Unique Document Identification Numbering System

[Wolf.K]

Hi folks,

I just wonder, if anyone can give some new input on this topic? I have been working with ISO 13485 for several years, and the QMS was quite straight forward, as we just copied the chapter numbering of this standard (which is similar to 9001). But now I am working at another place, without QMS requirements, but would like to introduce a numbering scheme to the documentation. But not just for 9001, but for all processes. It should be a simple system suitable for small companies as well as for international corporations - that means, it should be capable to provide a logical numbering for all processes any company can have. Is there something like that out in the wild?

Truly yours
Wolf

 

[Miner]

Does an existing document management system (DMS) exist that can be leveraged for what you intend to accomplish? Some ERP systems, such as SAP, have a DMS built in. Documents do not need an intelligent numbering system given how easy it is to search for keywords. If you do go with an intelligent numbering system, build it around your existing processes, not around the standards. Standards can change often abruptly. Processes evolve, usually slowly.

 

[Randy]

Do whatever you want in a way that works for you. Somebody like an auditor doesn't like it, toss 'em out the door.

Just control the process and get everyone internal to understand it.

It isn't anyone else's business unless they've got skin in the game or $$$$.

 

[FRA 2 FDA]

The answer really lies in what you want the numbering scheme to accomplish. For us, we have a VERY simple system. Our documents are divided into FRM, LST, SYS, TMP, WI and DWG for form, list, SOP (I know, SYS should be SOP but I inherited it that way and never needed to go through the pain of changing it), work instruction and drawing. Then each gets a 3 digit number in sequential order. That's it. No long, complicated system to link a form to it's parent document or to the clause of a standard or to its release date or any other extraneous info. The numbering system serves only to help divide out types of documents from one another, to help group them together in lists or in folders and to be an abbreviated way to refer to the document elsewhere (rather than typing out Complaint Handling and Customer Feedback Process, we can just put SYS-018). It is useful for us. Otherwise, the parent documents call out their related forms etc and those documents mostly reference the parent document so we don't need to link them by a numbering scheme. When we save them, we save them with useful titles ie: SYS-001 Document Control Procedure, so that is how people find what they are looking for. If it's a document you use all the time, you probably know it's the first in the list or about two-thirds of the way down and it always will be because of the numbering but you don't need to know that to find it.