YY/T 0595-2020: Translated English of Chinese Standard. (YYT 0595-2020, YY/T0595-2020, YYT0595-2020): Medical devices - Quality management systems - Guidance on the application of YY/T 0287-2017 [Tips: BUY here & GET online-reading at GOOGLE. Then, if you need unprotected-PDF for offline-reading, WRITE to Wayne: Sales@ChineseStandard.net]
https://www.chinesestandard.net, 2021 M03 20 - 174 pages
This standard provides guidelines for the application of medical device quality management system requirements in YY/T 0287-2017. This standard applies to organizations of various sizes and types, as well as suppliers or other external parties that provide products and services for them, which involves one or more stages of the life cycle of medical devices.
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acceptance criteria accordance achieve activities addition analysis applicable regulatory requirements appropriate approved audit authority batch carried cause changes cleaning communication complaint complete compliance conduct confirmation consider contamination continuous corrective measures design and development determine development process disposal document effectiveness ensure environment establish evaluation evidence example expected external final identify impact implementation important improvement inspection installation intended internal involved maintain maintenance management review manufacturing marketed materials medical devices meet the requirements methods monitoring and measurement necessary needs nonconformities operation organization organization shall document organization's packaging performance period personnel potential preventive measures problem procurement product realization production and service protection purchased products quality management system quality objectives reasons records regulations regulatory agencies release relevant responsibilities risk management safety specific stage standard sterilization storage suitability supplier top management traceability verification YY/T