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Hello, I have posted before and am trying to use th ecorrect area this time.
We are a medium sized machine shop that makes automotive machines and tooling for the machines, currently ISO 9001-2000 certified.
We have th eopportunity to make some medical part and one customer requests we get ISO 13485 to do this,.
I have templates of all the required procedures, but have some major confusion...
Is we go 13485, does everyting we do fall under the 13485, like our machines ans such? Can we run two systems, one for our automotive and one for medical.
I see that we need device history files and device master records. Can these be lumped in to one file?? We presently keep machine folders and tooling forlders, and I was hoping we could just add medical parts folders.
we will only be making parts for devices, not complete devices. No sterilization and so forth. Do we have to fulfill all the requirements and have procedures if we are not doing that, or just use exclusions?
please advise, thanks,,,,you guys and gals ROCK..
We are a medium sized machine shop that makes automotive machines and tooling for the machines, currently ISO 9001-2000 certified.
We have th eopportunity to make some medical part and one customer requests we get ISO 13485 to do this,.
I have templates of all the required procedures, but have some major confusion...
Is we go 13485, does everyting we do fall under the 13485, like our machines ans such? Can we run two systems, one for our automotive and one for medical.
I see that we need device history files and device master records. Can these be lumped in to one file?? We presently keep machine folders and tooling forlders, and I was hoping we could just add medical parts folders.
we will only be making parts for devices, not complete devices. No sterilization and so forth. Do we have to fulfill all the requirements and have procedures if we are not doing that, or just use exclusions?
please advise, thanks,,,,you guys and gals ROCK..
