iso 13485 相關
廣告
搜尋結果
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.
- p
ISO13485 是ISO組織針對醫療器材的專業要求所制定的品質管理系統，此管理系統之大框架是採用ISO9001:2008品質管理系統，不過由於醫療設備和製作藥品的公司有許多專門的要求，使得ISO9001的某些要求難以應用於醫療相關產業，因此才有了ISO13485這項針對醫療相關產業的品質管理系統。 若企業並非醫療器材相關，則是申請 ISO9001:2015 。 ISO13485:2016相較於ISO9001之差異. ISO13485:2016更加重視的面相有下列六點： 1 ）防止污染的附加要求。 2 ）以滿足客戶需求為主軸，而不是客戶的滿意度。 3 ）在產品開發的各個階段都需要文件化資訊。 4 ）特別重視品質管理系統的有效性，而不是持續改進。 5 ）設計和生產過程中的風險控管。
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.
其他人也問了
What if ISO 13485 is not applicable?
What is the difference between ISO 13485 and ISO 46001?
How often is ISO 13485 updated?
Is ISO 13485 current?
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...
特別是，ISO 13485 將開啟通往醫療界的大門. Gary Gelhaye，CFS，品管經理. 進入全球市場. 與 BSI 合作即表示醫療器材製造商選擇無縫接軌全球在地專家指導，而這些專家都擁有範圍廣泛的產品及技術領域管理經驗。 我們的專家擁有產品生命週期各層面的豐富實務經驗，包括研發、生產及品管。 BSI 荷蘭（2797）是業經核准的全方位公告單位（Notified Body），我們審查並確保醫療器材（MD）和體外診斷器材（IVD）符合歐盟法規和指令的要求。 BSI 英國（0086）也是英國認可機構（Approved Body）能夠提供 UKCA 的符合性評估。
