When must I inform the Notified Body of a change in my system, and do you do another audit?

In a Module D or D1 certification you have an ongoing obligation, this because it is required to operate an approved quality system. Such a quality system should be resistant to change and ensure continous operational compliance. This also means that you are subject to yearly surveillance on site.

Because of this fact you do not need to contact the Notified Body every single time something changes in your system, otherwise you would contact us pretty much every day to report a new version of a form or a new hire in the factory floor!). 

However what do you need to report? Certainly not every new version of every operational procedure, but if you alter your entire quality system or integrate a new factory there may be risks that fall outside of your existing certification, and these may be significant enough to first require Notified Body sign off. 

In some cases a new audit on-site will be required, in others it may be needed to submit documents which close any concern/issue. 

The general rule is as a starting point that as part of your QMS it is required to have a procedure/document where they appoint a member of staff who is responsible for the QMS and determine when they do (or dont) inform the Notified Body about changes to the quality system or issues encountered. These can include but are not limited to; 

• Integration of new production techniques not previously audited overhauling a significant part of production. 
• Altering the Quality system in a significant way that affects compliance with the regulation and which was not operationally tested. 
• Significant changes in methodology of monitoring (i.e. a new procedure for internal auditing)?
• Changes outside the scope of certification (new product types, locations e.t.c.) 

The above should be risk based, and are at the judgement of the manufacturer. Some may be imposed by us in the certification agreement. 

In case of a Module D1 certification for FPR, changes in technical documentation or new products are part of your scope as part of the quality system. If you want to add new products outside the scope this will automatically trigger a new audit. 

In case of Module D certification for DWD, changes in production methodology will trigger a new audit.