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ISO 14001 communication procedure lacking in ISO 13485

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Guest user Created:   Oct 07, 2021 Last commented:   Oct 08, 2021

ISO 14001 communication procedure lacking in ISO 13485

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?

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Oct 08, 2021


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.

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Oct 07, 2021

Oct 08, 2021