Documents Control for ISO 9001
We are a ISO 9001:2000 certified software house. I have following queries w.r.t the Document and Record control procedure in ISO.
1)Our procedure say that our all document are in softcopy in document management system. But as times goes we realize that hardcopy must be required of the same document as well as soft copy, like hard copy form of Detail Design document is required for the coding purpose and same is the cause for other hardcopy form. As far as soft copy is concerned they are of course controlled copy. But how we control hard copies ?.
2)What we decide that make all hardcopies form as uncontrolled document by stamping manually “uncontrolled” and also enter the relevant informations in document recall form which help us to trace which copy of specific document hold by whom. But this way also doesn’t work as people get bother with this process of stamping “uncontrolled” and to let enter the relevant information. Here stamping “uncontrolled” save us from documents being misused or taken along with employees to their home as these are supposed to be out of our QMS security/control scope.
3)If the process of stamping “ uncontrolled” is avoided then how to ensure that the document are controlled and secure because it is difficult to watch out for each and every member what they are taking and what they are not. ( it may possible in NASA but not in our company).
help me how to solve this problem and how u implement this procedure of Documents and Records control in their respective software houses.
Re: Documents Control for ISO 9001
This is what I did:
1) You have documented where controlled copies exist. It is someone's responsibility to own those copies and to update them when they are provided with updates. No owner, no updates. This process is randomly audited to make sure updates replace outdated material in a tmiely way. Alternatively, it could be someone's job to go and update all controlled copies as necessary. Each binder or other means of holding this documentation is numbered and this is also contained in the document of controlled copies. If a controlled copy is lost that fact is noted in the list and a new controlled copy can be released with a new number after an inquiry as to how the first one got lost. This way if the first one ever shows back up and somehow or other ends up being used, your normal process should catch any non-compliant activity, corrective action would follow, and the source (being the documentation) would be removed.
2) If someone wants an uncontrolled copy, let them have it. But yes, stamp each page of the document. This needs to be part of the procedure you have for document management regarding release of uncontrolled copies. An example of this would be a company you are a supplier for that wants to review your documentation before an audit. Because they are uncontrolled they are not worth recording, IMO, but your process may dictate otherwise.
3) This no longer applies, based on my response to #s 1 and 2.