Document control - ISO 13485:2003 - Obsolete controlled documents shall be retained?

J

jdipira7

#1
The standard states that the organization needs to define the period for which at least one copy of obsolete controlled documents shall be retained. Is this applicable to all quality management system documents or only those documents contained in the DMR and DHR?
 
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DannyK

Trusted Information Resource
#2
My interpretation is that it applies to all documents; not only those that are referenced in the DMR and DHR.

If you change your purchasing procedure, the obsolete copy should be retained for a period that you must define

Danny
 

Wes Bucey

Quite Involved in Discussions
#3
It also seems pretty clear that different documents or classes of documents can have different retention periods. The key seems to be in meeting customer and regulatory requirements as well as the "business purpose" requirements of the organization.
 
V

Vincnet

#4
During our last gap audit last week (sorry to put that in all my replies but I am proud of the result we got :eek: ) we had a remark (which would have been a NC in real life) because we did not stated clearly for each controlled document the retention period for obsolete documents (we were giving a duration in some SOPs but not in all of them). So not only the DMH and DHR

We agreed with the auditor on maintaining a matrix stating for each type of controlled ducument for how long we were keeping them. Simple easy and efficient.
If it works for a french auditor it might work for any (well I expect !)

V
 
W

wrodnigg

#5
Vincnet said:
If it works for a french auditor it might work for any (well I expect !)V
It would also work for an austrian auditor... ;)

I would say, there is no need to state a retention period for each (separate) document, but for all quality-related documents. It could be useful to divide them into groups and define the retention period for each group.

HTH,HAND~ghw
 
L

Linda W

#6
When I first started in QA I got a tip about using the matrix from an auditor and have used the matrix for years as my document that shows all records that are required by ISO-13485 (4.2.4) and FDA 820.180. The matrix lists is comprised of columns with these headings:
1 - records required for compliance,
2 - where they are stored,
3 - how they are protected,
4 - how they can be retrieved,
5 - retention time and disposition.

The document is titled "Control of Records." All those required records must be maintained at least equivalent to the lifetime of the medical device but not less than two years. MDD in Europe I believe requires minimum of 6 years.

Linda
 

Al Rosen

Staff member
Super Moderator
#8
liuyy said:
MDD requires minimum of 6 years,NOT 6 years.

liuyy
That's a minimum of 5 years after the manufacture of the last device. In the Medical Device Directive, annex II, it is specified in 6.1.
 
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