{"id":17625,"date":"2025-07-19T13:31:30","date_gmt":"2025-07-19T10:31:30","guid":{"rendered":"https:\/\/www.d-tek.com.tr\/?p=17625"},"modified":"2026-01-06T07:44:48","modified_gmt":"2026-01-06T04:44:48","slug":"tibbi-laboratuvar-yonetimi-ve-olumsuz-olaylara-hazirlik-turkiyede-yasal-zorunluluklar-ve-kalite-guvencesi","status":"publish","type":"post","link":"https:\/\/www.d-tek.com.tr\/en\/tibbi-laboratuvar-yonetimi-ve-olumsuz-olaylara-hazirlik-turkiyede-yasal-zorunluluklar-ve-kalite-guvencesi\/","title":{"rendered":"Medical Laboratory Management and Emergency Preparedness: Legal Requirements and Quality Assurance in T\u00fcrkiye"},"content":{"rendered":"<article><span style=\"font-size: 16px;\">Prof. Dr. Diler Aslan<\/span><\/article>\n<article><\/article>\n<article><span style=\"font-size: 16px;\">Medical laboratories are a fundamental building block of accurate diagnostic and treatment processes. However, things don&#039;t always go as planned in laboratory services. <strong>Medical device malfunctions, incorrect test results, user errors.<\/strong> or <strong>labeling deficiencies<\/strong> Factors such as these can lead to adverse events that directly affect patient safety.<\/span><span style=\"font-size: 16px;\">Because, <strong>systematic preparation for adverse events<\/strong> Doing so is not only a legal obligation; it is also key to protecting corporate reputation, patient safety, and service quality.<\/span><\/p>\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_82_2 counter-flat ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Highlighted Topics<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Toggle Table of Content\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewbox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewbox=\"0 0 24 24\" version=\"1.2\" baseprofile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ez-toc-columns-2' ><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.d-tek.com.tr\/en\/tibbi-laboratuvar-yonetimi-ve-olumsuz-olaylara-hazirlik-turkiyede-yasal-zorunluluklar-ve-kalite-guvencesi\/#Tibbi_Laboratuvarlarda_Olumsuz_Olay_Nedir\" >What is an Adverse Event in Medical Laboratories?<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.d-tek.com.tr\/en\/tibbi-laboratuvar-yonetimi-ve-olumsuz-olaylara-hazirlik-turkiyede-yasal-zorunluluklar-ve-kalite-guvencesi\/#Turkiyedeki_Mevzuat_Ne_Diyor\" >What does the legislation in T\u00fcrkiye say?<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.d-tek.com.tr\/en\/tibbi-laboratuvar-yonetimi-ve-olumsuz-olaylara-hazirlik-turkiyede-yasal-zorunluluklar-ve-kalite-guvencesi\/#Olumsuz_Olay_Bildirimi_Kim_Ne_Zaman_Nasil\" >Reporting Adverse Events: Who, When, How?<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.d-tek.com.tr\/en\/tibbi-laboratuvar-yonetimi-ve-olumsuz-olaylara-hazirlik-turkiyede-yasal-zorunluluklar-ve-kalite-guvencesi\/#Laboratuvarlar_Icin_Risk_Yonetimi_ve_ISO_14971\" >Risk Management for Laboratories and ISO 14971<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.d-tek.com.tr\/en\/tibbi-laboratuvar-yonetimi-ve-olumsuz-olaylara-hazirlik-turkiyede-yasal-zorunluluklar-ve-kalite-guvencesi\/#Danismanlikla_Surec_Nasil_Guclenir\" >How can the process be strengthened through consulting?<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.d-tek.com.tr\/en\/tibbi-laboratuvar-yonetimi-ve-olumsuz-olaylara-hazirlik-turkiyede-yasal-zorunluluklar-ve-kalite-guvencesi\/#Hazirlikli_Olmak_Icin_Bugun_Adim_Atin\" >Take action today to be prepared.<\/a><\/li><\/ul><\/nav><\/div>\n<h2><span class=\"ez-toc-section\" id=\"Tibbi_Laboratuvarlarda_Olumsuz_Olay_Nedir\"><\/span><span style=\"font-size: 16px;\">What is an Adverse Event in Medical Laboratories?<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-size: 16px;\">Adverse events are caused by a malfunction in a device&#039;s performance, an unexpected situation during use, or user error. <strong>harm to the patient, healthcare worker or a third party<\/strong>These are events that could result in such outcomes.<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Turkiyedeki_Mevzuat_Ne_Diyor\"><\/span><span style=\"font-size: 16px;\">What does the legislation in T\u00fcrkiye say?<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-size: 16px;\">In T\u00fcrkiye <strong>Medical Devices Warning System Circular<\/strong>, This mandates the detection, reporting, and monitoring of adverse events occurring after the placing of laboratory equipment on the market. Laboratories:<\/span><\/p>\n<ul>\n<li><span style=\"font-size: 16px;\">The events should be documented.<\/span><\/li>\n<li><span style=\"font-size: 16px;\">The device must document its make, model, and lot numbers.<\/span><\/li>\n<li><span style=\"font-size: 16px;\">To the Ministry <strong>Between 2 and 30 days<\/strong> notifications must be made at varying intervals.<\/span><\/li>\n<li><span style=\"font-size: 16px;\">They should prepare risk analysis and corrective action reports.<\/span><\/li>\n<\/ul>\n<h2><span class=\"ez-toc-section\" id=\"Olumsuz_Olay_Bildirimi_Kim_Ne_Zaman_Nasil\"><\/span><span style=\"font-size: 16px;\">Reporting Adverse Events: Who, When, How?<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-size: 16px;\">According to legal regulations, not only manufacturers, <strong>laboratory managers and users as well<\/strong> They are obligated to report the incidents. Delay or incomplete reporting may lead to legal penalties.<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Laboratuvarlar_Icin_Risk_Yonetimi_ve_ISO_14971\"><\/span><span style=\"font-size: 16px;\">Risk Management for Laboratories and ISO 14971<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-size: 16px;\"><strong>ISO 14971 standard<\/strong>, This is the international reference for managing risks related to medical devices. According to this standard, incident analyses and corrective action planning are required.<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Danismanlikla_Surec_Nasil_Guclenir\"><\/span><span style=\"font-size: 16px;\">How can the process be strengthened through consulting?<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-size: 16px;\">With our specialized consulting services for medical laboratories:<\/span><\/p>\n<ul>\n<li><span style=\"font-size: 16px;\">We establish and document your incident management processes.<\/span><\/li>\n<li><span style=\"font-size: 16px;\">We empower your staff with awareness training.<\/span><\/li>\n<li><span style=\"font-size: 16px;\">We develop risk assessment forms and procedures.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-size: 16px;\">In this way, not only the legislation, <strong>You also fully comply with international quality standards.<\/strong>.<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Hazirlikli_Olmak_Icin_Bugun_Adim_Atin\"><\/span><span style=\"font-size: 16px;\">Take action today to be prepared.<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-size: 16px;\">Adverse events can have significant consequences if preventative measures are not taken. To secure your institution, raise staff awareness, and strengthen a patient safety culture... <a class=\"color-button blue\" href=\"\/en\/iletisim\/\">Contact us immediately.<\/a>.<\/span><\/p>\n<p><strong>Notes: <\/strong><\/p>\n<p>All kits used for analysis\/testing\/examination are classified as medical devices. <em>in vitro<\/em> diagnostic (IVD) medical devices or <em>It is referred to as an in vitro medical device.<\/em><\/p>\n<p>\u201cAll software classified as &quot;software as a medical device&quot; is also considered a medical device. Detailed information about this software can be found at the following websites: &quot;https:\/\/www.fda.gov\/medical-devices\/digital-health-center-excellence\/software-medical-device-samd&quot; and &quot;https:\/\/health.ec.europa.eu\/system\/files\/2021-03\/md_mdcg_2021_mdsw_en_0.pdf&quot;.<\/p>\n<\/article>","protected":false},"excerpt":{"rendered":"<p>Prof. Dr. Diler Aslan T\u0131bbi laboratuvarlar, do\u011fru tan\u0131 ve tedavi s\u00fcre\u00e7lerinin temel yap\u0131 ta\u015flar\u0131ndan birisidir. Ancak laboratuvar hizmetlerinde her zaman i\u015fler planland\u0131\u011f\u0131 gibi gitmeyebilir. T\u0131bbi cihaz ar\u0131zalar\u0131, yanl\u0131\u015f test sonu\u00e7lar\u0131, kullan\u0131c\u0131 hatalar\u0131 ya da etiketleme yetersizlikleri gibi unsurlar, hasta g\u00fcvenli\u011fini do\u011frudan etkileyebilecek olumsuz olaylara yol a\u00e7abilir.Bu nedenle, olumsuz olaylara kar\u015f\u0131 sistemli bir haz\u0131rl\u0131k yapmak, sadece&hellip;<\/p>","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[63],"tags":[190,187,186,189,184,188,185,183],"post_series":[],"class_list":["post-17625","post","type-post","status-publish","format-standard","hentry","category-blog","tag-in-vitro-tani-cihazlari","tag-iso-15189-danismanlik","tag-laboratuvar-kalite-yonetimi","tag-laboratuvar-risk-yonetimi","tag-olumsuz-olay-bildirimi","tag-saglikta-hasta-guvenligi","tag-tibbi-cihaz-uyari-sistemi","tag-tibbi-laboratuvar-yonetimi","entry","no-media"],"_links":{"self":[{"href":"https:\/\/www.d-tek.com.tr\/en\/wp-json\/wp\/v2\/posts\/17625","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.d-tek.com.tr\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.d-tek.com.tr\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.d-tek.com.tr\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.d-tek.com.tr\/en\/wp-json\/wp\/v2\/comments?post=17625"}],"version-history":[{"count":6,"href":"https:\/\/www.d-tek.com.tr\/en\/wp-json\/wp\/v2\/posts\/17625\/revisions"}],"predecessor-version":[{"id":17633,"href":"https:\/\/www.d-tek.com.tr\/en\/wp-json\/wp\/v2\/posts\/17625\/revisions\/17633"}],"wp:attachment":[{"href":"https:\/\/www.d-tek.com.tr\/en\/wp-json\/wp\/v2\/media?parent=17625"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.d-tek.com.tr\/en\/wp-json\/wp\/v2\/categories?post=17625"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.d-tek.com.tr\/en\/wp-json\/wp\/v2\/tags?post=17625"},{"taxonomy":"post_series","embeddable":true,"href":"https:\/\/www.d-tek.com.tr\/en\/wp-json\/wp\/v2\/post_series?post=17625"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}