ISO17025 Testing Laboratory Equipment Calibration Requirements

M

MaryMalin

#1

Our company is registered to ISO9001 and AS9100 with our TestLab also accredited to ISO17025. To date, all testing done by our lab has been on our product only – no external requests,submissions, orders. With respect to testand measurement equipment used in our Test Lab, it has basically been assigned to one of two groups. Group 1 is equipment used for tests that must comply with ISO17025 requirements, and group 2 is equipmentused for tests that are not required to comply with ISO17025 requirements. Consequently, calibration for group 1equipment is performed by an outside company that is accredited to ISO17025,while group 2 equipment is calibrated internally or by an appropriate external calibration house.

Does the ISO17025 standard require that all test and measurement equipment used in an ISO17025 accredited lab be calibrated in accordance with ISO17025, or can this be limited to only that equipment used for tests that must comply with ISO 17025?
 
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dwperron

Trusted Information Resource
#2
17025 requires that:

5.5.2 Equipment and its software used for testing, calibration and sampling shall be capable of achieving the accuracy required and shall comply with specifications relevant to the tests and/or calibrations concerned. Calibration programmes shall be established for key quantities or values of the instruments where these properties have a significant effect on the results. Before being placed into service, equipment (including that used for sampling) shall be calibrated or checked to establish that it meets the laboratory's specification requirements and complies with the relevant standard specifications. It shall be checked and/or calibrated before use (see 5.6).

The easiest way to comply with these requirements is to use equipment that has received 17025 accredited calibrations, they are assumed to comply with the requirements. These requirements are only for accredited tests performed under your scope of accreditation - what you do with the rest of your equipment does not fall under the requirements of 17025. You will need to be able to prove that only 17025 calibrated equipment is used on your accredited testing, but you are already doing that per the standard in order to show measurement traceability.
 
#4
Hello, I am endeavoring to attain ISO 17025 accreditation for our existing test lab. One question I have is this: if our current Quality system that has been ISO 9001 certified for years were to continue to conduct internal calibrations on our gauges using a piece of equipment that is traceable to NIST and is calibrated by a lab that is accredited to ISO 17025, will it suffice for our accreditation? Thanks in advance!
 

dwperron

Trusted Information Resource
#5
This question defies a simple answer.
Yes, if you are going to calibrate your gauges for 17025 you must use equipment that has 17025 accredited calibrations.
But that is not sufficient for meeting calibration requirements for 17025. If you are doing the calibrations your lab, and your quality organization and management, must also meet the full requirements of 17025. You need to become a 17025 accredited calibration lab in addition to being a 17025 test lab. All of your work needs to be covered by your scope of accreditation.
 
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