MEDICALDEVICESQUESTIONNAIRE醫(yī)療器械--問卷調(diào)查表

1、document: gp4711 md questionnaire issue n : 2 page n : 3 of 8 continue on separate sheet if required 必要時可必要時可使用使用使用分頁分頁additional information (only for new quality management systems) 附加信息附加信息（ （只對新的質(zhì)量管理體系只對新的質(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 an x and

2、indicate what type of quality system you have? 如果是請用x 標明管理體系的形式（注 : 在適用的選項處雙擊就可標記）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 如果您有時間安排請?zhí)顚懴铝懈黜梚mplementation date of the system?體系實施日期is a pre-assessment audit required?是否需要預(yù)審have you commenced interna

3、l auditing? 是否已實施內(nèi)審yesnowhat is the approximate number of pages in the system excluding forms? 體系大約多少頁 (不包括表格)？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，

4、請陳述聯(lián)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(xiàn)在享用sgs 的其它服務(wù)，請陳述詳細情況if you have used (in the last two years only) or intend to use consultancy services for the activities to be certified please give the name of the consultanc

5、y organisation and/or the name of the individual consultant(s) 針對認證范圍，是否曾經(jīng)（在兩年內(nèi)）或打算運用顧問服務(wù)，如有，請注明顧問公司的名稱和/或顧問的姓名。document: gp4711 md questionnaire issue n : 2 page n : 3 of 8 continue on separate sheet if required 必要時可必要時可使用使用使用分頁分頁additional information (only for new quality management systems) 附加信息

6、附加信息（ （只對新的質(zhì)量管理體系只對新的質(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 an x and indicate what type of quality system you have? 如果是請用x 標明管理體系的形式（注 : 在適用的選項處雙擊就可標記）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 如果您有時間安排請?zhí)?/p>

7、寫下列各項implementation date of the system?體系實施日期is a pre-assessment audit required?是否需要預(yù)審have you commenced internal auditing? 是否已實施內(nèi)審yesnowhat is the approximate number of pages in the system excluding forms? 體系大約多少頁 (不包括表格)？background information背景信息has previous contact been made with sgs personnel?

8、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)，請陳述詳細情況if you have used (in the last two years only)

9、 or intend to use consultancy services for the activities to be certified please give the name of the consultancy organisation and/or the name of the individual consultant(s) 針對認證范圍，是否曾經(jīng)（在兩年內(nèi)）或打算運用顧問服務(wù)，如有，請注明顧問公司的名稱和/或顧問的姓名。document: gp4711 md questionnaire issue n : 2 page n : 3 of 8 continue on se

10、parate sheet if required 必要時可必要時可使用使用使用分頁分頁additional information (only for new quality management systems) 附加信息附加信息（ （只對新的質(zhì)量管理體系只對新的質(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 an x and indicate what type of quality system you have? 如果是請用x 標明管理體系的形式（注 : 在適用的選項處雙

11、擊就可標記）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 如果您有時間安排請?zhí)顚懴铝懈黜梚mplementation date of the system?體系實施日期is a pre-assessment audit required?是否需要預(yù)審have you commenced internal auditing? 是否已實施內(nèi)審yesnowhat is the approximate number of pages in the syste

12、m excluding forms? 體系大約多少頁 (不包括表格)？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

13、 any other sgs services please give details 如果現(xiàn)在享用sgs 的其它服務(wù)，請陳述詳細情況if you have used (in the last two years only) or intend to use consultancy services for the activities to be certified please give the name of the consultancy organisation and/or the name of the individual consultant(s) 針對認證范圍，是否曾經(jīng)（在

14、兩年內(nèi)）或打算運用顧問服務(wù)，如有，請注明顧問公司的名稱和/或顧問的姓名。document: gp4711 md questionnaire issue n : 2 page n : 3 of 8 continue on separate sheet if required 必要時可必要時可使用使用使用分頁分頁additional information (only for new quality management systems) 附加信息附加信息（ （只對新的質(zhì)量管理體系只對新的質(zhì)量管理體系） ）do you have a quality system? 是否有質(zhì)量管理體系yesnoif

15、 yes, please indicate with an x and indicate what type of quality system you have? 如果是請用x 標明管理體系的形式（注 : 在適用的選項處雙擊就可標記）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 如果您有時間安排請?zhí)顚懴铝懈黜梚mplementation date of the system?體系實施日期is a pre-assessment audit requi

16、red?是否需要預(yù)審have you commenced internal auditing? 是否已實施內(nèi)審yesnowhat is the approximate number of pages in the system excluding forms? 體系大約多少頁 (不包括表格)？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 applicabl

17、e the date of meeting/visit etc.如果是，請陳述聯(lián)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(xiàn)在享用sgs 的其它服務(wù)，請陳述詳細情況if you have used (in the last two years only) or intend to use consultancy services for the activities to be certified pl

18、ease give the name of the consultancy organisation and/or the name of the individual consultant(s) 針對認證范圍，是否曾經(jīng)（在兩年內(nèi)）或打算運用顧問服務(wù)，如有，請注明顧問公司的名稱和/或顧問的姓名。document: gp4711 md questionnaire issue n : 2 page n : 3 of 8 continue on separate sheet if required 必要時可必要時可使用使用使用分頁分頁additional information (only for

19、new quality management systems) 附加信息附加信息（ （只對新的質(zhì)量管理體系只對新的質(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 an x and indicate what type of quality system you have? 如果是請用x 標明管理體系的形式（注 : 在適用的選項處雙擊就可標記）paper 紙張的electronic 電子版的mixed 二者混合的please indicate if you have a times

20、cale(s) for the following 如果您有時間安排請?zhí)顚懴铝懈黜梚mplementation date of the system?體系實施日期is a pre-assessment audit required?是否需要預(yù)審have you commenced internal auditing? 是否已實施內(nèi)審yesnowhat is the approximate number of pages in the system excluding forms? 體系大約多少頁 (不包括表格)？background information背景信息has previous co

21、ntact 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)，請陳述詳細情況if you ha

22、ve used (in the last two years only) or intend to use consultancy services for the activities to be certified please give the name of the consultancy organisation and/or the name of the individual consultant(s) 針對認證范圍，是否曾經(jīng)（在兩年內(nèi)）或打算運用顧問服務(wù)，如有，請注明顧問公司的名稱和/或顧問的姓名。document: gp4711 md questionnaire issue

23、n : 2 page n : 3 of 8 continue on separate sheet if required 必要時可必要時可使用使用使用分頁分頁additional information (only for new quality management systems) 附加信息附加信息（ （只對新的質(zhì)量管理體系只對新的質(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 an x and indicate what type of quality system you have? 如果是請用x 標明管理體系的形式（注 : 在適用的選項處雙擊就可標記）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 如果您有時間安排請?zhí)顚懴铝懈黜梚mplementation date of the syste