Records Retention period - Non OEM

[Julia Crabtree]

Hello,

I am quality manager for a company accredited to ISO 13485, however we are not a manufacturer.

We own, service, repair, loan out and sell anaesthetic vaporisers to hospitals and vet practices, these devices have a life span of 20++ years.

I am assuming that we need to keep all records of the devices service records and test records for 20++ years, even though these records are not related to the manufacturing but for the ongoing maintenance of the device per annum?

Anyone any experience in this?

Thank you for any help!

 

[Chrisx]

ISO 13485 requires the records be retained for the lifetime of the device and no less then 2-years. Your organization needs to define the lifetime. The ISO technical committee published a guide "ISO 13485:2016 medical devices a practical guide". It's probably worth buying a copy and reviewing the guidance to clauses 4.2.4 and 4.2.5 It has some good guidance on how this may be defined. It might be defined based upon the service life of the device or how long continued support is provided. However, you may also need to consider potential liability if a patient is injured after the records are disposed.

 

[Ed Panek]

If you have service possibilities on devices over perhaps 20 years, why would you throw out previous service records? This seems like a business decision to keep them indefinitely.