Does a FMEA need to fall into the ISO Documentation?

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#13
... simply ask yourself do we need to ensure this information, whatever it is, is kept up to date and everyone has the latest copy ...
This goes back to the standard 4.2.1 d) You need to control those "documents needed by the organization to the effective planning, operation and control of its processes". If you look at an FMEA as only a record, then control it as a record. If you use the FMEA to plan, operate or control your process(es), then control it as a document.
 
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