13485問卷調(diào)查表-文庫吧
2025-07-09 01:32 本頁面
【正文】 indicate below: 如果同一個(gè)注冊認(rèn)證包括其它地址，請說明下列各項(xiàng)Location 2 第二場所Number of Employees 員工數(shù)Address 地址Post Code 郵編Processes/Activities 過程/活動(dòng)Location 3 第三場所Number of Employees 員工數(shù)Address 地址Post Code 郵編Processes/Activities 過程/活動(dòng)Continue on separate sheet if required 必要時(shí)可分頁使用Additional Information (only for new Quality Management Systems) 附加信息（只對新的質(zhì)量管理體系）Do you have a Quality System? 是否有質(zhì)量管理體系 YesNoIf YES, please indicate with a X and indicate what type of quality system 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(hào)）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 requir
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