ISO 13485-2016 Practical Guide
醫(yī)療器械實(shí)用指南 ISO/TC 210 的建議

Medical devices apracticalguide Advice from ISO/TC 210

適用范圍: This International Standard 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 design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g., technical support). This International Standard can also be used by suppliers or external parties that provide product including quality management system-related services to such organizations. Requirements of this International Standard are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Whenever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.

術(shù)語	描述
質(zhì)量管理體系 Quality Management System (QMS)	為實(shí)現(xiàn)質(zhì)量管理目標(biāo)所建立的體系，包括必要的組織結(jié)構(gòu)、政策、程序、過程和資源。
醫(yī)療設(shè)備 Medical Devices	用于診斷、治療或監(jiān)測人類疾病的儀器或裝置，需符合相關(guān)法規(guī)要求。

醫(yī)療設(shè)備多種多樣，包括但不限于X光機(jī)、超聲波檢測儀等。	用于醫(yī)療目的的各類器械和儀器，需符合ISO 13485標(biāo)準(zhǔn)要求。