About 7.6.3.2 External Laboratory - Calibration by Manufacturer

P

pfumvue - 2005

#1
Dear all,

Form description on 7.6.3.2, it means the external lab must satisfy the following:
(1) There shall be evidence that the external laboratory is acceptable to the customer, or
(2) The laboratory shall be accredited to ISO/IEC 17025 or national equivalent.
(3) When a qualified laboratory is not available for a given piece of equipment, calibration services may be performed by the equipment manufacturer.

I've some questions,
(a) Can our organization send equipment/working standard to equipment manufacturer rather than accredited lab? (Our organization will ensure that the requirements listed in 7.6.3.1 have been met.)
(b) Can our organization send equipment/working standard to one site which not satisfy (1)~(3)? (Our organization will ensure that the requirements listed in 7.6.3.1 have been met.) (ex: One lab has some items accredited to ISO/IEC 17025 or national equivalent, but other items(we need) may not be accredited. Can our organization send equipment/working standard to this site to calibrate/test?)

Thank you, in advance, for any help.

Annie
 
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D

D.Scott

#2
Annie - The quick answer to both questions is no.
(a) If there is an accredited lab having the calibration in its scope, you must use the lab and not the manufactuer. If the manufacturer was also accredited to 17025 then you could use the manufacturer. Only in a case where there is no accredited lab available to do the calibration are you allowed to use the manufacturer.
(b) The external lab must have the specific test/calibration listed in their scope. They must either get it added to their scope or you must find another lab to do the work.
Please note - when the standard states "acceptable to the customer" it means YOUR customer, not theirs. All of your customers who are affected by the equipment must give you approval to use a non-accredited lab.

Dave
 
P

pfumvue - 2005

#3
Thanks for Dave's reply.

Besides,I've some relative questions as follows,
(1) When we want to ensure the requirements listed in 7.6.3.1 have been met for equipment manufacturer, how do we check the item of "testing of the product" for manufacturer ?

(2) From 7.6.3.2-NOTE 2, it means that only "calibration" services may be performed by the equipment manufacturer, so inspection or test services just can send External/commercial/independent laboratory which is accredited to ISO/IEC 17025/national equivalent or acceptable to the customer ?

Thanks a lot.

Annie
 
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