【正文】 em you have? 如果是請用X標(biāo)明管理體系的形式PAPER紙張的ELECTRONIC 電子版的MIXED二者混合的Please indicate if you have a timescale(s) for the following 如果您有時(shí)間安排請?zhí)顚懴铝懈黜?xiàng)Implementation date of the system? 體系實(shí)施日期Is a preassessment audit required? 是否需要預(yù)審Have you pleted a management review? 是否完成管理評審YesNoHave you menced internal auditing? 是否開始內(nèi)審 YesNoWhat is the approximate number of pages in the System excluding forms? 包括表格體系大約多少頁？Background Information 背景信息Has previous contact been made with SGS Personnel? 是否和SGS聯(lián)系過YesNoIf YES, please state the name of the person and if applicable the date of meeting/visit etc. 如果是，請陳述聯(lián)系人、會(huì)面/訪問的日期Where did you hear about SGS? 在哪里聽說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）ISO 13485: 2003 (UKAS Accredited) 英國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（第一類無菌產(chǎn)品的全面質(zhì)量保證體系）Annex V (For sterility under Article 12) 附件V（第12條款中提及的無菌狀態(tài)）Annex V or VI (For metrology of Cl