ISO 13485 Tıbbi cihazlara yönelik belgelendirme

<!DOCTYPE html> <html lang="tr-TR"> <head> <title>ISO 13485 Tıbbi cihazlara yönelik belgelendirme</title> <meta charset="utf-8"> <meta http-equiv="X-UA-Compatible" content="IE=Edge"> <meta name="description" content="ISO 13485, tıbbi cihazlara yönelik, uluslararası QMS standardıdır ve ürün kalitesini ve mevzuat uygunluğunu garantilemek için kapsamlı bir çerçeve sağlar."> <meta name="keywords" content=""> <meta name="robots"> <link href="https://www.lrqa.com/tr-tr/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">  <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>   <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>  <script type="text/javascript" async src="https://bot.leadoo.com/bot/dynamic.js?company=i6ve0AXZ"></script> <link rel="icon" href="/static/images/favicons/LRQA-Icon-144.png"> <link rel="icon" href="/static/images/favicons/LRQA-Icon-192.png"> <link rel="apple-touch-icon" href="/static/images/favicons/LRQA-Icon-192.png"> <link rel="icon" href="/static/images/favicons/LRQA-Icon-196.png"> <link rel="icon" href="/static/images/favicons/LRQA-Icon-512.png"> <link rel="manifest" href="/static/lrqa/manifest.json"> <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" href="/static/css/lrqa/styles.css?v=2.4.2" as="style"> <link rel="preload" href="/static/js/lrqa/esm-app.js?v=2.4.2" crossorigin="anonymous" as="script"> <link rel="stylesheet" href="/static/css/lrqa/styles.css?v=2.4.2" /> <link rel="stylesheet" disabled media="(min-width: 48rem)" href="/static/css/lrqa/styles-media-min-width-48rem.css?v=2.4.2" /> <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=2.4.2" /> <link rel="stylesheet" disabled media="(prefers-reduced-motion: reduce)" href="/static/css/lrqa/styles-media-prefers-reduced-motion-reduce.css?v=2.4.2" /> <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=2.4.2" /> <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=2.4.2" /> <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=2.4.2" /> <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=2.4.2" /> <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=2.4.2" /> <link rel="stylesheet" href="/static/css/lrqa/styles-media-min-width-64rem-and-prefers-reduced-motion-reduce.css?v=2.4.2" /> <link rel="stylesheet" href="/static/css/lrqa/styles-media-prefers-reduced-motion-reduce.css?v=2.4.2" /> <link rel="stylesheet" href="/static/css/lrqa/styles-supports-not-margin-block-10px.css?v=2.4.2" /> <link rel="stylesheet" href="/static/css/lrqa/styles-supports-not-selectorp-hasp.css?v=2.4.2" /> <link rel="stylesheet" href="/static/css/lrqa/styles-supports-not-selector-focus-visible.css?v=2.4.2" /> <link rel="stylesheet" href="/static/css/lrqa/styles-supports-not-aspect-ratio-16-9.css?v=2.4.2" /> <link rel="stylesheet" href="/static/css/lrqa/epiforms.css?v=2.4.2" /> <link rel="stylesheet" href="/static/css/dialog.css?v=2.4.2" /> <link rel="stylesheet" href="/static/css/lrqa/dialog.css?v=2.4.2" /> <link rel="stylesheet" href="/static/css/lrqa/dialog-media-min-width-48rem.css?v=2.4.2" /> <link rel="stylesheet" href="/static/css/lrqa/dialog-supports-not-selector-focus-visible.css?v=2.4.2" /> <link rel="stylesheet" href="/static/css/lrqa/epiforms.css?v=2.4.2" /> <link rel="stylesheet" href="/static/css/lrqa/epiforms-media-min-width-64rem.css?v=2.4.2" /> <link rel="stylesheet" href="/static/css/lrqa/epiforms-media-prefers-reduced-motion-reduce.css?v=2.4.2" /> <link rel="stylesheet" href="/static/css/lrqa/epiforms-supports-not-margin-block-10px.css?v=2.4.2" /> <link rel="stylesheet" href="/static/css/lrqa/epiforms-supports-not-selector-focus-visible.css?v=2.4.2" /> <link rel="stylesheet" href="/static/css/lrqa/eventDetails.css?v=2.4.2" /> <link rel="stylesheet" href="/static/css/lrqa/eventDetails-supports-not-selectorp-hasp.css?v=2.4.2" /> <link rel="stylesheet" href="/static/css/lrqa/header.css?v=2.4.2" /> <link rel="stylesheet" href="/static/css/lrqa/header-media-max-width-63-9375rem-and-prefers-reduced-motion-reduce.css?v=2.4.2" /> <link rel="stylesheet" href="/static/css/lrqa/header-media-min-width-64rem-and-prefers-reduced-motion-reduce.css?v=2.4.2" /> <link rel="stylesheet" href="/static/css/lrqa/header-media-max-width-63-9375rem?v=2.4.2" /> <link rel="stylesheet" href="/static/css/lrqa/header-media-prefers-reduced-motion-reduce.css?v=2.4.2" /> <link rel="stylesheet" href="/static/css/lrqa/header-media-min-width-48rem.css?v=2.4.2" /> <link rel="stylesheet" href="/static/css/lrqa/header-media-max-width-63-9375rem.css?v=2.4.2" /> <link rel="stylesheet" href="/static/css/lrqa/header-supports-not-selector-focus-visible.css?v=2.4.2" /> <link rel="stylesheet" href="/static/css/lrqa/header-supports-not-margin-block-10px.css?v=2.4.2" /> <link rel="stylesheet" href="/static/css/lrqa/listing.css?v=2.4.2" /> <link rel="stylesheet" href="/static/css/lrqa/listing-media-min-width-64rem.css?v=2.4.2" /> <link rel="stylesheet" href="/static/css/lrqa/listing-media-prefers-reduced-motion-reduce.css?v=2.4.2" /> <link rel="stylesheet" href="/static/css/lrqa/listing-supports-not-selectorp-hasp.css?v=2.4.2" /> <link rel="stylesheet" href="/static/css/lrqa/listing-supports-not-selector-focus-visible.css?v=2.4.2" /> <link rel="stylesheet" href="/static/css/videoApi.css?v=2.4.2" /> </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 Tıbbi Cihazlar İçin Kalite Yönetim Sistemi"> <meta property="og:description" content="ISO 13485, tıbbi cihazlara yönelik, uluslararası QMS standardıdır ve ürün kalitesini ve mevzuat uygunluğunu garantilemek için kapsamlı bir çerçeve sağlar."> <meta property="og:url" content="https://www.lrqa.com/tr-tr/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="tr_TR"> <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 Tıbbi Cihazlar İçin Kalite Yönetim Sistemi"> <meta name="twitter:description" content="ISO 13485, tıbbi cihazlara yönelik, uluslararası QMS standardıdır ve ürün kalitesini ve mevzuat uygunluğunu garantilemek için kapsamlı bir çerçeve sağlar."> <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/tr-tr/iso-13485/"> </head> <body class="lrqa">  <noscript><iframe src="https://www.googletagmanager.com/ns.html?id=GTM-MDFXZ4S" height="0" width="0" style="display:none;visibility:hidden"></iframe></noscript>  <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"> Türkiye (Türkçe) </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">Dil seçenekleri</label> <input id="regionLangSelectInput" name="langSearch" class="pageHeaderLocalRegionSelInput" type="text" placeholder="Konum giriniz"> <button type="submit" class="pageHeaderLocalRegionSelSubmit"> <svg focusable="false" class="pageHeaderLocalRegionSelSubmitIcon"> <title>Gönder</title> <use href="/static/images/svg.svg#svg-search"></use> </svg> </button> </form> <ul class="pageHeaderLocalRegionSelList"> <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" tabindex="-1" aria-current="true" lang="tr-TR"> <span class="localLangTrans">Türkiye (Türkçe)</span> <span class="localLang" lang="en">Turkey (Turkish)</span> <svg focusable="false" class="localLangIcon"> <use href="/static/images/svg.svg#svg-tick"></use> </svg> </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> <li class="pageHeaderLocalRegionSelItem"> <a href="/zh-tw/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="zh-TW"> <span class="localLangTrans">中文（繁體）</span> <span class="localLang" lang="en">Greater China (Chinese Traditional)</span> </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> </ul> <p class="pageHeaderLocalRegionSelMenuText"></p> </div> </div> <ul class="pageHeaderButtonWrap pageHeaderEyebrow"> <li class="pageHeaderButton"> <a href="/tr-tr/hakkimizda/" class="pageHeaderEyebrowLink"> <span class="text"> Hakkımızda </span> </a> </li> <li class="pageHeaderButton"> <a href="/tr-tr/musteri-portali/" class="pageHeaderEyebrowLink"> <span class="text"> Müşteri portalları </span> </a> </li> <li class="pageHeaderButton"> <a href="/tr-tr/iletisim-kurun/" class="pageHeaderEyebrowContact cta"> <span class="text"> Bize ulaşın </span> </a> </li> </ul> <div class="pageHeaderLogo"> <a href="/tr-tr/" 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"> Menü </span> <span class="icon"> <svg focusable="false"> <use href="/static/images/svg.svg#svg-cross"></use> </svg> </span> <span class="text"> Kapat </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"> Assurance 4.0 </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"> Geri </span> </button> </li> <li class="navigationListItem parentLink"> <a class="navigationListItemLink" href="/tr-tr/hakkimizda/assurance-4.0/" target="_self"> <span class="text">Assurance 4.0</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/tr-tr/assure-assets-and-management-systems/" target="_self"> <span class="text">Assure Assets and Management Systems</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/tr-tr/achieve-product-integrity/" target="_self"> <span class="text">Achieve Product Integrity</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/tr-tr/source-responsibly/" target="_self"> <span class="text">Source Responsibly</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/tr-tr/navigate-the-energy-transition-and-achieve-net-zero/" target="_self"> <span class="text">Navigate the Energy Transition and Achieve Net Zero</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/tr-tr/strengthen-cybersecurity-maturity/" target="_self"> <span class="text">Strengthen Cybersecurity Maturity</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"> Sektörler </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"> Geri </span> </button> </li> <li class="navigationListItem parentLink"> <a class="navigationListItemLink" href="/tr-tr/sektorler/" target="_self"> <span class="text">Sektörler</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/tr-tr/yiyecek-icecek-agirlama/" target="_self"> <span class="text">Yiyecek ve içecek</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/tr-tr/mali-ve-profesyonel-hizmetler/" target="_self"> <span class="text">Mali ve Profesyonel Hizmetler</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/tr-tr/energy-and-renewables/" target="_self"> <span class="text">Enerji ve yenilenebilir kaynaklar</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/tr-tr/tasima-lojistik/" target="_self"> <span class="text">Taşımacılık ve Lojistik</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/tr-tr/bit-ve-telekomunikasyon/" target="_self"> <span class="text">ICT ve Telekom</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/tr-tr/consumer-goods-and-retail/" target="_self"> <span class="text">Tüketici ürünleri ve perakende</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/tr-tr/insaat-endustrisi/" target="_self"> <span class="text">İnşaat sektörü</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/tr-tr/saglik-tip/" target="_self"> <span class="text">Sağlık ve Tıp</span> </a> </li> <li class="navigationListItem extraLinkText"> <a class="navigationListItemLink" href="/tr-tr/iletisim-kurun/"> <span class="text">Sektörünüzü göremiyor musunuz?</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"> Hizmetler </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"> Geri </span> </button> </li> <li class="navigationListItem parentLink"> <a class="navigationListItemLink" href="/tr-tr/hizmetler/" target="_self"> <span class="text">Hizmetler</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"> Belgelendirme </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"> Geri </span> </button> </li> <li class="navigationListItem parentLink"> <a class="navigationListItemLink" href="/tr-tr/yasal-uyum/" target="_self"> <span class="text">Belgelendirme</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/tr-tr/transfer-certification-to-lrqa/" target="_self"> <span class="text">Sertifikanızı LRQA'ya transfer edin</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"> Kalite, Çevre, İş Sağlığı ve Güvenliği </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"> Geri </span> </button> </li> <li class="navigationListItem parentLink"> <a class="navigationListItemLink" href="/tr-tr/kalite-cevre-saglik-ve-guvenlik/" target="_self"> <span class="text">Kalite, Çevre, İş Sağlığı ve Güvenliği</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/tr-tr/iso-9001/" target="_self"> <span class="text">ISO 9001</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/tr-tr/iso-14001/" target="_self"> <span class="text">ISO 14001</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/tr-tr/iso-45001/" target="_self"> <span class="text">ISO 45001</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"> Yiyecek, İçecek ve Ağırlama </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"> Geri </span> </button> </li> <li class="navigationListItem parentLink"> <a class="navigationListItemLink" href="/tr-tr/yiyecek-icecek-agirlama/" target="_self"> <span class="text">Yiyecek, İçecek ve Ağırlama</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/tr-tr/fssc-22000/" target="_self"> <span class="text">FSSC 22000</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/tr-tr/brcgs-gida-guvenligi/" target="_self"> <span class="text">BRCGS</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/tr-tr/iso-22000/" target="_self"> <span class="text">ISO 22000</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/tr-tr/ifs/" target="_self"> <span class="text">IFS</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/tr-tr/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"> İklim Değişikliği ve Sürdürülebilirlik </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"> Geri </span> </button> </li> <li class="navigationListItem parentLink"> <a class="navigationListItemLink" href="/tr-tr/iklim-degisikligi-surdurulebilirlik/" target="_self"> <span class="text">İklim Değişikliği ve Sürdürülebilirlik</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/tr-tr/iso-14064/" target="_self"> <span class="text">ISO 14064 Sera Gazı Doğrulama</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/tr-tr/iso-50001/" target="_self"> <span class="text">ISO 50001</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/tr-tr/smeta/" target="_self"> <span class="text">SMETA</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"> Bilgi Güvenliği ve Siber Güvenlik </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"> Geri </span> </button> </li> <li class="navigationListItem parentLink"> <a class="navigationListItemLink" href="/tr-tr/bilgi-guvenligi-yonetimi/" target="_self"> <span class="text">Bilgi Güvenliği ve Siber Güvenlik</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/tr-tr/iso-27001/" target="_self"> <span class="text">ISO 27001</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/tr-tr/iso-20000/" target="_self"> <span class="text">ISO 20000-1</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/tr-tr/iso-22301/" target="_self"> <span class="text">ISO 22301</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"> Otomotiv, Havacılık ve Taşımacılık </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"> Geri </span> </button> </li> <li class="navigationListItem parentLink"> <a class="navigationListItemLink" href="/tr-tr/otomotiv-havacilik-tasimacilik/" target="_self"> <span class="text">Otomotiv, Havacılık ve Taşımacılık</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/tr-tr/iatf-16949/" target="_self"> <span class="text">IATF 16949</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/tr-tr/as9100/" target="_self"> <span class="text">AS 9100</span> </a> </li> </ul> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/tr-tr/iso-13485/" target="_self"> <span class="text">Medical - ISO 13485</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"> Denetim </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"> Geri </span> </button> </li> <li class="navigationListItem parentLink"> <a class="navigationListItemLink" href="/tr-tr/denetim-hizmetleri/" target="_self"> <span class="text">Denetim</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/en/codes-standards-regulations/" target="_self"> <span class="text">Codes, standards and regulations (EN)</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/en/materials-and-welding/" target="_self"> <span class="text">Welding and material services (EN)</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/tr-tr/insaat-endustrisi/" target="_self"> <span class="text">İnşaat sektörü</span> </a> </li> <li class="navigationListItem"> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/tr-tr/tedarik-zinciri-denetimi/" target="_self"> <span class="text">Tedarik zinciri ve satıcı denetimi</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/en/remote-inspection/" target="_self"> <span class="text">Uzaktan denetim</span> </a> </li> </ul> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/en/cyber-security-services/" target="_self"> <span class="text">Siber Güvenlik Hizmetleri (EN)</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/tr-tr/guvence-hizmetleri/" target="_self"> <span class="text">Doğrulama ve rapor güvencesi</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"> Eğitimler </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"> Geri </span> </button> </li> <li class="navigationListItem parentLink"> <p class="navigationListItemLink"> <span class="text">Eğitimler</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"> Tüm eğitim kursları </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"> Geri </span> </button> </li> <li class="navigationListItem parentLink"> <a class="navigationListItemLink" href="/tr-tr/egitim/genel/" target="_self"> <span class="text">Tüm eğitim kursları</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/tr-tr/egitim/kalite-cevre-is-sagligi-ve-guvenligi/" target="_self"> <span class="text">Kalite, Çevre ve İş Sağlığı & Güvenliği Eğitimleri</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/tr-tr/egitim/yiyecek-icecek-agirlama/" target="_self"> <span class="text">Yiyecek, içecek ve ağırlama eğitimleri</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/tr-tr/egitim/tibbi-cihazlar/" target="_self"> <span class="text">Tıbbi cihaz eğitimleri</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/tr-tr/egitim/bilgi-guvenligi-siber-guvenlik/" target="_self"> <span class="text">Siber güvenlik ve bilgi güvenliği eğitimleri</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/tr-tr/egitim/iklim-degisikligi-surdurulebilirlik/" target="_self"> <span class="text">İklim değişikliği ve sürdürülebilirlik eğitimleri</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/tr-tr/egitim/otomotiv-havacilik-tasimacilik/" target="_self"> <span class="text">Otomotiv, havacılık ve taşımacılık eğitimleri</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"> Çevrimiçi eğitimler </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"> Geri </span> </button> </li> <li class="navigationListItem parentLink"> <a class="navigationListItemLink" href="/tr-tr/egitim/cevirimici-sanal-sinif-egitimleri/" target="_self"> <span class="text">Çevrimiçi eğitimler</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/tr-tr/egitim/web-tabanli-ogrenme/" target="_self"> <span class="text">Virtual sınıf kursları</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/tr-tr/egitim/e-ogrenim/" target="_self"> <span class="text">eLearning</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/tr-tr/egitim/blended/" target="_self"> <span class="text">Karma eğitim</span> </a> </li> </ul> </li> <li class="navigationListItem"> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="https://training-portal.lrqa.com/lmt/clmsBrowseV2.prMain?site=lrqaext&in_region=gr&in_lang=tr" target="_blank"> <span class="text">Training portal</span> </a> </li> </ul> </li> <li class="navigationListItem extraLinkText"> <a class="navigationListItemLink" href="/tr-tr/iletisim-kurun/"> <span class="text">İstediğiniz standardı veya kodu göremiyor musunuz?</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"> Haberler </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"> Geri </span> </button> </li> <li class="navigationListItem parentLink"> <p class="navigationListItemLink"> <span class="text">Haberler</span> </p> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/tr-tr/guncel-haberler/" target="_self"> <span class="text">En son haberler</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/tr-tr/insights/articles/" target="_self"> <span class="text">Makaleler</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/tr-tr/case-studies/" target="_self"> <span class="text">Örnek vaka çalışmaları</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/tr-tr/kaynaklar/" target="_self"> <span class="text">Kaynaklar</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/tr-tr/kaynaklar/cins/" target="_self"> <span class="text">Müşteri Bilgi Notları (CIN)</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/tr-tr/hakkimizda/yonetim-sistemleri-akreditasyonlarimiz/" target="_self"> <span class="text">Akreditasyonlar</span> </a> </li> </ul> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/tr-tr/etkinlikler/" target="_self"> <span class="text">Etkinlikler ve webinarlar</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/tr-tr/careers/" target="_self"> <span class="text">Kariyer</span> </a> </li> <li class="navigationListItem extraLink "> <a href="/tr-tr/hakkimizda/" class="extraLinkText"> <span class="text"> Hakkımızda </span> </a> </li> <li class="navigationListItem extraLink "> <a href="/tr-tr/musteri-portali/" class="extraLinkText"> <span class="text"> Müşteri portalları </span> </a> </li> </ul> </nav> </div> <div class="pageHeaderButtonWrap pageHeaderSearchButton"> <div class="pageHeaderButton search"> <button type="button"> <span class="text"> Ara </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>Kapat</title> <use href="/static/images/svg.svg#svg-close"></use> </svg> </span> </button> </div> </div> <div class="pageHeaderSearch" inert=""> <div class="searchWrap"> <form action="/tr-tr/ara/" method="get" class="searchForm"> <input type="search" name="q" placeholder="Aradığınızı bulun" autocomplete="on" id="q" class="searchFormInput"> <label for="headerSearchInput" class="searchFormLabel">Form ara</label> <button type="submit" class="searchFormSubmit cta"> <span class="icon"> <svg focusable="false"> <title>Açık arama</title> <use href="/static/images/svg.svg#svg-search"></use> </svg> </span> <span class="text">Ara</span> </button> </form> </div> <figure class="quickLinks"> <figcaption class="quickLinksTitle">Aradığınızı buldunuz mu?</figcaption> <div class="swipeNav col-12"> <div class="swipeNavWrap"> <ul class="swipeNavList"> <li class="swipeNavListItem"> <a href="/tr-tr/etkinlikler/" class="swipeNavLink cta ctaTertiary"> <span class="text"> Etkinlikler </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="/tr-tr/"> <span class="breadcrumbsLinkText"> Home </span> <span class="breadcrumbsLinkText breadcrumbsLinkTextPrevious"> Önceki sayfaya dön </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" > Tıbbi cihaz endüstrisinin gerekliliklerine uyum gösterin. </h1> <p class="heroSummary" > ISO 13485, tıbbi cihaz üreticilerine ürün kalitesini ve mevzuat uygunluğunu sağlamaları için kapsamlı bir çerçeve sunar. </p> <p class="heroSubtitle" > ISO 13485 Tıbbi Cihazlar İçin Kalite Yönetim Sistemi </p> <ul class="heroList" > <li class="heroListItem"> <a href="/tr-tr/iso-13485/belgelendirme/" class="arrowLink arrowLinkBold">ISO 13485 hizmetleri</a> </li> <li class="heroListItem"> <a href="/tr-tr/iso-13485/iso-13485-egitim/" class="arrowLink arrowLinkBold">Eğitim</a> </li> </ul> </div> </div><div class="stickyCtaContainer twoItems" id="Shared+global+sticky+CTA+-+BA"> <a href="tel:+90 216 232 40 88" class="stickyCtaButton" > <span class="icon"> <svg focusable="false"> <use href="/static/images/svg.svg#svg-phoneRinging"></use> </svg> </span> <span class="text"> +90 216 232 40 88 </span> </a> <button type="button" class="stickyCtaButton modalButton" data-dialog="modal2" > <span class="icon"> <svg focusable="false"> <use href="/static/images/svg.svg#svg-letter"></use> </svg> </span> <span class="text"> Fiyat teklifi isteyin </span> </button> <dialog id="modal2"> <div class="dialogWrap"> <button type="button" class="innerDialogButton"> <svg focusable="false" class="white"> <title>Close</title> <use href="/static/images/svg.svg#svg-close"></use> </svg> </button> <div class="dialogWrapInner"> <div class="stickyCtaDialog white"> <div class="stickyCtaDialogContent"> <h3 class="stickyCtaDialogHeader">Fiyat teklifi isteyin</h3> <div class="stickyCtaDialogIframeContainer"> <iframe class="stickyCtaDialogIframe" src="https://info.lrqa.com/l/12702/2021-10-05/c4df2b" loading="lazy" id="iFrameResizer2" style="overflow: hidden;" scrolling="no"> </iframe> </div> </div> </div> </div> </div> </dialog> </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="/tr-tr/iso-13485/iso-13485-egitim/" class="swipeNavLink cta ctaTertiary"> <span class="text"> Eğitim </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>Genel Bakış</h4><p>Tıbbi cihaz üretiminin sıkı yönetmeliklerle düzenlenen dünyasında kuruluşlar, her cihazın hem müşterilerin beklentilerini, hem de yürürlükteki yönetmelikleri karşıladığını sergilemek zorundadır. Lloyd’un Register (LRQA), pazar lansmanı zamanında gerçekleştirebilmek için hassas ürün geliştirme yaşam döngüleri olan ISO 13485’in katı gereksinimlerini karşılama çabalarında müşterilerini desteklemektedir.</p> <p>1 Mart 2016’da yayınlanan tıbbi cihazlara yönelik uluslararası Kalite Yönetim Sistemi (Quality Management System - QMS) standardı ISO 13485:2016’da (Tıbbi Cihazlar – Kalite yönetim sistemleri – Mevzuat Gereklilikleri), Uluslararası Akreditasyon Forumu (International Accreditation Forum - IAF), belgeye sahip olan kuruluşlara önceki sürümlerden geçiş yapmaları için üç yıl tanımaktadır. ISO 13485:2012, uyumlaştırılmış standart ve uygunluk varsayımı olarak konumunu, geçiş döneminin sonuna kadar muhafaza edecektir.</p> <p>ISO 13485:2016; çalışma ortamı, risk yönetimi, tasarım kontrolü ve mevzuat gereklilikleri konusunda daha kapsamlı belgelendirme gerektiren çok sayıda üstü kapalı, ancak ayrıntılı değişiklik getirmektedir. Revize standartta, QMS’e risk-tabanlı bir yaklaşım ihtiyacı, mevzuat gerekliliklerine ve üst yönetimin sorumluluklarına daha güçlü odaklanma, tedarikçiler ve dış kaynak kullanılan faaliyetler üzerinde artan kontroller, ve ürünün tüm yaşam döngüsünde risk yönetimine vurgu yer almaktadır.</p> <p>ISO 13485 hem tıbbi cihaz üreticileri, hem de tıbbi cihaz üreticilerini destekleyen kuruluşlar için geçerlidir. Üreticilerin, ‘cihazların müşteri taleplerini ve yürürlükteki mevzuat gerekliliklerini tutarlı şekilde yerine getirmesi’ görevine temelden destek verir.</p> <p>Güncellenen ISO 13485:2016, Mart 2019’da önceki tüm sürümlerin yerini alacaktır. </p> </div></div><div class="promoBlock themeMint promoBlockFrame col-12 spacingSmall canvas canvasWhite" id="TR+Training+Calendar+2024"> <div class="container"> <div class="promoBlockWrap"> <div class="promoBlockWrapContent"> <h3 class="promoBlockHeading" > LRQA'nin sunduğu tüm eğitimleri görmek ister misiniz? </h3> <p class="promoBlockSummary" > <span class="promoBlockSummarySpacer"></span> Eğitim broşürümüzü indirin ve LRQA'nin eğitimleri ilgili meslek kuruluşları tarafından onaylanmış ve LRQA’nin yönetim sistemleri denetim deneyimine dayanan eğitimlerdir.
Şimdi indirin.
 </p> <a href="https://info.lrqa.com/tr-training-calendar-january-june-24" class="promoBlockLink arrowLink arrowLinkBold" > LRQA'nin sunduğu tüm eğitimleri görmek ister misiniz? </a> </div> <div class="promoBlockImage" > <img src="/cdn-cgi/image/width=640,format=auto/globalassets/_shared-images/non-standard-social-tab-alt-opengraph-image-with-caption-alt-desktopmobile-rich-text-inline/business-assurance/gr-ba-cts-calendar-a4_brochure_mockup_cover.png" srcset="/cdn-cgi/image/width=264,format=auto/globalassets/_shared-images/non-standard-social-tab-alt-opengraph-image-with-caption-alt-desktopmobile-rich-text-inline/business-assurance/gr-ba-cts-calendar-a4_brochure_mockup_cover.png 264w,/cdn-cgi/image/width=304,format=auto/globalassets/_shared-images/non-standard-social-tab-alt-opengraph-image-with-caption-alt-desktopmobile-rich-text-inline/business-assurance/gr-ba-cts-calendar-a4_brochure_mockup_cover.png 304w,/cdn-cgi/image/width=350,format=auto/globalassets/_shared-images/non-standard-social-tab-alt-opengraph-image-with-caption-alt-desktopmobile-rich-text-inline/business-assurance/gr-ba-cts-calendar-a4_brochure_mockup_cover.png 350w,/cdn-cgi/image/width=415,format=auto/globalassets/_shared-images/non-standard-social-tab-alt-opengraph-image-with-caption-alt-desktopmobile-rich-text-inline/business-assurance/gr-ba-cts-calendar-a4_brochure_mockup_cover.png 415w,/cdn-cgi/image/width=452,format=auto/globalassets/_shared-images/non-standard-social-tab-alt-opengraph-image-with-caption-alt-desktopmobile-rich-text-inline/business-assurance/gr-ba-cts-calendar-a4_brochure_mockup_cover.png 452w,/cdn-cgi/image/width=528,format=auto/globalassets/_shared-images/non-standard-social-tab-alt-opengraph-image-with-caption-alt-desktopmobile-rich-text-inline/business-assurance/gr-ba-cts-calendar-a4_brochure_mockup_cover.png 528w,/cdn-cgi/image/width=560,format=auto/globalassets/_shared-images/non-standard-social-tab-alt-opengraph-image-with-caption-alt-desktopmobile-rich-text-inline/business-assurance/gr-ba-cts-calendar-a4_brochure_mockup_cover.png 560w,/cdn-cgi/image/width=608,format=auto/globalassets/_shared-images/non-standard-social-tab-alt-opengraph-image-with-caption-alt-desktopmobile-rich-text-inline/business-assurance/gr-ba-cts-calendar-a4_brochure_mockup_cover.png 608w,/cdn-cgi/image/width=640,format=auto/globalassets/_shared-images/non-standard-social-tab-alt-opengraph-image-with-caption-alt-desktopmobile-rich-text-inline/business-assurance/gr-ba-cts-calendar-a4_brochure_mockup_cover.png 640w,/cdn-cgi/image/width=700,format=auto/globalassets/_shared-images/non-standard-social-tab-alt-opengraph-image-with-caption-alt-desktopmobile-rich-text-inline/business-assurance/gr-ba-cts-calendar-a4_brochure_mockup_cover.png 700w,/cdn-cgi/image/width=792,format=auto/globalassets/_shared-images/non-standard-social-tab-alt-opengraph-image-with-caption-alt-desktopmobile-rich-text-inline/business-assurance/gr-ba-cts-calendar-a4_brochure_mockup_cover.png 792w,/cdn-cgi/image/width=830,format=auto/globalassets/_shared-images/non-standard-social-tab-alt-opengraph-image-with-caption-alt-desktopmobile-rich-text-inline/business-assurance/gr-ba-cts-calendar-a4_brochure_mockup_cover.png 830w,/cdn-cgi/image/width=904,format=auto/globalassets/_shared-images/non-standard-social-tab-alt-opengraph-image-with-caption-alt-desktopmobile-rich-text-inline/business-assurance/gr-ba-cts-calendar-a4_brochure_mockup_cover.png 904w,/cdn-cgi/image/width=912,format=auto/globalassets/_shared-images/non-standard-social-tab-alt-opengraph-image-with-caption-alt-desktopmobile-rich-text-inline/business-assurance/gr-ba-cts-calendar-a4_brochure_mockup_cover.png 912w,/cdn-cgi/image/width=1050,format=auto/globalassets/_shared-images/non-standard-social-tab-alt-opengraph-image-with-caption-alt-desktopmobile-rich-text-inline/business-assurance/gr-ba-cts-calendar-a4_brochure_mockup_cover.png 1050w,/cdn-cgi/image/width=1120,format=auto/globalassets/_shared-images/non-standard-social-tab-alt-opengraph-image-with-caption-alt-desktopmobile-rich-text-inline/business-assurance/gr-ba-cts-calendar-a4_brochure_mockup_cover.png 1120w,/cdn-cgi/image/width=1245,format=auto/globalassets/_shared-images/non-standard-social-tab-alt-opengraph-image-with-caption-alt-desktopmobile-rich-text-inline/business-assurance/gr-ba-cts-calendar-a4_brochure_mockup_cover.png 1245w,/cdn-cgi/image/width=1280,format=auto/globalassets/_shared-images/non-standard-social-tab-alt-opengraph-image-with-caption-alt-desktopmobile-rich-text-inline/business-assurance/gr-ba-cts-calendar-a4_brochure_mockup_cover.png 1280w,/cdn-cgi/image/width=1356,format=auto/globalassets/_shared-images/non-standard-social-tab-alt-opengraph-image-with-caption-alt-desktopmobile-rich-text-inline/business-assurance/gr-ba-cts-calendar-a4_brochure_mockup_cover.png 1356w,/cdn-cgi/image/width=1680,format=auto/globalassets/_shared-images/non-standard-social-tab-alt-opengraph-image-with-caption-alt-desktopmobile-rich-text-inline/business-assurance/gr-ba-cts-calendar-a4_brochure_mockup_cover.png 1680w,/cdn-cgi/image/width=1920,format=auto/globalassets/_shared-images/non-standard-social-tab-alt-opengraph-image-with-caption-alt-desktopmobile-rich-text-inline/business-assurance/gr-ba-cts-calendar-a4_brochure_mockup_cover.png 1920w" sizes="(min-width: 1440px) 640px, (min-width: 1280px) calc((100vw - 160px) / 2), (min-width: 1024px) calc((100vw - 120px) / 2), (min-width: 768px) calc((100vw - 80px) / 2), calc(100vw - 20px)" alt="training-calendar" loading="lazy" decoding="auto" fetchpriority="auto" class="promoBlockImageImg" width="200" height="200" /> </div> </div> </div> </div><div class="textBlock col-12 spacingSmall" id="Body+main+-+Benefits+of+ISO+13485"> <div class="wysiwyg" > <h4>ISO 13485’in Avantajları</h4><h4>Ticaret serbestisi</h4> <p>Birçok üretici, tedarikçilerin ISO 13485 belgesine sahip olmasını zorunlu kılarak, standardı rekabetçi kalabilmenin bir önkoşulu haline getirmiştir.</p> <h4>Tutarlı kalite</h4> <p>Hasta güvenliği, tıbbi ürünlerin kalitesine dayanır. ISO 13485 belgelendirmesi, üreticilere, tüm tedarik zinciri boyunca kuruluşların uygunluğa/uyumluluğa ulaşabileceğine ve bunu sürdürebileceğine dair güven verir.</p> <h4>Risk yönetimi</h4> <p>ISO 13485 sertifikasına hak kazanmak, kazaları önlemenin ve hasta güvenliğine öncelik vermenin proaktif bir yöntemidir. Bu, üreticilerde ürün kusurlarının yol açacağı itibar kaybı riskinin en aza indirilmesine yardımcı olur.</p> </div></div><div class="textBlock col-12 spacingSmall" id="Body+main+-+Need+help+with+ISO+13485%3f"> <div class="wysiwyg" > <h4>ISO 13485 konusunda yardıma mı ihtiyacınız var?</h4><p>Tıbbi cihaz üretimi dünyasının uluslararası onaylı standardı ISO 13485, rakiplerinizi, tüm ürün geliştirme döngüsündeki riskleri en aza indirerek yenmenize yardımcı olur.</p> <p>LR’ın sistematik yaklaşımı sayesinde ürün geliştirme sürecinin her aşamasında uygun desteği alarak, ürününüzün pazara zamanında sunulmasını kolaylaştıracaksınız.</p> <p>LRQA, <a href="/tr-tr/iso-13485/belgelendirme/?epslanguage=tr-TR">belgelendirme</a>, <a href="/tr-tr/iso-13485/belgelendirme/?epslanguage=tr-TR">mevcut durum analizi</a> ve eğitim dahil olmak üzere, ‘uygunluğa ulaşma’ yolculuğunuzu desteklemek için tasarlanmış çok çeşitli ISO 13485 hizmetleri sunmaktadır.</p> </div></div><div class="textBlock col-12 spacingSmall" id="Body+main+-+ISO+13485+Why+work+with+us%3f"> <div class="wysiwyg" > <h4>Neden bizimle çalışmalısınız?</h4><h4>Güvence konusunda kararlılık</h4> <p>LRQA, her defasında doğru sonuçlar çıkarabilmek için, her kalite yönetim sistemi sürecini son derece titiz, analitik bir hassasiyetle araştırır.</p> <h4>Teknik uzmanlık</h4> <p>LRQA, Birleşik Krallık Akreditasyon Servisi (United Kingdom Accreditation Service - UKAS) ve Kanada Standartlar Konseyi (Standards Council of Canada - SCC) tarafından ISO 13485:2016 belgelendirmesi için akredite edilmiştir; ayrıca MDSAP programı kapsamında da Yetkili Denetleme Kuruluşu statüsündeyiz. İş ihtiyaçlarınızla eşleştirerek görevlendirdiğimiz sektör uzmanları olan denetçilerimiz, QMS’inizin sizi kısa ve uzun dönemde olumlu etkilere taşıyacak, etkili bir şekilde denetlenmesini sağlar.</p> </div></div> </section> <section class="grid bottomContent" > <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"> <li class="socialListItem"> <a href="https://twitter.com/lrqa" class="socialListItemLink" rel="noopener" target="_blank"> <img decoding="auto" fetchpriority="auto" src="/cdn-cgi/image/width=20,format=auto/globalassets/_shared-images/twitter2.png" srcset="/cdn-cgi/image/width=20,format=auto/globalassets/_shared-images/twitter2.png 20w,/cdn-cgi/image/width=40,format=auto/globalassets/_shared-images/twitter2.png 40w,/cdn-cgi/image/width=60,format=auto/globalassets/_shared-images/twitter2.png 60w" sizes="20px" alt="" loading="lazy" class="" width="21" height="22" /> </a> </li> <li class="socialListItem"> <a href="https://www.linkedin.com/company/lrqa" class="socialListItemLink" rel="noopener"> <img decoding="auto" fetchpriority="auto" src="/cdn-cgi/image/width=20,format=auto/globalassets/_shared-images/linkedin-icon-1.png" srcset="/cdn-cgi/image/width=20,format=auto/globalassets/_shared-images/linkedin-icon-1.png 20w,/cdn-cgi/image/width=40,format=auto/globalassets/_shared-images/linkedin-icon-1.png 40w,/cdn-cgi/image/width=60,format=auto/globalassets/_shared-images/linkedin-icon-1.png 60w" sizes="20px" alt="LinkedIn icon in mint green" loading="lazy" class="" width="134" height="134" /> </a> </li> </ul> </div> <ul class="footerList"> <li class="footerListItem"> <a href="/tr-tr/hakkimizda/" class="footerListItemLink">Biz kimiz</a> </li> <li class="footerListItem"> <a href="/tr-tr/careers/" class="footerListItemLink">Kariyer</a> </li> <li class="footerListItem"> <a href="/tr-tr/kaynaklar/" class="footerListItemLink">Kaynaklar</a> </li> </ul> <div class="wysiwyg"> <p style="text-align: center;"><span data-contrast="none" xml:lang="EN-GB" lang="EN-GB" class="TextRun SCXW255060939 BCX8"><span class="NormalTextRun SCXW255060939 BCX8">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, </span><span class="NormalTextRun SpellingErrorV2Themed SCXW255060939 BCX8">Bickenhill</span><span class="NormalTextRun SCXW255060939 BCX8"> Lane, Birmingham B37 7ES. © 2024 LRQA Group Limited</span></span><span data-contrast="auto" xml:lang="EN-GB" lang="EN-GB" class="TextRun SCXW255060939 BCX8"><span class="NormalTextRun SCXW255060939 BCX8">.</span></span><span class="EOP SCXW255060939 BCX8" data-ccp-props="{}"> </span></p> </div> <ul class="footerList"> <li class="footerListItem"> <a href="/en/privacy-notice/" class="footerListItemLink supplemetaryLink">Gizlilik Bildirimi (EN)</a> </li> <li class="footerListItem"> <a href="/tr-tr/cerez-politikasi/" class="footerListItemLink supplemetaryLink">Çerez politikası</a> </li> <li class="footerListItem"> <a href="/tr-tr/kullanim-kosullari/" class="footerListItemLink supplemetaryLink">Kullanım koşulları</a> </li> <li class="footerListItem"> <a href="/en/who-we-are/modern-slavery/" class="footerListItemLink supplemetaryLink">Modern Slavery Statement (ENG)</a> </li> <li class="footerListItem"> <a href="/en/who-we-are/governance-policies/" class="footerListItemLink supplemetaryLink">Governance (ENG)</a> </li> </ul> </footer> <script data-ot-ignore type="module" src="/static/js/lrqa/esm-app.js?v=2.4.2"></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> <script type="application/ld+json">{"@context":"https://schema.org","@type":"Article","name":"ISO 13485 T\u0131bbi Cihazlar \u0130\u00E7in Kalite Y\u00F6netim Sistemi","url":"https://www.lrqa.com/tr-tr/iso-13485/","dateCreated":"2019-06-20","dateModified":"2019-06-20","headline":"ISO 13485 T\u0131bbi Cihazlar \u0130\u00E7in Kalite Y\u00F6netim Sistemi","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\u003ETR Training Calendar 2024\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>

CINXE.COM

ISO 13485 Tıbbi cihazlara yönelik belgelendirme