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ISO 13485 Eğitimi

Tıbbi cihazlar için kalite yönetimi sisteminin oluşturulması, belge alınma aşamasının başarıyla sonlanması ve işletmelerin sistemi tam olarak anlaması için bu sistemi tanıtacak eğitimlere gerek duyulmaktadır. İşletme sahibinin ve personelin kalite yönetim sistemini doğru ve net olarak anlaması oluşturulan sistemin etkin şekilde yönetilmesinde etkili olacaktır. Danışmanlık firmasıyla kalite yönetimi oluşturma ve belgelendirme için birlikte çalışmaya karar verirken eğitimler konusunda ön bilgi almayı da unutmayınız.

ISO 13485 Eğitim İçeriği

Tıbbi cihazların kalite yönetimi için verilen eğitimlerde ISO 13485 standartları göz önünde bulundurularak içerik hazırlanmaktadır. Danışmanlık firmalarında verilen bu eğitimler işinde uzman, deneyimli kişiler tarafından verilmektedir. Eğitim içerikleri, danışmanlık firmalarınca farklı şekilde isimlendirilip programlanıyor olsa da anlatılan temel içerik ISO tarafından belirtilen standartlar çerçevesindedir. Eğitim kapsamında katılımcılara ISO 13485 kalite yönetim sisteminin ne olduğu, bu sistemin yararları, ISO 13485’in diğer sistemler ile uyumu, konuyla alakalı genel bilgiler anlatılmaktadır. Eğitim sona erdiğinde katılımcı ISO 13485 tıbbi cihazlar için kalite yönetimi sistemi konusuna yeterli derecede hakim olacaktır.

Uygulamalı eğitimlerde yönetimin rolü, uygulama süreçlerinin örneklerle tanıtımı, denetim ve denetime hazırlık, belgelendirme sürecinin planlanması gibi konular ele alınabilmektedir. Böylece katılımcılar ISO 13485 sistem oluşumu ve belgelendirme süreçlerinde kendilerini neyin beklediğini net bir şekilde görebilmektedir.

Eğitime Kimler Katılmalı?

İşletmesinin Türkiye’de ve dünyada rekabette bir adım önde olmasını isteyenler, sağlık konusunda hassasiyetli davrananlar ve müşteri memnuniyetini, güvenini önemseyenler ISO 13485 kalite yönetim sistemini geç kalmadan oluşturmalıdır. Sistemin net olarak oluşması ve yerleşmesi için ISO 13485 eğitiminin alınmasına fayda vardır. Eğitimler işletmenin yönetici kadrosu, kariyerinde ilerlemek isteyen çalışanlar katılabilirler.

ISO 13485 Eğitim Süresi

ISO 13485 tıbbi cihazlar için kalite yönetimi sistemine yönelik eğitimlerin süresi danışmanlık firmalarının programına göre değişiklik göstermektedir. Genel olarak bakıldığında eğitimlerin ortalama 2 gün sürdüğü görülmektedir. Program doğru ayarlandığında sistemin anlatılması için 2 gün yeterli olmaktadır. Bunun için günlük ders saatinin ortalama 9 saat civarında olması yeterli olacaktır. Katılımcılar işletme çalışanı ve sahibi olacağı için programlar çalışma yoğunluğuna göre esnek şekilde de hazırlanabilir. Bu durumda ortalama 5 gün civarında olan eğitim programları da mevcuttur.

ISO 13485 Eğitim Ücreti

ISO 13485 kalite yönetim sistemi eğitimlerinde ücret konusunda geniş bir yelpaze vardır. Ücretler danışmanlık firmalarının inisiyatifinde olduğundan çok değişkendir. Eğitimin içeriği, yoğunluğu gibi birçok detaya göre şekillenen ücretlendirmeler olmasına karşın indirimli veya ücretsiz eğitimler de verildiği bilinmektedir. Bazı danışmanlık firmaları, işletmenin kalite yönetim sistemini oluşturma sürecinde danışmanlığını yaparsa işletmelere ücretsiz eğitim imkanı sunmaktadır. Ayrıca firmaya kendinizle beraber birkaç işletme getirirseniz eğitimlerden indirimli olarak yararlanma şansına da sahipsiniz.

ISO 13485 Eğitiminin Hedefi

ISO tarafından belirlenmiş kalite yönetim sistemi standartlarının ilgili kişilere doğru ve detaylı şekilde aktarılması bu eğitimlerin en temel hedefidir. Çoğu zaman üzerinde değişiklikler olan kalite yönetim sistemlerinde öğrenilecek yeni bilgiler ortaya çıkmaktadır. Katılımcıların en güncel şekilde ISO 13485 standartlarını öğrenmesi için hazırlanan bu eğitimler sayesinde işletme yönetimi ve çalışanları teknik bilgiler dışında iş hayatlarında işe yarayacak birçok bilgiyi de öğrenmektedir. Özellikle belgelendirme aşamasına gelmeden önce alınan eğitim bu süreci daha kolay atlatabilmekte etkili olmaktadır.

ISO 13485 Eğitim Seçenekleri

ISO 13485 eğitimi almak isteyen katılımcıların çalışma şartları ve eğitime katılabilme durumları düşünülerek danışmanlık firmaları tarafından hazırlanan eğitim programları çeşitlendirilmiştir. Derslere doğrudan katılabilecek olanlar için en iyi alternatif yüz yüze verilen eğitimlerdir. Her katılımcıyla doğrudan ilgilenme imkanı olduğu için eğitim amacına daha doğru yoldan ulaşabilmektedir. Uygulamaları birebir görerek anlamak adına yüz yüze eğitimin tercih edilmesi daha doğrudur.

Yüz yüze eğitim için vakit konusunda sıkıntı varsa online eğitimler değerlendirilebilir. Eğitimin içeriği bakımından değişiklik yoktur ama online eğitimin kalitesi, yüz yüze eğitime göre daha düşüktür. Eğitmenle iletişim halinde olmamak eğitim sürecinin tıkanarak ilerlemesine neden olur. Online eğitim programlarında son teknoloji sistemler kullanan danışmanlık firmalarında, canlı ders gibi alternatifler daha uygun olacaktır. Ayrıca internet üzerinden verilen eğitimler daha iyi bir sonuç elde etmek için eğitim sonunda pekiştirme amacıyla yapılacak testler, videolu anlatımlar tekrar gözden geçirilebilir.

Ayrıca Bakınız.

ISO 13485 Belgesi Nasıl Alınır?

ISO 13485 belgesinin alınması sürecinde danışmanlık firmalarının ciddi katkıları olacaktır. Hatta belge verilmesi aşamasına gelene …

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