Would you advice to build the structure of the folders like you have provided (ex. 00 is the Procedure for Document and Record Control, the second is folder 01 the Project Plan, the next folder is the Quality Policy) or to have a structure that corresponds directly to ISO 13485 ex 4. Quality Management system, 5. Management responsibility, 6. Resource management etc) and store there the corresponding processes? What is more recommended for notified body audits?
As we now move towards an ISO 13485 QMS additional to our existing ISO 17025 and maybe more QMS will follow we face the problem that we are doing so far everything manually, print, sign scan etc. The more documents we have the more probable is that we will miss something. Any suggestions from your experience how to simplify this work or how companies with several QMS system deal with this problem? I have seen that you speak about Conformio, would this be a solution or other suggestions?
The structure of the folder is meant to give you a base to organize the QMS and to pr ovide you with an ease of accessibility and retrieval during the actual audit. So you can build the structure both ways depending on which suits you better in terms of organization and as long as you have the appropriate documentation in place to comply with ISO 13485.
Notified body does not usually meddle with how the company organizes the structure of the folders so it is only important that you can provide the documentation when being asked for it by the auditors.
Advisera has a platform known as Conformio which is a compliance implementation and maintenance platform that has a document management component that was purpose-built to support the certification process. It has a simple and user-friendly Document management system incorporated. You are able to upload, download, edit and delete your files, create new ones and sort them in folders which you can also add and manage. We will be happy to give you a tour if you are interested, please just let us know.