Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by karenlin, Apr 8, 2016.
Every change notice required communication? How about typo error?
Typos normally don't require the full change control process and can be corrected directly on the Master original - as long as they don't change the meaning of the text. Proper control requires that the person making the correction signs and dates next to it. If additionally there is room for a full name (or at least initials) that could help keep track, otherwise the person can be identified through the signature register. When issuing the next formal revision the typos can be corrected in the print, but that's not urgent.
It depends what kind of error or typo, I would suggest to you to enter in Engineering Change notification all word that by mistake can change the meaning of the sentence (specially for a specific critical processes) .
I would notify by ECN any change that could be also an homonym/homophone/homograph word that actually change the meaning specially if was not well understood since the document implementation.
Some "Tipos" can be corrected without a notification if the meaning of the sentence does not change with the correction of the "typos" see my point?
Separate names with a comma.