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1、 QUESTIONNAIRE MEDICAL DEVICES QU1MD Issue5 第 1 页 共 7 页 医疗器械问卷调查表医疗器械问卷调查表 Completion Guidance Notes 填表指引:填表指引: 1. On receipt of the completed Questionnaire, SGS will prepare and submit a No Obligation proposal detailing the assessment, certification and other costs. 当收到完整的问卷调查表后,SGS国际认证服务部将当即准备并发出一
2、份详细的报价建议书,其中包括评审,认证及其它费用。 2. If you are an existing client applying for additional certification please indicate additions only. For extensions to scope to existing certification please use SGS Notification forms. 如果您已经是SGS的客户只需列明现在增加的认证申请。对于范围的扩展认证请用SGS的表格 3. Please return in electronic format or h
3、ard copy to your local SGS certification office as shown 请将完成的电子版或硬拷贝问卷返回SGS当地的认证办公室。 SGS Hong Kong Ltd 香港通用公证行有限公司香港通用公证行有限公司 Room 2012-2018 ,20/F,Metrople Square ,2 On Yiu Street, Siu Lek Yuen ,Sha Tin , N.T., Hong Kong 香港新界沙田小沥源安耀街香港新界沙田小沥源安耀街2号新都广场二十楼二零一二至二零一八室号新都广场二十楼二零一二至二零一八室 Tel: : (852) 276
4、53620, Fax : (852) 23332257, ? : ? : GENERAL INFORMATION 基本信息基本信息 Company/Organisation Details 公司/组织的详细信息: Name of Company or Organisation 公司或组织的名称 Division or Trading Name for Certificate 要求公司获取证书的机构或贸易公司 Company VAT (TVA) Number 公司的增值税号 Main Address (Certification Address) 审核的地址 Invoicing Addres
5、s (If different) 税务地址(如不同时) If company is part of a group, please specify group 如果公司是集团公司的一部分请说明集团公司的名称 Company Web Site Address 公司网址 Management Representative (Contact) 管理者代表(联络人) Position 职务 E-mail address 电子邮箱 Tel No: 电话 Fax No: 传真 MD/Chief Executive (or equivalent) 执行总裁(或相当者) Number of Employees
6、 员工数量员工数量 Total number of employees in the organization 组织总员工数 Total number of employees in the activities to be certified by this proposal 包含在此认证范围内的总员工数 Do you operate a shift system or conduct any activities outside daytime working hours? 是否有倒班或白天工作时间以外的活动 Yes No If YES, indicate shift patterns.
7、如果有,指明倒班模式 QUESTIONNAIRE MEDICAL DEVICES QU1MD Issue5 第 2 页 共 7 页 Processes 过程过程 Please list the main processes or activities on the main site 请列出审核现场的主要过程或活动 Locations/Multi site Registrations 多地址注册多地址注册 If you wish to include other sites in the same registration, please indicate below: 如果同一个注册认证包括
8、其它地址,请说明下列各项 Location 2 第二场所 Number of Employees 员工数 Address 地址 Post Code 邮编 Processes/Activities 过程/活动 Location 3 第三场所 Number of Employees 员工数 Address 地址 Post Code 邮编 Processes/Activities 过程/活动 Continue on separate sheet if required 必要时可分页使用必要时可分页使用 Additional Information (only for new Quality Mana
9、gement Systems) 附加信息(只对新的质量管理体系)附加信息(只对新的质量管理体系)Do you have a Quality System? 是否有质量管理体系 Yes No If YES, please indicate with a X and indicate what type of quality system you have? 如果是请用X标明管理体系的形式 PAPER纸张的 ELECTRONIC 电子版的 MIXED二者混合的 Please indicate if you have a timescale(s) for the following 如果您有时间安排
10、请填写下列各项 Implementation date of the system? 体系实施日期 Is a pre-assessment audit required? 是否需要预审 Have you completed a management review? 是否完成管理评审 Yes No Have you commenced internal auditing? 是否开始内审 Yes No What is the approximate number of pages in the System excluding forms? 包括表格体系大约多少页? QUESTIONNAIRE M
11、EDICAL DEVICES QU1MD Issue5 第 3 页 共 7 页 Background Information 背景信息背景信息 Has previous contact been made with SGS Personnel? 是否和SGS联系过 Yes No If YES, please state the name of the person and if applicable the date of meeting/visit etc. 如果是,请陈述联系人、会面/访问的日期 Where did you hear about SGS? 在哪里听说SGS公司的 If yo
12、u currently use any other SGS Services please give details 如果现在享用SGS的其它服务,请陈述详细情况 MEDICAL DEVICE INFORMATION 医疗器械信息医疗器械信息 Certification 认证认证 Please indicate with X the certification you wish to achieve with SGS 请用X标明您希望SGS提供的认证 ISO 9001: 2000, and please give details of any intended exclusions (clau
13、se numbers) ISO9001:2000认证,并给出想要删减的详细资料(标准的条款号) ISO 13485: 2003 (UKAS Accredited) 英国UKAS认可的ISO13485:2003 ISO 13485: 2003 under CMDCAS (Canada) 加拿大CMACAS认可的ISO13485:2003 ISO 13485: 2003 Cover Letter for Taiwan 台湾认可的ISO13485:2003 ISO 13485: 2003 for Japanese approval 日本认可的ISO13485:2003 Site Inspection
14、 on behalf of FDA (21CFR Part 820) (Note: FDA must require an inspection) 代表FDA的现场检验 (注:FDA要求必须检查) Directive 93/42/EEC for CE Marking (Indicate one only) 关于CE标志的93/42/EEC指令 (只选择以下中的一种) Annex II (Full Quality Assurance System) 附件II(全面质量保证体系) Annex V (Production Quality Assurance) 附件V(生产质量保证体系) Annex
15、VI (Product Quality Assurance) 附件VI(产品质量保证体系) Annex V (For sterility of Class 1 products) 附件V(第一类无菌产品的全面质量保证体系) Annex V (For sterility under Article 12) 附件V(第12条款中提及的无菌状态) Annex V or VI (For metrology of Class 1 products) 附件V或VI(具有测量功能的第一类产品的生产或产品质量保证体系) Annex III (EC Type Examination) 附件III(EC型式试验)
16、 Applies to Class 2b and 3 devices and unnecessary with Annex II 适用于第IIb和III类医疗器械及不需按附件II要求 Annex IV (EC Verification) 附件IV(EC验证) QUESTIONNAIRE MEDICAL DEVICES QU1MD Issue5 第 4 页 共 7 页 Please define proposed scope of SGS registration for these standards, if applicable. 适当时详细说明以上标准的认证审核的范围 ISO 9000: 2000 ISO13485: 2003 Please add any other QMS cer