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Who is ISO 13485 for? ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to
ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, [1] published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices.
EN ISO 13485 is the medical device industry's quality management system (QMS) harmonized standard; written to specify requirements for an organisation to design and implement a quality management system to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
This International Standard specifies requirements for a quality management system that can be used by an organization involved in one or more stages of the life-cycle of a medical device, including design and development, production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices, and...
ISO 13485醫療器材品質管理系統可改善企業內部流程、提升效率、降低成本並監督供應鏈，證明醫材產品有效安全，符合各國法規要求。BSI有150多位醫療器材專家，在研發、生產製造和品質保證有豐富經驗。
ISO 13485 係基於ISO 9001專為符合性品質目標管理循BSI之稽核人員具有卓越的產業經驗,並通過嚴格的內部教育環概念 — 計劃、執行、檢查及行動。 因此,它在本質上訓練和BSI資格認證過程 -- 包括品質管理系統最佳實踐之稽核更加法規導向,而且需要更徹底文件化的品質管理系統。 技巧、了解關鍵製造流程、預測相關標準規範之解釋方向等。 ISO 13485是為了協助醫療器材製造商設計、建立和維持. BSI之稽核員為最先進技術規範要求之專家,並針對新的需求其流程有效性之品質管理系統。 它確保製造商持續設計、和未來的變化持續受訓,研發、生產、安裝及交付安全且符合其預期目的的醫療器材。 BSI將確保客戶均已充分準備,並就未來的法規和符合性問題進行妥善規劃。
