13485問(wèn)卷調(diào)查表-文庫(kù)吧在線(xiàn)文庫(kù)
【正文】 of meeting/visit etc. 如果是，請(qǐng)陳述聯(lián)系人、會(huì)面/訪(fǎng)問(wèn)的日期Where did you hear about SGS? 在哪里聽(tīng)說(shuō)SGS公司的If you currently use any other SGS Services please give details 如果現(xiàn)在享用SGS的其它服務(wù)，請(qǐng)陳述詳細(xì)情況MEDICAL DEVICE INFORMATION 醫(yī)療器械信息Certification 認(rèn)證Please indicate with X the certification you wish to achieve with SGS 請(qǐng)用X標(biāo)明您希望SGS提供的認(rèn)證ISO 9001: 2000, and please give details of any intended exclusions (clause numbers)ISO9001:2000認(rèn)證，并給出想要?jiǎng)h減的詳細(xì)資料（標(biāo)準(zhǔn)的條款號(hào)）ISO 13485: 2003 (UKAS Accredited) 英國(guó)UKAS認(rèn)可的ISO13485:2003ISO 13485: 2003 under CMDCAS (Canada) 加拿大CMACAS認(rèn)可的ISO13485:2003ISO 13485: 2003 Cover Letter for Taiwan 臺(tái)灣認(rèn)可的ISO13485:2003ISO 13485: 2003 for Japanese approval 日本認(rèn)可的ISO13485:2003Site Inspection on behalf of FDA (21CFR Part 820) (Note: FDA must require an inspection)代表FDA的現(xiàn)場(chǎng)檢驗(yàn) （注:FDA要求必須檢查）Directive 93/42/EEC for CE Marking (Indicate one only) 關(guān)于CE標(biāo)志的93/42/EEC指令 (只選擇以下中的一種)Annex II (Full Quality Assurance System) 附件II（全面質(zhì)量保證體系） Annex V (Production Quality Assurance) 附件V（生產(chǎn)質(zhì)量保證體系）Annex VI (Product Quality Assurance) 附件VI（產(chǎn)品質(zhì)量保證體系）Annex V (For sterility of Class 1 products) 附件V（第一類(lèi)無(wú)菌產(chǎn)品的全面質(zhì)量保證體系）Annex V (For sterility under Article 12) 附件V（第12條款中提及的無(wú)菌狀態(tài)）Annex V or VI (For metrology of Class 1 products) 附件V或VI（具有測(cè)量功能的第一類(lèi)產(chǎn)品的生產(chǎn)或產(chǎn)品質(zhì)量保證體系）Annex III (EC Type Examination) 附件III（EC型式試驗(yàn)）Applies to Class 2b and 3 devices and unnecessary with Annex II適用于第IIb和III類(lèi)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(shuō)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(qǐng)?zhí)砑尤魏纹渌ＭJ(rèn)證的體系（例如。 QUESTIONNAIRE – MEDICAL DEVICES 醫(yī)療器械問(wèn)卷調(diào)查表Completion Guidance Not
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