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href="http://www.cdcfah.com/zh/"><span>展會信息</span></a></li></ul></div></nav><section class="wrap clearfix"><section class="container clearfix tcPro"><section class="home-main container clearfix"><div id="lkcz29f" class="twoCol"><div id="i23tpmj" class="page-proshow clearfix"><p class="current"> 當(dāng)前位置:<a href="http://www.cdcfah.com/">首頁?<a href="http://www.cdcfah.com/cp/">產(chǎn)品供應(yīng)</a>?<a href="http://www.cdcfah.com/cp/second-_swfw/">商務(wù)服務(wù)</a>?<a href="http://www.cdcfah.com/cp/third-swfw_qtswfw/">其他商務(wù)服務(wù)</a>?吉林農(nóng)產(chǎn)品質(zhì)量可追溯體系誠信服務(wù) 上海貞碼信息科技供應(yīng)</p><div id="8neb2rl" class="leftbox clearfix"><h1>吉林農(nóng)產(chǎn)品質(zhì)量可追溯體系誠信服務(wù) 上海貞碼信息科技供應(yīng)</h1><div id="7jlsu7e" class="proBig"><div id="nhovxwi" class="bigimg"><div><p class="pic"><img src="https://tyunfile.71360.com/UploadFile/xunshi/637345817219843750/6871061.png" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div><div id="zt83ldk" class="smallimg"><div><p class="pic"><img src="https://tyunfile.71360.com/UploadFile/xunshi/637345817219843750/6871061.png" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div></div><div id="iczbikq" class="content"><p><span>需求數(shù)量：</span>0</p><p><span>價格要求：</span>面議</p><p><span>所在地：</span>上海市</p><p><span>包裝要求：</span><span style="color: #f30;"></span></p><p><span>產(chǎn)品關(guān)鍵詞：</span>吉林農(nóng)產(chǎn)品質(zhì)量可追溯體系,UDI</p><p><span>***更新：</span>2020-09-03 22:17:50</p><p><span id="click" >瀏覽次數(shù)：5次</span></p><a rel="nofollow" class="button">聯(lián)系我們</a></div></div><div id="rqx8roq" class="rightbox"><h3>公司基本資料信息</h3><p style="border:0;"><a rel="nofollow">上海貞碼信息科技有限公司</a></p><p><span>聯(lián)系人：</span>貞碼科技陳先生</p><p><span>郵箱: </span>77740203@qq.com</p><p><span>電話: </span>18601787597</p><p><span>傳真: </span>18601_</p><p><span>網(wǎng)址: </span>http://www.idcodema.com</p><p><span>手機: </span>18601-787597</p><p><span>地址: </span>上海市閔行區(qū)蓮花南路2899號蓮谷科技園1號樓A305室</p><p>[當(dāng)前離線] <a rel="nofollow"> [加為商友] </a><a rel="nofollow"> [發(fā)送信件] </a></p></div></div><div id="bqc97so" class="page-proshow02"><p class="title">詳細說明</p><div id="vf8yzry" class="box"><p><p style="text-indent:25px">醫(yī)療器械UDI經(jīng)營質(zhì)量管理規(guī)范：進貨查驗記錄和銷售記錄應(yīng)當(dāng)保存至醫(yī)療器械UDI有效期后2年；無有效期的，不得少于5年。植入類醫(yī)療器械UDI進貨查驗記錄和銷售記錄應(yīng)當(dāng)長久保存，吉林農(nóng)產(chǎn)品質(zhì)量可追溯體系。重點查看企業(yè)質(zhì)量管理制度中是否明確進貨查驗記錄和銷售記錄應(yīng)當(dāng)保存至醫(yī)療器械UDI有效期后2年；無有效期的，不得少于5年，吉林農(nóng)產(chǎn)品質(zhì)量可追溯體系。植入類醫(yī)療器械UDI查驗記錄和銷售記錄應(yīng)當(dāng)長久保存。抽查企業(yè)進貨查驗記錄和銷售記錄相關(guān)檔案是否按制度要求保存，吉林農(nóng)產(chǎn)品質(zhì)量可追溯體系。企業(yè)質(zhì)量管理人員應(yīng)當(dāng)具有國家認可的相關(guān)專業(yè)學(xué)歷或職稱。醫(yī)療器械UDI標(biāo)識數(shù)據(jù)匯聚和共享通過醫(yī)療器械標(biāo)識數(shù)據(jù)庫實現(xiàn)。吉林農(nóng)產(chǎn)品質(zhì)量可追溯體系</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="吉林農(nóng)產(chǎn)品質(zhì)量可追溯體系,UDI" src="https://tyunfile.71360.com/UploadFile/xunshi/637345817219843750/6871061.png"></div><p style="text-indent:25px">醫(yī)療器械UDI經(jīng)營質(zhì)量管理規(guī)范：企業(yè)應(yīng)當(dāng)根據(jù)經(jīng)營范圍和經(jīng)營規(guī)模建立相應(yīng)的質(zhì)量管理記錄制度。了解企業(yè)經(jīng)營范圍和經(jīng)營規(guī)模，重點查看企業(yè)質(zhì)量管理記錄和質(zhì)量管理檔案，其內(nèi)容是否包括但不限于以下適用內(nèi)容：（一）首營企業(yè)/首營品種審核記錄；（二）購進記錄；（三）進貨查驗（包括采購、驗收）記錄；（四）在庫養(yǎng)護、檢查記錄；（五）出庫、運輸、銷售記錄；（六）售后服務(wù)記錄；（七）質(zhì)量查詢、投訴、抽查情況記錄；（八）退貨記錄；（九）不合格品處置相關(guān)記錄；海南產(chǎn)品信息可追溯系統(tǒng)醫(yī)療器械UDI標(biāo)識數(shù)據(jù)載體，是指存儲或者傳輸醫(yī)療器械標(biāo)識的數(shù)據(jù)媒介。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="吉林農(nóng)產(chǎn)品質(zhì)量可追溯體系,UDI" src="https://tyunfile.71360.com/UploadFile/xunshi/637345817095419922/5887373.png"></div><p style="text-indent:25px">醫(yī)療器械UDI國際化合規(guī)性，您了解多少？第十五條注冊人/備案人應(yīng)當(dāng)在申請醫(yī)療器械UDI注冊、注冊變更或者辦理備案時，在注冊/備案管理系統(tǒng)中提交其產(chǎn)品標(biāo)識。注冊人/備案人應(yīng)當(dāng)在產(chǎn)品上市銷售前，將產(chǎn)品標(biāo)識和相關(guān)數(shù)據(jù)上傳至醫(yī)療器械UDI標(biāo)識數(shù)據(jù)庫。第十六條藥品監(jiān)督管理部門可根據(jù)監(jiān)管需求調(diào)用和管理相關(guān)數(shù)據(jù)。鼓勵各相關(guān)方采用先進信息化手段、應(yīng)用醫(yī)療器械UDI標(biāo)識，對醫(yī)療器械UDI在生產(chǎn)、經(jīng)營、使用等環(huán)節(jié)進行管理。第十七條本規(guī)則下列用語的含義：自動識別和數(shù)據(jù)采集，是指不通過鍵盤直接將數(shù)據(jù)輸入計算機系統(tǒng)或者其他微處理器控制的設(shè)備的技術(shù)。人工識讀，是指與機器識讀媒介相對應(yīng)的，可由人眼直接識別的編碼信息。</p><p style="text-indent:25px">從產(chǎn)業(yè)角度看，對于醫(yī)療器械UDI生產(chǎn)企業(yè)，利用標(biāo)識有助于提升企業(yè)信息化管理水平，建立產(chǎn)品追溯體系，加強行業(yè)自律，提升企業(yè)管理效能，助推醫(yī)療器械UDI產(chǎn)業(yè)高質(zhì)量發(fā)展。對于醫(yī)療器械UDI經(jīng)營企業(yè)，利用標(biāo)識，可建立符合現(xiàn)代化的物流體系，實現(xiàn)醫(yī)療器械UDI供應(yīng)鏈的透明化、可視化、智能化。對于醫(yī)療機構(gòu)，利用標(biāo)識，有利于減少用械差錯，提升院內(nèi)耗材管理水平，維護患者安全。對于衛(wèi)生行政管理部門，利用標(biāo)識，可強化對醫(yī)療用械行為的規(guī)范化管理，推動建立健康醫(yī)療大數(shù)據(jù)，提高衛(wèi)生管理效率，助力健康中國戰(zhàn)略。醫(yī)療器械UDI產(chǎn)品標(biāo)識是識別注冊人/備案人、醫(yī)療器械型號規(guī)格和包裝的代碼。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="吉林農(nóng)產(chǎn)品質(zhì)量可追溯體系,UDI" src="https://tyunfile.71360.com/UploadFile/xunshi/637345817450019531/4187422.png"></div><p style="text-indent:25px">醫(yī)療器械UDI經(jīng)營質(zhì)量管理規(guī)范：企業(yè)應(yīng)當(dāng)設(shè)置或配備與經(jīng)營規(guī)模、經(jīng)營范圍相適應(yīng)的，并符合相關(guān)資格要求的質(zhì)量管理、經(jīng)營等關(guān)鍵崗位人員。從事質(zhì)量管理工作的人員應(yīng)當(dāng)在職在崗。重點查看擔(dān)任企業(yè)質(zhì)量管理及經(jīng)營等上述關(guān)鍵崗位人員的勞動用工合同、簡歷、學(xué)歷或者職稱、職業(yè)資質(zhì)證明文件和培訓(xùn)記錄等，確認企業(yè)質(zhì)量管理、經(jīng)營等關(guān)鍵崗位人員相關(guān)專業(yè)學(xué)歷、職稱、工作經(jīng)歷等是否符合上述適用要求，質(zhì)量管理、經(jīng)營等關(guān)鍵崗位人員配置是否與經(jīng)營規(guī)模、經(jīng)營范圍相適應(yīng)（有特殊規(guī)定的，從其規(guī)定）；通過現(xiàn)場談話、查看質(zhì)量管理、經(jīng)營等關(guān)鍵崗位人員履職記錄等方式確認其在職在崗情況。對于醫(yī)保部門，有助于在采購招標(biāo)中精確識別醫(yī)療器械UDI，推動實現(xiàn)結(jié)算透明化，打擊**和濫用行為。寧夏UDI一站式服務(wù)</p><p style="text-indent:25px">醫(yī)療器械UDI標(biāo)識包括產(chǎn)品標(biāo)識和生產(chǎn)標(biāo)識。吉林農(nóng)產(chǎn)品質(zhì)量可追溯體系</p><p style="text-indent:25px">醫(yī)療器械UDI經(jīng)營質(zhì)量管理規(guī)范：從事第二類、第三類醫(yī)療器械UDI批發(fā)業(yè)務(wù)和第三類醫(yī)療器械UDI零售業(yè)務(wù)的企業(yè)還應(yīng)當(dāng)制定購貨者資格審核、醫(yī)療器械UDI追蹤溯源、質(zhì)量管理制度執(zhí)行情況考核的規(guī)定。第三類醫(yī)療器械UDI經(jīng)營企業(yè)應(yīng)當(dāng)建立質(zhì)量管理自查制度，于每年年底前向所在地設(shè)區(qū)的市級食品藥品監(jiān)督管理部門提交年度自查報告。重點查看從事第二類、第三類醫(yī)療器械UDI批發(fā)業(yè)務(wù)和第三類醫(yī)療器械UDI零售業(yè)務(wù)的企業(yè)制定的購貨者資格審核制度、醫(yī)療器械UDI追蹤溯源制度、質(zhì)量管理制度執(zhí)行情況考核規(guī)定和第三類醫(yī)療器械UDI經(jīng)營企業(yè)質(zhì)量管理自查和年度報告制度；抽查企業(yè)實施記錄，確認企業(yè)是否實施相關(guān)規(guī)定與制度。吉林農(nóng)產(chǎn)品質(zhì)量可追溯體系</p><p style="text-indent:25px">上海貞碼信息科技有限公司致力于通信產(chǎn)品，以科技創(chuàng)新實現(xiàn)***管理的追求。貞碼科技深耕行業(yè)多年，始終以客戶的需求為向?qū)?，為客戶提?**的生碼打碼客戶端，碼標(biāo)，智能追溯，掃碼通VA。貞碼科技繼續(xù)堅定不移地走高質(zhì)量發(fā)展道路，既要實現(xiàn)基本面穩(wěn)定增長，又要聚焦關(guān)鍵領(lǐng)域，實現(xiàn)轉(zhuǎn)型再突破。貞碼科技始終關(guān)注自身，在風(fēng)云變化的時代，對自身的建設(shè)毫不懈怠，高度的專注與執(zhí)著使貞碼科技在行業(yè)的從容而自信。</p></p><br /><p>文章來源地址: http://www.cdcfah.com/cp/1146906.html</p></div></div></div></div></div><div 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