Do I need to be certified to both ISO 13485 and ISO 9001 or just one?
Do I need to be certified to both ISO 13485 and ISO 9001 or just one?
Manufacturers of medical devices or in vitro diagnostics are required to be ISO 13485 certified. Some, however, choose to also obtain ISO 9001 certification. Other organizations may opt solely for ISO 9001.
Do I need to be certified to both ISO 13485 and ISO 9001 or just one?
Manufacturers of medical devices or in vitro diagnostics are required to be ISO 13485 certified. Some, however, choose to also obtain ISO 9001 certification. Other organizations may opt solely for ISO 9001.
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