13485問(wèn)卷調(diào)查表(完整版)
【正文】 es 填表指引：1. On receipt of the pleted Questionnaire, SGS will prepare and submit a No Obligation proposal detailing the assessment, certification and other costs. 當(dāng)收到完整的問(wèn)卷調(diào)查表后,SGS國(guó)際認(rèn)證服務(wù)部將當(dāng)即準(zhǔn)備并發(fā)出一份詳細(xì)的報(bào)價(jià)建議書(shū),其中包括評(píng)審,認(rèn)證及其它費(fèi)用。對(duì)于范圍的擴(kuò)展認(rèn)證請(qǐng)用SGS的表格3. Please return in electronic format or hard copy to your local SGS certification office as shown 請(qǐng)將完成的電子版或硬拷貝問(wèn)卷返回SGS當(dāng)?shù)氐恼J(rèn)證辦公室。（僅供參考）EU歐洲USA 美國(guó)Canada加拿大Australia/New Zealand 澳大利亞/新西蘭Japan日本PRC (China) 中國(guó)大陸ROC (Taiwan) 中國(guó)臺(tái)灣Other Asian Countries其它亞洲國(guó)家Russian States俄羅斯 Near/Middle East 中東Africa 非洲South America南美 Processes 過(guò)程Do you undertake design activities at the registration address?在注冊(cè)的地址是否從事產(chǎn)品的設(shè)計(jì)活動(dòng)YesNoDo you design puter software (. to control your devices)?產(chǎn)品設(shè)計(jì)中是否包括設(shè)計(jì)計(jì)算機(jī)軟件 （例如用于控制醫(yī)療器械）YesNoIn what language(s) are the design and regulatory documents available? 設(shè)計(jì)和法規(guī)文件是什么語(yǔ)言？Is you technical documentation plete, if not when do you expect it will be?技術(shù)文件是否已完成？如果沒(méi)有完成，預(yù)計(jì)什么時(shí)候能完成？YesNoDo you undertake any operations within a controlled environment or cleanroom?是否有在受控環(huán)境和潔凈室完成的任何操作？YesNoIf YES, please give details 如果有，請(qǐng)?jiān)斒黾?xì)節(jié)Are some of your products supplied by you sterile? 您是否有提供消毒的產(chǎn)品？YesNoDo you operate sterilization processes? 貴公司是否有滅菌過(guò)程？YesNoIf YES, please give details of the type of processes 如有,請(qǐng)描述滅菌過(guò)程的類(lèi)型Do you use a sterilization subcontractor? 是否有滅菌的分包方?YesNoIf YES, please give name and type of process and a copy of any ISO 13485 certification. 如果有，請(qǐng)給出滅菌過(guò)程的名稱(chēng)和類(lèi)型以及其ISO13485證書(shū)的復(fù)印件Are there any other critical operations or services carried out by a sub contractor? 是否有其它由分包方承擔(dān)的關(guān)鍵性操作或服務(wù)YesNoIf YES, give details and a copy of the certification where possible.如果有，可能情況下提供證書(shū)復(fù)印件及下列詳情：Company公司Activity活動(dòng)Standard標(biāo)準(zhǔn)Certification Company認(rèn)證公司
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