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The understanding of the authorities' requirements is a prerequisite for correct execution of the specified guidelines.

ISO Requirements

The ISO guidelines 2001 and 13485 have significantly changed. Process orientated reasoning and knowledge management needs to be lived.

Anything, that is not written down, has not been done. This is the principle of quality assurance. It is required to describe each individual operation in detail according to the guidelines.

Are your individual operations simple and clearly described?
Do they correspond to the working steps of the employees?
Do your employees know the set operation procedures? Do you know the latest changes of the ISO guidelines and did you already implement them accordingly?

We generate the required documents and SOPs (Standard Operation Procedures) for you and also will take over the training of your co-workers.