Retention period of documents and records

M

MDRepair Canada

Starting to get Involved
Dear all,
New question regarding the QMS of a repair company and the retention period of documents and records. Considering we do not own the medical devices we repair, how can we determine the retention period of our quality records (audits reports, management reviews, NCs, etc.) if we do not know what is the lifetime of the MDs
Many thanks for your help!
Best regards,
 
S

Schkund

Involved In Discussions
Does the retention period of the documents necessarily need to last as long as the lifetime of the finished medical device that is being repaired? Is it a requirement of the standard that document retention last the entire life of the medical device, or could you keep it for a shorter amount of time with appropriate justification? (Not rhetorical questions, I'm genuinely curious).

I would think that the performance of a service/repair would not necessitate that you keep documents for the lifetime of the medical device itself (especially if you didn't manufacture the device); rather, it would simply be important to retain the documents long enough to ensure that the repair performed by your company was effective. I know that means that you then need to defend that definition... (how long does a repair company need to retain records in order to ensure that the repair is effective?), but once you can justify your company's answer to that question, you'll likely have much more consistent retention period.

Now I'm curious to hear more about this from the Elsmar experts!
 
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