R
Hi All, 
I have been tasked to ensure we comply to ISO13485 clause 7.6 (as i look after the company calibration system), i have completed most of it, but am a little stuck on the part of the clause that states:-
'In addition, the organization shall assess and record tha validty of the previous measuring results when the equipment is found not to conform to requirements. the organization shall take appropriate action on the equipment and any product affected. records of the results of calibration and verification shall be maintained.'
so far we have managed to get all our calibration companies to amend their records so that they indicate if any adjustments were made to the equipment and also to supply us with the 'As received' results. so with this i know if anything was out of spec before handing back to the owner.
i gather this is not enough and i need to create some kind of document/record that proves we have assesed the 'risk' and determind that the out of tolerance results do or do-not have a negative impact on products that have already been manufactured or tested using the out of tolernace equipment? if this is the case i am a little stuck on what needs to be contained within this document / record as i have never been involved in any type of risk management in the past....... does anybody have an example of the form i need to use in order to satisfy this part of the standard.
TIA
Zla

I have been tasked to ensure we comply to ISO13485 clause 7.6 (as i look after the company calibration system), i have completed most of it, but am a little stuck on the part of the clause that states:-
'In addition, the organization shall assess and record tha validty of the previous measuring results when the equipment is found not to conform to requirements. the organization shall take appropriate action on the equipment and any product affected. records of the results of calibration and verification shall be maintained.'
so far we have managed to get all our calibration companies to amend their records so that they indicate if any adjustments were made to the equipment and also to supply us with the 'As received' results. so with this i know if anything was out of spec before handing back to the owner.
i gather this is not enough and i need to create some kind of document/record that proves we have assesed the 'risk' and determind that the out of tolerance results do or do-not have a negative impact on products that have already been manufactured or tested using the out of tolernace equipment? if this is the case i am a little stuck on what needs to be contained within this document / record as i have never been involved in any type of risk management in the past....... does anybody have an example of the form i need to use in order to satisfy this part of the standard.
TIA
Zla