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

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https://www.chinesestandard.net, 20.03.2021 - 174 Seiten
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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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Inhalt

Foreword
4
Management responsibilities
28
Resource management
42
Product realization
53
Measurement analysis and improvement
122
Appendix A Informative Examples of the process of integrating applicable
160
References
173

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Über den Autor (2021)

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