13485問卷調查表(編輯修改稿)
2025-08-20 01:32 本頁面
【文章內容簡介】 e an inspection)代表FDA的現(xiàn)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。 ISO14001,BRC CP,等等）Do you have existing certification which you wish to transfer to SGS? 現(xiàn)有的認證中，是否有想轉到SGS的認證YesNoIf YES, please give details and attach or send copies of certificates and schedules如果有請附上證書復印件及時間表并填寫下列各項Certification Body 認證機構Certificate Number(s) 證書號Assessment Standard(s)審核標準Date of last Audit 最后一次審核的時間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)有的認證中，是否有繼續(xù)由其它認證機構認證但是在準備認證方案時希望SGS參與的認證？YesNoIf YES, please give details and attach or send copies of certificates and schedules如果有請附上證書復印件及時間表并填寫下列各項Certification Body 認證機構Certificate Number(s) 證書號Assessment Standard(s) 審核標準Date of last Audit 最后一次審核的時間What is your preferred month/year for the SGS
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