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This standard specifies requirements for a quality management system that can be used by an organization that processes medical devices. It can also be used by internal and external parties to assess the organization's ability to meet customer and regulatory requirements.
Author | AAMI |
---|---|
Editor | AAMI |
Document type | Standard |
Format | File |
Confirmation date | 2017-07-18 |
ICS | 03.100.70 : Management systems 11.020.01 : Quality and environmental management in health care |
Year | 2017 |
Document history | |
Country | USA |
Keyword | ANSI 90;ANSI/AAMI 90;90;ANSI/AAMI ST90-2017 |