Does BLE sniffer with correspond SW has the ISO9001?

[VadymS]

In our company developing medical devices only tool with ISO9001 can be used. Does the ISO9001 quality standard cover BLE sniffer with correspond SW?

[VadymS]

Thank you for your response.
Can i get and how can i get the Nordic response to our QA manager that the BLE sniffer developed and tested under the ISO9001. The BLE sniffer works with SW tools Wireshark and Python and these programs are integral part of the BLE sniffer. And you guarantee that the BLE Sniffer using these tools designed and work as expected according to quality compliance ISO9001.

[awneil]

You need to distinguish between things that are used purely for "indication", and things which are used for measurement.

For measurements & things that your design relies upon, you need things to be properly calibrated, etc.

For indication, you don't.

Your Quality Manual should have procedures on this.

I would strongly suspect that the BLE sniffer falls into the "for indication only" category.