Does anyone have an example of a procedure for determining a critical supplier and an example of a Quality Agreement that would be used for different types of Critical Suppliers.
I would think a Quality Agreement for a component supplier would be different than a supplier of services or for an...
I'm a trainee in regulatiuon and quality management system. I'm asked to do the clinical evaluation for a medical device
Does any one have an exemple or template of (regarding to the recommendation of the Meddev 2.7/1 révision 4 and new EU regulation) :
- a clinical investigation...
I am new at creating documents and Iam very lost. We are being audited to the new standard and we do not have a Product Safety procedure written. Because of the nature of our business, we do not have any products that fall in this category at the moment. Does anyone have a procedure we...
We have a calibration recall system in place. Sometimes, personnel are unable to locate the gages on recall and they are presumed lost until they turn up. Of course they do not always turn up.
How should I address lost gages in the recall.
Does anyone have a lost gage procedure?
I was just...
HI, I need just to somebody explain me about procedure Design and Development according to AS9100D?
I just start to write procedure for whole company. We are small company, and here on std. part 8.3 Im block :D.
For design and development I need document for planing?
That document must be...
I am in the process of creating FMEA for all the process in CNC manufacturing like production/planning, QA, receiving, shipping, purchasing, sales/quotation, accounting, health & safety. Please advise where I can find samples related to all above processes.
I am seeking examples of Corrective Action Processes in the form of procedures or process maps or other formats. I downloaded some examples from the web and Elsmar. Just wanted to put up a request looking for any new examples.