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济宁市医疗器械生产企业自查表

发布时间：作者：中区

<p style="text-align: center"> </p>
<div style="text-align: center; margin: 0cm 0cm 0pt -27pt" align="center"><span style="font-size: 16pt">济宁市医疗器械生产企业自查表</span></div>
<div style="line-height: 22pt"><span style="font-size: 12pt">企业名称：</span><u><span style="font-size: 12pt">                                                                    </span></u></div>
<div style="line-height: 22pt"><span style="font-size: 12pt">生产地址：</span><u><span style="font-size: 12pt">                                                                    </span></u><span style="font-size: 12pt">  </span></div>
<div style="line-height: 22pt"><span style="font-size: 12pt">企业负责人：</span><u><span style="font-size: 12pt">                  </span></u><span style="font-size: 12pt">电话：</span><u><span style="font-size: 12pt">               </span></u><span style="font-size: 12pt">手机：</span><u><span style="font-size: 12pt">                    </span></u></div>
<div style="line-height: 22pt"><span style="font-size: 12pt">联系人</span><span style="font-size: 12pt">：</span><u><span style="font-size: 12pt">                </span></u><span style="font-size: 12pt">联系电话：</span><u><span style="font-size: 12pt">                </span></u><span style="font-size: 12pt">手机：</span><u><span style="font-size: 12pt">                    </span></u></div>
<div style="line-height: 22pt"><span style="font-size: 12pt">填表日期<u>：</u></span><u><span style="font-size: 12pt">                       </span></u><span style="font-size: 12pt"> </span><span style="font-size: 12pt">填表人<u>：</u></span><u><span style="font-size: 12pt">                                     </span></u></div>
<div style="line-height: 22pt"><span style="font-size: 12pt">参加自查人员签名：</span><u><span style="font-size: 12pt">                                                           </span></u></div>
<div style="line-height: 22pt"><span style="font-size: 12pt">主要产品种类或名称：</span><u><span style="font-size: 12pt">                                                                                          </span></u></div>
<div style="line-height: 25pt"><span style="font-size: 12pt">生产方式：</span><span style="font-size: 12pt">           </span><span style="font-size: 12pt">□</span><span style="font-size: 12pt">自己生产</span><span style="font-size: 12pt">            </span><span style="font-size: 12pt">□</span><span style="font-size: 12pt">委托加工</span></div>
<p style="text-align: center">
<table border="1" cellspacing="0" cellpadding="0" style="border-bottom: medium none; border-left: medium none; border-collapse: collapse; border-top: medium none; border-right: medium none">
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            <div align="center"><b><span style="font-size: 12pt">序号</span></b></div>
            </td>
            <td width="60" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 45pt; padding-right: 5.4pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div align="center"><b><span style="font-size: 12pt">项目</span></b></div>
            </td>
            <td width="349" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 262.1pt; padding-right: 5.4pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div align="center"><b><span style="font-size: 12pt">检查内容</span></b></div>
            </td>
            <td width="84" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 63pt; padding-right: 5.4pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div align="center"><b><span style="font-size: 12pt">自查情况</span></b></div>
            </td>
            <td width="120" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div align="center"><b><span style="font-size: 12pt">整改情况</span></b></div>
            </td>
        </tr>
        <tr style="height: 5.25pt">
            <td valign="top" width="35" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 25.9pt; padding-right: 5.4pt; height: 5.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b><span style="font-size: 12pt">1</span></b></div>
            </td>
            <td rowspan="4" width="60" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 45pt; padding-right: 5.4pt; height: 5.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div align="center"><b><span style="font-size: 12pt">证件</span></b></div>
            <div align="center"><b> </b></div>
            </td>
            <td valign="top" width="349" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 262.1pt; padding-right: 5.4pt; height: 5.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div>企业生产的产品是否在许可证范围内</div>
            </td>
            <td valign="top" width="84" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 63pt; padding-right: 5.4pt; height: 5.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
            <td valign="top" rowspan="4" width="120" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; height: 5.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
        </tr>
        <tr style="height: 5.25pt">
            <td valign="top" width="35" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 25.9pt; padding-right: 5.4pt; height: 5.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b><span style="font-size: 12pt">2</span></b></div>
            </td>
            <td valign="top" width="349" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 262.1pt; padding-right: 5.4pt; height: 5.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div>企业生产许可证是否在有效期内</div>
            </td>
            <td valign="top" width="84" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 63pt; padding-right: 5.4pt; height: 5.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
        </tr>
        <tr style="height: 5.25pt">
            <td valign="top" width="35" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 25.9pt; padding-right: 5.4pt; height: 5.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b><span style="font-size: 12pt">3</span></b></div>
            </td>
            <td valign="top" width="349" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 262.1pt; padding-right: 5.4pt; height: 5.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div>受委托加工企业是否有相关产品生产许可证</div>
            </td>
            <td valign="top" width="84" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 63pt; padding-right: 5.4pt; height: 5.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
        </tr>
        <tr style="height: 5.25pt">
            <td valign="top" width="35" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 25.9pt; padding-right: 5.4pt; height: 5.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b><span style="font-size: 12pt">4</span></b></div>
            </td>
            <td valign="top" width="349" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 262.1pt; padding-right: 5.4pt; height: 5.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div>企业生产的产品是否有产品注册证</div>
            </td>
            <td valign="top" width="84" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 63pt; padding-right: 5.4pt; height: 5.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
        </tr>
        <tr style="height: 5.25pt">
            <td valign="top" width="35" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 25.9pt; padding-right: 5.4pt; height: 5.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b><span style="font-size: 12pt">5</span></b></div>
            </td>
            <td rowspan="3" width="60" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 45pt; padding-right: 5.4pt; height: 5.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div align="center"><b><span style="font-size: 12pt">制度文件</span></b></div>
            </td>
            <td valign="top" width="349" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 262.1pt; padding-right: 5.4pt; height: 5.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div>企业是否建立质量管理制度及相应的质量管理文件</div>
            </td>
            <td valign="top" width="84" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 63pt; padding-right: 5.4pt; height: 5.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
            <td valign="top" rowspan="3" width="120" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; height: 5.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
        </tr>
        <tr style="height: 5.25pt">
            <td valign="top" width="35" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 25.9pt; padding-right: 5.4pt; height: 5.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b><span style="font-size: 12pt">6</span></b></div>
            </td>
            <td valign="top" width="349" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 262.1pt; padding-right: 5.4pt; height: 5.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div>企业是否保存有关医疗器械监督管理方面的法规、规章和规范性文件，是否制定法规培训的计划</div>
            </td>
            <td valign="top" width="84" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 63pt; padding-right: 5.4pt; height: 5.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
        </tr>
        <tr style="height: 5.25pt">
            <td valign="top" width="35" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 25.9pt; padding-right: 5.4pt; height: 5.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b><span style="font-size: 12pt">7</span></b></div>
            </td>
            <td valign="top" width="349" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 262.1pt; padding-right: 5.4pt; height: 5.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div>企业是否及时浏览国家、省、市药监部门的网站，了解、收集最新的规定、要求及通知，并自觉执行最新法规要求</div>
            </td>
            <td valign="top" width="84" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 63pt; padding-right: 5.4pt; height: 5.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
        </tr>
        <tr style="height: 7.9pt">
            <td valign="top" width="35" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 25.9pt; padding-right: 5.4pt; height: 7.9pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b><span style="font-size: 12pt">8</span></b></div>
            </td>
            <td rowspan="2" width="60" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 45pt; padding-right: 5.4pt; height: 7.9pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div align="center"><b><span style="font-size: 12pt">部门设置</span></b></div>
            </td>
            <td valign="top" width="349" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 262.1pt; padding-right: 5.4pt; height: 7.9pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div>企业是否具有健全的质量管理机构，职能部门是否设置合理并职能清晰</div>
            </td>
            <td valign="top" width="84" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 63pt; padding-right: 5.4pt; height: 7.9pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
            <td valign="top" rowspan="2" width="120" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; height: 7.9pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
        </tr>
        <tr style="height: 7.85pt">
            <td valign="top" width="35" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 25.9pt; padding-right: 5.4pt; height: 7.85pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b><span style="font-size: 12pt">9</span></b></div>
            </td>
            <td valign="top" width="349" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 262.1pt; padding-right: 5.4pt; height: 7.85pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div>企业是否确定各部门负责人及其职责</div>
            </td>
            <td valign="top" width="84" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 63pt; padding-right: 5.4pt; height: 7.85pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b> </b></div>
            </td>
        </tr>
        <tr style="height: 2.25pt">
            <td valign="top" width="35" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 25.9pt; padding-right: 5.4pt; height: 2.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b><span style="font-size: 12pt">10</span></b></div>
            </td>
            <td rowspan="8" width="60" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 45pt; padding-right: 5.4pt; height: 2.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div align="center"><b><span style="font-size: 12pt">人力资源</span></b></div>
            </td>
            <td valign="top" width="349" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 262.1pt; padding-right: 5.4pt; height: 2.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div>企业主要负责人是否熟悉国家有关医疗器械的法律法规，熟悉产品生产过程</div>
            </td>
            <td valign="top" width="84" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 63pt; padding-right: 5.4pt; height: 2.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div style="text-indent: -168pt; margin: 0cm 0cm 0pt 168pt"> </div>
            </td>
            <td valign="top" rowspan="8" width="120" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; height: 2.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
        </tr>
        <tr style="height: 2.25pt">
            <td valign="top" width="35" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 25.9pt; padding-right: 5.4pt; height: 2.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b><span style="font-size: 12pt">11</span></b></div>
            </td>
            <td valign="top" width="349" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 262.1pt; padding-right: 5.4pt; height: 2.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div>企业是否配备与产品生产相适应的技术人员并职责分明</div>
            </td>
            <td valign="top" width="84" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 63pt; padding-right: 5.4pt; height: 2.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b> </b></div>
            </td>
        </tr>
        <tr style="height: 2.25pt">
            <td valign="top" width="35" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 25.9pt; padding-right: 5.4pt; height: 2.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b><span style="font-size: 12pt">12</span></b></div>
            </td>
            <td valign="top" width="349" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 262.1pt; padding-right: 5.4pt; height: 2.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div>生产部门负责人是否熟悉产品的生产工艺并职责分明</div>
            </td>
            <td valign="top" width="84" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 63pt; padding-right: 5.4pt; height: 2.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
        </tr>
        <tr style="height: 2.25pt">
            <td valign="top" width="35" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 25.9pt; padding-right: 5.4pt; height: 2.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b><span style="font-size: 12pt">13</span></b></div>
            </td>
            <td valign="top" width="349" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 262.1pt; padding-right: 5.4pt; height: 2.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div>质检部门负责人是否熟悉产品检验要求及相关技术要求</div>
            </td>
            <td valign="top" width="84" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 63pt; padding-right: 5.4pt; height: 2.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
        </tr>
        <tr style="height: 2.25pt">
            <td valign="top" width="35" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 25.9pt; padding-right: 5.4pt; height: 2.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b><span style="font-size: 12pt">14</span></b></div>
            </td>
            <td valign="top" width="349" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 262.1pt; padding-right: 5.4pt; height: 2.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div>生产部门负责人与质检部门负责人是否互不兼任</div>
            </td>
            <td valign="top" width="84" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 63pt; padding-right: 5.4pt; height: 2.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
        </tr>
        <tr style="height: 2.25pt">
            <td valign="top" width="35" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 25.9pt; padding-right: 5.4pt; height: 2.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b><span style="font-size: 12pt">15</span></b></div>
            </td>
            <td valign="top" width="349" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 262.1pt; padding-right: 5.4pt; height: 2.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div>生产及检测人员是否经过岗前培训</div>
            </td>
            <td valign="top" width="84" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 63pt; padding-right: 5.4pt; height: 2.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b> </b></div>
            </td>
        </tr>
        <tr style="height: 2.25pt">
            <td valign="top" width="35" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 25.9pt; padding-right: 5.4pt; height: 2.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b>16</b></div>
            </td>
            <td valign="top" width="349" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 262.1pt; padding-right: 5.4pt; height: 2.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div>直接接触无菌医疗器械产品人员的健康状况是否符合有关规定</div>
            </td>
            <td valign="top" width="84" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 63pt; padding-right: 5.4pt; height: 2.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
        </tr>
        <tr style="height: 2.25pt">
            <td valign="top" width="35" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 25.9pt; padding-right: 5.4pt; height: 2.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b>17</b></div>
            </td>
            <td valign="top" width="349" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 262.1pt; padding-right: 5.4pt; height: 2.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div>企业是否具备一名以上合格的医疗器械内审员</div>
            </td>
            <td valign="top" width="84" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 63pt; padding-right: 5.4pt; height: 2.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
        </tr>
        <tr style="height: 1.8pt">
            <td valign="top" width="35" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 25.9pt; padding-right: 5.4pt; height: 1.8pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b>18</b></div>
            </td>
            <td rowspan="7" width="60" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 45pt; padding-right: 5.4pt; height: 1.8pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div align="center"><b><span style="font-size: 12pt">基础设施</span></b></div>
            </td>
            <td valign="top" width="349" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 262.1pt; padding-right: 5.4pt; height: 1.8pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div>企业是否具有与所生产产品相适应的生产车间，生产环境是否清洁整齐</div>
            </td>
            <td valign="top" width="84" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 63pt; padding-right: 5.4pt; height: 1.8pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
            <td valign="top" rowspan="7" width="120" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; height: 1.8pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
        </tr>
        <tr style="height: 1.55pt">
            <td valign="top" width="35" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 25.9pt; padding-right: 5.4pt; height: 1.55pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b>19</b></div>
            </td>
            <td valign="top" width="349" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 262.1pt; padding-right: 5.4pt; height: 1.55pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div>生产设备是否能够满足生产要求并正常运作</div>
            </td>
            <td valign="top" width="84" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 63pt; padding-right: 5.4pt; height: 1.55pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
        </tr>
        <tr style="height: 1.55pt">
            <td valign="top" width="35" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 25.9pt; padding-right: 5.4pt; height: 1.55pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b>20</b></div>
            </td>
            <td valign="top" width="349" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 262.1pt; padding-right: 5.4pt; height: 1.55pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div>生产设备是否定期检查、维护、保养，并做好记录</div>
            </td>
            <td valign="top" width="84" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 63pt; padding-right: 5.4pt; height: 1.55pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b> </b></div>
            </td>
        </tr>
        <tr style="height: 1.55pt">
            <td valign="top" width="35" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 25.9pt; padding-right: 5.4pt; height: 1.55pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b>21</b></div>
            </td>
            <td valign="top" width="349" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 262.1pt; padding-right: 5.4pt; height: 1.55pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div>企业是否具有专门的检测室（区）</div>
            </td>
            <td valign="top" width="84" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 63pt; padding-right: 5.4pt; height: 1.55pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
        </tr>
        <tr style="height: 1.55pt">
            <td valign="top" width="35" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 25.9pt; padding-right: 5.4pt; height: 1.55pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b>22</b></div>
            </td>
            <td valign="top" width="349" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 262.1pt; padding-right: 5.4pt; height: 1.55pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div>检测设备是否能够满足产品标准规定的出厂检验要求，计量设备是否定期进行计量认定</div>
            </td>
            <td valign="top" width="84" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 63pt; padding-right: 5.4pt; height: 1.55pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
        </tr>
        <tr style="height: 1.55pt">
            <td valign="top" width="35" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 25.9pt; padding-right: 5.4pt; height: 1.55pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b>23</b></div>
            </td>
            <td valign="top" width="349" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 262.1pt; padding-right: 5.4pt; height: 1.55pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div>企业是否具有专门的原料仓库和成品仓库；</div>
            </td>
            <td valign="top" width="84" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 63pt; padding-right: 5.4pt; height: 1.55pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
        </tr>
        <tr style="height: 1.55pt">
            <td valign="top" width="35" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 25.9pt; padding-right: 5.4pt; height: 1.55pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b>24</b></div>
            </td>
            <td valign="top" width="349" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 262.1pt; padding-right: 5.4pt; height: 1.55pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div>仓库是否有明确的功能分区，并标识清楚；仓库是否具有必须的环境检测设备和消防设施</div>
            </td>
            <td valign="top" width="84" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 63pt; padding-right: 5.4pt; height: 1.55pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
        </tr>
        <tr style="height: 7.95pt">
            <td valign="top" width="35" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 25.9pt; padding-right: 5.4pt; height: 7.95pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b>25</b></div>
            </td>
            <td rowspan="4" width="60" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 45pt; padding-right: 5.4pt; height: 7.95pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div align="center"><b><span style="font-size: 12pt">采购控制</span></b></div>
            </td>
            <td valign="top" width="349" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 262.1pt; padding-right: 5.4pt; height: 7.95pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div>企业是否建立原材料采购程序</div>
            </td>
            <td valign="top" width="84" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 63pt; padding-right: 5.4pt; height: 7.95pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
            <td valign="top" rowspan="4" width="120" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; height: 7.95pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
        </tr>
        <tr style="height: 10.3pt">
            <td valign="top" width="35" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 25.9pt; padding-right: 5.4pt; height: 10.3pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b>26</b></div>
            </td>
            <td valign="top" width="349" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 262.1pt; padding-right: 5.4pt; height: 10.3pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div>企业是否建立原材料检验标准及检验程序</div>
            </td>
            <td valign="top" width="84" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 63pt; padding-right: 5.4pt; height: 10.3pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b> </b></div>
            </td>
        </tr>
        <tr style="height: 7.85pt">
            <td valign="top" width="35" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 25.9pt; padding-right: 5.4pt; height: 7.85pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b>27</b></div>
            </td>
            <td valign="top" width="349" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 262.1pt; padding-right: 5.4pt; height: 7.85pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div>企业是否对原材料供应商进行考核或评定</div>
            </td>
            <td valign="top" width="84" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 63pt; padding-right: 5.4pt; height: 7.85pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
        </tr>
        <tr style="height: 7.85pt">
            <td valign="top" width="35" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 25.9pt; padding-right: 5.4pt; height: 7.85pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b>28</b></div>
            </td>
            <td valign="top" width="349" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 262.1pt; padding-right: 5.4pt; height: 7.85pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div>企业是否有所有原材料采购记录、检验记录</div>
            </td>
            <td valign="top" width="84" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 63pt; padding-right: 5.4pt; height: 7.85pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
        </tr>
        <tr style="height: 5.25pt">
            <td valign="top" width="35" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 25.9pt; padding-right: 5.4pt; height: 5.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b>29</b></div>
            </td>
            <td rowspan="6" width="60" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 45pt; padding-right: 5.4pt; height: 5.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div align="center"><b><span style="font-size: 12pt">生产控制</span></b></div>
            </td>
            <td valign="top" width="349" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 262.1pt; padding-right: 5.4pt; height: 5.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div>企业是否建立保存全部技术规范和应用的技术文件（包括产品技术文件清单）</div>
            </td>
            <td valign="top" width="84" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 63pt; padding-right: 5.4pt; height: 5.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
            <td valign="top" rowspan="6" width="120" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; height: 5.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
        </tr>
        <tr style="height: 5.25pt">
            <td valign="top" width="35" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 25.9pt; padding-right: 5.4pt; height: 5.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b>30</b></div>
            </td>
            <td valign="top" width="349" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 262.1pt; padding-right: 5.4pt; height: 5.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div>企业是否明确产品的生产工艺规程并有作业指导书</div>
            </td>
            <td valign="top" width="84" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 63pt; padding-right: 5.4pt; height: 5.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b> </b></div>
            </td>
        </tr>
        <tr style="height: 5.25pt">
            <td valign="top" width="35" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 25.9pt; padding-right: 5.4pt; height: 5.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b>31</b></div>
            </td>
            <td valign="top" width="349" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 262.1pt; padding-right: 5.4pt; height: 5.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div>企业是否按照产品标准及相关要求规范组织生产</div>
            </td>
            <td valign="top" width="84" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 63pt; padding-right: 5.4pt; height: 5.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
        </tr>
        <tr style="height: 5.25pt">
            <td valign="top" width="35" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 25.9pt; padding-right: 5.4pt; height: 5.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b>32</b></div>
            </td>
            <td valign="top" width="349" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 262.1pt; padding-right: 5.4pt; height: 5.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div>生产过程是否有记录</div>
            </td>
            <td valign="top" width="84" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 63pt; padding-right: 5.4pt; height: 5.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
        </tr>
        <tr style="height: 5.25pt">
            <td valign="top" width="35" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 25.9pt; padding-right: 5.4pt; height: 5.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b>33</b></div>
            </td>
            <td valign="top" width="349" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 262.1pt; padding-right: 5.4pt; height: 5.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div>产品生产过程是否有清晰的状态标识和可追溯标识</div>
            </td>
            <td valign="top" width="84" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 63pt; padding-right: 5.4pt; height: 5.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
        </tr>
        <tr style="height: 5.25pt">
            <td valign="top" width="35" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 25.9pt; padding-right: 5.4pt; height: 5.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b>34</b></div>
            </td>
            <td valign="top" width="349" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 262.1pt; padding-right: 5.4pt; height: 5.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div>企业是否进行产品生产过程检验和最终检验，出厂检验是否符合产品标准要求，合格产品是否具有合格证</div>
            </td>
            <td valign="top" width="84" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 63pt; padding-right: 5.4pt; height: 5.25pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
        </tr>
        <tr style="height: 6.9pt">
            <td valign="top" width="35" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 25.9pt; padding-right: 5.4pt; height: 6.9pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b>35</b></div>
            </td>
            <td rowspan="2" width="60" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 45pt; padding-right: 5.4pt; height: 6.9pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div align="center"><b>销售及售后服务</b></div>
            </td>
            <td valign="top" width="349" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 262.1pt; padding-right: 5.4pt; height: 6.9pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div>企业产品销售对象是否合法</div>
            </td>
            <td valign="top" width="84" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 63pt; padding-right: 5.4pt; height: 6.9pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
            <td valign="top" rowspan="2" width="120" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; height: 6.9pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
        </tr>
        <tr style="height: 7.9pt">
            <td valign="top" width="35" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 25.9pt; padding-right: 5.4pt; height: 7.9pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b>36</b></div>
            </td>
            <td valign="top" width="349" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 262.1pt; padding-right: 5.4pt; height: 7.9pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div>企业是否认真做好售后服务、处理顾客投诉并保存相关的售后服务记录</div>
            </td>
            <td valign="top" width="84" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 63pt; padding-right: 5.4pt; height: 7.9pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
        </tr>
        <tr style="height: 3.15pt">
            <td valign="top" width="35" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 25.9pt; padding-right: 5.4pt; height: 3.15pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b>37</b></div>
            </td>
            <td rowspan="5" width="60" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 45pt; padding-right: 5.4pt; height: 3.15pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div align="center"><b>其他</b></div>
            </td>
            <td valign="top" width="349" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 262.1pt; padding-right: 5.4pt; height: 3.15pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div>企业是否对不合格产品的处理有规范程序</div>
            </td>
            <td valign="top" width="84" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 63pt; padding-right: 5.4pt; height: 3.15pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
            <td valign="top" rowspan="5" width="120" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; height: 3.15pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
        </tr>
        <tr style="height: 3.15pt">
            <td valign="top" width="35" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 25.9pt; padding-right: 5.4pt; height: 3.15pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b>38</b></div>
            </td>
            <td valign="top" width="349" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 262.1pt; padding-right: 5.4pt; height: 3.15pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div>企业是否对所生产产品的质量事故或不良事件及时上报有关部门</div>
            </td>
            <td valign="top" width="84" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 63pt; padding-right: 5.4pt; height: 3.15pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b> </b></div>
            </td>
        </tr>
        <tr style="height: 3.15pt">
            <td valign="top" width="35" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 25.9pt; padding-right: 5.4pt; height: 3.15pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b>39</b></div>
            </td>
            <td valign="top" width="349" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 262.1pt; padding-right: 5.4pt; height: 3.15pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div>企业是否对存在的质量问题或潜在的质量问题采取积极的纠正措施</div>
            </td>
            <td valign="top" width="84" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 63pt; padding-right: 5.4pt; height: 3.15pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
        </tr>
        <tr style="height: 3.15pt">
            <td valign="top" width="35" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 25.9pt; padding-right: 5.4pt; height: 3.15pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b>40</b></div>
            </td>
            <td valign="top" width="349" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 262.1pt; padding-right: 5.4pt; height: 3.15pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div>企业是否按时进行年度情况上报</div>
            </td>
            <td valign="top" width="84" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 63pt; padding-right: 5.4pt; height: 3.15pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
        </tr>
        <tr style="height: 3.15pt">
            <td valign="top" width="35" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 25.9pt; padding-right: 5.4pt; height: 3.15pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b>41</b></div>
            </td>
            <td valign="top" width="349" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 262.1pt; padding-right: 5.4pt; height: 3.15pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div>委托加工是否符合国家相关的规定要求</div>
            </td>
            <td valign="top" width="84" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 63pt; padding-right: 5.4pt; height: 3.15pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
        </tr>
        <tr style="height: 3.15pt">
            <td valign="top" width="35" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 25.9pt; padding-right: 5.4pt; height: 3.15pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b>42</b></div>
            </td>
            <td valign="top" width="60" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 45pt; padding-right: 5.4pt; height: 3.15pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
            <td valign="top" width="349" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 262.1pt; padding-right: 5.4pt; height: 3.15pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div>产品的说明书、标签和包装标识是否符合《医疗器械说明书、标签和包装标识管理规定》的要求</div>
            </td>
            <td valign="top" width="84" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 63pt; padding-right: 5.4pt; height: 3.15pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
            <td valign="top" width="120" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; height: 3.15pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
        </tr>
    </tbody>
</table>
</p>
<div> </div>

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