Re: Need help
somnath,
The plant's process-based management system may be described in its Quality Manual. In other words the manual describes what is. Some manuals describe what shall be.
If this system conforms to ISO 9001, it's manual describes, or refers to a procedure that describes, the plant's evidence of using an improving its management system to determine and fulfill customer requirements.
The quality system record describes what actually happened. History in other words.
You have both the manual and the records already.
Make sure the plant's management system fulfills the U.S. FDA requirements by identifying processes missing from the system and any controls missing from its processes. Invest in putting these missing processes and controls in place.
The updated management system will then generate the evidence of conformity to the U.S. FDA requirements.
In other words it's about what the plant actually does not about what documents and records say what is and what was done.
John
