Both, it depends on how you purchased the standard.
The good thing is that you did not approach for the role, you were approached so that is a good sign. Congragualtion @Colin Pitman on your new...
ISO 9001 8.5.1 B) the availability and use of suitable monitoring and measuring resources. ISO 9001 8.5.1 e) the appointment of competent persons...
Do you manage manual good received number for all your raw materials? I presume you have the batch number too that is allocated at the time of...
Agree with you. It doesn't matter what language, the principle of the ISO would be same. Can't you request for a different auditor who knows your...
If there is a change in following criteria, then you need to re-register the device. Manufacturer name changes Sponsor name changes Class of...
I do not think any regulation available related to RFID in Australia and New Zealand.
Or you can put as available for 'particular market only'
I believe that it is not a mandatory requirement, But you need to make sure that they can supply products as per your specifications and you have...
ISO 14155:2011:Clinical investigation of medical devices for human subjects -- Good clinical practice
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