M
A chemical testing laboratory has listed on its A2LA Scope of Accreditation, several methods for ICP-MS. The method has validated standard detection limits for all of these methods. However, they also have, in the same written SOP, low level and ultra low level detection limits. The low level and ultra low level detection limits are not validated.
The laboratory uses an "ISO 17025" and a "non-ISO" report format for its results. The ISO 17025 report format does NOT contain the use of the A2LA symbol or make any reference to accreditation, but it does contain all elements, as required by the ISO 17025:2005 standard, including the method number. This method number directly corresponds to the same method number on their Scope of Accreditation.
I initially wrote a nonconformance on an internal audit. My nonconformance was that:
My thought being that a client, who pulls the Scope of Accreditation while looking at their test report (which states the method number) would incorrectly assume it was covered under the Accreditation.
Does everyone agree that this is a nonconformance? If so, what clause of the standard? Also, what would be a good corrective action? We have considered separating the low level detection limit methods from the standard level detection limits methods and also have considered a "deviation" on the final report. Any thoughts? Now, I am having second thoughts. The laboratory has been accredited for several years and has gone through three different assessors. This has not been noted as a problem in any audit.
Thanks for any help!
The laboratory uses an "ISO 17025" and a "non-ISO" report format for its results. The ISO 17025 report format does NOT contain the use of the A2LA symbol or make any reference to accreditation, but it does contain all elements, as required by the ISO 17025:2005 standard, including the method number. This method number directly corresponds to the same method number on their Scope of Accreditation.
I initially wrote a nonconformance on an internal audit. My nonconformance was that:
My thought being that a client, who pulls the Scope of Accreditation while looking at their test report (which states the method number) would incorrectly assume it was covered under the Accreditation.
Does everyone agree that this is a nonconformance? If so, what clause of the standard? Also, what would be a good corrective action? We have considered separating the low level detection limit methods from the standard level detection limits methods and also have considered a "deviation" on the final report. Any thoughts? Now, I am having second thoughts. The laboratory has been accredited for several years and has gone through three different assessors. This has not been noted as a problem in any audit.
Thanks for any help!
Last edited by a moderator:
