K
Katydid
Help!!! I just received a directive that I can't change. Per the owner, we will change our surveillance audit on September 26th from ISO9001:2000 to be a registration to ISO13485:2003. The managers here don't mind if we end up with some majors as long as at the end of the corrective action period we have the certificate to ISO13485:2003.
What would you do first? I found the Internal Quality Management System Audit Checklist (ISO 13485:2003/ISO 9001:2000) checklist in the links, but is there anything that might get me focused on the most critical areas first?
My biggest problem I forsee is that we do not employ Risk Management. Do we have to do this for all of our products, or can we do it on a broader scale?
Also, If you had the option, would you remove the continuous improvement and customer satisfaction from your system to make it easier, or if your system was working, would you just leave it.
Here is my general gameplan, any input would be appreciated:
1) Gap analysis (that's why I need a quick checklist)
2) Fill as many gaps as possible in next 3 weeks - Including changing quality
policy and objectives
3) Train, train, train for at least a week
4) Try to fit in an internal audit and a Management Review prior to
September 26th.
YIKES, can you tell this task has me on edge this afternoon. I just need some calming words and direction before I loose focus on the goal, a 6 1/2 week transition to ISO13485:2003. By the way, I ordered ISO13485, ISO14971, ISO TR 14969, and ISO 19011 today, but I am guessing I won't be able to digest it all before I need to start writing/implementing/auditing/ etc. our new system. HELP!!!
Thanks so much for listening!
What would you do first? I found the Internal Quality Management System Audit Checklist (ISO 13485:2003/ISO 9001:2000) checklist in the links, but is there anything that might get me focused on the most critical areas first?
My biggest problem I forsee is that we do not employ Risk Management. Do we have to do this for all of our products, or can we do it on a broader scale?
Also, If you had the option, would you remove the continuous improvement and customer satisfaction from your system to make it easier, or if your system was working, would you just leave it.
Here is my general gameplan, any input would be appreciated:
1) Gap analysis (that's why I need a quick checklist)
2) Fill as many gaps as possible in next 3 weeks - Including changing quality
policy and objectives
3) Train, train, train for at least a week
4) Try to fit in an internal audit and a Management Review prior to
September 26th.
YIKES, can you tell this task has me on edge this afternoon. I just need some calming words and direction before I loose focus on the goal, a 6 1/2 week transition to ISO13485:2003. By the way, I ordered ISO13485, ISO14971, ISO TR 14969, and ISO 19011 today, but I am guessing I won't be able to digest it all before I need to start writing/implementing/auditing/ etc. our new system. HELP!!!
Thanks so much for listening!