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Sunday, 20 May 2012

ISO15378 / ISO13485

  • ISO13485 / ISO15378 合約條款定明保證合格,
  • ISO13485 / ISO15378 管理體系培訓,
  • ISO13485 / ISO15378 系統文件編寫,
  • ISO13485 / ISO15378 基礎設施要求,
  • ISO13485 / ISO15378 記錄整理 ( 最少三個月營運記錄 ) …. ,
  • ISO13485 / ISO15378 審核及糾正指導,
  • 協助獲取 ISO13485 / ISO15378 證書,

ISO13485 / ISO15378 顧問服務

ISO13485 醫療器械 品質管制體系 用於法規的要求，該標準可適用於所有的醫療器械的設計和開發、生產、安裝和服務以及相關服務的設計、開發和提供。

  • 確定以下內容的執行：
  • 醫療器械的品質目標和要求；
  • 針對醫療器械確定過程、文件檔案和資源的需求；
  • 醫療器械所要求的驗證、確認、監視、核對和試驗活動，以及醫療器械接收準則；

為生產程及其醫療器械滿足要求提供證據所需要的記錄。

ISO 14971 風險管理的需求；

  • Council Directive 93/42/EEC – CE Technical Report
  • J-GMP
  • CMDCAS
  • QSR80

ISO15378 醫療和制藥用輸液、灌輸和注射設備
良好製造實踐是與使制藥部門的公司能把污染、混淆和錯誤案例減到最低限度或消除的品質控制和品質保障相關的。I

SO15378∶2006 藥品的原始包裝材料

ISO9001∶2000 應用的特殊要求"的發佈，代表了國際上關於良好的大多數意見，建立了一個能夠用於品質改進、培訓、審核和認證的基準。

ISO15378∶2006 是在制藥部門專家的參與下開發的，它把ISO9001∶2000的品質管制要求與有關藥品原始包裝的設計、製造和供應的良好製造實踐的原則融合在一個單一的檔中。此外，新標準還為風險管理和有效性提供了指南，並與當前的發展相一致，在這兩個方面都包含了指南附件。該標準可適用於所有的原始包裝材料（玻璃、橡膠、塑膠和鋁等）。

ISO15378∶2006 是由ISO技術委員會關於"醫療和制藥用輸液、灌輸和注射設備"的ISO/TC76開發的。

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