Of these documents which have to be Live Documents and which ones Records?

[QAMTY]

Hi all
Its a simple question, but I wonder how to manage
This issue.
Of these documents ,which have to be live documents and which ones records?

1. Excel master list of documents
2. Excel Master list of records
3. Yearly Excel audits program
4. Excel List and follow-up of risks (9001 2015)
5. Excel file of context and interested parties.

Please explain the reason which apply for each
document.

Thanks

 

[Ajit Basrur]

All becomes "documented information". What is the intent of your categorization ?

 

[QAMTY]

Thanks Ajit

I mean

which of them have to be kept as a record, signed and stored somewhere and which as live document (an excel file which changes frequently).
What is the criteria of an auditor for each type of document?
in which state should it be?



As example:

Excel master list of documents
Well is changing frequently, so is a live document
Excel Master list of records
Well is changing frequently, so is a live document

Yearly Excel audits program
should it be a record?, I mean a program once authorized in certain date and signed off? or an excel file

Excel List and follow-up of risks (9001 2015)
should it be a record? a list of risk detected at certan time?
or a live document changing frequently?

Excel file of context and interested parties.
should it be a record? a list of context and Interested parties detected at certan time?
or a live document which is changing frequently?

I hope is clear my explanation.

thanks

 

[Kronos147]

What does your documented procedure for control of documents say?

You design your system in a fashion to retain documented information of compliance. If you choose to call some documents "live" and some "records", that is your call to make.

 

[dwperron]

If it is a document you must go through the "Documented Information" process of Section 7.5. How you use and define them determines how to proceed:

You have a Master Documents List in Excel. If you designate the file to be the master document you will need to go through the document control processes on it. If you define a printed hardcopy of the Excel file to be the master document then it will need to go through document control.

Whatever method you choose for these "live" documents you will have to control the master so that you know what is the current revision.

 

[Johnnymo62]

This thread probably should be moved to the ISO 13485:2016 - Medical Device Quality Management Systems forum in case there are more specific requirements...

 

[Jim Wynne]

This thread probably should be moved to the ISO 13485:2016 - Medical Device Quality Management Systems forum in case there are more specific requirements...

Done. Several posts moved.