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Questions related to accreditation and calibration

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Guest user Created:   Feb 18, 2021 Last commented:   Feb 19, 2021

Questions related to accreditation and calibration

1. I have a question about achieving ISO 17025 accreditation for a specific lab at fixed premises. Once you attain accreditation for a lab can you also expand the accreditation to another premises? Would the lab tests being performed in the new premises have to be re-validated etc?

2. Another question regarding calibration due dates. Is it ok to write a calibration due date on a calibration cert for a device we have calibrated? Do we need to write a disclaimer saying the calibration interval is determined by the customer? I've seen this on a number of ISO17025-accredited certificates.

3. One last question, we use a subfraction of an ISO 12103-1 standard dust for calibrating our dust monitors. Does this material need to be tested (particle distribution) by an ISO 17025 accredited laboratory? we have a particle distribution from a non-accredited lab for the material. I am concerned that as we are using it as a reference material we would need to have an accredited certificate of the particle distribution.

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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 Feb 19, 2021

You asked

Once you attain accreditation for a lab can you also expand the accreditation to another premises? Would the lab tests being performed in the new premises have to be re-validated etc?

Accreditation is typically per site, so in that case each site would need a separate accreditation assessment. You could obviously share QMS documentation, but records , including MV would be required for each site. Alternatively, for some programmes the new premises could be accredited under a satellite program as falling under the quality management system of an accredited head office / reference laboratory. I suggest you confirm this with the particular accreditation body – it will depend on their policies and programme on offer.

You also asked

Is it ok to write a calibration due date on a calibration cert for a device we have calibrated? Do we need to write a disclaimer saying the calibration interval is determined by the customer? I've seen this on a number of ISO17025-accredited certificates.

It is not acceptable to specify a date and then state a waiver as described. ISO 17025 specifies that the calibration laboratory cannot document any recommendation on the calibration interval, unless agreed with the customer. This means if there is evidence of agreement, you can include the date. No waiver is applicable.

And you asked

we use a subfraction of an ISO 12103-1 standard dust for calibrating our dust monitors. Does this material need to be tested (particle distribution) by an ISO 17025 accredited laboratory? we have a particle distribution from a non-accredited lab for the material. I am concerned that as we are using it as a reference material we would need to have an accredited certificate of the particle distribution.

To answer this question ISO 17025 6.5 applies, as well as the policy of your accreditation body. As an example, see TPS 57 UKAS Policy on Selection and Use of Reference Materials (Edition 4, June 2020). Yes, you are right, as a calibration lab issuing a certificate with a reported measurement uncertainty, the material should ideally be certified to achieve that assurance. For example, in the UKAS TP57 they state UKAS recommends the use of accredited reference material producers and calibration laboratories where they exist. Basically, in a testing context this requirement may be less stringent as a testing lab would need to provide assurance that the results are traceable, along with a known Measurement uncertainty. This they in fact get from the calibration lab. The context is different if you are issuing a calibration certificate. I do suggest a call to your accreditation body to confirm this, before incurring additional costs. The link to TPS 57 is availabe form https://www.ukas.com/resources/publications/laboratory-accreditation/

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Feb 18, 2021

Feb 19, 2021