K
Hello,
I am a little overwhelmed. We will be audited (ISO 13485) the first week of January.This is our 3rd audit. I have had the responsibility of regulatory documents since Sept of this year. I am still trying to get things in order but feel like I have barely scratched the surface.
I have a lot to change, revise, update and/or totally redo with our quality manual. Although I have received notice outlining the areas of the audit I am finding it difficult to just "fix" those areas because they obviously relate to other sections in the quality manual.
Can anyone guide me on how to deal with the audit?
Also, the people before me had a "master copy" of the manual and a "working copy", both are exactly the same with all documents being stamped as "control documents". Can someone explain what is the purpose of the "working copy"?
Thank you in advance,
Katrina
I am a little overwhelmed. We will be audited (ISO 13485) the first week of January.This is our 3rd audit. I have had the responsibility of regulatory documents since Sept of this year. I am still trying to get things in order but feel like I have barely scratched the surface.
I have a lot to change, revise, update and/or totally redo with our quality manual. Although I have received notice outlining the areas of the audit I am finding it difficult to just "fix" those areas because they obviously relate to other sections in the quality manual.
Can anyone guide me on how to deal with the audit?
Also, the people before me had a "master copy" of the manual and a "working copy", both are exactly the same with all documents being stamped as "control documents". Can someone explain what is the purpose of the "working copy"?
Thank you in advance,
Katrina
You can only get done what you can get done!