What is the intent of the term "document" in ISO 13485:2016?


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The new ISO 13485:2016 defines the term "document" as establish, implement and maintain. Does anyone know the intent of this change?

This is confusing as FDA defines the term "establish" as define, document (in writing or electronically), and implement.


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Re: What is the intent of the term "document"?

The intent was to avoid the need to include the full "establish, implement and maintain" each time the standard required something to be documented.

Although the majority of the time this was accomplished without problems, there's some instances in which it creates confusion..
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