{"id":18307,"date":"2026-10-06T09:52:47","date_gmt":"2026-10-06T06:52:47","guid":{"rendered":"https:\/\/www.kalitekit.com.tr\/?post_type=product&#038;p=18307"},"modified":"2026-10-06T09:52:51","modified_gmt":"2026-10-06T06:52:51","slug":"iso-13485-ic-tetkikci-egitimi","status":"publish","type":"product","link":"https:\/\/www.kalitekit.com.tr\/en\/product\/iso-13485-ic-tetkikci-egitimi\/","title":{"rendered":"ISO 13485:2016 \u0130\u00e7 Tetkik\u00e7i E\u011fitimi ve Sertifika Program\u0131"},"content":{"rendered":"<article class=\"kalitekit-egitim\">\n<section><strong>ISO 13485:2016 \u0130\u00e7 Tetkik\u00e7i E\u011fitimi ve Sertifika Program\u0131<\/strong>, t\u0131bbi cihaz kalite y\u00f6netim sistemlerinde i\u00e7 tetkik ger\u00e7ekle\u015ftirmek isteyen kalite profesyonelleri, m\u00fchendisler, biyologlar, reg\u00fclasyon \u00e7al\u0131\u015fanlar\u0131 ve sekt\u00f6re girmek isteyen kat\u0131l\u0131mc\u0131lar i\u00e7in haz\u0131rlanm\u0131\u015f uygulama odakl\u0131 bir e\u011fitimdir.<\/p>\n<p>ISO 13485 kapsam\u0131nda etkili bir i\u00e7 tetkik yaln\u0131zca prosed\u00fcrlerin mevcut olup olmad\u0131\u011f\u0131n\u0131n kontrol edilmesi de\u011fildir. Tetkik\u00e7i; prosesin ger\u00e7ekten uygulan\u0131p uygulanmad\u0131\u011f\u0131n\u0131, kay\u0131tlar\u0131n birbiriyle tutarl\u0131 olup olmad\u0131\u011f\u0131n\u0131, objektif kan\u0131tlar\u0131n gereklilikleri destekleyip desteklemedi\u011fini ve tespit edilen problemlerin kalite y\u00f6netim sistemi \u00fczerindeki etkisini de\u011ferlendirebilmelidir.<\/p>\n<p>Bu e\u011fitimde <strong>tetkik program\u0131n\u0131n haz\u0131rlanmas\u0131ndan proses bazl\u0131 tetkik yakla\u015f\u0131m\u0131na, objektif kan\u0131t toplamadan profesyonel uygunsuzluk yaz\u0131m\u0131na, CAPA takibinden tetkik raporlamaya kadar<\/strong> bir i\u00e7 tetkik\u00e7inin ihtiya\u00e7 duydu\u011fu temel ve uygulamal\u0131 yetkinlikler sistematik olarak ele al\u0131nmaktad\u0131r.<\/p>\n<p>ISO 13485 standard\u0131na ilk kez \u00e7al\u0131\u015f\u0131yorsan\u0131z e\u011fitime ba\u015flamadan \u00f6nce<br \/>\n<a title=\"ISO 13485:2016 Temel Gereklilikler E\u011fitimi\" href=\"https:\/\/www.kalitekit.com.tr\/en\/product\/iso-134852016-kalite-yonetim-sistemi-temel-egitim\/\"><strong>ISO 13485:2016 Temel Gereklilikler E\u011fitimi<\/strong><\/a><br \/>\nile standard\u0131n genel yap\u0131s\u0131n\u0131 \u00f6\u011frenmeniz \u00f6nerilir.<\/p>\n<\/section>\n<section>\n<h2>ISO 13485 \u0130\u00e7 Tetkik\u00e7i E\u011fitimi Nedir?<\/h2>\n<p><strong>ISO 13485 i\u00e7 tetkik\u00e7i e\u011fitimi<\/strong>, bir kurulu\u015fun t\u0131bbi cihaz kalite y\u00f6netim sistemini planl\u0131 ve sistematik \u015fekilde de\u011ferlendirebilecek ki\u015filerin ihtiya\u00e7 duydu\u011fu tetkik yakla\u015f\u0131m\u0131n\u0131 \u00f6\u011fretmeyi ama\u00e7lar.<\/p>\n<p>\u0130\u00e7 tetkikte ama\u00e7 yaln\u0131zca hata bulmak de\u011fildir. Tetkik; kalite y\u00f6netim sisteminin belirlenen kriterlere uygunlu\u011funu, proseslerin etkin bi\u00e7imde uygulan\u0131p uygulanmad\u0131\u011f\u0131n\u0131 ve sistemin s\u00fcrd\u00fcr\u00fclebilirli\u011fini objektif kan\u0131tlar \u00fczerinden de\u011ferlendirmek i\u00e7in kullan\u0131l\u0131r.<\/p>\n<p>Bu nedenle iyi bir i\u00e7 tetkik\u00e7i yaln\u0131zca standard maddelerini bilmekle yetinmez. Do\u011fru sorular\u0131 sorabilmeli, kay\u0131tlar aras\u0131nda ba\u011flant\u0131 kurabilmeli, proses i\u00e7erisindeki tetkik izini takip edebilmeli ve ula\u015ft\u0131\u011f\u0131 sonucu kan\u0131ta dayal\u0131 bi\u00e7imde raporlayabilmelidir.<\/p>\n<p>Kalite y\u00f6netim sistemlerinde tetkik yakla\u015f\u0131m\u0131na ili\u015fkin uluslararas\u0131 rehber hakk\u0131nda bilgi i\u00e7in<br \/>\n<a title=\"ISO 19011 Guidelines for auditing management systems\" href=\"https:\/\/www.iso.org\/standard\/19011\" target=\"_blank\" rel=\"noopener\">ISO 19011 \u2013 Guidelines for auditing management systems<\/a><br \/>\nresm\u00ee ISO sayfas\u0131 incelenebilir.<\/p>\n<\/section>\n<section>\n<h2>Bu E\u011fitim Size Ne Kazand\u0131r\u0131r?<\/h2>\n<p>Bu program, yaln\u0131zca teorik bilgi vermek yerine kat\u0131l\u0131mc\u0131n\u0131n <strong>bir i\u00e7 tetkik s\u0131ras\u0131nda nas\u0131l d\u00fc\u015f\u00fcnmesi ve nas\u0131l hareket etmesi gerekti\u011fini<\/strong> kavramas\u0131n\u0131 ama\u00e7lar.<\/p>\n<div style=\"background: #f5f9fc; border-left: 4px solid #163b67; padding: 20px; margin: 22px 0;\"><strong>E\u011fitimin temel yakla\u015f\u0131m\u0131:<\/strong><\/p>\n<p>Tetkik kriteri \u2192 Tetkik sorusu \u2192 Objektif kan\u0131t \u2192 Bulgu \u2192 Uygunsuzluk \u2192 D\u00fczeltici faaliyet \u2192 Etkinlik kontrol\u00fc<\/p><\/div>\n<p>E\u011fitimi tamamlad\u0131ktan sonra kat\u0131l\u0131mc\u0131;<\/p>\n<ul>\n<li>ISO 13485 kapsam\u0131nda i\u00e7 tetkikin amac\u0131n\u0131 ve kalite y\u00f6netim sistemi i\u00e7erisindeki yerini a\u00e7\u0131klayabilir.<\/li>\n<li>Y\u0131ll\u0131k i\u00e7 tetkik program\u0131 ve tekil tetkik plan\u0131 haz\u0131rlayabilir.<\/li>\n<li>Tetkik kapsam\u0131n\u0131, kriterlerini ve hedeflerini belirleyebilir.<\/li>\n<li>Proses bazl\u0131 tetkik yakla\u015f\u0131m\u0131n\u0131 uygulayabilir.<\/li>\n<li>Tetkik s\u0131ras\u0131nda uygun soru tekniklerini kullanabilir.<\/li>\n<li>Dok\u00fcman, kay\u0131t, g\u00f6zlem ve g\u00f6r\u00fc\u015fmelerden objektif kan\u0131t toplayabilir.<\/li>\n<li>Prosesler aras\u0131nda tetkik izi olu\u015fturabilir.<\/li>\n<li>Uygunluk, g\u00f6zlem ve uygunsuzluk aras\u0131ndaki fark\u0131 de\u011ferlendirebilir.<\/li>\n<li>Kan\u0131ta dayal\u0131 ve savunulabilir uygunsuzluk ifadeleri haz\u0131rlayabilir.<\/li>\n<li>\u0130\u00e7 tetkik sonu\u00e7lar\u0131n\u0131 raporlayabilir.<\/li>\n<li>D\u00fczeltici faaliyet ve CAPA kay\u0131tlar\u0131n\u0131 takip edebilir.<\/li>\n<li>Faaliyetlerin etkinli\u011fini de\u011ferlendirebilir.<\/li>\n<\/ul>\n<\/section>\n<section>\n<h2>ISO 13485 \u0130\u00e7 Tetkik\u00e7i E\u011fitimi Kimler \u0130\u00e7in Uygundur?<\/h2>\n<p>Bu e\u011fitim \u00f6zellikle t\u0131bbi cihaz sekt\u00f6r\u00fcnde kalite y\u00f6netimi, kalite g\u00fcvence ve reg\u00fclasyon s\u00fcre\u00e7lerinde \u00e7al\u0131\u015fan veya bu alanlarda kariyer yapmak isteyen ki\u015filer i\u00e7in haz\u0131rlanm\u0131\u015ft\u0131r.<\/p>\n<ul>\n<li>Kalite G\u00fcvence Uzmanlar\u0131<\/li>\n<li>Kalite Y\u00f6netim Sistemi \u00e7al\u0131\u015fanlar\u0131<\/li>\n<li>\u0130\u00e7 tetkik\u00e7i olarak g\u00f6revlendirilecek personeller<\/li>\n<li>Kalite m\u00fchendisleri<\/li>\n<li>Biyomedikal m\u00fchendisleri<\/li>\n<li>Biyologlar, kimyagerler ve ilgili m\u00fchendislik b\u00f6l\u00fcmlerinden mezunlar<\/li>\n<li>Regulatory Affairs \/ Reg\u00fclasyon \u00e7al\u0131\u015fanlar\u0131<\/li>\n<li>T\u0131bbi cihaz \u00fcreticilerinin kalite personeli<\/li>\n<li>ISO 13485 alan\u0131nda kariyer yapmak isteyen yeni mezunlar<\/li>\n<li>T\u0131bbi cihaz kalite ve reg\u00fclasyon dan\u0131\u015fmanlar\u0131<\/li>\n<\/ul>\n<p>T\u0131bbi cihaz sekt\u00f6r\u00fcne hen\u00fcz yeni ba\u015fl\u0131yorsan\u0131z KaliteKit&#8217;in<br \/>\n<a title=\"T\u0131bbi Cihaz Mevzuat\u0131 E\u011fitimi\" href=\"https:\/\/www.kalitekit.com.tr\/en\/product\/tibbi-cihaz-mevzuati-egitimi\/\">\u00fccretsiz T\u0131bbi Cihaz Mevzuat\u0131 E\u011fitimi<\/a><br \/>\nile temel mevzuat kavramlar\u0131n\u0131 da inceleyebilirsiniz.<\/p>\n<\/section>\n<section>\n<h2>ISO 13485:2016 \u0130\u00e7 Tetkik\u00e7i E\u011fitimi \u0130\u00e7eri\u011fi<\/h2>\n<h3>1. ISO 13485 ve \u0130\u00e7 Tetkike Giri\u015f<\/h3>\n<ul>\n<li>ISO 13485 kalite y\u00f6netim sistemine genel bak\u0131\u015f<\/li>\n<li>\u0130\u00e7 tetkikin amac\u0131 ve kalite sistemi i\u00e7erisindeki yeri<\/li>\n<li>\u0130\u00e7 tetkik, d\u0131\u015f tetkik ve belgelendirme denetimi aras\u0131ndaki farklar<\/li>\n<li>Tetkik\u00e7inin g\u00f6rev ve sorumluluklar\u0131<\/li>\n<li>Tarafs\u0131zl\u0131k, ba\u011f\u0131ms\u0131zl\u0131k, gizlilik ve kan\u0131ta dayal\u0131 yakla\u015f\u0131m<\/li>\n<\/ul>\n<h3>2. \u0130\u00e7 Tetkik Program\u0131n\u0131n Planlanmas\u0131<\/h3>\n<ul>\n<li>Y\u0131ll\u0131k i\u00e7 tetkik program\u0131n\u0131n olu\u015fturulmas\u0131<\/li>\n<li>Tetkik kapsam\u0131n\u0131n belirlenmesi<\/li>\n<li>Tetkik kriterlerinin tan\u0131mlanmas\u0131<\/li>\n<li>Risk bazl\u0131 tetkik yakla\u015f\u0131m\u0131<\/li>\n<li>\u00d6nceki tetkik sonu\u00e7lar\u0131n\u0131n dikkate al\u0131nmas\u0131<\/li>\n<li>Tetkik s\u0131kl\u0131\u011f\u0131n\u0131n belirlenmesi<\/li>\n<\/ul>\n<h3>3. Tetkik Plan\u0131n\u0131n Haz\u0131rlanmas\u0131<\/h3>\n<ul>\n<li>Tetkik hedeflerinin belirlenmesi<\/li>\n<li>Tetkik ekibi ve sorumluluklar<\/li>\n<li>Zaman plan\u0131n\u0131n haz\u0131rlanmas\u0131<\/li>\n<li>Tetkik edilecek proseslerin belirlenmesi<\/li>\n<li>A\u00e7\u0131l\u0131\u015f ve kapan\u0131\u015f toplant\u0131lar\u0131<\/li>\n<li>\u00d6rnek i\u00e7 tetkik plan\u0131<\/li>\n<\/ul>\n<h3>4. Proses Bazl\u0131 Tetkik Yakla\u015f\u0131m\u0131<\/h3>\n<ul>\n<li>Proses yakla\u015f\u0131m\u0131n\u0131n i\u00e7 tetkikte kullan\u0131lmas\u0131<\/li>\n<li>Proses girdileri ve \u00e7\u0131kt\u0131lar\u0131<\/li>\n<li>Prosesler aras\u0131ndaki etkile\u015fim<\/li>\n<li>Kay\u0131tlar \u00fczerinden proses takibi<\/li>\n<li>Tetkik izi olu\u015fturma<\/li>\n<li>\u00c7apraz kontrol y\u00f6ntemleri<\/li>\n<\/ul>\n<h3>5. Tetkik Sorular\u0131 ve G\u00f6r\u00fc\u015fme Teknikleri<\/h3>\n<ul>\n<li>A\u00e7\u0131k u\u00e7lu ve kapal\u0131 u\u00e7lu sorular<\/li>\n<li>Takip sorular\u0131<\/li>\n<li>Objektif kan\u0131t talep etme<\/li>\n<li>\u00c7al\u0131\u015fan g\u00f6r\u00fc\u015fmeleri<\/li>\n<li>Y\u00f6nlendirici sorulardan ka\u00e7\u0131nma<\/li>\n<li>Proses bazl\u0131 \u00f6rnek tetkik sorular\u0131<\/li>\n<\/ul>\n<h3>6. Objektif Kan\u0131t Toplama<\/h3>\n<ul>\n<li>Dok\u00fcman inceleme<\/li>\n<li>Kay\u0131t inceleme<\/li>\n<li>Saha g\u00f6zlemi<\/li>\n<li>Personel g\u00f6r\u00fc\u015fmeleri<\/li>\n<li>\u00d6rnekleme yakla\u015f\u0131m\u0131<\/li>\n<li>Kan\u0131tlar\u0131n do\u011frulanmas\u0131<\/li>\n<li>Tek bir kan\u0131t \u00fczerinden hatal\u0131 sonuca ula\u015fma riski<\/li>\n<\/ul>\n<h3>7. ISO 13485 Proseslerinin Tetkiki<\/h3>\n<ul>\n<li>Dok\u00fcman ve kay\u0131t kontrol\u00fc<\/li>\n<li>Y\u00f6netimin sorumlulu\u011fu<\/li>\n<li>Personel yetkinli\u011fi ve e\u011fitim<\/li>\n<li>Tasar\u0131m ve geli\u015ftirme<\/li>\n<li>Sat\u0131n alma ve tedarik\u00e7i y\u00f6netimi<\/li>\n<li>\u00dcretim ve hizmet sunumu<\/li>\n<li>Proses validasyonu<\/li>\n<li>\u00dcr\u00fcn tan\u0131mlama ve izlenebilirlik<\/li>\n<li>\u0130zleme ve \u00f6l\u00e7me ekipmanlar\u0131<\/li>\n<li>Geri bildirim ve \u015fik\u00e2yet y\u00f6netimi<\/li>\n<li>Uygunsuz \u00fcr\u00fcn kontrol\u00fc<\/li>\n<li>D\u00fczeltici faaliyet ve CAPA<\/li>\n<li>Veri analizi<\/li>\n<li>Y\u00f6netimin g\u00f6zden ge\u00e7irmesi<\/li>\n<\/ul>\n<h3>8. Tetkik Bulgular\u0131n\u0131n De\u011ferlendirilmesi<\/h3>\n<ul>\n<li>Uygunluk ve uygunsuzluk kavramlar\u0131<\/li>\n<li>Objektif kan\u0131t ile kriter aras\u0131ndaki ili\u015fki<\/li>\n<li>G\u00f6zlem ve iyile\u015ftirme f\u0131rsatlar\u0131<\/li>\n<li>Sistematik problemlerin de\u011ferlendirilmesi<\/li>\n<li>Bulgunun gereklilik ile ili\u015fkilendirilmesi<\/li>\n<\/ul>\n<h3>9. Profesyonel Uygunsuzluk Yaz\u0131m\u0131<\/h3>\n<ul>\n<li>\u0130yi bir uygunsuzluk ifadesinin yap\u0131s\u0131<\/li>\n<li>Kriter \u2013 kan\u0131t \u2013 uygunsuzluk ba\u011flant\u0131s\u0131<\/li>\n<li>Belirsiz ve yorum i\u00e7eren ifadelerden ka\u00e7\u0131nma<\/li>\n<li>Yanl\u0131\u015f yaz\u0131lm\u0131\u015f uygunsuzluk \u00f6rnekleri<\/li>\n<li>Profesyonel uygunsuzluk yaz\u0131m \u00f6rnekleri<\/li>\n<li>Farkl\u0131 ISO 13485 proseslerinden uygulamalar<\/li>\n<\/ul>\n<h3>10. Tetkik Raporlama ve Kapan\u0131\u015f<\/h3>\n<ul>\n<li>Kapan\u0131\u015f toplant\u0131s\u0131n\u0131n y\u00fcr\u00fct\u00fclmesi<\/li>\n<li>Tetkik raporunun haz\u0131rlanmas\u0131<\/li>\n<li>Bulgular\u0131n sunulmas\u0131<\/li>\n<li>Sorumluluk ve hedef tarihlerin takibi<\/li>\n<li>Tetkik kay\u0131tlar\u0131n\u0131n korunmas\u0131<\/li>\n<\/ul>\n<h3>11. CAPA ve Tetkik Sonras\u0131 Takip<\/h3>\n<ul>\n<li>D\u00fczeltme ve d\u00fczeltici faaliyet fark\u0131<\/li>\n<li>K\u00f6k neden analizi<\/li>\n<li>CAPA ile tetkik bulgusu aras\u0131ndaki ba\u011flant\u0131<\/li>\n<li>Faaliyet planlar\u0131n\u0131n de\u011ferlendirilmesi<\/li>\n<li>Etkinlik kontrol\u00fc<\/li>\n<li>Uygunsuzlu\u011fun kapat\u0131lmas\u0131<\/li>\n<\/ul>\n<p>Uygunsuzluk ve CAPA s\u00fcre\u00e7leri hakk\u0131nda ayr\u0131ca KaliteKit<br \/>\n<a title=\"ISO 13485 Uygunsuzluk Kapatma Hizmeti\" href=\"https:\/\/www.kalitekit.com.tr\/en\/uygunsuzluk-kapatma-hizmeti\/\">Uygunsuzluk Kapatma Hizmeti<\/a><br \/>\nsayfas\u0131ndaki uygulama yakla\u015f\u0131m\u0131n\u0131 inceleyebilirsiniz.<\/p>\n<h3>12. Uygulamal\u0131 \u0130\u00e7 Tetkik Vakalar\u0131<\/h3>\n<p>E\u011fitim yaln\u0131zca teorik anlat\u0131mdan olu\u015fmaz. Kat\u0131l\u0131mc\u0131n\u0131n tetkik\u00e7i bak\u0131\u015f a\u00e7\u0131s\u0131n\u0131 geli\u015ftirmesi i\u00e7in farkl\u0131 proseslerden uygulamal\u0131 vakalar kullan\u0131l\u0131r.<\/p>\n<ul>\n<li>Tedarik\u00e7i y\u00f6netimi<\/li>\n<li>E\u011fitim ve personel yetkinli\u011fi<\/li>\n<li>CAPA<\/li>\n<li>Dok\u00fcman kontrol\u00fc<\/li>\n<li>Kalibrasyon<\/li>\n<li>\u015eik\u00e2yet y\u00f6netimi<\/li>\n<li>\u00dcretim kay\u0131tlar\u0131<\/li>\n<li>Proses validasyonu<\/li>\n<li>Tasar\u0131m ve geli\u015ftirme kay\u0131tlar\u0131<\/li>\n<\/ul>\n<h3>13. Uygulamal\u0131 \u0130\u00e7 Tetkik Sim\u00fclasyonu<\/h3>\n<p>Kat\u0131l\u0131mc\u0131, \u00f6rnek bir t\u0131bbi cihaz \u00fcreticisinin kay\u0131t ve proseslerini tetkik\u00e7i bak\u0131\u015f a\u00e7\u0131s\u0131yla de\u011ferlendirir.<\/p>\n<ul>\n<li>Tetkik kapsam\u0131n\u0131n de\u011ferlendirilmesi<\/li>\n<li>Prosed\u00fcr ve kay\u0131tlar\u0131n incelenmesi<\/li>\n<li>Objektif kan\u0131tlar\u0131n s\u0131n\u0131fland\u0131r\u0131lmas\u0131<\/li>\n<li>Potansiyel bulgular\u0131n belirlenmesi<\/li>\n<li>Uygunsuzluklar\u0131n yaz\u0131lmas\u0131<\/li>\n<li>Uzman \u00e7\u00f6z\u00fcm\u00fc ile kar\u015f\u0131la\u015ft\u0131rma<\/li>\n<\/ul>\n<p>T\u0131bbi cihaz denetimlerinin genel yakla\u015f\u0131m\u0131n\u0131 ayr\u0131ca<br \/>\n<a title=\"T\u0131bbi cihazlarda denetim nas\u0131l yap\u0131l\u0131r?\" href=\"https:\/\/www.kalitekit.com.tr\/en\/soru-cevap\/tibbi-cihazlarda-denetim-nasil-yapilir\/\">T\u0131bbi cihazlarda denetim nas\u0131l yap\u0131l\u0131r?<\/a><br \/>\nba\u015fl\u0131kl\u0131 KaliteKit uzman i\u00e7eri\u011finde inceleyebilirsiniz.<\/p>\n<\/section>\n<section>\n<h2>E\u011fitime Dahil Olan Materyaller<\/h2>\n<div style=\"background: #f7fafc; border: 1px solid #dfe8ef; padding: 24px; margin: 22px 0; border-radius: 6px;\">\n<p><strong>E\u011fitim paketine yaln\u0131zca e\u011fitim dok\u00fcman\u0131 de\u011fil, uygulamada kullanabilece\u011finiz profesyonel materyaller de dahildir.<\/strong><\/p>\n<ul>\n<li>Profesyonel ISO 13485:2016 \u0130\u00e7 Tetkik\u00e7i E\u011fitim Dok\u00fcman\u0131<\/li>\n<li>Uygulamal\u0131 i\u00e7 tetkik vaka \u00e7al\u0131\u015fmalar\u0131<\/li>\n<li>Ba\u015ftan sona i\u00e7 tetkik sim\u00fclasyonu<\/li>\n<li>Profesyonel uygunsuzluk yaz\u0131m \u00f6rnekleri<\/li>\n<li>Proses bazl\u0131 \u00f6rnek tetkik sorular\u0131<\/li>\n<li>120 soruluk de\u011ferlendirme soru havuzu<\/li>\n<li>Online de\u011ferlendirme s\u0131nav\u0131<\/li>\n<li>QR kodlu ve \u00e7evrim i\u00e7i do\u011frulanabilir Kat\u0131l\u0131m ve Ba\u015far\u0131 Belgesi<\/li>\n<\/ul>\n<\/div>\n<h3>7 D\u00fczenlenebilir \u0130\u00e7 Tetkik \u015eablonu<\/h3>\n<ol>\n<li>Y\u0131ll\u0131k \u0130\u00e7 Tetkik Program\u0131<\/li>\n<li>Tekil \u0130\u00e7 Tetkik Plan\u0131<\/li>\n<li>Proses Bazl\u0131 \u0130\u00e7 Tetkik Kontrol Listesi<\/li>\n<li>Uygunsuzluk \/ Bulgu Kay\u0131t Formu<\/li>\n<li>\u0130\u00e7 Tetkik Raporu<\/li>\n<li>Bulgu Takip ve Etkinlik Kontrol Formu<\/li>\n<li>Tetkik\u00e7i Yetkinlik De\u011ferlendirme Formu<\/li>\n<\/ol>\n<p>Bu \u015fablonlar e\u011fitim sonras\u0131nda kendi kurulu\u015funuzdaki i\u00e7 tetkik \u00e7al\u0131\u015fmalar\u0131n\u0131n yap\u0131land\u0131r\u0131lmas\u0131na yard\u0131mc\u0131 olacak \u015fekilde d\u00fczenlenebilir formatta sunulur.<\/p>\n<\/section>\n<section>\n<h2>E\u011fitim Nas\u0131l Uygulan\u0131r?<\/h2>\n<p>KaliteKit e\u011fitim modeli canl\u0131 ders zorunlulu\u011fu olmadan, kat\u0131l\u0131mc\u0131n\u0131n kendi \u00e7al\u0131\u015fma h\u0131z\u0131na g\u00f6re ilerleyebilece\u011fi \u015fekilde tasarlanm\u0131\u015ft\u0131r.<\/p>\n<div style=\"display: grid; grid-template-columns: repeat(auto-fit,minmax(180px,1fr)); gap: 15px; margin: 25px 0;\">\n<div style=\"border: 1px solid #e2e8ee; padding: 18px; border-radius: 6px;\"><strong>1. E\u011fitime Kay\u0131t Olun<\/strong>Sat\u0131n alma i\u015fleminin ard\u0131ndan e\u011fitim hesab\u0131n\u0131za tan\u0131mlan\u0131r.<\/p>\n<\/div>\n<div style=\"border: 1px solid #e2e8ee; padding: 18px; border-radius: 6px;\"><strong>2. Dok\u00fcman\u0131 \u0130nceleyin<\/strong>Profesyonel PDF e\u011fitim dok\u00fcman\u0131n\u0131 kendi h\u0131z\u0131n\u0131zda \u00e7al\u0131\u015f\u0131n.<\/p>\n<\/div>\n<div style=\"border: 1px solid #e2e8ee; padding: 18px; border-radius: 6px;\"><strong>3. S\u0131nava Girin<\/strong>E\u011fitim i\u00e7eri\u011fini tamamlad\u0131ktan sonra online de\u011ferlendirmeye kat\u0131l\u0131n.<\/p>\n<\/div>\n<div style=\"border: 1px solid #e2e8ee; padding: 18px; border-radius: 6px;\"><strong>4. Belgenizi Al\u0131n<\/strong>Ba\u015far\u0131 ko\u015fulunu sa\u011flad\u0131\u011f\u0131n\u0131zda do\u011frulanabilir belgenize eri\u015fin.<\/p>\n<\/div>\n<\/div>\n<\/section>\n<section>\n<h2>ISO 13485 \u0130\u00e7 Tetkik\u00e7i S\u0131nav\u0131<\/h2>\n<p>E\u011fitim sonunda kat\u0131l\u0131mc\u0131n\u0131n temel bilgi ve uygulama yakla\u015f\u0131m\u0131n\u0131 de\u011ferlendirmek amac\u0131yla \u00e7evrim i\u00e7i s\u0131nav uygulan\u0131r.<\/p>\n<table style=\"width: 100%; border-collapse: collapse; margin: 20px 0;\">\n<tbody>\n<tr>\n<td style=\"padding: 10px; border: 1px solid #ddd;\"><strong>S\u0131nav t\u00fcr\u00fc<\/strong><\/td>\n<td style=\"padding: 10px; border: 1px solid #ddd;\">\u00c7oktan se\u00e7meli online de\u011ferlendirme<\/td>\n<\/tr>\n<tr>\n<td style=\"padding: 10px; border: 1px solid #ddd;\"><strong>Soru havuzu<\/strong><\/td>\n<td style=\"padding: 10px; border: 1px solid #ddd;\">120 soru<\/td>\n<\/tr>\n<tr>\n<td style=\"padding: 10px; border: 1px solid #ddd;\"><strong>S\u0131nav soru say\u0131s\u0131<\/strong><\/td>\n<td style=\"padding: 10px; border: 1px solid #ddd;\">30 soru<\/td>\n<\/tr>\n<tr>\n<td style=\"padding: 10px; border: 1px solid #ddd;\"><strong>Ba\u015far\u0131 kriteri<\/strong><\/td>\n<td style=\"padding: 10px; border: 1px solid #ddd;\">%70<\/td>\n<\/tr>\n<tr>\n<td style=\"padding: 10px; border: 1px solid #ddd;\"><strong>S\u0131nav s\u00fcresi<\/strong><\/td>\n<td style=\"padding: 10px; border: 1px solid #ddd;\">45 dakika<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>S\u0131nav sorular\u0131; i\u00e7 tetkik planlama, objektif kan\u0131t, proses yakla\u015f\u0131m\u0131, ISO 13485 gereklilikleri, uygunsuzluk yaz\u0131m\u0131 ve tetkik sonras\u0131 takip gibi e\u011fitim kapsam\u0131ndaki ba\u015fl\u0131klardan olu\u015fturulur.<\/p>\n<\/section>\n<section>\n<h2>ISO 13485 \u0130\u00e7 Tetkik\u00e7i Sertifikas\u0131 \/ Ba\u015far\u0131 Belgesi<\/h2>\n<p>E\u011fitim i\u00e7eri\u011fini tamamlayan ve de\u011ferlendirme s\u0131nav\u0131nda belirlenen ba\u015far\u0131 kriterini sa\u011flayan kat\u0131l\u0131mc\u0131lar ad\u0131na <strong>ISO 13485:2016 \u0130\u00e7 Tetkik\u00e7i E\u011fitimi Kat\u0131l\u0131m ve Ba\u015far\u0131 Belgesi<\/strong> d\u00fczenlenir.<\/p>\n<p>Belge KaliteKit sistemi \u00fczerinden dijital olarak olu\u015fturulur ve benzersiz belge numaras\u0131 ile QR kod kullan\u0131larak \u00e7evrim i\u00e7i do\u011frulanabilir.<\/p>\n<div style=\"background: #fff8e5; border-left: 4px solid #e4ad25; padding: 18px; margin: 22px 0;\"><strong>Belge hakk\u0131nda \u00f6nemli bilgilendirme:<\/strong><br \/>\nD\u00fczenlenen belge, kat\u0131l\u0131mc\u0131n\u0131n ISO 13485:2016 \u0130\u00e7 Tetkik\u00e7i E\u011fitimini tamamlad\u0131\u011f\u0131n\u0131 ve e\u011fitim sonu de\u011ferlendirmesinde ba\u015far\u0131l\u0131 oldu\u011funu g\u00f6sterir. Akredite personel belgelendirme sertifikas\u0131, resm\u00ee mesleki yeterlilik belgesi veya kurulu\u015f ad\u0131na d\u00fczenlenmi\u015f ISO 13485 kalite y\u00f6netim sistemi sertifikas\u0131 de\u011fildir.<\/div>\n<\/section>\n<section>\n<h2>ISO 13485 Nedir?<\/h2>\n<p><strong>ISO 13485:2016<\/strong>, t\u0131bbi cihaz sekt\u00f6r\u00fcne \u00f6zg\u00fc kalite y\u00f6netim sistemi gerekliliklerini tan\u0131mlayan uluslararas\u0131 standartt\u0131r. Standart; dok\u00fcmantasyon, y\u00f6netim sorumlulu\u011fu, personel yetkinli\u011fi, tasar\u0131m ve geli\u015ftirme, sat\u0131n alma, \u00fcretim, izlenebilirlik, \u015fik\u00e2yet y\u00f6netimi, i\u00e7 tetkik ve d\u00fczeltici faaliyet gibi kalite sistemi s\u00fcre\u00e7lerini kapsar.<\/p>\n<p>Standard\u0131n kapsam\u0131 ve g\u00fcncel durumu i\u00e7in<br \/>\n<a title=\"ISO 13485 Medical Devices resmi ISO sayfas\u0131\" href=\"https:\/\/www.iso.org\/iso-13485-medical-devices.html\" target=\"_blank\" rel=\"noopener\">ISO&#8217;nun ISO 13485 resmi sayfas\u0131n\u0131<\/a><br \/>\ninceleyebilirsiniz.<\/p>\n<p>Kurulu\u015funuz i\u00e7in kalite y\u00f6netim sistemi kurulumu, dok\u00fcmantasyon, i\u00e7 tetkik veya denetime haz\u0131rl\u0131k deste\u011fine ihtiya\u00e7 duyuyorsan\u0131z<br \/>\n<a title=\"ISO 13485 Dan\u0131\u015fmanl\u0131\u011f\u0131\" href=\"https:\/\/www.kalitekit.com.tr\/en\/iso-13485-danismanligi\/\"><strong>ISO 13485 Dan\u0131\u015fmanl\u0131\u011f\u0131<\/strong><\/a><br \/>\nhizmetimizi inceleyebilirsiniz.<\/p>\n<\/section>\n<section>\n<h2>ISO 13485 \u0130\u00e7 Tetkik\u00e7i E\u011fitimi Hakk\u0131nda S\u0131k Sorulan Sorular<\/h2>\n<details style=\"margin-bottom: 12px;\">\n<summary><strong>ISO 13485 \u0130\u00e7 Tetkik\u00e7i E\u011fitimi kimler i\u00e7in uygundur?<\/strong><\/summary>\n<p>E\u011fitim; kalite g\u00fcvence uzmanlar\u0131, kalite m\u00fchendisleri, biyomedikal m\u00fchendisleri, reg\u00fclasyon \u00e7al\u0131\u015fanlar\u0131, ISO 13485 kalite y\u00f6netim sisteminde g\u00f6rev alan personeller ve t\u0131bbi cihaz kalite alan\u0131nda kariyer yapmak isteyen ki\u015filer i\u00e7in uygundur.<\/p>\n<\/details>\n<details style=\"margin-bottom: 12px;\">\n<summary><strong>E\u011fitim canl\u0131 m\u0131?<\/strong><\/summary>\n<p>Hay\u0131r. E\u011fitim profesyonel PDF dok\u00fcman\u0131 \u00fczerinden kendi h\u0131z\u0131n\u0131zda tamamlan\u0131r. E\u011fitim i\u00e7eri\u011fini \u00e7al\u0131\u015ft\u0131ktan sonra \u00e7evrim i\u00e7i de\u011ferlendirme s\u0131nav\u0131na kat\u0131labilirsiniz.<\/p>\n<\/details>\n<details style=\"margin-bottom: 12px;\">\n<summary><strong>E\u011fitim sonunda belge veriliyor mu?<\/strong><\/summary>\n<p>Evet. E\u011fitim sonu de\u011ferlendirme s\u0131nav\u0131nda belirlenen ba\u015far\u0131 ko\u015fulunu sa\u011flayan kat\u0131l\u0131mc\u0131lar ad\u0131na QR kodlu ve \u00e7evrim i\u00e7i do\u011frulanabilir ISO 13485:2016 \u0130\u00e7 Tetkik\u00e7i E\u011fitimi Kat\u0131l\u0131m ve Ba\u015far\u0131 Belgesi d\u00fczenlenir.<\/p>\n<\/details>\n<details style=\"margin-bottom: 12px;\">\n<summary><strong>ISO 13485 hakk\u0131nda \u00f6nceden bilgi sahibi olmak gerekir mi?<\/strong><\/summary>\n<p>Zorunlu de\u011fildir; ancak ISO 13485 standard\u0131n\u0131n temel yap\u0131s\u0131na a\u015fina olmak e\u011fitimin daha verimli ilerlemesini sa\u011flar. Temel bilgiye ihtiya\u00e7 duyan kat\u0131l\u0131mc\u0131lar \u00f6nce KaliteKit ISO 13485:2016 Temel Gereklilikler E\u011fitimini tamamlayabilir.<\/p>\n<\/details>\n<details style=\"margin-bottom: 12px;\">\n<summary><strong>ISO 13485 i\u00e7 tetkik\u00e7i ve i\u00e7 denet\u00e7i ayn\u0131 \u015fey midir?<\/strong><\/summary>\n<p>Kalite y\u00f6netim sistemlerinde T\u00fcrk\u00e7e kullan\u0131mda \u201ci\u00e7 tetkik\u00e7i\u201d ve \u201ci\u00e7 denet\u00e7i\u201d ifadeleri s\u0131kl\u0131kla ayn\u0131 ama\u00e7la kullan\u0131lmaktad\u0131r. Bu e\u011fitimde standart ve kalite y\u00f6netim sistemi terminolojisine uygun olarak \u201ci\u00e7 tetkik\u00e7i\u201d ifadesi kullan\u0131lmaktad\u0131r.<\/p>\n<\/details>\n<details style=\"margin-bottom: 12px;\">\n<summary><strong>E\u011fitim yaln\u0131zca teorik bilgi mi i\u00e7eriyor?<\/strong><\/summary>\n<p>Hay\u0131r. E\u011fitimde proses bazl\u0131 tetkik yakla\u015f\u0131m\u0131, \u00f6rnek tetkik sorular\u0131, profesyonel uygunsuzluk yaz\u0131m\u0131, uygulamal\u0131 vakalar, tetkik izleri ve \u00f6rnek bir t\u0131bbi cihaz firmas\u0131 \u00fczerinden i\u00e7 tetkik sim\u00fclasyonu bulunmaktad\u0131r.<\/p>\n<\/details>\n<details style=\"margin-bottom: 12px;\">\n<summary><strong>E\u011fitime dahil \u015fablonlar kullan\u0131labilir mi?<\/strong><\/summary>\n<p>E\u011fitim paketinde y\u0131ll\u0131k i\u00e7 tetkik program\u0131, tetkik plan\u0131, proses bazl\u0131 kontrol listesi, uygunsuzluk kay\u0131t formu, tetkik raporu, takip formu ve tetkik\u00e7i yetkinlik de\u011ferlendirme formu olmak \u00fczere d\u00fczenlenebilir profesyonel \u015fablonlar yer almaktad\u0131r.<\/p>\n<\/details>\n<\/section>\n<section style=\"background: #f4f8fb; padding: 28px; margin-top: 30px; border-radius: 8px; text-align: center;\">\n<h2>ISO 13485 \u0130\u00e7 Tetkik Yetkinli\u011finizi Geli\u015ftirin<\/h2>\n<p>\u0130\u00e7 tetkiki yaln\u0131zca bir kontrol listesi faaliyeti olarak de\u011fil; prosesleri, kay\u0131tlar\u0131 ve objektif kan\u0131tlar\u0131 birlikte de\u011ferlendiren profesyonel bir kalite arac\u0131 olarak kullanmay\u0131 \u00f6\u011frenin.<\/p>\n<p><strong>Profesyonel e\u011fitim dok\u00fcman\u0131 + uygulamal\u0131 vakalar + i\u00e7 tetkik sim\u00fclasyonu + 7 d\u00fczenlenebilir \u015fablon + online s\u0131nav + do\u011frulanabilir ba\u015far\u0131 belgesi.<\/strong><\/p>\n<p>KaliteKit&#8217;in di\u011fer t\u0131bbi cihaz e\u011fitimlerini g\u00f6rmek i\u00e7in<br \/>\n<a title=\"KaliteKit E\u011fitim Katalo\u011fu\" href=\"https:\/\/www.kalitekit.com.tr\/en\/egitim-katalog\/\"><strong>E\u011fitim Katalo\u011funu inceleyebilirsiniz.<\/strong><\/a><\/p>\n<\/section>\n<\/article>","protected":false},"excerpt":{"rendered":"<div class=\"kalitekit-egitim-kisa\">\n<p><strong>ISO 13485:2016 \u0130\u00e7 Tetkik\u00e7i E\u011fitimi<\/strong> ile t\u0131bbi cihaz kalite y\u00f6netim sistemlerinde i\u00e7 tetkiki planlamay\u0131, uygulamay\u0131, objektif kan\u0131t toplamay\u0131, uygunsuzluk yazmay\u0131 ve tetkik sonu\u00e7lar\u0131n\u0131 takip etmeyi \u00f6\u011frenin.<\/p>\n<p>\u2713 Profesyonel PDF e\u011fitim dok\u00fcman\u0131<br \/>\n\u2713 Uygulamal\u0131 i\u00e7 tetkik vakalar\u0131 ve tetkik sim\u00fclasyonu<br \/>\n\u2713 120 soruluk de\u011ferlendirme soru havuzu<br \/>\n\u2713 7 d\u00fczenlenebilir profesyonel i\u00e7 tetkik \u015fablonu<br \/>\n\u2713 Online de\u011ferlendirme s\u0131nav\u0131<br \/>\n\u2713 QR kodlu ve \u00e7evrim i\u00e7i do\u011frulanabilir Kat\u0131l\u0131m ve Ba\u015far\u0131 Belgesi<\/p>\n<p><strong>Kendi h\u0131z\u0131n\u0131zda \u00e7al\u0131\u015f\u0131n, s\u0131nav\u0131 ba\u015far\u0131yla tamamlay\u0131n ve ISO 13485 i\u00e7 tetkik\u00e7i e\u011fitiminizi belgeleyin.<\/strong><\/p>\n<\/div>","protected":false},"featured_media":0,"comment_status":"open","ping_status":"closed","template":"","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center 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