Document coding system
We recently started with the use of your toolkit to implement ISO13485.
I would like to get some advise about the use of document codes.
Procedures are suggested to be PR-XX
Record: PR-XX-Y (with XX the same as the corresponding procedure)
But how would you differentiate: forms, sheets, workinstructions, reports,...
In a previous company I used to work with SOP (standard operating procedures), WI (for workinstructions) , FORM (for forms and sheets), REP (for reports). This was ISO 15189.
Can you advise what could be a good document coding system for the different records?
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A coding system in our toolkit is just a suggestion. It means that you can use your own system however it suits you and how you feel you and your employees will do better. It is just necessary to ensure that current revision status of and changes to documentation are identified; that relevant versions of applicable documents are available at the point of use, and to that documents remain legible and readily identifiable.
If you would like to differentiate stated documents and records, you can use the system from your previous company. So, you can code your documents with SOP, WI, FORM, and REP and just add a number, or you can also add a department code. Here are some examples:
SOP-01 can be procedure for Document management, SOP-02 can be Internal audit procedure.SOP-Q-01 can be code for the first standard operating procedure for Quality department; SOP-SAL-01 can be first standard operating procedure in the Sales department.
This is only the suggestion.
For more details please see the following article:
- What are Common mistakes with ISO 13485:2016 documentation control and how to avoid them https://advisera.com/13485academy/blog/2018/03/14/common-mistakes-with-iso-134852016-documentation-control-and-how-to-avoid-them
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May 19, 2020