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ISO13485認證標準中關于刪減的規定 發布時間: 2022-09-20 15:42 點擊:
ISO13485認證標準中關于刪減的規定
Provisions on deletion in ISO13485 certification standard
ISO13485認證標準的1.2節“應用”中有較詳細的規定。本標準的所有要求是針對提供醫療器械的組織,不論組織的類型或規模。如果法規要求允許對設計和開發控制進行刪減,則在質量管理體系中刪減它們可認為是合理的。
Section 1.2 "Application" of ISO13485 certification standard has more detailed provisions. All requirements of this standard are for organizations providing medical devices, regardless of the type or size of the organization. If the regulatory requirements allow the deletion of design and development controls, it is reasonable to delete them in the quality management system.
這些法規能夠提供另一種安排,這些安排要在質量管理體系中加以說明。
These regulations can provide another arrangement, which should be described in the quality management system.
組織有責任確保在符合本標準的聲明中反映出對設計和開發控制的刪減。
It is the responsibility of the organization to ensure that deletions from design and development controls are reflected in statements that conform to this standard.
ISO13485/' target='_blank'>ISO13485標準強調“保持其有效性”在ISO9001標準條文中許多“持續改進”之處在ISO13485/' target='_blank'>ISO13485標準中均改為“保持其有效性”,這是因為當前法規的目標是質量管理體系的有效性,以持續生產安全有效的產品。
The ISO13485 standard emphasizes that "maintaining its effectiveness" is changed to "maintaining its effectiveness" in the ISO13485 standard where many "continuous improvements" are found in the ISO9001 standard articles. This is because the goal of the current regulations is to ensure the effectiveness of the quality management system, so as to continuously produce safe and effective products.
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