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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 help them with their auditing processes.
Abstract. 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. Such organizations can be involved in one or more stages of the life-cycle, including ...
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ISO13485:2016是什麼？. 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 ...
2019年2月2日 · 國內的醫療器材製造業者一旦通過 ISO13485 認證，就等於拿到出口歐盟的通關門票，並有助於企業開拓國際市場。 此外，為了更快打入國際市場，國內醫療器材製造業者建立品質管理系統時，已逐漸把 「ISO 9001：2015」＋「ISO13485：2016」＋「歐盟CE」三大 ...
ISO 13485. 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.
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What is the difference between ISO 13485 and ISO 9001?
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Does ISO 13485 apply to medical devices?
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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。
