盈彩

quality

質量體系

    • 質量理念

      醫療器械產品質量關乎病患的生命安全、關乎企業的生存發展。

    • 質量方針

      顧客導向、技術為先、全員參與、不斷改進。

    • 質量體系與認證

      西山科技嚴格按照國內外醫療器械相關法規、標準要求,建立了適宜、充分、有效的質量管理體系,確保向顧客提供滿足要求的醫療器械產品。

      公司產品全生命周期的管理滿足GXP體系的要求,即《醫療器械臨床試驗質量管理規范(GCP)》、《醫療器械生產質量管理規范(GMP)》、《醫療器械經營質量管理規范(GSP)》等。 公司2004年已通過YY/T 0287 idt ISO 13485、GB/T 19001 idt ISO 9001質量管理體系認證。

      公司主營產品先后獲得歐盟CE認證,韓國KFDA(韓國食品藥品監督管理局)等市場準入許可。

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