The factory inspection will take place over one or two days, during which we evaluate the QA system:
1) Overall evaluation of the quality organisation and quality system
2) Inspection of the production line
3) Evaluation of internal test results

Usually there will be time left during the inspection to have a discussion of general points, e.g. standardisation, market development, test methods, etc.

The requirements are:
The manufacturer must have a quality organisation that is independent of the production and development
The quality system must be fully implemented and well documented
The manufacturer must be capable of measuring critical technical parameters with relevant test instrumentation that is calibrated
An adequate process control system must be part of the quality system