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

SGquality

Quite Involved in Discussions
#1
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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Marcelo

Inactive Registered Visitor
#2
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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