Identifying Changes and Revisions in QMS Documents - 4.2.3.c Requirements

Crusader

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#11
I used to have a change record within the procedure documents. Forms and work instructions never had that info - in the document.


Now, I use a review and approval form as a cover sheet for the marked up document that is routed for review. All changes are identified on the draft document and/or the cover R&A sheet. When the doc is released/published, it will not show any changes....avoids confusion.

This method has passed several ISO 9001:2008 audits. :D
 
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cgaro

#12
Hi ... I have a question if someone can help me. Can you tell me please where in ISO 9001:2008, 13485 and AS9100 does it speak about corrections to documents and white-out being prohibited for use?


Thanks so much!!
 
#13
Hi ... I have a question if someone can help me. Can you tell me please where in ISO 9001:2008, 13485 and AS9100 does it speak about corrections to documents and white-out being prohibited for use?


Thanks so much!!
Simple! It doesn't! As long as your own controls (procedure) doesn't prohibit them ISO 9001/AS9100 is mute on the subject.
 
#14
I don't have AS in front of me, but I can clearly state that neither ISO 9001, nor ISO 13485 have no such requirement. I am fairly certain that AS doe not prohibit the use of whiteout.

With that stated, customers and/or regulators may have requirements prohibiting whiteout or erasing. Over all, it probably is not a good idea. I see very little positive application in using whiteout in records. I think it would be better for my middle initial be wrong on a record, than someone using whiteout.
 
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