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Hikayemiz

KAPSAM’da 2008 yılından bu yana Türkiye’nin en büyük sanayi ili olan Kocaeli’de sağlık tesisleri için yenilikçi otomasyon sistemleri, yazılım çözümleri ve güvenli sarf malzemeler geliştirip üretiyoruz.

Uzman olduğumuz spesifik çalışma alanımızda Türkiye’nin en kapsamlı üretim yelpazesine sahip firması ve pazar lideri konumundayız. Yerli sermaye ve üretimin vermiş olduğu güçle ülkemizin sağlık alanındaki dışa bağımlılığını azaltmasına katkı sağlıyor, teknoloji transferi noktasında önemli adımlar atıyoruz.

Ülkemizdeki bu başarı hikayemizin yenilerini artık dünyanın bir çok ülkesinde yazıyor, Türkiye’mizin katma değeri yüksek ürün ihracatına katkı sağlamanın haklı sevincini ve gururunu yaşıyoruz. Bu özel sağlık alanında dünyanın sayılı üreticilerinden biri konumundayız ve “Türkiye” markasının değerini dünyanın her köşesinde artırmak için genç ve dinamik ekibimizle var gücümüzle çalışıyoruz.

Kalite Politikamız

Tüm ürünlerimizi uluslararası kalite standartlarına tam uyumlu olarak üretiyoruz ve tavizsiz bir kalite politikası uyguluyoruz.

Tesisimiz ISO 13485:2016 ve ISO 9001:2015 kalite yönetim sistemlerine göre RoyalCert® tarafından sertifikalandırılmıştır.

Tıbbi cihazlarımız, AB 93/42/EEC Tıbbi Cihaz Direktifi kapsamında KIWA® AB onay kuruluşu tarafından denetlenmektedir.

Steril tek kullanımlık malzemelerimizin montajı, ambalajlanması ve sterilizasyon işlemleri, üretim tesisimizin yüksek teknolojiye sahip TS EN ISO 14644 uyumlu temiz oda alanında gerçekleştirilmektedir. Üretimimizin hassas son kontrolleri, özel laboratuar koşullarında uzman personellerimiz tarafından titizlikle yapılmaktadır.

Steril tek kullanımlık malzemelerimizin biyouyumluluk, partikül madde muhafazası, doldurma hacmi, kimyasal, fiziksel v.b. çeşitli testleri bağımsız akredite kuruluşlara yaptırılmaktadır.

Elektromekanik cihazlarımız;

• ASHP ve GMP yönergeleriyle uyumlu ve 2014/35 / EU yönetmeliğine göre CE sertifikalıdır.
• Aşağıdaki gerekliliklere göre akredite laboratuarlar tarafından test edilmiş ve onaylanmıştır:

     - IEC 60601 - Tıbbi elektrikli ekipman
     - IEC 61010 - Ölçüm, kontrol ve laboratuvar kullanımı için elektrikli ekipman için Alçak Gerilim Direktifi (LVD) güvenliği
     - IEC 61326 - Ölçüm, kontrol ve laboratuvar kullanımı için elektrikli ekipman için Elektromanyetik Uyumluluk (EMC)

Kalite Belgelerimiz

-  ISO 13485:2016 | İndir

-  ISO 9001:2015 | İndir

-  Sınıf2 Tıbbi Cihazlarımızın CE Belgesi | İndir

-  TSE Hizmet Yeterlilik Belgesi | İndir

Daha fazla bilgi için kalite departmanımızla kalite@kapsamsaglik.com.tr mail adresinden iletişime geçebilirsiniz.

Etkinlikler

TR