Document Retention Schedule Requirements per ISO 13485

E

EmbTech

Hello,
Now that itis the end of the year is near it is time for the Quality Report to be written. One problem.....We recieved a non comformity for not having a Document Retention Scheduel. I have gotten pretty far on this task but I according to ISO 13485 it seems that it does not have to be too indepth or too lengthy. I was wondering if anyone can has an example of a Document Retention Schedule.

Thanking you in advance.
 
G

George Weiss

Your requested schedule: Some parts would be generic, and some would be product specific.
You did not mention if you were a medical device MFTR, and what class of device, if so.
Including the FDA requirements would be a good listing.
Giving a hint as to your business might trigger a post, and a schedule attachment specific to your needs.
 
E

EmbTech

I'm sorry. Yes I do work for a medical supply company. We manufactuer class III Devices.
 

sagai

Quite Involved in Discussions
If I understood you correctly, last sentence in 4.2.3 states this requirement.
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Sz.
 
G

George Weiss

If I understood you correctly, last sentence in 4.2.3 states this requirement.
br
Sz.

I have some more stuff, and the 4.2.3 subclause:
Document retention begins with a DRP, (document retention policy). Examples @
http://www.abanet.org/lpm/lpt/articles/sampledocretentionpolicy.pdf
http://www.acfe.com/documents/sample-documents/sample_document_retention_policy.pdf
http://managementhelp.org/misc/Sample-Document-Retention-Destruction-Policy.pdf
Retention time for general company documents @
http://www.windes.com/images/pdfs/RecordRetentionGuidelines.pdf
retention times for medical devices from FDA 21 CFR 820.180 @
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.180
There is more specifics about types of documents at the FDA of course.
An internal audit checklist for your concern ISO 13485 4.2.3 @
http://www.isoxp.com/PrdResources/aqaFiles/ISO13ChkDemo.doc
ISO 13485 sub clause 4.2.3: Control of documents
[ This period shall ensure that documents to which medical devices have been manufactured and tested are available for at least the lifetime of the medical device as defined by the organization, but not less than the retention period of any resulting record (see 4.2.4), or as specified by relevant regulatory requirements.]
This last line above was mentioned by previous poster, SAGAI
Referenced from @
http://qualitymanagement.hrvinet.com/documentation-requirements-of-iso-13485/
Your question was about a document schedule requirements for ISO 13485.
The general requirements are guided by the standard ISO 1485.
The retention [TIMEs] are governed by all kinds of laws and regulations.
FDA has a blanket of device Life +2 years, and in some countries device life + 5 years.
I have not provided the actual list of FDA or other medical device records needing retention.
 
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