ISO13485:2016 4.2.4 Control Of Documents - Lifetime of the Medical Device

qualityegghead

Lives from Inspector to Director of Quality
#1
The last paragraph of this clause indicates "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..." which appears to be setting a bar. It goes on: "but not less than the retention period of any resulting record" thus giving us parameters. Am I correct? Our record retention has always been (15) years for quality records unless otherwise specified by contract. We do have aerospace records for the life of the product +20 years but not for medical records. So my question is: as long as we require retention for the documents to which medical devices are manufactured and tested to be not less than (15) years and up to the life of the device, we are in compliance?

EDIT ADD: I answered my own question here.
 
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Marc

Hunkered Down for the Duration
Staff member
Admin
#2
It will be nice if you would kindly post what you found to help others.
 

qualityegghead

Lives from Inspector to Director of Quality
#3
The answer to what I was asking is, yes the organization has the requirement to require and state the retention period for product related documents (tests etc.) in a procedure. Since the minimum retention time per our procedure is 15 years, the subject records cannot be required to be retained for less than that period up to and including the life of the product. This is not new to the 2016 revision.
 
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