W
Working for a Medical Device company that designs, manufactures, and distributes devices throughout the world, there are 4 key standards requirements that need to be compliant to as of today anyways.
Does anyone know of or have an example of how to show our notified bodies audits are being performed according to ISO 13485: 1996/2003, FDA QSR requirements, Canadian Medical Device Requirements (CMDR), and the Medical Device Directives (MDD)?.
I have read the threads and seen the matrices of some of the mentioned standards. I did not find one that incorporated all of them.
Even with a matrix, how does one use the matrix to show the systems are audited in accordance. Is it simply stating it in the Audit scope/plan? Is it a matter of showing the matrix to the external auditors? Please advise
I understand how useful to show the differences and similarities across the regs, but how are you suppose to incorporate that into the auditing process?
Much of the regs overlap so conducting another audit with new regs is not going to have any different results.
Thanks in advance
Does anyone know of or have an example of how to show our notified bodies audits are being performed according to ISO 13485: 1996/2003, FDA QSR requirements, Canadian Medical Device Requirements (CMDR), and the Medical Device Directives (MDD)?.
I have read the threads and seen the matrices of some of the mentioned standards. I did not find one that incorporated all of them.
Even with a matrix, how does one use the matrix to show the systems are audited in accordance. Is it simply stating it in the Audit scope/plan? Is it a matter of showing the matrix to the external auditors? Please advise
I understand how useful to show the differences and similarities across the regs, but how are you suppose to incorporate that into the auditing process?
Much of the regs overlap so conducting another audit with new regs is not going to have any different results.
Thanks in advance