time than planned Note that report items will also be invoiced when draft reports are issued and awaiting comments from client
15. Customer may terminate the Agreement with Nemko reserves the right to charge incurred costs and lost revenue in case of customers late cancellations relative to the service quoted.
16. If the Customer has any objections to the invoice, such objections must be made in writing to Nemko within 14 days after receipt of the invoice. The Customer accepts that objections to the invoice raised later than 14 days after receipt of the invoice are considered time-barred. The Customer is not entitled to offset any amount owed to Nemko against amounts owed to the Customer.
17. Payment of invoices shall take place within 30 days from issuance.
18. Without prejudice to any other right or remedies, if the Customer fails to pay Nemko on the due date, Nemko may;
19. Charge interest on such sum from the due date of payment at the monthly rate of 1,5%, accruing on a daily basis and being compounded monthly until payment is made; and
20. Suspend all services until payment has been made in full. Notwithstanding any such suspension of the services, the Customer shall pay Nemko for all rendered services by Nemko up to the date of suspension, plus all documented interest and suspension costs and expenses incurred by Nemko; and reimburse Nemko for all costs and expenses of collection of the invoiced amount, including reasonable legal fees