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Compliance

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Guest user Created:   Oct 19, 2021 Last commented:   Oct 23, 2021

Compliance

We manufacture a Streaming Current detector and calibrate using a 100ppm solution of a 50% solids polyamine. How can we comply with this code?
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ISO 17025 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 17025 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Tracey Evans Oct 20, 2021

I assume when you say comply with this code, you are referring to implementing and becoming accredited to ISO/IEC 17025.

If you wish to calibrate the devices you manufacture before release and perform accredited calibrations for clients on an ongoing basis, you should apply for accreditation as a calibration laboratory. This involves purchasing the Standard and initiating an Implementation Project. Implementation involves putting into place all the mandatory management and technical  processes and procedures, along with establishing documents such as a quality manual, procedures, and forms. ISO 17025 guides you on monitoring and evaluation activities such as internal audits. When the audit process and management review indicate, through objective evidence, that the laboratory has effectively implemented ISO 17025, you can apply for accreditation. 

To assist you, Advisera provides free resources such as whitepapers, webinars that you can access for further information. Here is the link: https://advisera.com/17025academy/free-downloads/

Then  have a look at the ISO 17025 Toolkit preview and implementation support options at https://advisera.com/17025academy/iso-17025-documentation-toolkit/ The toolkit may be a solution to assist you with implementation.

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Guest user Oct 21, 2021

Thanks for the response.  It seems we will have to comply fully with the standard as we do calibrations for our customers and the cost to outsource the calibration for the units sent back to us would be expensive.  We also do calibrations in the field when the client requires us to go to site, so our procedures would have to include that as well.  Do you have an idea of the audit costs to become accredited?  I will be discussing this accreditation with my colleagues and no doubt we will be getting back to you.  Mu biggest concern is how to relate our measurements back to an SI unit.

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Tracey Evans Oct 23, 2021

If there are certified calibrators for the test method then you could provide the traceability that way. 

I suggest you contact the national accreditation body or preferred accreditation body and discuss what programme your work would fall under. Then you will know if you need to address traceabilty as a calibration test (i.e calibration lab) or equipment performance test (i.e a testing lab). At the same time, the accreditation body will be able to provide an estimate of the costs to apply for accreditation.

Then regarding your implementation costs, they will depend on your scope of work and whether you use a consultant or a toolkit. For more information have a look at my response to a similar question regrding costs; at https://community.advisera.com/topic/iso-17025-accreditation-2/. There are number of links there to assist with further.

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Oct 19, 2021

Oct 23, 2021