Controlled information versus defined documents / records

[James]

Hello all

I'm wondering to what extent I can rely on the existing types and sources of controlled information for my new 13485 system, rather than having to impose document/record templates across 4 departments which will follow the system?

For example, Is it acceptable to say that the information parameters defined on 'form A' must be maintained by all departments. Ideally they would use 'form A' and keep it as a record either electronically or in paper format. If one department translates 'form A' data fields onto a departmental system they are using, this meets the requirements. However, if they fail to record all of the information defined on 'form A', this is a non-conformity.

Essentially I want to define what information must be documented, but allow flexibility in how this is documented for each department because of their existing system differences.

Thoughts appreciated..

James

 

[Tagin]

ISO 13485 4.2.4 refers specifically to control of 'documents', not control of 'fields on documents'. You need to have controls in procedures for revisioning, approvals, storage, obsolescence, etc. for documents (i.e., 4.2.4a-h, and 4.2.5 for records). What you propose (specifying the required fields on documents) is merely addressing one small aspect of 4.2.4a ("adequacy").

 

[James]

ISO 13485 4.2.4 refers specifically to control of 'documents', not control of 'fields on documents'. You need to have controls in procedures for revisioning, approvals, storage, obsolescence, etc. for documents (i.e., 4.2.4a-h, and 4.2.5 for records). What you propose (specifying the required fields on documents) is merely addressing one small aspect of 4.2.4a ("adequacy").

4.2.4 states "documents required by the QMS shall be controlled"... Physical 'documents' dont exist because I'd argue that they aren't required. Information by way of records is required, and is entered into electronic systems, which is a central principle with developing paperless healthcare systems. Creating a physical 'document' to replicate and duplicate electronic system fields doesn't seem a good use of resources to me as it takes us in a backwards direction away from electronic systems.

Having checked ISO 9000, the definition of "document" states "The medium can be paper, magnetic, electronic or optical computer disc, photograph or master sample, or combination thereof".

I guess I need to work out a way of controlling the combination of electronic sources I'm thinking about


Cheers

James

 

[indubioush]

However, if they fail to record all of the information defined on 'form A', this is a non-conformity.

Not exactly true. You should allow certain fields to be not applicable if the same form is used for different situations. For these situations, the field will contain an "N/A." Your associated procedure should further clarify.