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.

[Joakim Jakobsen]

Hi.

I assume the answer is no, but I'll forward your question internally and ask our developers.

Best regards,
Joakim

[Joakim Jakobsen]

Got some information about this internally, and Nordic Semiconductor is ISO9001 certified as an organization. ISO9001 doesn't directly have anything to do with SW development or certification, but it just means that Nordic has defined processes and procedures for everything we do, and that is verified by internal and external auditing. So our software development process is part of our ISO 9001 process for managing the company.