13485問卷調(diào)查表(文件)
【正文】 devices and unnecessary with Annex II適用于第IIb和III類醫(yī)療器械及不需按附件II要求Annex IV (EC Verification) 附件IV（EC驗(yàn)證） Please define proposed scope of SGS registration for these standards, if applicable. 適當(dāng)時(shí)詳細(xì)說明以上標(biāo)準(zhǔn)的認(rèn)證審核的范圍ISO 9000: 2000ISO13485: 2003 Please add any other QMS certification to be included in this proposal (. ISO 14001, BRC CP, etc)請?zhí)砑尤魏纹渌ＭJ(rèn)證的體系（例如。 QUESTIONNAIRE – MEDICAL DEVICES 醫(yī)療器械問卷調(diào)查表Completion Guidance Notes 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)收到完整的問卷調(diào)查表后,SGS國際認(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,其中包括評(píng)審,認(rèn)證及其它費(fèi)用。 ISO14001,BRC CP,等等）Do you have existing certification which you wish to transfer to SGS? 現(xiàn)有的認(rèn)證中，是否有想轉(zhuǎn)到SGS的認(rèn)證YesNoIf YES, please give details and attach or send copies of certificates and schedules如果有請附上證書復(fù)印件及時(shí)間表并填寫下列各項(xiàng)Certification Body 認(rèn)證機(jī)構(gòu)Certificate Number(s) 證書號(hào)Assessment Standard(s)審核標(biāo)準(zhǔn)Date of last Audit 最后一次審核的時(shí)間Do you have existing certification which you wish to continue with another Certification Body but you wish SGS to take into account when preparing a proposal?現(xiàn)有的認(rèn)證中，是否有繼續(xù)由其它認(rèn)證機(jī)構(gòu)認(rèn)證但是在準(zhǔn)備認(rèn)證方案時(shí)希望SGS參與的認(rèn)證？YesNoIf YES, please give details and attach or send copies of certificates and schedules如果有請附上證書復(fù)印件及時(shí)間表并填寫下列各項(xiàng)Certification Body 認(rèn)證機(jī)構(gòu)Certificate Number(s) 證書號(hào)Assessment Standard(s) 審核標(biāo)準(zhǔn)Date of last Audit 最后一次審核的時(shí)間What is your preferred month/year for the SGS Assessment? 您首選的SGS的審核時(shí)間？Markets 市場It can help us to understand your certification requirements if you indicate the markets where you are currently selling devices in your name or where you wish to sell in the near future. (This question is optional as we cannot guarantee to provide appropriate certification) 如果您簡要說明用您的品牌銷售的醫(yī)療器械正賣去的地方或希望不遠(yuǎn)的將賣去的地方，將會(huì)有利于我們理解您的認(rèn)證
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