Hello Cove People,
Hoping I can get some advice on implementing our system from ISO 9001 to 13485 - A little background on our company is that we are a plastics manufacturer mainly focused on medical compounds. We do NOT make medical devices, we just make the plastic pellets that eventually become the medical devices (i.e. catheters)
Now, I understand I can exclude anything in section 7 of the standard as long as I have a good reason.
I was going to exlude clause 7.5.3.2.2 Particular requirements for active implantable medical devices and implantable medical devices This clause basically states that we will have records regarding materials used and environment conditions. And it states that our distributors (truck deliver vendors) are to maintain records of when and where they deliver our product.
Although we technically already have this clause covered, I was going to exclude it mainly because, again, we do NOT make medical devices, just the material that eventually becomes the medical device.
Now I have come across this clause: 8.2.4.2 Particular requirements for active implantable medical devices and implantable medical devices "The organization shall record the indentity of personnel performing any inspection or testing."
Again, we have this covered and would adhere to this requirement. I am just a little confused because I would think I would either have to include or exclude both, not just one. And of course, I don't think that I can exclude anything besides a requirement in section 7.
So should I just include both, even though the title of the clause states implantable devices, even though we do NOT make devices?
Thanks for any help!!!
Nikki
Hoping I can get some advice on implementing our system from ISO 9001 to 13485 - A little background on our company is that we are a plastics manufacturer mainly focused on medical compounds. We do NOT make medical devices, we just make the plastic pellets that eventually become the medical devices (i.e. catheters)
Now, I understand I can exclude anything in section 7 of the standard as long as I have a good reason.
I was going to exlude clause 7.5.3.2.2 Particular requirements for active implantable medical devices and implantable medical devices This clause basically states that we will have records regarding materials used and environment conditions. And it states that our distributors (truck deliver vendors) are to maintain records of when and where they deliver our product.
Although we technically already have this clause covered, I was going to exclude it mainly because, again, we do NOT make medical devices, just the material that eventually becomes the medical device.
Now I have come across this clause: 8.2.4.2 Particular requirements for active implantable medical devices and implantable medical devices "The organization shall record the indentity of personnel performing any inspection or testing."
Again, we have this covered and would adhere to this requirement. I am just a little confused because I would think I would either have to include or exclude both, not just one. And of course, I don't think that I can exclude anything besides a requirement in section 7.
So should I just include both, even though the title of the clause states implantable devices, even though we do NOT make devices?
Thanks for any help!!!
Nikki
