wooden nickle
Involved In Discussions
Is it necessary to rev a document when obsoleting it?
Is it necessary to rev a document when obsoleting it?
I believe ISO 13485 is telling us differently in clause 4.2.3 Control of Documents;
"The organization shall ensure that changes to documents are reviewed and approved either by the original approving function or another designated function which has access to pertinent background information upon which to base its decisions".
I believe that to obsolete a document without the originators approval is contrary to the standard. Obsoleting a document is definitely changing it, there may be ramifications the Quality System Coordinator is not aware of. All original reviewers should be in agreement that the document needs to be obsoleted.
Thank you Jim, but isn't it true that the only way you can document the approval to obsolete the document of all the signers of the document is through rev control.