{"id":704,"date":"2026-03-29T00:31:55","date_gmt":"2026-03-28T21:31:55","guid":{"rendered":"https:\/\/www.bplussolutions.com\/?p=704"},"modified":"2026-05-12T13:48:49","modified_gmt":"2026-05-12T10:48:49","slug":"what-should-you-include-in-your-mdr-internal-audit-checklist-a-practical-guide-for-medical-device-companies","status":"publish","type":"post","link":"https:\/\/www.bplussolutions.com\/tr\/what-should-you-include-in-your-mdr-internal-audit-checklist-a-practical-guide-for-medical-device-companies\/","title":{"rendered":"\u0130\u00e7 Denetim: Masan\u0131n Di\u011fer Taraf\u0131ndan"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"704\" class=\"elementor elementor-704\" data-elementor-settings=\"{&quot;element_pack_global_tooltip_width&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;element_pack_global_tooltip_width_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;element_pack_global_tooltip_width_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;element_pack_global_tooltip_padding&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;top&quot;:&quot;&quot;,&quot;right&quot;:&quot;&quot;,&quot;bottom&quot;:&quot;&quot;,&quot;left&quot;:&quot;&quot;,&quot;isLinked&quot;:true},&quot;element_pack_global_tooltip_padding_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;top&quot;:&quot;&quot;,&quot;right&quot;:&quot;&quot;,&quot;bottom&quot;:&quot;&quot;,&quot;left&quot;:&quot;&quot;,&quot;isLinked&quot;:true},&quot;element_pack_global_tooltip_padding_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;top&quot;:&quot;&quot;,&quot;right&quot;:&quot;&quot;,&quot;bottom&quot;:&quot;&quot;,&quot;left&quot;:&quot;&quot;,&quot;isLinked&quot;:true},&quot;element_pack_global_tooltip_border_radius&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;top&quot;:&quot;&quot;,&quot;right&quot;:&quot;&quot;,&quot;bottom&quot;:&quot;&quot;,&quot;left&quot;:&quot;&quot;,&quot;isLinked&quot;:true},&quot;element_pack_global_tooltip_border_radius_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;top&quot;:&quot;&quot;,&quot;right&quot;:&quot;&quot;,&quot;bottom&quot;:&quot;&quot;,&quot;left&quot;:&quot;&quot;,&quot;isLinked&quot;:true},&quot;element_pack_global_tooltip_border_radius_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;top&quot;:&quot;&quot;,&quot;right&quot;:&quot;&quot;,&quot;bottom&quot;:&quot;&quot;,&quot;left&quot;:&quot;&quot;,&quot;isLinked&quot;:true}}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-263c29a9 e-flex e-con-boxed e-con e-parent\" data-id=\"263c29a9\" data-element_type=\"container\" data-settings=\"{&quot;ekit_has_onepagescroll_dot&quot;:&quot;yes&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2e22ea40 elementor-widget elementor-widget-text-editor\" data-id=\"2e22ea40\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p style=\"font-weight: 400;\"><strong>Giri\u015f<\/strong><\/p><p style=\"font-weight: 400;\">Bir Onaylanm\u0131\u015f Kurulu\u015f denet\u00e7isi olarak \u00e7ok say\u0131da i\u00e7 denetim raporu okuyorum. \u0130yi olanlar bana firman\u0131n benden \u00f6nce kendi bo\u015fluklar\u0131n\u0131 buldu\u011funu s\u00f6yler. K\u00f6t\u00fc olanlar ise denetimin sadece MDR gere\u011fi yap\u0131ld\u0131\u011f\u0131n\u0131 g\u00f6sterir.<\/p><p style=\"font-weight: 400;\">Bu iki t\u00fcr i\u00e7 denetim aras\u0131ndaki fark, kontrol listesinin uzunlu\u011fu de\u011fildir. Fark, niyette yatar. \u0130yi kurgulanm\u0131\u015f bir kontrol listesi insanlar\u0131 d\u00fcr\u00fcst konu\u015fmaya zorlar, rahats\u0131z edici bulgular\u0131 ortaya \u00e7\u0131kar\u0131r ve \"belgelendi\" ile \"\u00e7al\u0131\u015f\u0131yor\" ayn\u0131 \u015feydir gibi rahat varsay\u0131m\u0131 sars\u0131yor. Zay\u0131f bir listeyse yaln\u0131zca herkesin zaten duymak istedi\u011fini teyit eder.<\/p><p style=\"font-weight: 400;\">Sizin MDR i\u00e7 denetim listeniz neleri i\u00e7ermeli ve ben \u00f6zellikle nelere bak\u0131yorum gelin birlikte inceleyelim.<\/p><ol><li style=\"font-weight: 400;\"><strong> 1. Organizasyonel Yap\u0131 ve Hukuki Netlik<\/strong><\/li><\/ol><p style=\"font-weight: 400;\">\u0130lk bakt\u0131\u011f\u0131m \u015fey:\n\ud83d\udc49 Her prosesin bir sahibi var m\u0131?<\/p><p style=\"font-weight: 400;\">Kula\u011fa basit gelebilir, ama sahipsiz prosesler g\u00f6rd\u00fc\u011f\u00fcm en yayg\u0131n organizasyonel zay\u0131fl\u0131k kayna\u011f\u0131 \u2014 ve QMS'lerine ciddi yat\u0131r\u0131m yapm\u0131\u015f firmalarda bile \u015fa\u015f\u0131rt\u0131c\u0131 derecede s\u0131k kar\u015f\u0131la\u015f\u0131yorum. Bir prosesin ba\u015f\u0131na bir isim yaz\u0131lmad\u0131\u011f\u0131nda, proses ortadan kaybolmaz. Ekipler aras\u0131 bo\u015flu\u011fa d\u00fc\u015fer. \u015eik\u00e2yet y\u00f6netimi teknik olarak vard\u0131r ama d\u00f6ng\u00fcy\u00fc kapatmaktan kimse sorumlu de\u011fildir. Tedarik\u00e7i de\u011ferlendirmesi iki y\u0131lda bir yap\u0131l\u0131r, \u00e7\u00fcnk\u00fc herkes ba\u015fka birinin takip etti\u011fini varsayar. Risk dosyas\u0131 reaktif olarak g\u00fcncellenir, \u00e7\u00fcnk\u00fc g\u00fcncel tutmaktan sorumlu tek bir ki\u015fi yoktur.<\/p><p style=\"font-weight: 400;\">Standart maddelerin yine yerinde olmas\u0131 gerekir \u2014 hukuki stat\u00fc, sahiplik yap\u0131s\u0131, raporlama hatlar\u0131, g\u00f6rev ve yetkiler, ana \u015firket ili\u015fkileri \u2014 ama bir denet\u00e7i olarak benim do\u011frulad\u0131\u011f\u0131m sadece dok\u00fcmantasyon de\u011fil. Sizin yap\u0131n\u0131z\u0131n ger\u00e7ekten hesap verebilirlik \u00fcretip \u00fcretmedi\u011fini do\u011fruluyorum.<\/p><p style=\"font-weight: 400;\">\u0130\u00e7 denetiminize eklenmesi de\u011ferli birka\u00e7 soru:<\/p><ul><li>KYS' nizdeki her kilit proses i\u00e7in, performans de\u011ferlendirmesi o prosesin i\u015fleyip i\u015flemedi\u011fini yans\u0131tan tek bir ki\u015fi s\u00f6yleyebiliyor musunuz?<\/li><li>\u0130ki ekibin \u201cpayla\u015f\u0131yoruz\u201d dedi\u011fi prosesler var m\u0131? Payla\u015f\u0131lm\u0131\u015f sahiplik neredeyse her zaman \u201cger\u00e7ek sahiplik yok\u201d demektir.<\/li><li>Bir y\u0131ldan uzun s\u00fcredir g\u00fcncellenmemi\u015f prosed\u00fcrlere bak\u0131n. Sebep nadiren \u201cgerekmiyordu\u201d olur \u2014 genellikle onlar\u0131 tekrar elden ge\u00e7irmeye yetecek kadar kimsenin kendini sorumlu hissetmedi\u011fi i\u00e7in g\u00fcncellenmemi\u015ftir.<\/li><\/ul><p style=\"font-weight: 400;\">Net bir organizasyonel yap\u0131, parlak bir organizasyon \u015femas\u0131na sahip olmakla ilgili de\u011fildir. Her sorumlulu\u011fun birinin masas\u0131na d\u00fc\u015ft\u00fc\u011f\u00fcnden emin olmakla ilgilidir. Sahiplik ger\u00e7ek oldu\u011funda bo\u015fluklar erken y\u00fczeye \u00e7\u0131kar. Sahiplik da\u011f\u0131lm\u0131\u015fsa bo\u015fluklar d\u0131\u015f denetimler s\u0131ras\u0131nda y\u00fczeye \u00e7\u0131kar \u2014 ve o noktada art\u0131k iyile\u015ftirmiyor, a\u00e7\u0131kl\u0131yorsunuzdur.<\/p><ol start=\"2\"><li style=\"font-weight: 400;\"><strong> Ba\u011f\u0131ms\u0131zl\u0131k ve Tarafs\u0131zl\u0131k<\/strong><\/li><\/ol><p style=\"font-weight: 400;\">Bir Onaylanm\u0131\u015f Kurulu\u015f denet\u00e7isi olarak \u00e7ok say\u0131da i\u00e7 denetim raporu okuyorum. \u0130yi olanlar bana firman\u0131n benden \u00f6nce kendi bo\u015fluklar\u0131n\u0131 buldu\u011funu s\u00f6yler. K\u00f6t\u00fc olanlar bana denetimin MDR gerektirdi\u011fi i\u00e7in yap\u0131ld\u0131\u011f\u0131n\u0131 s\u00f6yler \u2014 firman\u0131n ger\u00e7ekten neyin yanl\u0131\u015f oldu\u011funu \u00f6\u011frenmek istedi\u011fi i\u00e7in de\u011fil.\nBu iki t\u00fcr i\u00e7 denetim aras\u0131ndaki fark, kontrol listesinin uzunlu\u011fu de\u011fildir. Niyettir. \u0130yi tasarlanm\u0131\u015f bir kontrol listesi d\u00fcr\u00fcst konu\u015fmalar\u0131 zorlar, rahats\u0131z edici bulgular\u0131 g\u00fcn y\u00fcz\u00fcne \u00e7\u0131kar\u0131r ve \u201cbelgelenmi\u015f\u201d ile \u201c\u00e7al\u0131\u015f\u0131yor\u201d e\u015fitli\u011fi gibi rahat varsay\u0131mlar\u0131 sorgular. Zay\u0131f olan ise herkesin zaten inanmak istedi\u011fi \u015feyi onaylar.\nPeki MDR i\u00e7 denetim kontrol listenizde ne olmal\u0131? Sizin denetiminizi denetliyor olsayd\u0131m neye bakaca\u011f\u0131m\u0131 payla\u015f\u0131yorum.<\/p><p style=\"font-weight: 400;\">Cevap evetse, dok\u00fcmantasyona bakmadan \u00f6nce bir problem var demektir. \u00dcretim ve kalitenin temelde farkl\u0131 motivasyonlar\u0131 vard\u0131r. \u00dcretim sevkiyat yapmak ister \u2014 teslim tarihlerini tutturmak, sipari\u015fleri kar\u015f\u0131lamak, gelir hedeflerine ula\u015fmak. Kalite ise gerekti\u011finde sevkiyat\u0131 durdurmaya, parti reddetmeye, \u00fcr\u00fcn lansman\u0131n\u0131 ertelemeye raz\u0131 olmal\u0131d\u0131r. Ayn\u0131 ki\u015fi iki \u015fapkay\u0131 birden takt\u0131\u011f\u0131nda, sistem kendini sorgulama yetene\u011fini kaybeder. Kalite kararlar\u0131 sessizce \u00fcretim bask\u0131s\u0131na tabi h\u00e2le gelir \u2014 kimse bilin\u00e7li olarak b\u00f6yle olmas\u0131n\u0131 istemese bile.<\/p><p style=\"font-weight: 400;\">Bu, yap\u0131sal \u00e7\u0131kar \u00e7at\u0131\u015fmas\u0131n\u0131n en net \u00f6rneklerinden biridir ve \u00f6zellikle maliyet d\u00fc\u015f\u00fcrmek i\u00e7in rolleri birle\u015ftiren k\u00fc\u00e7\u00fck \u00fcreticilerde s\u0131k\u00e7a g\u00f6r\u00fcl\u00fcr. MDR'nin bu birle\u015ftirmeye izin vermemesinin bir sebebi vard\u0131r: ba\u011f\u0131ms\u0131zl\u0131k organizasyon \u015femas\u0131na tasarlanmal\u0131d\u0131r, sadece bir politika dok\u00fcman\u0131nda iddia edilmemelidir.<\/p><p style=\"font-weight: 400;\">\u0130\u00e7 denetiminiz \u015funlar\u0131 do\u011frulamal\u0131:<\/p><ul><li>\u00dcretim ve kalite aras\u0131nda fonksiyonel ayr\u0131m, ve \u00fcst y\u00f6netime ula\u015fana kadar bulu\u015fmayan raporlama hatlar\u0131<\/li><li>Kalite kararlar\u0131n\u0131 imzalayan ki\u015filerin \u00fcretim \u00e7\u0131kt\u0131s\u0131 veya ticari hedeflerle ilgili do\u011frudan sorumlulu\u011fu olup olmad\u0131\u011f\u0131<\/li><li>Yaln\u0131zca mevcut de\u011fil, firma b\u00fcy\u00fcd\u00fck\u00e7e, yeniden yap\u0131land\u0131k\u00e7a veya yeni i\u015fe al\u0131mlar yap\u0131ld\u0131k\u00e7a ortaya \u00e7\u0131kan yeni \u00e7at\u0131\u015fmalar\u0131 da tan\u0131mlama ve y\u00f6netme prosed\u00fcrleri<\/li><li>Karar vericilerin bir s\u00fcr\u00fcm onay\u0131n\u0131 reddedebilece\u011fine veya kayg\u0131lar\u0131n\u0131 ticari bask\u0131 olmadan \u00fcst seviyeye ta\u015f\u0131yabilece\u011fine dair belgeli kan\u0131t<\/li><\/ul><p style=\"font-weight: 400;\">Alg\u0131lanan \u00e7\u0131kar \u00e7at\u0131\u015fmalar\u0131 da MDR kapsam\u0131nda \u00f6nemlidir. Makul bir d\u0131\u015far\u0131dan bakan ki\u015fi sizin yap\u0131n\u0131za bak\u0131p \u201cbu ki\u015fi nas\u0131l ba\u011f\u0131ms\u0131z olabilir ki?\u201d diye soracaksa \u2014 o ki\u015finin pratikte nas\u0131l davrand\u0131\u011f\u0131ndan ba\u011f\u0131ms\u0131z olarak elinizde gelmekte olan bir bulgu vard\u0131r.<\/p><p style=\"font-weight: 400;\">Denetledi\u011fim en g\u00fc\u00e7l\u00fc firmalar ba\u011f\u0131ms\u0131zl\u0131\u011f\u0131 bir varl\u0131k olarak g\u00f6r\u00fcr. \u0130\u015fe al\u0131m kararlar\u0131na, raporlama yap\u0131lar\u0131na ve te\u015fvik planlar\u0131na bunu g\u00f6merler. En zay\u0131flar\u0131 ise ba\u011f\u0131ms\u0131zl\u0131\u011f\u0131 politika dok\u00fcman\u0131ndaki bir paragraf olarak g\u00f6r\u00fcr ve kimsenin onu fazla dikkatli okumamas\u0131n\u0131 umar.<\/p><ol start=\"3\"><li style=\"font-weight: 400;\"><strong> Gizlilik ve Bilgi Kontrol\u00fc<\/strong><\/li><\/ol><p style=\"font-weight: 400;\">Hassas verilerin i\u015flenmesi s\u0131k\u0131 kontrol gerektirir.<\/p><p style=\"font-weight: 400;\">\u0130\u00e7 denetiminiz; gizlilik prosed\u00fcrlerinin tan\u0131mland\u0131\u011f\u0131n\u0131 ve uyguland\u0131\u011f\u0131n\u0131, bilgiye eri\u015fimin k\u0131s\u0131tland\u0131\u011f\u0131n\u0131 ve kontrol edildi\u011fini, personelin gizlilik y\u00fck\u00fcml\u00fcl\u00fcklerini anlay\u0131p bunlara uydu\u011funu ve t\u00fcm uygunluk de\u011ferlendirme faaliyetleri boyunca bilginin korundu\u011funu teyit etmelidir.<\/p><p style=\"font-weight: 400;\">Bu \u00f6zellikle klinik ve teknik dok\u00fcmantasyon i\u00e7in kritiktir.<\/p><ol start=\"4\"><li style=\"font-weight: 400;\"><strong> Sorumluluk ve Finansal S\u00fcrd\u00fcr\u00fclebilirlik<\/strong><\/li><\/ol><p style=\"font-weight: 400;\">Finansal sa\u011flaml\u0131k \u00e7o\u011fu zaman g\u00f6z ard\u0131 edilir ama esast\u0131r.<\/p><p style=\"font-weight: 400;\">Denetiminizin \u015funlar\u0131 kapsad\u0131\u011f\u0131ndan emin olun: faaliyetlerinizle uyumlu yeterli sorumluluk sigortas\u0131, cihazlar\u0131n\u0131z\u0131n risk profilini yans\u0131tan teminat, yeterli finansal kaynaklar\u0131n mevcudiyeti ve uzun vadeli operasyonel s\u00fcrd\u00fcr\u00fclebilirlik.<\/p><p style=\"font-weight: 400;\">Bu, bir organizasyon olarak g\u00fcvenilirli\u011finizi ve itibar\u0131n\u0131z\u0131 g\u00f6sterir.<\/p><ol start=\"5\"><li style=\"font-weight: 400;\"><strong> Kalite Y\u00f6netim Sistemi (KYS)<\/strong><\/li><\/ol><p style=\"font-weight: 400;\">KYS, MDR uyumunun bel kemi\u011fidir \u2014 ama bir Onaylanm\u0131\u015f Kurulu\u015f denet\u00e7isi olarak her denetimde d\u00f6nd\u00fc\u011f\u00fcm soru \u015fu: bu KYS ger\u00e7ekten firmaya m\u0131 ait, yoksa onu kuran dan\u0131\u015fmana m\u0131?<\/p><p style=\"font-weight: 400;\">Bu sahada g\u00f6rd\u00fc\u011f\u00fcm en rahats\u0131z edici desenlerden biri. Tamamen bir d\u0131\u015f dan\u0131\u015fmana devredilmi\u015f \u2014 ve hi\u00e7bir zaman firman\u0131n k\u00fclt\u00fcr\u00fcne n\u00fcfuz etmemi\u015f \u2014 bir KYS, k\u00e2\u011f\u0131t \u00fczerinde eksiksiz g\u00f6r\u00fcn\u00fcr, ama kalite ekibinin d\u0131\u015f\u0131ndaki biriyle konu\u015fur konu\u015fmaz da\u011f\u0131l\u0131r. M\u00fchendisler prosed\u00fcrleri tan\u0131maz. Sat\u0131\u015f, \u015fik\u00e2yetlerin nas\u0131l akt\u0131\u011f\u0131n\u0131 bilmez. Y\u00f6netim g\u00f6zden ge\u00e7irmeleri liderli\u011fin ger\u00e7ek kararlar\u0131 gibi de\u011fil, bir dan\u0131\u015fman\u0131n raporu gibi okunur.<\/p><p style=\"font-weight: 400;\">KYS, bir s\u00f6zle\u015fmenin sonunda teslim edilen bir \u00e7\u0131kt\u0131 de\u011fildir. Firman\u0131n nas\u0131l i\u015fledi\u011fidir. Bu y\u00fczden i\u00e7 denetiminiz standart maddelere bakt\u0131\u011f\u0131nda \u2014 KYS kuruldu mu, dok\u00fcman kontrol\u00fc etkin mi, CAPA'lar kapat\u0131ld\u0131 m\u0131, y\u00f6netim g\u00f6zden ge\u00e7irmeleri yap\u0131ld\u0131 m\u0131 \u2014 bir katman daha derine inin:<\/p><ul><li>Kalite ekibi d\u0131\u015f\u0131ndan \u00fc\u00e7 \u00e7al\u0131\u015fana QMS'inizdeki bir temel prosesi kendi s\u00f6zleriyle tarif etmesini isteyin. Yapam\u0131yorlarsa, sistem hen\u00fcz i\u00e7eride sahiplenilmemi\u015f demektir.<\/li><li>Y\u00f6netim g\u00f6zden ge\u00e7irme tutanaklar\u0131n\u0131n tonunu okuyun. Bir d\u0131\u015f taraf\u0131n yazm\u0131\u015f gibi geliyorsa, bu ara\u015ft\u0131r\u0131lmaya de\u011fer bir i\u015farettir.<\/li><li>K\u00e2\u011f\u0131t \u00fczerindeki prosed\u00fcr sahipli\u011fini, i\u015fi g\u00fcnl\u00fck olarak ger\u00e7ekten kimin yapt\u0131\u011f\u0131yla kar\u015f\u0131la\u015ft\u0131r\u0131n. Buradaki uyumsuzluk gelmekte olan bir bulgudur.<\/li><\/ul><p style=\"font-weight: 400;\">Sadece klas\u00f6r i\u00e7inde ve dan\u0131\u015fman \u00e7\u0131kt\u0131s\u0131 olarak var olan bir KYS, ne hastalar\u0131n\u0131z\u0131 ne de i\u015finizi korur. Denetimlerde kar\u015f\u0131la\u015ft\u0131\u011f\u0131m en g\u00fc\u00e7l\u00fc sistemler \u2014 minimal bulguyla ge\u00e7enler \u2014 g\u00f6m\u00fcl\u00fc hissedilir. \u0130nsanlar bir dok\u00fcmana bakmadan prosed\u00fcrlerinden do\u011fal olarak bahseder. Ger\u00e7ek bir KYS b\u00f6yle g\u00f6r\u00fcn\u00fcr.<\/p><ol start=\"6\"><li style=\"font-weight: 400;\"><strong> \u0130\u00e7 Denetim Sisteminin Etkinli\u011fi<\/strong><\/li><\/ol><p style=\"font-weight: 400;\">Kendi denetimim s\u0131ras\u0131nda bir firman\u0131n i\u00e7 denetim raporlar\u0131n\u0131 inceledi\u011fimde, iki desen bana s\u00fcrecin ger\u00e7ek mi yoksa performatif mi oldu\u011funu an\u0131nda s\u00f6yler \u2014 ve hi\u00e7biri prosed\u00fcrlerin k\u00e2\u011f\u0131t \u00fczerinde var olup olmad\u0131\u011f\u0131yla ilgili de\u011fildir.<\/p><p style=\"font-weight: 400;\">Birincisi, raporun kendisinin format\u0131d\u0131r. Denetim kontrol listeniz el yaz\u0131s\u0131yla dolduruluyorsa \u2014 bas\u0131lm\u0131\u015f bir formun \u00fcst\u00fcne kalem-k\u00e2\u011f\u0131t girdileri \u2014 bu denetimin ger\u00e7ekten ne zaman yap\u0131ld\u0131\u011f\u0131n\u0131 sorgulamaya ba\u015flar\u0131m. Olgun i\u00e7 denetim sistemleri, girdileri zaman damgalayan, denet\u00e7i kimli\u011fini takip eden ve de\u011fi\u015ftirilemez bir kay\u0131t olu\u015fturan elektronik ara\u00e7lar kullan\u0131r. El yaz\u0131s\u0131yla doldurulmu\u015f formlar, denetim s\u0131ras\u0131nda ne kadar kolay doldurulabiliyorsa, ben sahaya gelmeden \u00f6nceki sabah da o kadar kolay doldurulabilir. Yanl\u0131\u015f olmak zorunda de\u011filler, ama hesap verebilirlik i\u00e7in kurulmam\u0131\u015f bir sistemin sinyalidir.<\/p><p style=\"font-weight: 400;\">\u0130kincisi, raporun ne buldu\u011fudur. Birden fazla b\u00f6l\u00fcmde \u201cDok\u00fcman incelendi, bulgu yok\u201d gibi girdiler g\u00f6r\u00fcyorsam \u2014 ya da daha k\u00f6t\u00fcs\u00fc, s\u0131f\u0131r bulgulu bir denetim raporu g\u00f6r\u00fcyorsam \u2014 ger\u00e7ekten endi\u015felenirim. Kapsaml\u0131 bir i\u00e7 denetim her zaman bir \u015feyleri g\u00fcn y\u00fcz\u00fcne \u00e7\u0131kar\u0131r: iyile\u015ftirilebilecek bir proses, biraz g\u00fcncelli\u011fini yitirmi\u015f bir prosed\u00fcr, bulunmas\u0131 zor bir e\u011fitim kayd\u0131. S\u0131f\u0131r bulgu m\u00fckemmel bir QMS anlam\u0131na gelmez. Denetimin ya yeterince derine inmedi\u011fi ya da denet\u00e7inin ger\u00e7ekten g\u00f6rd\u00fc\u011f\u00fcn\u00fc yazmaya rahat olmad\u0131\u011f\u0131 anlam\u0131na gelir.<\/p><p style=\"font-weight: 400;\">Anlaml\u0131 bir denetim raporu k\u00e2\u011f\u0131t \u00fczerinde \u015f\u00f6yle g\u00f6r\u00fcn\u00fcr:<\/p><ul><li>Spesifik kan\u0131tlar incelenmi\u015ftir (kay\u0131t numaralar\u0131, dok\u00fcman versiyonlar\u0131, \u00f6rneklem b\u00fcy\u00fckl\u00fckleri)<\/li><li>Neyin kontrol edildi\u011fi ile neyin sonu\u00e7land\u0131r\u0131ld\u0131\u011f\u0131 aras\u0131nda net bir ayr\u0131m vard\u0131r<\/li><li>Bulgular da\u011f\u0131l\u0131m g\u00f6sterir \u2014 baz\u0131 k\u00fc\u00e7\u00fck iyile\u015ftirmeler, baz\u0131 netle\u015ftirmeler, ara s\u0131ra daha ciddi bir \u015fey<\/li><li>D\u00fcr\u00fcst dil kullan\u0131l\u0131r. Her yerde \u201cyeterli\u201d ve \u201cuygun\u201d tekrarlan\u0131yorsa, bunun kendisi bir k\u0131rm\u0131z\u0131 bayrakt\u0131r.<\/li><\/ul><p style=\"font-weight: 400;\">\u0130\u00e7 denetimler d\u0131\u015f denetimlerin provas\u0131 de\u011fildir. Firman\u0131n kendi bo\u015fluklar\u0131n\u0131 \u00f6zel olarak bulma \u015fans\u0131d\u0131r. \u0130\u00e7 denetimleriniz tertemiz \u00e7\u0131kmaya devam ederken d\u0131\u015f denetimleriniz s\u00fcrekli bulgu vermeyse, soru QMS'inizde problem olup olmad\u0131\u011f\u0131 de\u011fildir \u2014 i\u00e7 denetim sisteminizin onlar\u0131 bulacak kadar d\u00fcr\u00fcst olup olmad\u0131\u011f\u0131d\u0131r.<\/p><ol start=\"7\"><li style=\"font-weight: 400;\"><strong> Personel Yetkinli\u011fi ve Tarafs\u0131zl\u0131\u011f\u0131<\/strong><\/li><\/ol><p style=\"font-weight: 400;\">G\u00fcvenilir bir i\u00e7 denetim i\u00e7in yetkin ve tarafs\u0131z personel esast\u0131r.<\/p><p style=\"font-weight: 400;\">Kontrol listeniz; personelin niteliklerinin ve deneyiminin belgelendi\u011fini, t\u00fcm faaliyetler i\u00e7in yeterli kayna\u011f\u0131n mevcut oldu\u011funu, e\u011fitim programlar\u0131n\u0131n uyguland\u0131\u011f\u0131n\u0131 ve s\u00fcrekli g\u00fcncellendi\u011fini, sorumluluklar\u0131n ve yetki seviyelerinin net olarak tan\u0131mland\u0131\u011f\u0131n\u0131 do\u011frulamal\u0131d\u0131r.<\/p><p style=\"font-weight: 400;\">Buna ek olarak, denet\u00e7i ba\u011f\u0131ms\u0131z olmal\u0131 ve kan\u0131ta dayal\u0131 tarafs\u0131z kararlar verebilmelidir.<\/p><p style=\"font-weight: 400;\">\u0130\u00e7 denetiminizi d\u0131\u015f kaynakl\u0131 olarak y\u00fcr\u00fctmeyi tercih edebilirsiniz; bu son derece etkili bir yakla\u015f\u0131m olabilir. Ancak ayn\u0131 ki\u015finin veya kurulu\u015fun ayn\u0131 anda size dan\u0131\u015fmanl\u0131k hizmeti vermedi\u011finden emin olmak kritik \u00f6nem ta\u015f\u0131r. Bu, \u00e7\u0131kar \u00e7at\u0131\u015fmas\u0131 yarat\u0131r ve tarafs\u0131zl\u0131kla ilgili ciddi bulgulara yol a\u00e7abilir.<\/p><p style=\"font-weight: 400;\">Hem yetkin hem de ger\u00e7ekten ba\u011f\u0131ms\u0131z bir denet\u00e7i se\u00e7mek, g\u00fcvenilirli\u011fin korunmas\u0131 ve Onaylanm\u0131\u015f Kurulu\u015f denetimlerinin ge\u00e7ilmesi a\u00e7\u0131s\u0131ndan kilit \u00f6neme sahiptir.<\/p><p style=\"font-weight: 400;\"><strong>Sonu\u00e7<\/strong><\/p><p style=\"font-weight: 400;\">Onaylanm\u0131\u015f Kurulu\u015f taraf\u0131nda ge\u00e7irdi\u011fim y\u0131llardan sonra en net g\u00f6rd\u00fc\u011f\u00fcm desen \u015fu: d\u0131\u015f denetimlerde zorlanan firmalar genellikle dok\u00fcman\u0131 eksik olanlar de\u011fildir. Dok\u00fcmanlar\u0131 olan ama o dok\u00fcmanlar\u0131n firman\u0131n ger\u00e7ekte nas\u0131l \u00e7al\u0131\u015ft\u0131\u011f\u0131n\u0131 yans\u0131tmad\u0131\u011f\u0131 firmalard\u0131r.<\/p><p style=\"font-weight: 400;\">Ger\u00e7ek bir i\u00e7 denetim QMS'inizi iyi g\u00f6stermeye \u00e7al\u0131\u015fmaz. QMS'inizin ger\u00e7ekten \u00e7al\u0131\u015fmas\u0131n\u0131 sa\u011flamaya \u00e7al\u0131\u015f\u0131r \u2014 ki bu daha zor, daha rahats\u0131z edici ve sonsuz kat daha de\u011ferlidir. \u0130\u00e7 denetiminizin g\u00fcn y\u00fcz\u00fcne \u00e7\u0131kard\u0131\u011f\u0131 her bo\u015fluk, sonradan bana a\u00e7\u0131klamak zorunda kalmayaca\u011f\u0131n\u0131z bir bo\u015fluktur.<\/p><p style=\"font-weight: 400;\">Kontrol listenizi g\u00fcvenli cevaplar\u0131n de\u011fil, d\u00fcr\u00fcst sorular\u0131n etraf\u0131nda kurarsan\u0131z, gerisi kendili\u011finden h\u00e2llolur. D\u0131\u015f denetimler bir stres testi olmaktan \u00e7\u0131kar ve zaten bildi\u011finiz \u015feyin onay\u0131na d\u00f6n\u00fc\u015f\u00fcr.<\/p><p style=\"font-weight: 400;\">B+ Solutions'da her \u00e7al\u0131\u015fmaya katt\u0131\u011f\u0131m\u0131z bak\u0131\u015f a\u00e7\u0131s\u0131 budur \u2014 do\u011frudan Onaylanm\u0131\u015f Kurulu\u015f deneyimiyle bilgilendirilmi\u015f, denet\u00e7ilerin ger\u00e7ekten neye bakt\u0131\u011f\u0131 etraf\u0131nda yap\u0131land\u0131r\u0131lm\u0131\u015f, k\u00e2\u011f\u0131t \u00fczerinde de\u011fil pratikte \u00e7al\u0131\u015fan sistemlere odakl\u0131.<\/p><p style=\"font-weight: 400;\">Hedefledi\u011finiz denetim haz\u0131rl\u0131\u011f\u0131 buysa, konu\u015fal\u0131m.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-d98105e e-flex e-con-boxed e-con e-parent\" data-id=\"d98105e\" data-element_type=\"container\" data-settings=\"{&quot;ekit_has_onepagescroll_dot&quot;:&quot;yes&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4a3dc25 elementor-widget elementor-widget-text-editor\" data-id=\"4a3dc25\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p data-start=\"1020\" data-end=\"1108\">MDR compliance is not just about passing audits\u2014it\u2019s about building a system that works.<\/p><p data-start=\"1110\" data-end=\"1263\">At <span class=\"hover:entity-accent entity-underline inline cursor-pointer align-baseline\"><span class=\"whitespace-normal\">B Plus Solutions<\/span><\/span>, we work with companies that want to move beyond reactive compliance and build sustainable, audit-ready systems.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b520a1c elementor-align-center elementor-widget elementor-widget-button\" data-id=\"b520a1c\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/www.bplussolutions.com\/tr\/contact\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">If that\u2019s your goal, let\u2019s talk<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Introduction As a Notified Body auditor, I read a lot of internal audit reports. The good ones tell me the company is finding its own gaps before I ever walk in. The bad ones tell me the audit was done because MDR requires it \u2014 not because the company actually wanted to know what was [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[19],"tags":[],"class_list":["post-704","post","type-post","status-publish","format-standard","hentry","category-insights"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.8 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>MDR Internal Audit Checklist: What Auditors Actually Look For<\/title>\n<meta name=\"description\" content=\"A Notified Body auditor on what your MDR internal audit checklist should include \u2014 and what auditors really look for during conformity assessment.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, 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