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Migrating to an ISO 13485:2016 Compliant Document Control System

G

gretzles

#1
I am implementing an ISO 13485:2016 quality system. The company has previously been accredited to 9001 but haven't renewed it for several years. There is a legacy of documents that were previously controlled and are being used. These documents use several different document code systems (acquired from merging companies etc).

I'd appreciate any suggestions on how to migrate the existing documents over to the new system. Should I create another doc code system or try to use one of the existing ones. How do I manage the progress while some documents are controlled and others may appear to be (they have a doc code) but aren't controlled.

I want to minimise the confusion to the document users as much as possible.
 
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Marc

Fully vaccinated are you?
Staff member
Admin
#2
The first question I have is what do you have at this point. Is it mostly paper, a mix of paper and electronic?

Is this one facility or do you have multiple locations?

I assume this is a manufacturing company - Is that a correct assumption?
 
G

gretzles

#3
It is a manufacturing company.
The documents used in production are paper, however there are lots of other electronic documents that have been given codes, but have been let loose in the wild of shared network drives.
There are multiple facilities, however the scope of the quality system is initially only for one site. There is a large product range with only a couple of medical devices to be manufactured at this one location.
 
M

medi12

#4
I think it depends on how the document code system is designed and whether you are able to identify all existing documents. There is no requirement regarding a document code system in the 13485 and it simply depends on YOUR requirements. So use the existing system if it is practicable/well established and you be able to identify all existing documents. If this is not the case, design a new Doc-Code-System.

Regarding your uncontrolled documents. The 13485 requires much more controlled document as the 9001, therefore it could be that currently uncontrolled documents must be controlled. It depends regarding all other docs. Either you need it internally and the staff must use these "uncontrolled" documents then I would control it to avoid any confusing.

Medi12
 

Marc

Fully vaccinated are you?
Staff member
Admin
#5
Document control isn't that big a deal with respect to the essential requirements. In medical devices, though, you will see more emphasis on reviews and approvals, electronic signatures and such (see medi12's post above, for example).

I would map out all the existing systems and make a plan which ties the existing plans together. If you believe there will be stability (no near term mergers, etc.) you should be able to make a plan.

What you will probably find is aspects such as budget restraints and such. That is, you may come up with a good system design which management will not fund (as an example). And, it may be that you can tie the systems together through a reference matrix.

The more details you give here, the more we can give our thoughts.

Do remember there is an entire forum on document control here which you can read through for thoughts.
 
G

gretzles

#6
I'm leaning towards starting a new system so I can give more meaningful codes (currently everything just gets a sequential number no matter what kind of document it is) and so I can easily identify the documents that are controlled.
 
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