Where to Document Exclusions per ISO 13485 and ISO 9001

[rick melton]

Hi Gang,

We are trying to decide where to document our exclusions per ISO 13485 and ISO 9000-2000.
We have a Corporate level Quality Manual. We have six divisions, however they are not the same as far as registrations. After saying all that, I guess my question is Do we document the exclusions in the Corporate Quality Manual (which would have to define each divisions requirements) or does each division document it at their levlel?

Any suggestions??

Rick

[Al Rosen]

Originally Posted by rick melton

Hi Gang,

We are trying to decide where to document our exclusions per ISO 13485 and ISO 9000-2000.
We have a Corporate level Quality Manual. We have six divisions, however they are not the same as far as registrations. After saying all that, I guess my question is Do we document the exclusions in the Corporate Quality Manual (which would have to define each divisions requirements) or does each division document it at their levlel?

Any suggestions??

Rick

Rick:

I think if your registering each division individiually, the exclusions would be at the division level. Does each division have its own Quality Manual? Does each division operate independently? Have its own products? Are all divisions in one facility? What makes sense to your operation?

[SteelWoman]

Agree with the above - if each division holds it's own certification, each should have it's own exclusion document. We also have multiple divisions and have one "corporate" dictated quality manual. Generic to cover ALL the divisions, so any specific info needs to be maintained at the local level.