Device operating procedures
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Must the operating procedures for the device be in a bound version? Can it be bound in a loose-leaf format? Is there any regulatory standard as a basis?
There are no mandatory requirements in this regard; our standard operation manuals are not bound in hard cover – they are printed on paper and kept on site. However, for some critical operations or the procedure guidelines for specific positions, these are posted on site.
Our company binds everything by ourselves
Is there a requirement that the operating procedures cannot be bound in loose-leaf format but must be bound with glue, to prevent unauthorized modifications?
Our company uses paper versions that are posted on site!