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 0287-2017https://www.chinesestandard.net, 20.03.2021 - 174 Seiten 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. |
Inhalt
| 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 |
| 173 | |
Häufige Begriffe und Wortgruppen
acceptance criteria adequacy and effectiveness applicable regulatory requirements appropriate approved Article batch production complaint handling compliance computer software control requirements corrective measures country or region data sources design and development development changes development input development output development process development verification disposal documented procedures electrostatic discharge ensure environment evaluation example external parties feedback forming documents impact implementation improvement stage installation internal audits investigation maintain maintenance management review manufacturing measures taken measuring equipment meet the requirements methods monitoring and measurement necessary needs nonconforming products operation organization shall document organization should determine organization should document organization's quality management outsourcing packaging personnel potential nonconformities preventive measures procurement product realization process Product recall product requirements production and service purchased products quality management system quality objectives quality policy regulations regulatory agencies relevant risk management activities safety and performance standard sterile barrier system sterilization process storage supplier top management upgrade