The Documentation of Data Analysis for an ISO 13485 Medical Device Submission

[SteveK]

In Reply to Parent Post by Ginnie

Hi everyone,

I'm back with more questions. The auditor said that our audit procedure is too vague, it is only 2 pages. I'm to rewrite the procedure and I'm not sure where to begin or where I can find examples. I would greatly appreciate any information that I can obtain.

With much graditude for finding this web site.

Ginnie

Hi Ginnie,

My Internal Audit SOP is only 3 pages (of text) and I've not had any issues with our NB. I've attached a copy (it obviously references other 'Acme' documents).

I hope this helps.

Steve

[Ginnie]

Thanks so much. I'm so happy to have found this web site. It is such a competitive and fast paced world you cannot find any mentors to help a new bee.
Again much appreciation,
Ginnie