S
Cari,
TS clause 7.5.1.7 regards servicing, can I have simple explanation, if any of our components are non conforming and are returned to us and as a result of investigation we re-work the product and return to said customer is that not servicing? Where is the distinction between the definition of the word service which takes on a differrent context depending on use or am I having a middle age moment here.
Shallowmike
TS clause 7.5.1.7 regards servicing, can I have simple explanation, if any of our components are non conforming and are returned to us and as a result of investigation we re-work the product and return to said customer is that not servicing? Where is the distinction between the definition of the word service which takes on a differrent context depending on use or am I having a middle age moment here.
Shallowmike
Hello everyone...i need help on the service provision definition as well and I am hopng that this is still a germane topic for someone given the time that has passed since this conversation started. Lets begin with the the phrase "where servicing is a specified requirement", if the manufacturer of a device "specifies" that for the device to continue to provide its intended use, the device needs to be regularly serviced or serviced on request, these provisions apply under 21CFR820 and ISO 13485. It is defined in 21CFR206 that premature failure or breakage does not constitute servicing and as such is a good definition of what servicing is. Returns or requests for service where service is not a specified requirment are complaints and should be handled as such. Under the comlpaints investigation process, the device might still be repaired or replaced but not necessarily as part of a routine service program. If in agreement, i seek publications that defend this position. Best regards! QAW