Hi Sam, interesting that you find this "review".
The next line of thought is not directed at you, but at all of us in the QA/RA business.
Experiences with all NB's show that the workload is through the roof. Increased scrutiny of their Competent Authorities (competent by definition..., not hindered by any knowledge on how industry really works), Impact of the joint audits as part of the Dali plan (ancient history - o, no, only 6-7 years ago) --> less NB's, increase qualification requirements, etc etc.
We can all go on and fill in more details here...
As industry, we can also take another point of view and need to realize that we do need their services. How can we ensure that the reduced resources they (NB's) have available, are used more effectively?
Ok, I will give a potential answer: By implementing processes that result in demonstrably compliant dossiers and QMS's. And make that not only the QA/RA responsibility, but the complete company. Don't sent in dossiers that still require addition information or take the approach "let's give it a shot". That's waisting time.
"But management wants us to submit, because we (= Sales/marketing) have already announced this product is almost CE certified". Don't tell me you never heard that before...
If you show your NB that you stick to their timelines, they will stick to yours. And yes, right now, communications can be improved. But not only from the side of NB's...
Easy said, I know, when you have at least found a Notified Body. There still are some accepting clients. Put in the effort to find them. An email to the
[email protected] will typically not result in any response.
Concluding, all, stay positive, explain to management why more time is needed and continue to work your magic. Internally and towards NB's.
Regardless of how they can be a pain in the A.S.S., we need them. Hopefully they need us too...
