In the iso 14001 EMS there is a section about communication within the company. However in the iso 13485 toolkit there is no such procedure or document. Why is this?. We have our audit on Monday, and one point within iso 13485 is about communication. How should I think here?
In ISO 13485:2016 there are no requirements that communication within the company must have documented procedure. In requirement 5.5.3 Internal communication is stated that top management must ensure that appropriate communication within the company must be established.
In our toolkit, internal communication is mentioned in the Quality Manual, chapter 5.5.3 Internal communication. In the comment, you can see that we put “Adapt to organization practice”. Here you can describe whether you have bulletin boards, what information is placed and communicated on these powerful boards, whether you have a policy until when emails may be sent during the day, how quickly you need to respond to an e-mail, how important paper information travel around the company etc.