Periodically verifying revision levels of published standards

[MDRexpert]

Hello Everyone,

I was wondering if there is any guidance or requirements that states how often companies should assess and complete the assessment for changes to standards within?
Is there a timeframe? This is not for the standard timeline, this is for company timeline.
Example, a periodic review during management review will have the standards identified and tracked? But how is timeline assessed?


Thanks!

 

[Jim Wynne]

Are you asking about periodically verifying revision levels of published standards (ISO, ANSI, e.g.)?

 

[MDRexpert]

Are you asking about periodically verifying revision levels of published standards (ISO, ANSI, e.g.)?

Yes, Sir!

 

[Ed Panek]

We have a subscription and they remind us when a corrigendum or new release occurs. Our Risk-Based approach we review the changes immediately when it comes out and assign a score and letter to file/memo.

1) High risk to device or users or regulatory safety or performance - Immediate action required
2) Medium risk - begin a project to adjust to new requirements or during QMS updates/maintenance already on the schedule
3) Low rIsk - Address when new testing or development aligns with requirements

 

[Thee Bouyyy]

We have a subscription from Techstreet Enterprise. They are sending us the email as soon as any changes in specs/ standards. Once the notification arrives from Techstreet, we are calling Engineering Team, Quality Team, MR and Director to discuss this further in detailed. We are using the following form to implement the changes. This includes action plan, responsibility and target date of implementation. For us, this is the easiest method till now.