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ISO 13485 belgesinin alınması sürecinde danışmanlık firmalarının ciddi katkıları olacaktır. Hatta belge verilmesi aşamasına gelene kadar hemen her süreçte danışmanlık firmasının varlığı söz konusudur. Bu nedenle ISO 13485 belgesi almak düşüncesindeyseniz işe öncelikle iyi bir firmayla anlaşmakla başlamalısınız. İyi bir danışmanlık firması başlayacak süreci etkin bir şekilde yöneterek belgelendirme sürecinizi başarıyla sonuçlandıracaktır. Bu süreçte danışmanınıza destek olarak daha etkin bir iş birliği kurabilirsiniz.
Danışmanlık Firması ile Anlaşma
Belge sahibi olabilmek için size gerekli eğitimleri verecek, kendi deneyimlerini paylaşacak, kalite sisteminizi oluşturmanız için her adımda desteğini sunacak danışmanlık firmanızla anlaşmaya başlayacak ilk adımı atabilirsiniz. Firma anlaşma sonrasında işletmeye gelecek ve hali hazırdaki durum ile olması gereken standartları gösteren bir rapor hazırlayacaktır. Hazırlanan rapor neticesinde yapılması gereken işlemler işletmeye anlatılır ve süreç başlar.
Tıbbi Cihazlar Yönetim Sisteminin Kurulması
ISO 13485 belgesine sahip olabilmek için öncelikle sistemin kurulması gerekmektedir. Eksikliklerin görüldüğü rapor incelendikten sonra düzenlemeler sırasıyla yapılmaya başlanmalı. Eksiklerin çokluğuna azlığına göre bu belgelendirme öncesi sürecin ne kadar süreceği değişiklik göstermektedir. Tüm düzenlenmeler danışman desteği ve kontrolü ile yapıldıktan sonra artık belgelendirme aşamasına geçilebilir.
Belgelendirme Başvurusu
Danışmanlık firmanız belgelendirme kuruluşları arasından anlaşmalı olduklarından belgelendirme için fiyat teklifi alacaktır. Fiyatlar işletmenin büyüklüğüne göre denetimin süresi ve kapsamı değişeceğinden farklılık gösterir. Sunulan fiyat tekliflerinde ilk belgelendirme fiyatı, ara denetim ve belge yenileme ücretleri sözleşme ile size verilecektir. Teklifler için kendiniz için en uygun olanı seçtikten sonra ilk ödemeyi yapıp gerekli belgeleri müracaat için belgelendirme kuruluşuna teslim edebilirsiniz. Tüm bu adımlar, danışmanınız tarafından yapılıp takip edilebilir.
Denetim Süreci
Başvuru yapıldıktan sonra belgelendirme kuruluşu tarafından size denetimin yapılacağı gün ve saat ile ilgili bilgi verilecektir. Söylenen tarihte denetime gelen kuruluş yetkilileri başvuruda sunulan belgeler ile çelişki olmaması adına her türlü detayı ISO 13485 standartlarına göre değerlendirir. Denetim ziyareti başarılı geçmişse işletmenin belge almaya hak kazandığına karar verilir. Karar olumsuz olursa eksiklerin giderilmesi için işletmeye zaman verilecektir.
ISO 13485 Belgesini Alma
Denetimden olumlu sonuç çıkması halinde belge almaya hak kazanmışsanız belgelendirme kurulu belgenizi hazırlayarak size teslim edecektir. Bu dakikadan itibaren ISO 13485 belgesine sahip olan bir kuruluş olarak faaliyetlerini göstereceksiniz. Elde ettiğiniz belgenin devamlılığını sağlamak için kurduğunuz tıbbi cihazlar yönetim sisteminin standartlarını korumalı, kendinizi geliştirmeye devam etmelisiniz.
Belge Yenileme
Aldığınız ISO 13485 belgesi üç yıl süreyle geçerli olacaktır. Üç yıl sonrasında belge yenileme işleminin yapılması gerekir. Belgenin geçerlilik süresi dolmadan bir iki ay kadar önce uzatma talebinizi belgelendirme kuruluşuna bildirmelisiniz. Gerekli incelemeler yapıldıktan sonra belge geçerlilik süresi üç yıl daha uzatılabilecektir. Belge yenileme sürecinde de yine danışmanlık firmasından destek alabilirsiniz.
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