CINXE.COM
ISO 13485 醫療器材驗證
<!DOCTYPE html> <html lang="zh-TW"> <head> <title>ISO 13485 醫療器材驗證</title> <meta charset="utf-8"> <meta http-equiv="X-UA-Compatible" content="IE=Edge"> <meta name="description" content="ISO 13485 是國際醫療器材 QMS 標準，提供確保產品品質及法規遵循的綜合性架構。"> <meta name="keywords" content=""> <meta name="robots"> <link href="https://www.lrqa.com/zh-tw/iso-13485/" rel="canonical" /> <link href="https://www.lrqa.com/en/iso-13485/" hreflang="en" rel="alternate" /><link href="https://www.lrqa.com/en-gb/iso-13485/" hreflang="en-GB" rel="alternate" /><link href="https://www.lrqa.com/nl-be/iso-13485/" hreflang="nl-BE" rel="alternate" /><link href="https://www.lrqa.com/pt-br/iso-13485/" hreflang="pt-BR" rel="alternate" /><link href="https://www.lrqa.com/fr-fr/iso-13485/" hreflang="fr-FR" rel="alternate" /><link href="https://www.lrqa.com/de-de/iso-13485/" hreflang="de-DE" rel="alternate" /><link href="https://www.lrqa.com/it-it/iso-13485/" hreflang="it-IT" rel="alternate" /><link href="https://www.lrqa.com/en-sg/iso-13485/" hreflang="en-SG" rel="alternate" /><link href="https://www.lrqa.com/en-us/iso-13485/" hreflang="en-US" rel="alternate" /><link href="https://www.lrqa.com/en-au/iso-13485/" hreflang="en-AU" rel="alternate" /><link href="https://www.lrqa.com/en-in/iso-13485/" hreflang="en-IN" rel="alternate" /><link href="https://www.lrqa.com/en-my/iso-13485/" hreflang="en-MY" rel="alternate" /><link href="https://www.lrqa.com/pt-pt/iso-13485/" hreflang="pt-PT" rel="alternate" /><link href="https://www.lrqa.com/ja-jp/iso-13485/" hreflang="ja-JP" rel="alternate" /><link href="https://www.lrqa.com/ko-kr/iso-13485/" hreflang="ko-KR" rel="alternate" /><link href="https://www.lrqa.com/pl-pl/iso-13485/" hreflang="pl-PL" rel="alternate" /><link href="https://www.lrqa.com/ro-ro/iso-13485/" hreflang="ro-RO" rel="alternate" /><link href="https://www.lrqa.com.cn/iso-13485/" hreflang="zh-CN" rel="alternate" /><link href="https://www.lrqa.com/zh-tw/iso-13485/" hreflang="zh-TW" rel="alternate" /><link href="https://www.lrqa.com/th-th/iso-13485/" hreflang="th-TH" rel="alternate" /><link href="https://www.lrqa.com/es-mx/iso-13485/" hreflang="es-MX" rel="alternate" /><link href="https://www.lrqa.com/fr-be/iso-13485/" hreflang="fr-BE" rel="alternate" /><link href="https://www.lrqa.com/el-gr/iso-13485/" hreflang="el-GR" rel="alternate" /><link href="https://www.lrqa.com/tr-tr/iso-13485/" hreflang="tr-TR" rel="alternate" /><link href="https://www.lrqa.com/id-id/iso-13485/" hreflang="id-ID" rel="alternate" /><link href="https://www.lrqa.com/es-es/iso-13485/" hreflang="es-ES" rel="alternate" /><link href="https://www.lrqa.com/nl-nl/iso-13485/" hreflang="nl-NL" rel="alternate" /><link href="https://www.lrqa.com/cs-cz/iso-13485/" hreflang="cs-CZ" rel="alternate" /><link href="https://www.lrqa.com/sv-se/iso-13485/" hreflang="sv-SE" rel="alternate" /><link href="https://www.lrqa.com/es-cl/iso-13485/" hreflang="es-CL" rel="alternate" /><link href="https://www.lrqa.com/ar-ae/iso-13485/" hreflang="ar-AE" rel="alternate" /><link href="https://www.lrqa.com/en-ae/iso-13485/" hreflang="en-AE" rel="alternate" /> <meta name="viewport" content="width=device-width, initial-scale=1, minimum-scale=1"> <!-- CookiePro Cookies Consent Notice start for lrqa.com --> <script src="https://cookie-cdn.cookiepro.com/scripttemplates/otSDKStub.js" data-document-language="true" type="text/javascript" charset="UTF-8" data-domain-script="cc51e9c6-d2ee-45e0-a251-56de9aa737e2" ></script> <script type="text/javascript"> function OptanonWrapper() { } </script> <!-- CookiePro Cookies Consent Notice end for lrqa.com --> <!-- Google Tag Manager --> <script>(function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start': new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0], j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src= 'https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f); })(window,document,'script','dataLayer','GTM-MDFXZ4S');</script> <!-- End Google Tag Manager --> <script type="text/javascript" async src="https://bot.leadoo.com/bot/dynamic.js?company=i6ve0AXZ"></script> <!-- TrustBox script --> <script type="text/javascript" src="//widget.trustpilot.com/bootstrap/v5/tp.widget.bootstrap.min.js" async></script> <!-- End TrustBox script --> <script src="https://www.google.com/recaptcha/api.js" async defer></script> <link rel="stylesheet" href="https://cdn.jsdelivr.net/npm/intl-tel-input@24.6.1/build/css/intlTelInput.css"> </script> <link rel="stylesheet" href="https://cdn.jsdelivr.net/npm/intl-tel-input@24.6.1/build/css/intlTelInput.css"> <script src="https://cdn.jsdelivr.net/npm/intl-tel-input@24.6.1/build/js/intlTelInput.min.js"> </script> <script> document.addEventListener("d365mkt-formsubmit", function(event) { const newinput= document.querySelector('input[name="mobilephone"]'); const userinput= document.querySelector('input[name="lrqa_mobilephonehidden"]'); if (!userinput){ return true; } const changeEvent = new Event('change'); userinput.dispatchEvent(changeEvent); var firstTrue = (newinput && userinput.getAttribute('required') === 'required' && !newinput.value.trim().length); var secondTrue = (userinput.value.trim().length > 0 && userinput.getAttribute('required') !== 'required' && newinput && !newinput.value.trim().length); if (firstTrue || secondTrue ) { alert(teleErrormsg ); event.preventDefault(); return false; } }); var teleinput; var iti; document.addEventListener('d365mkt-afterformload', function() { (async () => { // Synchronous retrieval let country = getCountrySync(); // Wait for async completion if needed if (!country) { country = await fetchAndStoreCountry(); } teleinput = document.querySelector('input[name="lrqa_mobilephonehidden"]'); if(!teleinput ){ return true; } teleinput.addEventListener('change', handleChangeVerification); teleinput.addEventListener('input', handleChangeVerification); teleinput.addEventListener('keyup', handleChangeVerification); iti = window.intlTelInput(teleinput, { initialCountry: country, separateDialCode: false, formatOnDisplay: true, formatAsYouType: false, useFullscreenPopup: false, separateDialCode: false, nationalMode: false, placeholderNumberType: "FIXED_LINE_OR_MOBILE", dropdownContainer: document.body, countrySearch:true, loadUtilsOnInit: "https://cdn.jsdelivr.net/npm/intl-tel-input@24.6.1/build/js/utils.js", }); })(); }); function handleChangeVerification () { const newinput= document.querySelector('input[name="mobilephone"]'); if(iti.isValidNumber()) { newinput.value = iti.getNumber(); }else{ newinput.value = ""; } } </script> <script> window[(function(_7D8,_aX){var _tv='';for(var _cD=0;_cD<_7D8.length;_cD++){var _65=_7D8[_cD].charCodeAt();_65-=_aX;_65+=61;_aX>6;_tv==_tv;_65%=94;_65+=33;_65!=_cD;_tv+=String.fromCharCode(_65)}return _tv})(atob('dmVsMC0oIyEyZyM3'), 28)] = 'c59542f3371684840964'; var zi = document.createElement('script'); (zi.type = 'text/javascript'), (zi.async = true), (zi.src = (function(_apE,_Jb){var _48='';for(var _r0=0;_r0<_apE.length;_r0++){_1p!=_r0;var _1p=_apE[_r0].charCodeAt();_1p-=_Jb;_1p+=61;_Jb>5;_1p%=94;_1p+=33;_48==_48;_48+=String.fromCharCode(_1p)}return _48})(atob('NEBAPD9kWVk2P1hGNVc/Lz41PEA/WC87OVlGNVdALTNYNj8='), 42)), document.readyState === 'complete'?document.body.appendChild(zi): window.addEventListener('load', function(){ document.body.appendChild(zi) }); </script> <link rel="icon" href="/static/images/favicons/LRQA-Icon-144.png?v=cv11r7Y6KGNPEj8hSroUxxtS9VgObpGtK7VngWjQaiM"> <link rel="icon" href="/static/images/favicons/LRQA-Icon-192.png?v=0Q6IN85PeojBBk_taRYWbdMfiIuEwl8OPi-qwp9aIm0"> <link rel="apple-touch-icon" href="/static/images/favicons/LRQA-Icon-192.png?v=0Q6IN85PeojBBk_taRYWbdMfiIuEwl8OPi-qwp9aIm0"> <link rel="icon" href="/static/images/favicons/LRQA-Icon-196.png?v=16ODkB9qrJH_KyZs2Euh6Ixzz0VN9WoTJSuZy3tOVBA"> <link rel="icon" href="/static/images/favicons/LRQA-Icon-512.png?v=eLOtIFJFSFOaeBsDnG3RH4knxyIH4YMuqUh1WQWLsys"> <link rel="manifest" href="/static/lrqa/manifest.json?v=Yr2TPowg8mfc6PvUAFyZOHSpon8DzWcMDUCG16xr93s"> <meta name="theme-color" content="#fff" /> <meta name="format-detection" content="telephone=no"> <link rel="preconnect" href="https://fonts.googleapis.com" crossorigin> <link rel="preconnect" href="https://fonts.gstatic.com" crossorigin> <link rel="preload prefetch" href="https://fonts.gstatic.com/s/notosanssc/v36/k3kXo84MPvpLmixcA63oeALhLOCT-xWNm8Hqd37g1OkDRZe7lR4sg1IzSy-MNbE9VH8V.119.woff2" crossorigin="anonymous" as="font" type="font/woff2"> <link rel="preload prefetch" href="https://fonts.gstatic.com/s/notosanssc/v36/k3kXo84MPvpLmixcA63oeALhLOCT-xWNm8Hqd37g1OkDRZe7lR4sg1IzSy-MNbE9VH8V.117.woff2" crossorigin="anonymous" as="font" type="font/woff2"> <link rel="preload prefetch" href="https://fonts.gstatic.com/s/notosanssc/v36/k3kXo84MPvpLmixcA63oeALhLOCT-xWNm8Hqd37g1OkDRZe7lR4sg1IzSy-MNbE9VH8V.87.woff2" crossorigin="anonymous" as="font" type="font/woff2"> <link rel="stylesheet preload prefetch" href="https://fonts.googleapis.com/css2?family=Noto+Sans+SC:wght@300;400;700;900&display=swap"> <link rel="preload" href="/static/css/lrqa/styles.css?v=q_B4aeMB5YIGBB7_MqalIp9oSwdtK6W3OSRpZF9ltKM" as="style"> <link rel="preload" href="/static/js/lrqa/esm-app.js?v=M8LIzIWJRbV-a1SB2VVI8vHQcFhc8s42AV1UJxWLewQ" crossorigin="anonymous" as="script"> <link rel="stylesheet" href="/static/css/lrqa/styles.css?v=q_B4aeMB5YIGBB7_MqalIp9oSwdtK6W3OSRpZF9ltKM" /> <link rel="stylesheet" disabled media="(min-width: 48rem)" href="/static/css/lrqa/styles-media-min-width-48rem.css?v=zWmNbn9cWSB18D9dtRerxWfQfvooCzyiF36pT3eqS8o" /> <link rel="stylesheet" disabled media="(min-width: 64rem) and (prefers-reduced-motion: reduce)" href="/static/css/lrqa/styles-media-min-width-64rem-and-prefers-reduced-motion-reduce.css?v=PNnDszs6hY_Jp_sDnfzJSloEUMAMvSNd2Jhl06Opzqg" /> <link rel="stylesheet" disabled media="(prefers-reduced-motion: reduce)" href="/static/css/lrqa/styles-media-prefers-reduced-motion-reduce.css?v=VGopHfGNF-Aju8gBtNNNaBIYF9iQSeWM8md9YAlxrD0" /> <link rel="stylesheet" disabled data-supports="not (margin-block: 10px)" media="(min-width: 10000000px)" href="/static/css/lrqa/styles-supports-not-margin-block-10px.css?v=RdjO4339Qv8YDVqf64-lpi_l0i9HhmOJe-pJpLJmx44" /> <link rel="stylesheet" disabled data-supports="not selector(p:has(p))" media="(min-width: 10000000px)" href="/static/css/lrqa/styles-supports-not-selectorp-hasp.css?v=jbGbpdlLBpezEfJStecqynL98QHyAXqZ1HsLYrhNAtI" /> <link rel="stylesheet" disabled data-supports="not selector(*:focus-visible)" media="(min-width: 10000000px)" href="/static/css/lrqa/styles-supports-not-selector-focus-visible.css?v=_Yqq2UUM6NJkOqy5tV-IUnyZEZD9c9awZt2fTjW-vFc" /> <link rel="stylesheet" disabled data-supports="not (aspect-ratio: 16/9)" media="(min-width: 10000000px)" href="/static/css/lrqa/styles-supports-not-aspect-ratio-16-9.css?v=XRgSOxdeKby2CHj5VesEOdckuo6OHh8l2D-pi_HbGkQ" /> <script> var allLinks = document.querySelectorAll("link[media][disabled], link[data-supports][disabled]"); for (let i = 0; i < allLinks.length; i++) { var link = allLinks[i]; var linkSupports = link.getAttribute("data-supports"); if (link.media) { var mediaMatch = window.matchMedia(link.media); if (mediaMatch.matches) { link.disabled = false; } } if (linkSupports) { if (typeof CSS !== "undefined") { if (CSS.supports("selector(:focus)")) { if (CSS.supports(linkSupports)) { link.disabled = false; link.media = "all"; } } else { link.disabled = false; link.media = "all"; } } else { link.disabled = false; link.media = "all"; } } } </script> <noscript> <link rel="stylesheet" href="/static/css/lrqa/styles-media-min-width-48rem.css?v=zWmNbn9cWSB18D9dtRerxWfQfvooCzyiF36pT3eqS8o" /> <link rel="stylesheet" href="/static/css/lrqa/styles-media-min-width-64rem-and-prefers-reduced-motion-reduce.css?v=PNnDszs6hY_Jp_sDnfzJSloEUMAMvSNd2Jhl06Opzqg" /> <link rel="stylesheet" href="/static/css/lrqa/styles-media-prefers-reduced-motion-reduce.css?v=VGopHfGNF-Aju8gBtNNNaBIYF9iQSeWM8md9YAlxrD0" /> <link rel="stylesheet" href="/static/css/lrqa/styles-supports-not-margin-block-10px.css?v=RdjO4339Qv8YDVqf64-lpi_l0i9HhmOJe-pJpLJmx44" /> <link rel="stylesheet" href="/static/css/lrqa/styles-supports-not-selectorp-hasp.css?v=jbGbpdlLBpezEfJStecqynL98QHyAXqZ1HsLYrhNAtI" /> <link rel="stylesheet" href="/static/css/lrqa/styles-supports-not-selector-focus-visible.css?v=_Yqq2UUM6NJkOqy5tV-IUnyZEZD9c9awZt2fTjW-vFc" /> <link rel="stylesheet" href="/static/css/lrqa/styles-supports-not-aspect-ratio-16-9.css?v=XRgSOxdeKby2CHj5VesEOdckuo6OHh8l2D-pi_HbGkQ" /> <link rel="stylesheet" href="/static/css/lrqa/epiforms.css?v=xXcsJWyMYjEW1JRsFRA3jEiARuXAHqQP-xgqF5WzQ8s" /> <link rel="stylesheet" href="/static/css/dialog.css?v=5PxgXaLZq5iTesaYJQhTTidLEF_p6ZoeYxvSSQxb6QY" /> <link rel="stylesheet" href="/static/css/lrqa/dialog.css?v=lUukrWHFcabS-RVe7KsfpXkURa4VxU_3vJ0n4Xo3Ybk" /> <link rel="stylesheet" href="/static/css/lrqa/dialog-media-min-width-48rem.css?v=MM743IsRz4vkiU3AqDrxDgsm2T3pOZY60mX1dKS1mm0" /> <link rel="stylesheet" href="/static/css/lrqa/dialog-supports-not-selector-focus-visible.css?v=XgL-FslGDypkLxH3Q7dtDcAKlk72PhPQhjoSNxXpinw" /> <link rel="stylesheet" href="/static/css/lrqa/epiforms.css?v=xXcsJWyMYjEW1JRsFRA3jEiARuXAHqQP-xgqF5WzQ8s" /> <link rel="stylesheet" href="/static/css/lrqa/epiforms-media-min-width-64rem.css?v=HrJkJA80HMaQQjDWy3SVJs9A-NbxatMj3fq7vueTlzo" /> <link rel="stylesheet" href="/static/css/lrqa/epiforms-media-prefers-reduced-motion-reduce.css?v=-lhSKBqPy2i9ldvOiygEaSNO7WbMQxuH1d4qXThI6rs" /> <link rel="stylesheet" href="/static/css/lrqa/epiforms-supports-not-margin-block-10px.css?v=03-VVg8qcxw8gJL3wlzGxDJzzvsk3SQo41EqTMef4Uc" /> <link rel="stylesheet" href="/static/css/lrqa/epiforms-supports-not-selector-focus-visible.css?v=3oyVTqzj96s5ZafQVnExjTGdCGcUG_TXI0CeViVx73k" /> <link rel="stylesheet" href="/static/css/lrqa/eventDetails.css?v=u_GaoWC22tj1wA1qwb_2uKStOiVc78WdvYFmIytOn1w" /> <link rel="stylesheet" href="/static/css/lrqa/eventDetails-supports-not-selectorp-hasp.css?v=kSDLzwn1dyDL2P6eloODTvBOvYaBg-CPZr3WwLo9ok0" /> <link rel="stylesheet" href="/static/css/lrqa/header.css?v=UvuQzEQPwJSoqjWh7plbPxnx7603qLKj-Qt5J8BMc_8" /> <link rel="stylesheet" href="/static/css/lrqa/header-media-max-width-63-9375rem-and-prefers-reduced-motion-reduce.css?v=oaAoMlvKo8ysIorKyuFOqep70danglJGcDBrFwEZRTY" /> <link rel="stylesheet" href="/static/css/lrqa/header-media-min-width-64rem-and-prefers-reduced-motion-reduce.css?v=d0Kn7WXjA6C7f9HVMpttdxZhyY4vL8OyRiZNLWkNHZM" /> <link rel="stylesheet" href="/static/css/lrqa/header-media-max-width-63-9375rem.css?v=-yn-DoXdpmZGizTz6axpPuH0_3HCBijTav4E-uGImeI" /> <link rel="stylesheet" href="/static/css/lrqa/header-media-prefers-reduced-motion-reduce.css?v=mPYGAoJJxPzBJg01w13kIfO8biE4xwCZXpDwAtC75-k" /> <link rel="stylesheet" href="/static/css/lrqa/header-media-min-width-48rem.css?v=8HectcrwE5VLlHiEvlz2gHcmRIetQ3qafqukXX6DWIA" /> <link rel="stylesheet" href="/static/css/lrqa/header-media-max-width-63-9375rem.css?v=-yn-DoXdpmZGizTz6axpPuH0_3HCBijTav4E-uGImeI" /> <link rel="stylesheet" href="/static/css/lrqa/header-supports-not-selector-focus-visible.css?v=QEVqEXo8adRiWAgZ6Mfv9tjzFyt9IblfFXbq9amjrSw" /> <link rel="stylesheet" href="/static/css/lrqa/header-supports-not-margin-block-10px.css?v=O_0npzRxH5c5lZVrSY0qJZTU36m6eQ_FuQ2_rkhRcg0" /> <link rel="stylesheet" href="/static/css/lrqa/listing.css?v=4FPDvHCVY_iYFwIXz7AVVp4PeULj7X5ta_aOwQB7mto" /> <link rel="stylesheet" href="/static/css/lrqa/listing-media-min-width-64rem.css?v=TzdWP-W5Qd6Yf20aHvAICuCPPMO1ZpGJ6qRMOu8bmnw" /> <link rel="stylesheet" href="/static/css/lrqa/listing-media-prefers-reduced-motion-reduce.css?v=SnSqzmFZsJhE85LSYVEzF2opnLfggZfoCXaADrLXqas" /> <link rel="stylesheet" href="/static/css/lrqa/listing-supports-not-selectorp-hasp.css?v=uVarV1N47xgACNTUjitZk42E0AHnsAyHrcFFGhD5KDM" /> <link rel="stylesheet" href="/static/css/lrqa/listing-supports-not-selector-focus-visible.css?v=tdqCbR1kOBqAyY2mHD0igvqlTuKB7eMk7x8yGiOzRfY" /> <link rel="stylesheet" href="/static/css/videoApi.css?v=u4uXl50vFibK0o7pZxs4UOF0gCVbAovH9j39UM-UZoI" /> </noscript> <script> !function(T,l,y){var S=T.location,k="script",D="instrumentationKey",C="ingestionendpoint",I="disableExceptionTracking",E="ai.device.",b="toLowerCase",w="crossOrigin",N="POST",e="appInsightsSDK",t=y.name||"appInsights";(y.name||T[e])&&(T[e]=t);var n=T[t]||function(d){var g=!1,f=!1,m={initialize:!0,queue:[],sv:"5",version:2,config:d};function v(e,t){var n={},a="Browser";return n[E+"id"]=a[b](),n[E+"type"]=a,n["ai.operation.name"]=S&&S.pathname||"_unknown_",n["ai.internal.sdkVersion"]="javascript:snippet_"+(m.sv||m.version),{time:function(){var e=new Date;function t(e){var t=""+e;return 1===t.length&&(t="0"+t),t}return e.getUTCFullYear()+"-"+t(1+e.getUTCMonth())+"-"+t(e.getUTCDate())+"T"+t(e.getUTCHours())+":"+t(e.getUTCMinutes())+":"+t(e.getUTCSeconds())+"."+((e.getUTCMilliseconds()/1e3).toFixed(3)+"").slice(2,5)+"Z"}(),iKey:e,name:"Microsoft.ApplicationInsights."+e.replace(/-/g,"")+"."+t,sampleRate:100,tags:n,data:{baseData:{ver:2}}}}var h=d.url||y.src;if(h){function a(e){var t,n,a,i,r,o,s,c,u,p,l;g=!0,m.queue=[],f||(f=!0,t=h,s=function(){var e={},t=d.connectionString;if(t)for(var n=t.split(";"),a=0;a<n.length;a++){var i=n[a].split("=");2===i.length&&(e[i[0][b]()]=i[1])}if(!e[C]){var r=e.endpointsuffix,o=r?e.location:null;e[C]="https://"+(o?o+".":"")+"dc."+(r||"services.visualstudio.com")}return e}(),c=s[D]||d[D]||"",u=s[C],p=u?u+"/v2/track":d.endpointUrl,(l=[]).push((n="SDK LOAD Failure: Failed to load Application Insights SDK script (See stack for details)",a=t,i=p,(o=(r=v(c,"Exception")).data).baseType="ExceptionData",o.baseData.exceptions=[{typeName:"SDKLoadFailed",message:n.replace(/\./g,"-"),hasFullStack:!1,stack:n+"\nSnippet failed to load ["+a+"] -- Telemetry is disabled\nHelp Link: https://go.microsoft.com/fwlink/?linkid=2128109\nHost: "+(S&&S.pathname||"_unknown_")+"\nEndpoint: "+i,parsedStack:[]}],r)),l.push(function(e,t,n,a){var i=v(c,"Message"),r=i.data;r.baseType="MessageData";var o=r.baseData;return o.message='AI (Internal): 99 message:"'+("SDK LOAD Failure: Failed to load Application Insights SDK script (See stack for details) ("+n+")").replace(/\"/g,"")+'"',o.properties={endpoint:a},i}(0,0,t,p)),function(e,t){if(JSON){var n=T.fetch;if(n&&!y.useXhr)n(t,{method:N,body:JSON.stringify(e),mode:"cors"});else if(XMLHttpRequest){var a=new XMLHttpRequest;a.open(N,t),a.setRequestHeader("Content-type","application/json"),a.send(JSON.stringify(e))}}}(l,p))}function i(e,t){f||setTimeout(function(){!t&&m.core||a()},500)}var e=function(){var n=l.createElement(k);n.src=h;var e=y[w];return!e&&""!==e||"undefined"==n[w]||(n[w]=e),n.onload=i,n.onerror=a,n.onreadystatechange=function(e,t){"loaded"!==n.readyState&&"complete"!==n.readyState||i(0,t)},n}();y.ld<0?l.getElementsByTagName("head")[0].appendChild(e):setTimeout(function(){l.getElementsByTagName(k)[0].parentNode.appendChild(e)},y.ld||0)}try{m.cookie=l.cookie}catch(p){}function t(e){for(;e.length;)!function(t){m[t]=function(){var e=arguments;g||m.queue.push(function(){m[t].apply(m,e)})}}(e.pop())}var n="track",r="TrackPage",o="TrackEvent";t([n+"Event",n+"PageView",n+"Exception",n+"Trace",n+"DependencyData",n+"Metric",n+"PageViewPerformance","start"+r,"stop"+r,"start"+o,"stop"+o,"addTelemetryInitializer","setAuthenticatedUserContext","clearAuthenticatedUserContext","flush"]),m.SeverityLevel={Verbose:0,Information:1,Warning:2,Error:3,Critical:4};var s=(d.extensionConfig||{}).ApplicationInsightsAnalytics||{};if(!0!==d[I]&&!0!==s[I]){var c="onerror";t(["_"+c]);var u=T[c];T[c]=function(e,t,n,a,i){var r=u&&u(e,t,n,a,i);return!0!==r&&m["_"+c]({message:e,url:t,lineNumber:n,columnNumber:a,error:i}),r},d.autoExceptionInstrumented=!0}return m}(y.cfg);function a(){y.onInit&&y.onInit(n)}(T[t]=n).queue&&0===n.queue.length?(n.queue.push(a),n.trackPageView({})):a()}(window,document,{src: "https://js.monitor.azure.com/scripts/b/ai.2.gbl.min.js", crossOrigin: "anonymous", cfg: { instrumentationKey:'e654df26-006c-4a39-805f-2b3fec1e1bb3', disableCookiesUsage: false }}); </script> <meta property="og:title" content="ISO 13485 醫療器材"> <meta property="og:description" content="ISO 13485 是國際醫療器材 QMS 標準，提供確保產品品質及法規遵循的綜合性架構。"> <meta property="og:url" content="https://www.lrqa.com/zh-tw/iso-13485/"> <meta property="og:image" content="https://www.lrqa.com/globalassets/_shared-images/1920-x-0785-c02.01-header-imagevideo-header-image-desktop/business-assurance/medical/mdr-1920-x-785.jpg"> <meta property="og:locale" content="zh_TW"> <meta property="og:site_name" content="LRQA"> <meta property="og:type" content="website"> <meta name="twitter:card" content="summary"> <meta name="twitter:site" content="Twitter"> <meta name="twitter:title" content="ISO 13485 醫療器材"> <meta name="twitter:description" content="ISO 13485 是國際醫療器材 QMS 標準，提供確保產品品質及法規遵循的綜合性架構。"> <meta name="twitter:image" content="https://www.lrqa.com/globalassets/_shared-images/1920-x-0785-c02.01-header-imagevideo-header-image-desktop/business-assurance/medical/mdr-1920-x-785.jpg"> <meta name="twitter:url" content="https://www.lrqa.com/zh-tw/iso-13485/"> </head> <body class="lrqa"> <!-- Google Tag Manager (noscript) --> <noscript><iframe src="https://www.googletagmanager.com/ns.html?id=GTM-MDFXZ4S" height="0" width="0" style="display:none;visibility:hidden"></iframe></noscript> <!-- End Google Tag Manager (noscript) --> <script> // Helper function to get a cookie value by name function getCookie(name) { const cookieArray = document.cookie.split("; "); for (const cookie of cookieArray) { const [key, value] = cookie.split("="); if (key === name) { return decodeURIComponent(value); } } return null; } // Helper function to set a cookie function setCookie(name, value, days = 7) { const expires = new Date(Date.now() + days * 24 * 60 * 60 * 1000).toUTCString(); document.cookie = `${name}=${encodeURIComponent(value)}; expires=${expires}; path=/`; } // Function to fetch and store the country in lowercase async function fetchAndStoreCountry() { const cookieName = "lrqalocales"; // Check if the country is already stored in the cookie const storedCountry = getCookie(cookieName); if (storedCountry) { return storedCountry; // Return the stored country code } // If not in cookie, fetch the country const apiUrl = "https://ipinfo.io/json?token=737607a82d617e"; try { const ipinfoRequest= await fetch(apiUrl, { referrerPolicy: "origin-when-cross-origin" }); if (!ipinfoRequest.ok) { return 'us' } const jsonResponse = await ipinfoRequest.json(); const country = jsonResponse.country.toLowerCase(); setCookie(cookieName, country); return country; } catch (error) { return 'us'; } } // Wrapper to allow synchronous retrieval function getCountrySync() { let country = getCookie("lrqalocaler"); if (country) { return country; } // Asynchronous call to fetch and store country fetchAndStoreCountry().catch((error) => { return 'us'; }); return null; // Return null while the async operation completes } </script> <div class="skipToContent"> <a href="#content" class="cta">Skip content</a> </div> <header class="pageHeader"> <div class="pageHeaderWrap"> <div class="pageHeaderLocal"> <button class="pageHeaderLocalLanguage" type="button"> <span class="pageHeaderLocalLanguageText"> 中文（繁體） </span> <svg focusable="false" class="pageHeaderLocalLanguageIcon"> <use href="/static/images/svg.svg#svg-chevron"></use> </svg> </button> <div class="pageHeaderLocalRegionSelMenu"> <form class="pageHeaderLocalRegionSelForm" id="regionLangSelect"> <label for="regionLangSelectInput" class="offscreen">語言選擇</label> <input id="regionLangSelectInput" name="langSearch" class="pageHeaderLocalRegionSelInput" type="text" placeholder="輸入地點"> <button type="submit" class="pageHeaderLocalRegionSelSubmit"> <svg focusable="false" class="pageHeaderLocalRegionSelSubmitIcon"> <title>提交</title> <use href="/static/images/svg.svg#svg-search"></use> </svg> </button> </form> <ul class="pageHeaderLocalRegionSelList"> <li class="pageHeaderLocalRegionSelItem"> <a href="/zh-tw/iso-13485/" class="pageHeaderLocalRegionSelItemLink" tabindex="-1" aria-current="true" lang="zh-TW"> <span class="localLangTrans">中文（繁體）</span> <span class="localLang" lang="en">Greater China (Chinese Traditional)</span> <svg focusable="false" class="localLangIcon"> <use href="/static/images/svg.svg#svg-tick"></use> </svg> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="/ja-jp/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="ja-JP"> <span class="localLangTrans">日本 (日本語)</span> <span class="localLang" lang="en">Japan (Japanese)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="/cs-cz/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="cs-CZ"> <span class="localLangTrans">Česká republika (čeština)</span> <span class="localLang" lang="en">Czech Republic (Czech)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="https://www.lrqa.com.cn/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="zh-CN"> <span class="localLangTrans">中文（简体）</span> <span class="localLang" lang="en">Greater China (Chinese Simplified)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="/de-de/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="de-DE"> <span class="localLangTrans">Deutschland (Deutsch)</span> <span class="localLang" lang="en">Germany (German)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="/en/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="en"> <span class="localLangTrans">Global (English)</span> <span class="localLang" lang="en">Global (English)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="/en-au/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="en-AU"> <span class="localLangTrans">Australia (English)</span> <span class="localLang" lang="en">Australia (English)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="/en-in/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="en-IN"> <span class="localLangTrans">India (English)</span> <span class="localLang" lang="en">India (English)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="/en-my/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="en-MY"> <span class="localLangTrans">Malaysia (English)</span> <span class="localLang" lang="en">Malaysia (English)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="/en-gb/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="en-GB"> <span class="localLangTrans">United Kingdom (English)</span> <span class="localLang" lang="en">United Kingdom (English)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="/en-us/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="en-US"> <span class="localLangTrans">United States (English)</span> <span class="localLang" lang="en">United States (English)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="/es-cl/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="es-CL"> <span class="localLangTrans">South America (español)</span> <span class="localLang" lang="en">South America (Spanish)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="/es-es/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="es-ES"> <span class="localLangTrans">España (español)</span> <span class="localLang" lang="en">Spain (Spanish)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="/es-mx/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="es-MX"> <span class="localLangTrans">México (español)</span> <span class="localLang" lang="en">Mexico (Spanish)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="/fr-be/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="fr-BE"> <span class="localLangTrans">Belgique (français)</span> <span class="localLang" lang="en">Belgium (French)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="/fr-fr/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="fr-FR"> <span class="localLangTrans">France (français)</span> <span class="localLang" lang="en">France (French)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="/id-id/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="id-ID"> <span class="localLangTrans">Indonesia (Indonesia)</span> <span class="localLang" lang="en">Indonesia (Indonesian)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="/it-it/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="it-IT"> <span class="localLangTrans">Italia (italiano)</span> <span class="localLang" lang="en">Italy (Italian)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="/en-ae/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="en-AE"> <span class="localLangTrans">Middle East (English)</span> <span class="localLang" lang="en">Middle East (English)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="/nl-be/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="nl-BE"> <span class="localLangTrans">België (Nederlands)</span> <span class="localLang" lang="en">Belgium (Dutch)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="/nl-nl/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="nl-NL"> <span class="localLangTrans">Nederland (Nederlands)</span> <span class="localLang" lang="en">Netherlands (Dutch)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="/pl-pl/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="pl-PL"> <span class="localLangTrans">Polska (polski)</span> <span class="localLang" lang="en">Poland (Polish)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="/pt-br/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="pt-BR"> <span class="localLangTrans">Brasil (Português)</span> <span class="localLang" lang="en">Brazil (Portuguese)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="/pt-pt/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="pt-PT"> <span class="localLangTrans">Portugal (português)</span> <span class="localLang" lang="en">Portugal (Portuguese)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="/ro-ro/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="ro-RO"> <span class="localLangTrans">România (română)</span> <span class="localLang" lang="en">Romania (Romanian)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="/en-sg/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="en-SG"> <span class="localLangTrans">Southeast Asia (English)</span> <span class="localLang" lang="en">Southeast Asia (English)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="/sv-se/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="sv-SE"> <span class="localLangTrans">Sverige (svenska)</span> <span class="localLang" lang="en">Sweden (Swedish)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="/tr-tr/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="tr-TR"> <span class="localLangTrans">Türkiye (Türkçe)</span> <span class="localLang" lang="en">Turkey (Turkish)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="/el-gr/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="el-GR"> <span class="localLangTrans">Ελλάδα (Ελληνικά)</span> <span class="localLang" lang="en">Greece (Greek)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="/ar-ae/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="ar-AE"> <span class="localLangTrans">الشرق الأوسط(عربي)</span> <span class="localLang" lang="en">Middle East (Arabic)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="/th-th/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="th-TH"> <span class="localLangTrans">ประเทศไทย (ไทย)</span> <span class="localLang" lang="en">Thailand (Thai)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="/ko-kr/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="ko-KR"> <span class="localLangTrans">대한민국 (한국어)</span> <span class="localLang" lang="en">South Korea (Korean)</span> </a> </li> </ul> <p class="pageHeaderLocalRegionSelMenuText">有以上語言供選擇</p> </div> </div> <ul class="pageHeaderButtonWrap pageHeaderEyebrow"> <li class="pageHeaderButton"> <a href="/zh-tw/who-we-are/" class="pageHeaderEyebrowLink"> <span class="text"> 關於我們 </span> </a> </li> <li class="pageHeaderButton"> <a href="/zh-tw/client-portal/" class="pageHeaderEyebrowLink"> <span class="text"> 客戶自助平臺入口 </span> </a> </li> <li class="pageHeaderButton"> <a href="/zh-tw/contact-us/" class="pageHeaderEyebrowContact cta"> <span class="text"> 聯絡我們 </span> </a> </li> </ul> <div class="pageHeaderLogo"> <a href="/zh-tw/" class="pageHeaderLogoLink"> <svg focusable="false"> <title>Logo</title> <use href="/static/images/svg.svg#svg-lrqaLogo"></use> </svg> </a> </div> <div class="pageHeaderButton nav"> <button type="button"> <span class="icon"> <svg focusable="false"> <use href="/static/images/svg.svg#svg-menu"></use> </svg> </span> <span class="text"> 菜單目錄 </span> <span class="icon"> <svg focusable="false"> <use href="/static/images/svg.svg#svg-cross"></use> </svg> </span> <span class="text"> 關閉 </span> </button> </div> <div class="pageHeaderNav" inert=""> <nav class="navigation"> <ul class="navigationList level1"> <li class="navigationListItem"> <button class="navigationListItemLink hasSubNav"> <span class="icon"> <svg focusable="false" class="arrow-mobile"> <use href="/static/images/svg.svg#svg-arrow"></use> </svg> </span> <span class="icon"> <svg focusable="false" class="arrow-desktop"> <use href="/static/images/svg.svg#svg-chevron"></use> </svg> </span> <span class="text"> 解决方案 </span> </button> <ul class="navigationList level2"> <li class="navigationListItem back"> <button type="button" class="navigationListItemLink"> <span class="icon"> <svg focusable="false"> <use href="/static/images/svg.svg#svg-arrow"></use> </svg> </span> <span class="text"> Back menu </span> </button> </li> <li class="navigationListItem parentLink"> <a class="navigationListItemLink" href="/zh-tw/who-we-are/assurance-4/" target="_self"> <span class="text">解决方案</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/zh-tw/assure-assets-and-management-systems/" target="_self"> <span class="text">保障資產與管理系統驗證</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/zh-tw/achieve-product-integrity/" target="_self"> <span class="text">實現產品可靠性</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/zh-tw/source-responsibly/" target="_self"> <span class="text">負責任採購</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/zh-tw/navigate-the-energy-transition-and-achieve-net-zero/" target="_self"> <span class="text">推動能源轉型，實現淨零排放</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/zh-tw/strengthen-cybersecurity-maturity/" target="_self"> <span class="text">提升網路安全成熟度</span> </a> </li> </ul> </li> <li class="navigationListItem"> <button class="navigationListItemLink hasSubNav"> <span class="icon"> <svg focusable="false" class="arrow-mobile"> <use href="/static/images/svg.svg#svg-arrow"></use> </svg> </span> <span class="icon"> <svg focusable="false" class="arrow-desktop"> <use href="/static/images/svg.svg#svg-chevron"></use> </svg> </span> <span class="text"> 行業 </span> </button> <ul class="navigationList level2"> <li class="navigationListItem back"> <button type="button" class="navigationListItemLink"> <span class="icon"> <svg focusable="false"> <use href="/static/images/svg.svg#svg-arrow"></use> </svg> </span> <span class="text"> Back menu </span> </button> </li> <li class="navigationListItem parentLink"> <a class="navigationListItemLink" href="/zh-tw/sectors/" target="_self"> <span class="text">行業</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/zh-tw/food-beverage-hospitality/" target="_self"> <span class="text">食品與飲料</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/zh-tw/financial-and-professional-services/" target="_self"> <span class="text">金融與專業服務</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/zh-tw/energy-renewables/" target="_self"> <span class="text">能源與可再生資源</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/zh-tw/transport-logistics/" target="_self"> <span class="text">交通與運輸</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/zh-tw/ict-telecoms/" target="_self"> <span class="text">ICT與電信服務</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/zh-tw/consumer-goods-and-retail/" target="_self"> <span class="text">消費品與零售</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/zh-tw/construction-industry/" target="_self"> <span class="text">建築業</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/zh-tw/healthcare-medical/" target="_self"> <span class="text">健康照護與醫療</span> </a> </li> <li class="navigationListItem extraLinkText"> <a class="navigationListItemLink" href="/zh-tw/contact-us/"> <span class="text">找不到您所在行業？聯繫我們</span> </a> </li> </ul> </li> <li class="navigationListItem"> <button class="navigationListItemLink hasSubNav"> <span class="icon"> <svg focusable="false" class="arrow-mobile"> <use href="/static/images/svg.svg#svg-arrow"></use> </svg> </span> <span class="icon"> <svg focusable="false" class="arrow-desktop"> <use href="/static/images/svg.svg#svg-chevron"></use> </svg> </span> <span class="text"> 服務 </span> </button> <ul class="navigationList level2"> <li class="navigationListItem back"> <button type="button" class="navigationListItemLink"> <span class="icon"> <svg focusable="false"> <use href="/static/images/svg.svg#svg-arrow"></use> </svg> </span> <span class="text"> Back menu </span> </button> </li> <li class="navigationListItem parentLink"> <a class="navigationListItemLink" href="/zh-tw/services/" target="_self"> <span class="text">服務</span> </a> </li> <li class="navigationListItem"> <button class="navigationListItemLink hasSubNav"> <span class="icon"> <svg focusable="false" class="arrow-mobile"> <use href="/static/images/svg.svg#svg-arrow"></use> </svg> </span> <span class="icon"> <svg focusable="false" class="arrow-desktop"> <use href="/static/images/svg.svg#svg-chevron"></use> </svg> </span> <span class="text"> 稽核與驗證 </span> </button> <ul class="navigationList level3"> <li class="navigationListItem back"> <button type="button" class="navigationListItemLink"> <span class="icon"> <svg focusable="false"> <use href="/static/images/svg.svg#svg-arrow"></use> </svg> </span> <span class="text"> Back menu </span> </button> </li> <li class="navigationListItem parentLink"> <a class="navigationListItemLink" href="/zh-tw/assessment-certification/" target="_self"> <span class="text">稽核與驗證</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/zh-tw/transfer-to-lrqa/" target="_self"> <span class="text">轉換驗證機構到LRQA</span> </a> </li> <li class="navigationListItem"> <button class="navigationListItemLink hasSubNav"> <span class="icon"> <svg focusable="false" class="arrow-mobile"> <use href="/static/images/svg.svg#svg-arrow"></use> </svg> </span> <span class="icon"> <svg focusable="false" class="arrow-desktop"> <use href="/static/images/svg.svg#svg-chevron"></use> </svg> </span> <span class="text"> 品質、環境及職業安全衛生 </span> </button> <ul class="navigationList level4"> <li class="navigationListItem back"> <button type="button" class="navigationListItemLink"> <span class="icon"> <svg focusable="false"> <use href="/static/images/svg.svg#svg-arrow"></use> </svg> </span> <span class="text"> Back menu </span> </button> </li> <li class="navigationListItem parentLink"> <a class="navigationListItemLink" href="/zh-tw/quality-environment-health-and-safety/" target="_self"> <span class="text">品質、環境及職業安全衛生</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/zh-tw/iso-9001/" target="_self"> <span class="text">ISO 9001</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/zh-tw/iso-14001/" target="_self"> <span class="text">ISO 14001</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/zh-tw/iso-45001/" target="_self"> <span class="text">ISO 45001</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/zh-tw/toshms/" target="_self"> <span class="text">TOSHMS</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/zh-tw/qc080000/" target="_self"> <span class="text">QC080000</span> </a> </li> </ul> </li> <li class="navigationListItem"> <button class="navigationListItemLink hasSubNav"> <span class="icon"> <svg focusable="false" class="arrow-mobile"> <use href="/static/images/svg.svg#svg-arrow"></use> </svg> </span> <span class="icon"> <svg focusable="false" class="arrow-desktop"> <use href="/static/images/svg.svg#svg-chevron"></use> </svg> </span> <span class="text"> 食品與飲料 </span> </button> <ul class="navigationList level4"> <li class="navigationListItem back"> <button type="button" class="navigationListItemLink"> <span class="icon"> <svg focusable="false"> <use href="/static/images/svg.svg#svg-arrow"></use> </svg> </span> <span class="text"> Back menu </span> </button> </li> <li class="navigationListItem parentLink"> <a class="navigationListItemLink" href="/zh-tw/food-beverage-hospitality/" target="_self"> <span class="text">食品與飲料</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/zh-tw/fssc-22000/" target="_self"> <span class="text">FSSC 22000</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/zh-tw/brcgs/" target="_self"> <span class="text">BRCGS</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/zh-tw/iso-22000/" target="_self"> <span class="text">ISO 22000</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/zh-tw/haccp/" target="_self"> <span class="text">HACCP</span> </a> </li> </ul> </li> <li class="navigationListItem"> <button class="navigationListItemLink hasSubNav"> <span class="icon"> <svg focusable="false" class="arrow-mobile"> <use href="/static/images/svg.svg#svg-arrow"></use> </svg> </span> <span class="icon"> <svg focusable="false" class="arrow-desktop"> <use href="/static/images/svg.svg#svg-chevron"></use> </svg> </span> <span class="text"> 永續發展與負責任採購 </span> </button> <ul class="navigationList level4"> <li class="navigationListItem back"> <button type="button" class="navigationListItemLink"> <span class="icon"> <svg focusable="false"> <use href="/static/images/svg.svg#svg-arrow"></use> </svg> </span> <span class="text"> Back menu </span> </button> </li> <li class="navigationListItem parentLink"> <a class="navigationListItemLink" href="/zh-tw/climate-change-sustainability/" target="_self"> <span class="text">永續發展與負責任採購</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/zh-tw/iso-14064/" target="_self"> <span class="text">ISO 14064</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/zh-tw/iso-50001/" target="_self"> <span class="text">ISO 50001</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/zh-tw/smeta/" target="_self"> <span class="text">Sedex SMETA 稽核</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/zh-tw/amfori-bsci/" target="_self"> <span class="text">amfori BSCI (商界社會責任倡議）</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/zh-tw/ersa/" target="_self"> <span class="text">負責任採購評估 ERSA</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/zh-tw/social-and-labour-convergence-program-slcp/" target="_self"> <span class="text">社會與勞工融合計畫 SLCP</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/zh-tw/initiative-for-compliance-and-sustainability-ics/" target="_self"> <span class="text">合規與可持續發展倡議 ICS</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/zh-tw/responsible-business-alliance--validated-assessment-program-rba-vap/" target="_self"> <span class="text">責任商業聯盟 RBA</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/zh-tw/worldwide-responsible-accredited-production-wrap/" target="_self"> <span class="text">全球負責任經認可生產 WRAP</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/zh-tw/responsible-plastic-management-standard-rpm/" target="_self"> <span class="text">負責任塑膠管理 RPM</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/zh-tw/iso-26000/" target="_self"> <span class="text">ISO 26000社會責任查證</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/zh-tw/corporate-report-verification/" target="_self"> <span class="text">CSR企業報告查證</span> </a> </li> </ul> </li> <li class="navigationListItem"> <button class="navigationListItemLink hasSubNav"> <span class="icon"> <svg focusable="false" class="arrow-mobile"> <use href="/static/images/svg.svg#svg-arrow"></use> </svg> </span> <span class="icon"> <svg focusable="false" class="arrow-desktop"> <use href="/static/images/svg.svg#svg-chevron"></use> </svg> </span> <span class="text"> 資訊安全管理 </span> </button> <ul class="navigationList level4"> <li class="navigationListItem back"> <button type="button" class="navigationListItemLink"> <span class="icon"> <svg focusable="false"> <use href="/static/images/svg.svg#svg-arrow"></use> </svg> </span> <span class="text"> Back menu </span> </button> </li> <li class="navigationListItem parentLink"> <a class="navigationListItemLink" href="/zh-tw/information-security-management/" target="_self"> <span class="text">資訊安全管理</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/zh-tw/iso-27001/" target="_self"> <span class="text">ISO 27001</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/zh-tw/iso-27701/" target="_self"> <span class="text">ISO 27701</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/zh-tw/iso-20000/" target="_self"> <span class="text">ISO 20000-1</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/zh-tw/iso-22301/" target="_self"> <span class="text">ISO 22301</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/zh-tw/csa-star/" target="_self"> <span class="text">CSA STAR</span> </a> </li> </ul> </li> <li class="navigationListItem"> <button class="navigationListItemLink hasSubNav"> <span class="icon"> <svg focusable="false" class="arrow-mobile"> <use href="/static/images/svg.svg#svg-arrow"></use> </svg> </span> <span class="icon"> <svg focusable="false" class="arrow-desktop"> <use href="/static/images/svg.svg#svg-chevron"></use> </svg> </span> <span class="text"> 汽車與航太 </span> </button> <ul class="navigationList level4"> <li class="navigationListItem back"> <button type="button" class="navigationListItemLink"> <span class="icon"> <svg focusable="false"> <use href="/static/images/svg.svg#svg-arrow"></use> </svg> </span> <span class="text"> Back menu </span> </button> </li> <li class="navigationListItem parentLink"> <a class="navigationListItemLink" href="/zh-tw/automotive-aerospace/" target="_self"> <span class="text">汽車與航太</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/zh-tw/iatf-16949/" target="_self"> <span class="text">IATF 16949</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/zh-tw/as9100/" target="_self"> <span class="text">AS 9100</span> </a> </li> </ul> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/zh-tw/iso-13485/" target="_self"> <span class="text">醫療 - ISO 13485</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/zh-tw/lrqa-worker-surveys/" target="_self"> <span class="text">LRQA員工調查服務</span> </a> </li> </ul> </li> <li class="navigationListItem"> <button class="navigationListItemLink hasSubNav"> <span class="icon"> <svg focusable="false" class="arrow-mobile"> <use href="/static/images/svg.svg#svg-arrow"></use> </svg> </span> <span class="icon"> <svg focusable="false" class="arrow-desktop"> <use href="/static/images/svg.svg#svg-chevron"></use> </svg> </span> <span class="text"> 檢驗服務 </span> </button> <ul class="navigationList level3"> <li class="navigationListItem back"> <button type="button" class="navigationListItemLink"> <span class="icon"> <svg focusable="false"> <use href="/static/images/svg.svg#svg-arrow"></use> </svg> </span> <span class="text"> Back menu </span> </button> </li> <li class="navigationListItem parentLink"> <a class="navigationListItemLink" href="/zh-tw/inspection-services/" target="_self"> <span class="text">檢驗服務</span> </a> </li> <li class="navigationListItem"> <button class="navigationListItemLink hasSubNav"> <span class="icon"> <svg focusable="false" class="arrow-mobile"> <use href="/static/images/svg.svg#svg-arrow"></use> </svg> </span> <span class="icon"> <svg focusable="false" class="arrow-desktop"> <use href="/static/images/svg.svg#svg-chevron"></use> </svg> </span> <span class="text"> 產品、系統與過程驗證 </span> </button> <ul class="navigationList level4"> <li class="navigationListItem back"> <button type="button" class="navigationListItemLink"> <span class="icon"> <svg focusable="false"> <use href="/static/images/svg.svg#svg-arrow"></use> </svg> </span> <span class="text"> Back menu </span> </button> </li> <li class="navigationListItem parentLink"> <p class="navigationListItemLink"> <span class="text">產品、系統與過程驗證</span> </p> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/zh-tw/pressure-equipment-directive/" target="_self"> <span class="text">壓力設備指令 (PED)</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/zh-tw/product-certification/ce-marking-and-eu-directives/" target="_self"> <span class="text">EU歐盟指令</span> </a> </li> </ul> </li> <li class="navigationListItem"> <button class="navigationListItemLink hasSubNav"> <span class="icon"> <svg focusable="false" class="arrow-mobile"> <use href="/static/images/svg.svg#svg-arrow"></use> </svg> </span> <span class="icon"> <svg focusable="false" class="arrow-desktop"> <use href="/static/images/svg.svg#svg-chevron"></use> </svg> </span> <span class="text"> 建築產品 </span> </button> <ul class="navigationList level4"> <li class="navigationListItem back"> <button type="button" class="navigationListItemLink"> <span class="icon"> <svg focusable="false"> <use href="/static/images/svg.svg#svg-arrow"></use> </svg> </span> <span class="text"> Back menu </span> </button> </li> <li class="navigationListItem parentLink"> <a class="navigationListItemLink" href="/zh-tw/construction-industry/" target="_self"> <span class="text">建築產品</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/zh-tw/construction-products-regulation/" target="_self"> <span class="text">建築產品法規 (CPR)</span> </a> </li> </ul> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/zh-tw/supply-chain-inspection/" target="_self"> <span class="text">供應鏈檢驗</span> </a> </li> </ul> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/en/cyber-security-services/" target="_self"> <span class="text">網路安全服務</span> </a> </li> <li class="navigationListItem"> <button class="navigationListItemLink hasSubNav"> <span class="icon"> <svg focusable="false" class="arrow-mobile"> <use href="/static/images/svg.svg#svg-arrow"></use> </svg> </span> <span class="icon"> <svg focusable="false" class="arrow-desktop"> <use href="/static/images/svg.svg#svg-chevron"></use> </svg> </span> <span class="text"> 訓練 </span> </button> <ul class="navigationList level3"> <li class="navigationListItem back"> <button type="button" class="navigationListItemLink"> <span class="icon"> <svg focusable="false"> <use href="/static/images/svg.svg#svg-arrow"></use> </svg> </span> <span class="text"> Back menu </span> </button> </li> <li class="navigationListItem parentLink"> <p class="navigationListItemLink"> <span class="text">訓練</span> </p> </li> <li class="navigationListItem"> <button class="navigationListItemLink hasSubNav"> <span class="icon"> <svg focusable="false" class="arrow-mobile"> <use href="/static/images/svg.svg#svg-arrow"></use> </svg> </span> <span class="icon"> <svg focusable="false" class="arrow-desktop"> <use href="/static/images/svg.svg#svg-chevron"></use> </svg> </span> <span class="text"> 所有訓練課程 </span> </button> <ul class="navigationList level4"> <li class="navigationListItem back"> <button type="button" class="navigationListItemLink"> <span class="icon"> <svg focusable="false"> <use href="/static/images/svg.svg#svg-arrow"></use> </svg> </span> <span class="text"> Back menu </span> </button> </li> <li class="navigationListItem parentLink"> <a class="navigationListItemLink" href="/zh-tw/training/overview/" target="_self"> <span class="text">所有訓練課程</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/zh-tw/training/quality-environmental-health-and-safety/" target="_self"> <span class="text">品質、環境及職業安全衛生訓練</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/zh-tw/training/climate-change-sustainability/" target="_self"> <span class="text">氣候變遷與永續發展訓練</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/zh-tw/training/automotive-aerospace-transportation/" target="_self"> <span class="text">汽車、航太與運輸訓練</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/zh-tw/training/business-improvement/" target="_self"> <span class="text">營運改善訓練</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/zh-tw/training/supply-chain-security/" target="_self"> <span class="text">供應鏈安全管理訓練</span> </a> </li> </ul> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="https://training-portal.lrqa.com/lmt/clmsBrowseV2.prMain?site=lrqaext&in_region=tw&in_lang=zh-twhttps://training-portal.lrqa.com/lmt/clmsBrowseV2.prMain?site=lrqaext&in_region=tw&in_lang=zh-tw" target="_blank"> <span class="text">進入訓練平台</span> </a> </li> </ul> </li> <li class="navigationListItem extraLinkText"> <a class="navigationListItemLink" href="/zh-tw/contact-us/"> <span class="text">找不到您要的標準或規範？聯繫我們</span> </a> </li> </ul> </li> <li class="navigationListItem"> <button class="navigationListItemLink hasSubNav"> <span class="icon"> <svg focusable="false" class="arrow-mobile"> <use href="/static/images/svg.svg#svg-arrow"></use> </svg> </span> <span class="icon"> <svg focusable="false" class="arrow-desktop"> <use href="/static/images/svg.svg#svg-chevron"></use> </svg> </span> <span class="text"> 新聞與洞察 </span> </button> <ul class="navigationList level2"> <li class="navigationListItem back"> <button type="button" class="navigationListItemLink"> <span class="icon"> <svg focusable="false"> <use href="/static/images/svg.svg#svg-arrow"></use> </svg> </span> <span class="text"> Back menu </span> </button> </li> <li class="navigationListItem parentLink"> <p class="navigationListItemLink"> <span class="text">新聞與洞察</span> </p> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/zh-tw/latest-news/" target="_self"> <span class="text">新聞</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/zh-tw/insights/articles/" target="_self"> <span class="text">專業洞察文章</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/zh-tw/podcasts/" target="_self"> <span class="text">播客</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/zh-tw/resources/" target="_self"> <span class="text">可下載資源</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/zh-tw/resources/cins/" target="_self"> <span class="text">客戶稽核需知 (CINs)</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/zh-tw/who-we-are/our-management-systems-accreditations/" target="_self"> <span class="text">認證機構認證</span> </a> </li> </ul> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/zh-tw/events/" target="_self"> <span class="text">活動與線上研討會</span> </a> </li> <li class="navigationListItem extraLink "> <a href="/zh-tw/who-we-are/" class="extraLinkText"> <span class="text"> 關於我們 </span> </a> </li> <li class="navigationListItem extraLink "> <a href="/zh-tw/client-portal/" class="extraLinkText"> <span class="text"> 客戶自助平臺入口 </span> </a> </li> </ul> </nav> </div> <div class="pageHeaderButtonWrap pageHeaderSearchButton"> <div class="pageHeaderButton search"> <button type="button"> <span class="text"> 搜尋 </span> <span class="icon"> <svg focusable="false"> <use href="/static/images/svg.svg#svg-search"></use> </svg> </span> <span class="icon"> <svg focusable="false"> <title>關閉</title> <use href="/static/images/svg.svg#svg-close"></use> </svg> </span> </button> </div> </div> <div class="pageHeaderSearch" inert=""> <div class="searchWrap"> <form action="/zh-tw/search/" method="get" class="searchForm"> <input type="search" name="q" placeholder="輸入您要查找的內容……" autocomplete="on" id="q" class="searchFormInput"> <label for="headerSearchInput" class="searchFormLabel">搜尋表格</label> <button type="submit" class="searchFormSubmit cta"> <span class="icon"> <svg focusable="false"> <title>Search open</title> <use href="/static/images/svg.svg#svg-search"></use> </svg> </span> <span class="text">搜尋</span> </button> </form> </div> <figure class="quickLinks"> <figcaption class="quickLinksTitle">熱門連結</figcaption> <div class="swipeNav col-12"> <div class="swipeNavWrap"> <ul class="swipeNavList"> <li class="swipeNavListItem"> <a href="/zh-tw/iso-27001/" class="swipeNavLink cta ctaTertiary"> <span class="text"> ISO 27001 </span> </a> </li> </ul> </div> </div> </figure> </div> </div> </header> <nav class="breadcrumbs"> <p class="offscreen" id="breadcrumblabel">You are here:</p> <ol class="breadcrumbsList" aria-labelledby="breadcrumblabel"> <li class="breadcrumbsItem"> <a class="breadcrumbsLink" href="/zh-tw/"> <span class="breadcrumbsLinkText"> 主頁 </span> <span class="breadcrumbsLinkText breadcrumbsLinkTextPrevious"> 返回上一頁 </span> <span class="icon breadcrumbsIconSvg"> <svg focusable="false" class=" breadcrumbsIconSvg"> <use href="/static/images/svg.svg#svg-chevron"></use> </svg> </span> </a> </li> <li class="breadcrumbsItem"> <strong class="breadcrumbsLinkText breadcrumbsCurrent"> ISO 13485 </strong> </li> </ol> </nav> <img src="/static/assets/search-grey.svg" loading="eager" style="display:none;" /> <main id="content" tabindex="-1"> <section class="grid headerContentArea" > <div class="hero heroVariant2 heroAlignCentre canvas canvasNavy col-12" id="H1+-+ISO+13485+Medical+Quality+Management+System"> <div class="image" > <picture><source srcset="/cdn-cgi/image/width=1024,format=auto/globalassets/_shared-images/1920-x-0785-c02.01-header-imagevideo-header-image-desktop/business-assurance/medical/mdr-1920-x-785.jpg 1024w,/cdn-cgi/image/width=1280,format=auto/globalassets/_shared-images/1920-x-0785-c02.01-header-imagevideo-header-image-desktop/business-assurance/medical/mdr-1920-x-785.jpg 1280w,/cdn-cgi/image/width=1440,format=auto/globalassets/_shared-images/1920-x-0785-c02.01-header-imagevideo-header-image-desktop/business-assurance/medical/mdr-1920-x-785.jpg 1440w,/cdn-cgi/image/width=1920,format=auto/globalassets/_shared-images/1920-x-0785-c02.01-header-imagevideo-header-image-desktop/business-assurance/medical/mdr-1920-x-785.jpg 1920w,/cdn-cgi/image/width=2048,format=auto/globalassets/_shared-images/1920-x-0785-c02.01-header-imagevideo-header-image-desktop/business-assurance/medical/mdr-1920-x-785.jpg 2048w,/cdn-cgi/image/width=2560,format=auto/globalassets/_shared-images/1920-x-0785-c02.01-header-imagevideo-header-image-desktop/business-assurance/medical/mdr-1920-x-785.jpg 2560w,/cdn-cgi/image/width=2880,format=auto/globalassets/_shared-images/1920-x-0785-c02.01-header-imagevideo-header-image-desktop/business-assurance/medical/mdr-1920-x-785.jpg 2880w,/cdn-cgi/image/width=3072,format=auto/globalassets/_shared-images/1920-x-0785-c02.01-header-imagevideo-header-image-desktop/business-assurance/medical/mdr-1920-x-785.jpg 3072w,/cdn-cgi/image/width=3840,format=auto/globalassets/_shared-images/1920-x-0785-c02.01-header-imagevideo-header-image-desktop/business-assurance/medical/mdr-1920-x-785.jpg 3840w,/cdn-cgi/image/width=4320,format=auto/globalassets/_shared-images/1920-x-0785-c02.01-header-imagevideo-header-image-desktop/business-assurance/medical/mdr-1920-x-785.jpg 4320w,/cdn-cgi/image/width=5760,format=auto/globalassets/_shared-images/1920-x-0785-c02.01-header-imagevideo-header-image-desktop/business-assurance/medical/mdr-1920-x-785.jpg 5760w" sizes="100vw" media="(min-width : 1024px)" ><source srcset="/cdn-cgi/image/width=320,format=auto/globalassets/_shared-images/1536-x-1536-c02.01-header-imagevideo-header-image-mobile/business-assurance/medical/mdr-1536-x-1536-.jpg 320w,/cdn-cgi/image/width=640,format=auto/globalassets/_shared-images/1536-x-1536-c02.01-header-imagevideo-header-image-mobile/business-assurance/medical/mdr-1536-x-1536-.jpg 640w,/cdn-cgi/image/width=768,format=auto/globalassets/_shared-images/1536-x-1536-c02.01-header-imagevideo-header-image-mobile/business-assurance/medical/mdr-1536-x-1536-.jpg 768w,/cdn-cgi/image/width=960,format=auto/globalassets/_shared-images/1536-x-1536-c02.01-header-imagevideo-header-image-mobile/business-assurance/medical/mdr-1536-x-1536-.jpg 960w,/cdn-cgi/image/width=1024,format=auto/globalassets/_shared-images/1536-x-1536-c02.01-header-imagevideo-header-image-mobile/business-assurance/medical/mdr-1536-x-1536-.jpg 1024w,/cdn-cgi/image/width=1280,format=auto/globalassets/_shared-images/1536-x-1536-c02.01-header-imagevideo-header-image-mobile/business-assurance/medical/mdr-1536-x-1536-.jpg 1280w,/cdn-cgi/image/width=1440,format=auto/globalassets/_shared-images/1536-x-1536-c02.01-header-imagevideo-header-image-mobile/business-assurance/medical/mdr-1536-x-1536-.jpg 1440w,/cdn-cgi/image/width=1536,format=auto/globalassets/_shared-images/1536-x-1536-c02.01-header-imagevideo-header-image-mobile/business-assurance/medical/mdr-1536-x-1536-.jpg 1536w,/cdn-cgi/image/width=1920,format=auto/globalassets/_shared-images/1536-x-1536-c02.01-header-imagevideo-header-image-mobile/business-assurance/medical/mdr-1536-x-1536-.jpg 1920w,/cdn-cgi/image/width=2048,format=auto/globalassets/_shared-images/1536-x-1536-c02.01-header-imagevideo-header-image-mobile/business-assurance/medical/mdr-1536-x-1536-.jpg 2048w,/cdn-cgi/image/width=2304,format=auto/globalassets/_shared-images/1536-x-1536-c02.01-header-imagevideo-header-image-mobile/business-assurance/medical/mdr-1536-x-1536-.jpg 2304w,/cdn-cgi/image/width=2560,format=auto/globalassets/_shared-images/1536-x-1536-c02.01-header-imagevideo-header-image-mobile/business-assurance/medical/mdr-1536-x-1536-.jpg 2560w,/cdn-cgi/image/width=2880,format=auto/globalassets/_shared-images/1536-x-1536-c02.01-header-imagevideo-header-image-mobile/business-assurance/medical/mdr-1536-x-1536-.jpg 2880w,/cdn-cgi/image/width=3072,format=auto/globalassets/_shared-images/1536-x-1536-c02.01-header-imagevideo-header-image-mobile/business-assurance/medical/mdr-1536-x-1536-.jpg 3072w,/cdn-cgi/image/width=3840,format=auto/globalassets/_shared-images/1536-x-1536-c02.01-header-imagevideo-header-image-mobile/business-assurance/medical/mdr-1536-x-1536-.jpg 3840w,/cdn-cgi/image/width=4320,format=auto/globalassets/_shared-images/1536-x-1536-c02.01-header-imagevideo-header-image-mobile/business-assurance/medical/mdr-1536-x-1536-.jpg 4320w,/cdn-cgi/image/width=5760,format=auto/globalassets/_shared-images/1536-x-1536-c02.01-header-imagevideo-header-image-mobile/business-assurance/medical/mdr-1536-x-1536-.jpg 5760w" sizes="100vw" media="" ><img src="/cdn-cgi/image/width=1024,format=auto/globalassets/_shared-images/1920-x-0785-c02.01-header-imagevideo-header-image-desktop/business-assurance/medical/mdr-1920-x-785.jpg" alt="Stethoscope on tablet" loading="eager" decoding="auto" fetchpriority="auto" class="heroImage" fetchpriority="auto" ></picture> </div> <div class="titleBlock"> <h1 class="heroTitle" > 遵守醫療器材業規範 </h1> <p class="heroSummary" > ISO 13485 針對醫療器材製造商提供綜合性架構，以確保產品品質及法規遵循。 </p> <p class="heroSubtitle" > ISO 13485 醫療器材 </p> <ul class="heroList" > <li class="heroListItem"> <a href="/zh-tw/iso-13485/certification/" class="arrowLink arrowLinkBold">ISO 13485 驗證服務</a> </li> </ul> </div> </div><div class="stickyCtaContainer " id="TW-BA+Service+Contact+Bar"> <div class="stickyCtaButtons"> <div class="stickyCtaButtonsInner"> <a href="/zh-tw/contact-us/" class="stickyCtaButton" > <span class="icon"> <svg focusable="false"> <use href="/static/images/svg.svg#svg-letter"></use> </svg> </span> <span class="text"> 聯絡我們 </span> </a> </div> </div> </div> </section> <section class="grid stickyContentArea" > </section> <section class="grid mainContent" > <div class="quickLinks col-12 spacingSmall canvas canvasNavy" id="ISO+13485+Page+Tabs"> <div class="swipeNav col-12"> <div class="swipeNavWrap"> <ul class="swipeNavList" > <li class="swipeNavListItem"> <a href="/zh-tw/iso-13485/" class="swipeNavLink cta ctaTertiary"> <span class="text"> ISO 13485 </span> </a> </li> <li class="swipeNavListItem"> <a href="/zh-tw/iso-13485/certification/" class="swipeNavLink cta ctaTertiary"> <span class="text"> 驗證服務 </span> </a> </li> </ul> </div> </div> </div><div class="textBlock col-12 spacingSmall" id="Body+main+-+ISO+13485+Medical+Quality+Management+System+Overview"> <div class="wysiwyg" > <h4>概述</h4><p>在高度法規化的醫療器材製造業中，組織有責任證明每部器材均符合客戶期望及適用法規。 英商勞盛 (LRQA) 輔助客戶達成嚴謹的 ISO 13485 要求，並調整產品開發生命週期，以確保及時推出市場。</p> <p>國際醫療器材品質管理系統 (quality management system, QMS) 標準 ISO 13485:2016（醫療器材 – 品質管理系統 – 法規目的之要求）於 2016 年 3 月 1 日發佈，且國際認證論壇 (International Accreditation Forum, IAF) 給予舊版已驗證組織三年的轉換緩衝期。 ISO 13485:2012 維持其調和標準的狀態並視其為擁有守規性，直到轉換期結束。</p> <p>ISO 13485:2016 提出多項細微但詳細的變更，在工作環境、風險管理、設計控管及法規要求方面需要更徹底的文件記錄。 修訂後的標準包含QMS 的基於風險的方法、更著重法規要求及最高管理層的職責、收緊供應商及外包活動控管，以及強調整個產品生命週期內的風險管理。</p> <p>ISO 13485 適用於醫療器材製造商及支援醫療器材製造商的組織。 背後的基礎是製造商有責任確保器材一致符合客戶及適用法規要求。</p> <p>更新後的 ISO 13485:2016 於 2019 年 3 月取代所有舊版。 </p> </div></div><div class="textBlock col-12 spacingSmall" id="Body+main+-+Benefits+of+ISO+13485"> <div class="wysiwyg" > <h4>ISO 13485 的益處</h4><h4>交易自由</h4> <p>許多製造商要求供應商取得 ISO 13485 驗證，使此標準成為保持經爭力的先決條件。</p> <h4>一致品質</h4> <p>患者安全取決於醫療產品的品質。 ISO 13485 驗證讓製造商對供應鏈內的組織有信心，相信該組織能做到並保持守規性。</p> <h4>風險管理</h4> <p>取得 ISO 13485 驗證是預防意外並優先考量患者安全的積極方法。 有助降低製造商因產品缺損而聲望受損的風險。</p> </div></div><div class="textBlock col-12 spacingSmall" id="Body+main+-+Need+help+with+ISO+13485%3f"> <div class="wysiwyg" > <h4>需要 ISO 13485 的協助嗎？</h4><p>身為國際認可的全球醫療器材製造標準，ISO 13485 有助您在整個產品發展生命週期內盡量降低風險，在激烈競爭中脫穎而出。</p> <p>受惠於英商勞盛的系統性方法，您可以在產品每一個發展階段獲得適當的支援，促成產品及時推出市場。</p> <p>英商勞盛提供豐富的 ISO 13485 服務，包括<a href="/zh-tw/iso-13485/certification/?epslanguage=zh-TW">驗證</a>、<a href="/zh-tw/iso-13485/certification/?epslanguage=zh-TW">差異分析</a>及訓練，前述所有服務都是為了輔助您成功符合規範而打造。</p> </div></div><div class="textBlock col-12 spacingSmall" id="Body+main+-+ISO+13485+Why+work+with+us%3f"> <div class="wysiwyg" > <h4>為什麼與我們合作？</h4><h4>專注保障</h4> <p>英商勞盛以嚴格、準確的分析探究每個品質管理系統程序，每次都勾勒出準確的結論。</p> <h4>技術專長</h4> <p>英商勞盛獲得英國皇家認可委員會 (United Kingdom Accreditation Service, UKAS) 及加拿大標準委員會 (Standards Council of Canada, SCC) 認可提供 ISO 13485:2016 驗證，此外，英商勞盛也是 MDSAP 方案中的授權稽核組織。 評審員是依照您業務需求安排的產業專家，能夠有效稽核您的 QMS，並帶來正面的短期及長期影響。</p> </div></div> </section> <section class="grid bottomContent" > <div class="textBlock col-12" id="S02.18+Management+Systems+request+for+information+about+service"> <div class="wysiwyg" > <h4 style="text-align: center;">希望進一步瞭解此服務？</h4> <p style="text-align: center;"><a href="/zh-tw/contact-us/" class="cta">與我們聯絡</a></p> </div></div><div class="carouselBlock canvas canvasWhite col-12" id="S03.02+Generic+case+study"> </div><div class="carouselBlock canvas canvasNavy col-12 spacingLarge" id="S03.01+Generic+insights+carousel+(2)"> </div><div class="carouselBlock canvas canvasWhite col-12 spacingSmall" id="S03.03+Generic+events+list"> </div> </section> </main> <footer class="footer canvas canvasNavy"> <div class="footerLogo"> <img decoding="auto" fetchpriority="auto" class="" src="/cdn-cgi/image/width=120,format=auto/globalassets/logos/lrqa-white-logo---dark-background-cropped.png" srcset="/cdn-cgi/image/width=120,format=auto/globalassets/logos/lrqa-white-logo---dark-background-cropped.png 120w,/cdn-cgi/image/width=150,format=auto/globalassets/logos/lrqa-white-logo---dark-background-cropped.png 150w,/cdn-cgi/image/width=240,format=auto/globalassets/logos/lrqa-white-logo---dark-background-cropped.png 240w,/cdn-cgi/image/width=300,format=auto/globalassets/logos/lrqa-white-logo---dark-background-cropped.png 300w,/cdn-cgi/image/width=360,format=auto/globalassets/logos/lrqa-white-logo---dark-background-cropped.png 360w,/cdn-cgi/image/width=450,format=auto/globalassets/logos/lrqa-white-logo---dark-background-cropped.png 450w" sizes="(min-width: 1280px) 150px, 120px" alt="" loading="lazy" width="500" height="174" /> <ul class="socialList"> </ul> </div> <ul class="footerList"> <li class="footerListItem"> <a href="/zh-tw/who-we-are/" class="footerListItemLink">我們是誰</a> </li> <li class="footerListItem"> <a href="/en/careers/" class="footerListItemLink">工作機會 (英)</a> </li> <li class="footerListItem"> <a href="/zh-tw/resources/" class="footerListItemLink">資源</a> </li> </ul> <div class="wysiwyg"> <p class="bodyCopySmall" style="text-align: center;">LRQA and any variants are trading names of LRQA Group Limited, its subsidiaries and affiliates. LRQA Group Limited, registered number 1217474, is a limited company registered in England and Wales. Registered office: 1, Trinity Park, Bickenhill Lane, Birmingham B37 7ES. © 2025 LRQA Group Limited.</p> </div> <ul class="footerList"> <li class="footerListItem"> <a href="/zh-tw/privacy-notice/" class="footerListItemLink supplemetaryLink">隱私權聲明</a> </li> <li class="footerListItem"> <a href="/zh-tw/cookies-policy/" class="footerListItemLink supplemetaryLink">Cookie 政策</a> </li> <li class="footerListItem"> <a href="/zh-tw/terms-of-use/" class="footerListItemLink supplemetaryLink">使用條款</a> </li> <li class="footerListItem"> <a href="/en/who-we-are/modern-slavery/" class="footerListItemLink supplemetaryLink">現代奴隸制聲明(英文)</a> </li> <li class="footerListItem"> <a href="/en/who-we-are/governance-policies/" class="footerListItemLink supplemetaryLink">治理方針(英文)</a> </li> </ul> </footer> <script data-ot-ignore type="module" src="/static/js/lrqa/esm-app.js?v=M8LIzIWJRbV-a1SB2VVI8vHQcFhc8s42AV1UJxWLewQ"></script> <script defer="defer" src="/Util/Find/epi-util/find.js"></script> <script> document.addEventListener('DOMContentLoaded',function(){if(typeof FindApi === 'function'){var api = new FindApi();api.setApplicationUrl('/');api.setServiceApiBaseUrl('/find_v2/');api.processEventFromCurrentUri();api.bindWindowEvents();api.bindAClickEvent();api.sendBufferedEvents();}}) </script> <link rel="stylesheet" href="/siteassets/forms_css/additonal_styles_10_jan_25.css"> <script type="application/ld+json">{"@context":"https://schema.org","@type":"Article","name":"ISO 13485 \u91AB\u7642\u5668\u6750","url":"https://www.lrqa.com/zh-tw/iso-13485/","dateCreated":"2019-06-05","dateModified":"2019-06-05","headline":"ISO 13485 \u91AB\u7642\u5668\u6750","articleBody":"\u003Cdiv class=\u0022epi-contentfragment\u0022\u003EISO 13485 Page Tabs\u003C/div\u003E\u003Cdiv class=\u0022epi-contentfragment\u0022\u003EBody main - ISO 13485 Medical Quality Management System Overview\u003C/div\u003E\u003Cdiv class=\u0022epi-contentfragment\u0022\u003EBody main - Benefits of ISO 13485\u003C/div\u003E\u003Cdiv class=\u0022epi-contentfragment\u0022\u003EBody main - Need help with ISO 13485?\u003C/div\u003E\u003Cdiv class=\u0022epi-contentfragment\u0022\u003EBody main - ISO 13485 Why work with us?\u003C/div\u003E"}</script> </body> </html>