Coding records
I was hoping to get some more information in regards to the 3.1 Creation and identification of documents section in the Procedure for Document and Record Control.
There is a bullet that says:
Records are coded in the following way: [describe the organization’s standard practice].
To the best of my knowledge we have never “coded” any records in any particular way so I’m working on creating the logic for this.
The paper offers an example of adding a numerical number after the procedure’s document code but I’m not sure what I’m supposed to do with that record code after we’ve assigned it.
· Does that code need to be on the record?
· If so, how does that work with forms and their code?
o For example, say we have a procedure on logging non-conforming material. The procedure is coded “PR-001”, we have a form the employee needs to fill out coded “PR-001-F”, the employee fills it out and now it’s considered a “record” so what should the record be coded and does that now need to be written on the record itself?
· Also, how does that code need to appear on things that are run automatically like for example, backup logs? Do we just add that code to the file name of the backup?
I realize all of this is up to our discretion and I may be WAY overcomplicating this, but I’m drawing a blank on how to set it up.
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
You do not need to code records if it is not suitable for you. The point of the code is that you can differentiate your records. So any system that will allow you how to differentiate records is good. This way of coding in our documentation toolkit was just a suggestion, the way that we considered to be the best. But, do it as it is logical for you.
Your documentation must suit your company, organizational, and process needs
Considering the example from your question:
If you decide to you codes on the record, then one code will be for one type of the record. It means, that if you have a record PR-001-F, each time when your employee will use this form it will be written on it. It does not depend on the date of issue of that record or the content of the record. The code always stays the same. Some clients put that code in the header or footer.
Considering the records that run automatically like backup logs - yes you can add that code to the file name of the backup
More information about document management you can find on the following link:
- 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/
- How to structure Quality Management System documentation according to ISO 13485 https://advisera.com/13485academy/knowledgebase/how-to-structure-quality-management-system-documentation-according-to-iso-13485/
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Apr 02, 2021