Hi all;

We produce electronic circuit boards in very limited numbers (as in 10 units a year). All the soldering is done manually by (qualified) technicians.
We also are in the final phase of our ISO 13485 certification process and in our preliminary audit our consultant mentioned a validation is required soldering process since not all solders can verified.
We understand the reasoning behind this but we have no clue about how to tackle this since up until last week we never considered at soldering this way.
We'd appreciate a few pointers.

Thanks

Welcome to the Cove,

Soldering is always considered a special process and hence validation is required. I think you will gain more knowledge by reading through some previous discussions on the same subject. (http://Elsmar.com/Forums/search.php?do=process&titleonly=1&query=soldering+validation)

Hi

I have to say that the first thought I had after reading your post is - why don't day outsource these 10(!!!) units; the actions, you might need for doing it the right way at your company, may cost you more then have it done out of your company.

Is the soldering issue you're talking about is for a certified product or for development purposes?
If the first case is the caes, then...

Qualified employee (for soldering) must be IPC certified (and should maintain the certification).
If the related production file demends a control temperature for your soldering iron, then it should be calibrated (ISO13485...).
If your PCB is ESD based, then you got to have ESD environment, procedure/s etc...


Thanks, Arie

You can try to use IEC 62137 Ed. 1.0

For me it helped alot