13485問卷調查表-文庫吧在線文庫
【正文】 of meeting/visit etc. 如果是，請陳述聯系人、會面/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 如果現在享用SGS的其它服務，請陳述詳細情況MEDICAL DEVICE INFORMATION 醫(yī)療器械信息Certification 認證Please indicate with X the certification you wish to achieve with SGS 請用X標明您希望SGS提供的認證ISO 9001: 2000, and please give details of any intended exclusions (clause numbers)ISO9001:2000認證，并給出想要刪減的詳細資料（標準的條款號）ISO 13485: 2003 (UKAS Accredited) 英國UKAS認可的ISO13485:2003ISO 13485: 2003 under CMDCAS (Canada) 加拿大CMACAS認可的ISO13485:2003ISO 13485: 2003 Cover Letter for Taiwan 臺灣認可的ISO13485:2003ISO 13485: 2003 for Japanese approval 日本認可的ISO13485:2003Site Inspection on behalf of FDA (21CFR Part 820) (Note: FDA must require an inspection)代表FDA的現場檢驗 （注:FDA要求必須檢查）Directive 93/42/EEC for CE Marking (Indicate one only) 關于CE標志的93/42/EEC指令 (只選擇以下中的一種)Annex II (Full Quality Assurance System) 附件II（全面質量保證體系） Annex V (Production Quality Assurance) 附件V（生產質量保證體系）Annex VI (Product Quality Assurance) 附件VI（產品質量保證體系）Annex V (For sterility of Class 1 products) 附件V（第一類無菌產品的全面質量保證體系）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 Class 1 products) 附件V或VI（具有測量功能的第一類產品的生產或產品質量保證體系）Annex III (EC Type Examination) 附件III（EC型式試驗）Applies to Class 2b and 3 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驗證） Please define proposed scope of SGS registration for these standards, if applicable. 適當時詳細說明以上標準的認證審核的范圍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證的體系（例如。 QUESTIONNAIRE – MEDICAL DEVICES 醫(yī)療器械問卷調查表Completion Guidance Not
環(huán)評公示相關推薦
鄂ICP備17016276號-1