shruti_hiregange
Involved In Discussions
We have a major non-conformance to handle which is against a product's validation procedure issued in a continuous assessment in audit for ISO 13485. The procedure of sterilization is supposed to happen only at the customer end. And the non-conformance lies in the fact that we have not got the sterilization process validated. So we were asked to get that done from a laboratory that is accredited. After doing some good amount of searching we managed to find one lab which had the required facility to do the same. And has accreditation from NABL (National Accreditation Board for testing and Calibration Laboratories) in accordance with ISO/IEC 17025 for 'biological' and 'chemical' testing.
The same was conveyed to the auditor, he now asks if the scope for 'biological' and 'chemical' testing includes sterilization validation or not.
My question is this a standard requirement or is this a requirement particular to the body who's granted us ISO 13485? Because satisfying both the criteria's is something that's proving to be an uphill task here.
Please shed some light! Thanks!
The same was conveyed to the auditor, he now asks if the scope for 'biological' and 'chemical' testing includes sterilization validation or not.
My question is this a standard requirement or is this a requirement particular to the body who's granted us ISO 13485? Because satisfying both the criteria's is something that's proving to be an uphill task here.
Please shed some light! Thanks!