CECertificationContract合同認(rèn)證樣板

1、CE Certification Contract 合同認(rèn)證樣板CE Certification ContractCE 認(rèn)證合同Consignor (first party) 托付方(甲方)全稱：Venue 簽訂地點(diǎn)：City(Cou nty)市Date簽定日期： Year年Month月Date日C ertification Center(the second party)認(rèn)證方(乙方)全稱：ITC ASI A Co., LtdVenue 簽訂地點(diǎn)：City(Cou nty)市Date簽定日期： Year年Month月Date日Registration Number Of Contract 合

2、同登記編號(hào) :一 Content and Scope 合作的目的、內(nèi)容和范疇1. The second party shall perform conformity assessmentfor CE mar king to the applied products. The objective of conformity assessmentis toevaluate the compliance with the requirements of the MDD 93/42/EEC d irectives and applicable conformity procedure. 乙方按照甲方提

3、出的申請(qǐng)對(duì) 甲方的產(chǎn)品依據(jù)MDD 93/42/EEC歐盟指令，按照有關(guān)程序進(jìn)行合格評(píng)定。2. The type and model of product in CE product certification:甲方申請(qǐng) CE 認(rèn)證的產(chǎn)品描述(包括產(chǎn)品的型號(hào)、商標(biāo)、規(guī)格) ：二 Assessment fee and terms of payment 費(fèi)用及付款方式1. The CE conformity assessmentfee is RMB. CE 合格評(píng)定費(fèi)為 RMB。2. The first party should disburse from conformity assessment

4、fee (Se e Clause 2.1) RMB within three working days after the contract signed. The second party should carry out the assessmentafter reception of the f ee.Once CE conformity assessmentfinished, the second party shall send the copy of the certificate for verification by first party with invoice. Af t

5、er verification the first party should pay the all rest assessmentfee （See Clause 2.1） RMB to second party within three working days. Second part y should send the original certificate after reception of that amount.在簽訂合同后三個(gè)工作日內(nèi)，甲方向乙方預(yù)付合格評(píng)定費(fèi)中的 （即第二 條第一款 ） RMB ，在收到相應(yīng)的款項(xiàng)后，乙方開始認(rèn)證工作；在 CE 評(píng)審合格后， 乙方將證書確認(rèn)件

6、及付款通知函交與甲方， 確認(rèn)后 甲方應(yīng)在收到付款通知函后三個(gè)工作日內(nèi)向乙方支付其余合格評(píng)定費(fèi)（即第二條第一款 ） RMB ，乙方在收到余款后向甲方交付認(rèn)證書原件。3. The fee shall be disbursed to the account appointed by ITC ASIA.以上費(fèi)用打款到 ITC ASIA 指定賬戶Right and obligation of the first party 甲方的權(quán)益和義務(wù)1. The first party shall provide the relevant technical documentation i n accordanc

7、e with the Clauses of 1.2 of this Agreement. And all technica l documentation and medical quality management system should fulfill the requirements set by the second party.按照第一條第二款的協(xié)議內(nèi)容，甲方負(fù)責(zé)向乙方提交有關(guān)的技術(shù)文件， 所有技術(shù)文件和醫(yī)療器械質(zhì)量治理體系應(yīng)符合乙方要求；2. The test should be performed by the ISO 17025 accredited testing lab

8、oratory or nominated by ITC.產(chǎn)品檢測應(yīng)在獲得 ISO 17025 認(rèn)證的實(shí)驗(yàn)室或者得到 ITC 認(rèn)可的實(shí)驗(yàn) 室進(jìn)行；3. The first party shall implement the corrective actions based on the non conformity reports which issued by the second party during audit an d according to the evaluation of technical construction2 of 6 Registration Number Of

9、Contract 合同登記編號(hào) :file. First party should provide appropriate evidences to the second p arty against them.甲方負(fù)責(zé)對(duì)乙方在審查和技術(shù)文件評(píng)審工作中發(fā)覺的不合格項(xiàng)進(jìn)行整 改，并及時(shí)將有關(guān)的證據(jù)提供給乙方；4. The first party has the responsibility for the keeping of safety cha racteristic of its products and has to maintain the quality of CE qualific

10、ati on. The second party shall inform to the first party about the unsatisfied matters for the first partys product whenever they found the quality of th e products could not meet any regulation (s) or MDD directive (s).甲方應(yīng)對(duì)其產(chǎn)品安全特性負(fù)責(zé)， 保持 CE 認(rèn)證時(shí)質(zhì)量水平。 當(dāng)乙方發(fā)覺 甲方產(chǎn)品在歐盟市場不滿足指令要求或有關(guān)法律要求時(shí)，應(yīng)通知甲方須改 進(jìn)內(nèi)容，由甲方負(fù)責(zé)處理

11、；5. The first party is responsible for the preparation of the “ Declarati on of Conformity ” according to the applied Directive and the first party should keep the submitted Technical (Construction) File for 10 years. 甲 方應(yīng)按照指令要求公布符合性聲明，并保留符合性聲明和技術(shù)文件 10 年；6. The first party has the right to use its C

12、E mark according to the defined requirements and directives, and has the right to promote its CE r egistration to the public correctly after the acquisition of the certificate.在獲得CE證書后，甲方具有按規(guī)定正確使用 CE認(rèn)證標(biāo)記的權(quán)益和對(duì) 外正確宣傳產(chǎn)品認(rèn)證注冊(cè)資格的權(quán)益；7. The first party shall notifying the second party against major custo me

13、r complains and any significant changes in quality system, working pro cess, major production equipment, product specification and key suppliers.甲方應(yīng)將重大客戶投訴及在質(zhì)量體系、工藝、生產(chǎn)設(shè)備和關(guān)鍵供貨商 發(fā)生重大變化時(shí)通報(bào)乙方；8. The first party shall inform to the second party for the changes of its product scopes. The second party deci

14、des whether or not to carry out reassessmentor production inspection.甲方要求變更其認(rèn)證范疇時(shí)必須向乙方提出申請(qǐng)，由乙方?jīng)Q定是否重 新進(jìn)行產(chǎn)品審核或檢驗(yàn)；9. The first party shall oblige the requested assessmentset by the se cond party and provide necessary assistance, when on-site assessmentis n ecessary according to certification procedure.

15、甲方有義務(wù)遵守乙方認(rèn)證程序和要求，配合乙方工作，包括按照認(rèn)證 行業(yè)規(guī)定，乙方到甲方進(jìn)行現(xiàn)場評(píng)審時(shí)，甲方應(yīng)給與協(xié)助；10. During co-operation, when terminate the project due to first part y, first party shall make payment in terms of progress of the project; whe n terminate the project due to second party, first party owns right of reco urse.項(xiàng)目合作過程中，因甲方緣故中止項(xiàng)目

16、時(shí)，甲方應(yīng)按項(xiàng)目進(jìn)展程度支 付款項(xiàng)；因乙方緣故中止項(xiàng)目時(shí)，乙方應(yīng)賠付給甲方造成的直截了當(dāng)和間 接缺失，同時(shí)甲方擁有追索權(quán)；11. During the period of validity, the first party should accept surveil lance audit within the date one month before the certificate issuing. If the y refuse to accept the surveillance audit, the second party will cancel the certificate.

17、And the first party should return the original certificate to the second party.在證書有效期內(nèi)，甲方應(yīng)在每年證書頒發(fā)日期前一個(gè)月內(nèi)同意年審； 如拒不同意年審，乙方將撤銷該證書，甲方應(yīng)返還該證書原件。3 of 6 Registration Number Of Contract 合同登記編號(hào) : CE-090826-0四 . Right And Obligation of the Second Party 乙方的權(quán)益和義務(wù)1. When the contract signed the second party has t

18、o provide the inde x of directive(s) and standard(s) to the first party for conformity assessme nt.自本合同簽訂之日起，乙方負(fù)責(zé)組織認(rèn)證工作需要的指令和標(biāo)準(zhǔn)名目 (中文)，并將此名目正式提交給甲方；2. Since the date when the contract is signed, the second party has r esponsibility to forward the list of technical file for conformity assessmen t.自本合

19、同簽訂之日起，乙方負(fù)責(zé)向甲方提供認(rèn)證所需要的技術(shù)文件清 單(中文)；3. The second party shall arrange competent technical personnel bases on the needs of conformity assessment,the appointed assessmentteam s hould submit questions objectively and practically, and deal with relative questions in process of conformity assessmentjustly

20、and scientifically.乙方按照認(rèn)證工作需要配備有能力的專業(yè)技術(shù)人員，乙方指定的審核 組應(yīng)客觀、實(shí)事求是地提出咨詢題并公平、科學(xué)地處理審核中的有關(guān)咨詢 題；4. The second party shall provide the assessmentreport together with non-compliance notice to the first party for corrective actions.乙方應(yīng)該提交評(píng)審報(bào)告及不合格通知以便甲方進(jìn)行整改；5. The second party shall review the assessmentconclusion

21、 initially, and forward relative information to head office for final assessment.The second party should notice the conclusion to the first party in 3 working days once gets the result.乙方將認(rèn)證的結(jié)論進(jìn)行初步評(píng)審，初審?fù)ㄟ^后，將有關(guān)的資料送交乙 方總部進(jìn)行最終評(píng)審，取得評(píng)審結(jié)果后在三個(gè)工作日內(nèi)通知甲方；6. The second party shall carry out the assessmentfor p

22、roduct accor ding to the requirement of directive, to verify the legal access of product to the EU market.乙方按照歐盟產(chǎn)品指令要求對(duì)產(chǎn)品進(jìn)行評(píng)審，合格后確認(rèn)甲方產(chǎn)品具 備進(jìn)入歐盟市場資格；7. Second party assessthe technical document and system for the ap plied product by first party according to this contract. If the technical con structio

23、n file of the applied product and applicable tests meet the require ments of applicable EU Directive and applicable standards of testing, the first party should issue certificate by ITC.乙方按照合同規(guī)定對(duì)甲方申請(qǐng)的產(chǎn)品提供 CE申請(qǐng)和技術(shù)文件評(píng)審，按 照歐盟有關(guān)指令的要求確認(rèn)甲方技術(shù)文件和產(chǎn)品經(jīng)有關(guān)檢測合格后，為甲 方發(fā)放 ITC 評(píng)審的 CE 認(rèn)證證書。五 . Confidentiality 保密條款The

24、second party shall not give information to any third party regard ing the production and technical data of the first party in any forms, with the following exception. If not, the second party should pay the damages to first party.乙方不得將甲方經(jīng)營、生產(chǎn)狀況及技術(shù)信息以任何方式向第三方泄漏， 但下列情形除外。若乙方違反前述保密條款，乙方應(yīng)賠付給甲方造成的直 截了當(dāng)和間

25、接缺失。1. Information obtained by the second party before signing of this co ntract.此合同簽署前乙方收到的信息；4 of 6 Registration Number Of Contract 合同登記編號(hào) : CE-090826-0 12. Any information which is lawfully part of the public date.甲方在認(rèn)證范疇外已公布的資料；3. Legal access has been obtained.法律另有要求時(shí)；4. The authority has such

26、demand. 國家主管部門要求時(shí)。六 . The amendment and cancellation of the contract 合同的變更和解 除After the contract going into effect, the first party and the second pa rty should strictly carry out the obligations according to the contract. Any party cannot terminate or amend the contract on its own; the two parties

27、must negotiate and reach the agreement to complement, amend and termi nate the contract when necessary.合同生效后，甲乙雙方均應(yīng)嚴(yán)格按照本合同條款履行義務(wù)，任何一方 不得單獨(dú)終止、修改本合同；如需補(bǔ)充、修改和終止合同，須經(jīng)雙方和諧 一致達(dá)成共識(shí)后進(jìn)行。七 . Settlement of Disputes 爭議處理All the items of this contract are complied with the laws and regulat ions of the PRC. Disputes caused by this contract should be firstly solv