Document Index

contigo123

Involved In Discussions
#1
Hello,
We are a medical device company following ISO 13485 and currently maintain our documents on paper (active and obsolete versions). We also keep a master index at the front of the filing cabinet that lists the document names, revision numbers, and revision dates. This index gets updated whenever an SOP is revised. My question is: do we need to keep old versions of the master index? Other than a nice to have snapshot of what document revisions were in place on a given day, is there a requirement to keep the obsolete index?
Thank you
 
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indubioush

Quite Involved in Discussions
#2
Is the index value added for your organization? There is no requirement in ISO 13485 that you keep a separate index with revision numbers and revision dates. The documents themselves show the revision and date (or reference to change order), correct? Do you also have a change order log and/or a training matrix that shows the same information?

If you have an SOP that that specifically calls out the index record, then yes, you should keep those records. But again, I'm not sure what this index does for you. How do you use it?
 

contigo123

Involved In Discussions
#3
Is the index value added for your organization? There is no requirement in ISO 13485 that you keep a separate index with revision numbers and revision dates. The documents themselves show the revision and date (or reference to change order), correct? Do you also have a change order log and/or a training matrix that shows the same information?

If you have an SOP that that specifically calls out the index record, then yes, you should keep those records. But again, I'm not sure what this index does for you. How do you use it?
Thanks, the index just helps when we have audits, etc, so that we can show a list of current procedures. Your suggestion that maybe we don't need the revision numbers/dates is valid, perhaps we remove those and then just keep the list of documents. And our SOP just says that an index is created, but no indication of retention. I think we can probably do away with the old rev's...
 

Thee Bouyyy

Multiple Personalities
#5
Hello,
We are a medical device company following ISO 13485 and currently maintain our documents on paper (active and obsolete versions). We also keep a master index at the front of the filing cabinet that lists the document names, revision numbers, and revision dates. This index gets updated whenever an SOP is revised. My question is: do we need to keep old versions of the master index? Other than a nice to have snapshot of what document revisions were in place on a given day, is there a requirement to keep the obsolete index?
Thank you
There aren't any criteria for this. I recommend that you simply keep track of the most recent ones. It will assist you in recognising SOP overviews. There is no need to keep track of the obsolete one since it would cause confusion.

Also, if you haven't written about it in your SOP, I recommend that you don't generate unnecessary papers if they won't provide any value to your organisation.
 

pbojsen

Involved In Discussions
#6
Hi. Actual Doc Control person here. Have done this for MANY years.

1. The Master Document Register is usually maintained in an Excel spreadsheet, password protected, that anyone can view, but only Doc Control can revise. Doctypes are kept on different tabs by doc number.

2. While it is not a requirement to have a Master Document Register, how are you going to know what documents are controlled and which are not without one? Controlled documents should be in the MDR, and nothing else.

3. The Master Document Register itself is not a revision controlled document, it is a living document that has access controlled. Our group updates it every day so change control on it would be burdensome.

4. 13485 requires that you keep Obsolete copies. 4.2.4 Control of documents, last paragraph of the standard "The organization shall define the period for which at least one copy of obsolete documents shall be retained. . . . . at least the lifetime of the medical device as defined by the organization, but not less than the retention period of any resulting record, or as specified by applicable regulatory requirements."

5. When auditors as for the MDR, we go into the spreadsheet to the QMS SOPs, filter to the active SOPs (no Obsoletes, no Drafts) and give them the doc number, revision, Title, date released, and change order number, all of which is in the Master Document Register

Hope this helps.
 
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