P
pangchiaboon
Hi all,
Base on ISO13485 "the organization shall retain the records for a period of time at least equivalent to the lifetime of the medical device as defined by the organization, but not less than 2 years from the date of the product release by the organization or as specified by relevant regulatory requirements".
We have defined the retention period for product related records to be retained for at least 55 years, including records of outsourced process for traceability in the future.
How about records generated by external monitoring and measuring equipment calibration / verification service provider? Normally calibration / verification service provide will issue us calibration / verification cert.
1. Is it the only record that we need to retain?
2. Do we need to request calibration / verification supplier to keep their other internal records for 55 years? I think ISO 17025 does not required calibration/verification service provider to keep the records for so long.
3. What is our industrial practice?
Please advise. Thank you.
Base on ISO13485 "the organization shall retain the records for a period of time at least equivalent to the lifetime of the medical device as defined by the organization, but not less than 2 years from the date of the product release by the organization or as specified by relevant regulatory requirements".
We have defined the retention period for product related records to be retained for at least 55 years, including records of outsourced process for traceability in the future.
How about records generated by external monitoring and measuring equipment calibration / verification service provider? Normally calibration / verification service provide will issue us calibration / verification cert.
1. Is it the only record that we need to retain?
2. Do we need to request calibration / verification supplier to keep their other internal records for 55 years? I think ISO 17025 does not required calibration/verification service provider to keep the records for so long.
3. What is our industrial practice?
Please advise. Thank you.