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FAQ for ALACC

  1. Section 6.4.4. of the Guidelines states that reagents, reagent solutions, sample solutions, and internal reference materials [including certified reference materials (CRMS) used as internal reference materials] shall not be used past their expiration date without recorded verification that they are still suitable for use. Media and CRMS cannot be used beyond their expiration date. Note: Expired CRMs can be qualified as Reference Materials (RMS).

    The question is: when can an expired CRM be used?

    The difference between a RM and a CRM is that the CRM has the stated uncertainty while the RM does not. So, for example, take pH buffers. The interpretation is unless you are reporting pH on a test report, the buffer used does not need to be provided by a ISO 17034 /Guide 34 supplier (whose certificate must have the stated uncertainties). A CRM that has passed its expiration date thus can still be used if it is used in a manner that does not require the application of its measurement uncertainty. In both cases they must be evaluated for suitability after passing the expiration date.

    Reference:
    ISO Guide 80:2014
    Guidance for the in-house preparation of quality control materials (QCMs)


  2. Section 8.8.1. of the Guidelines states that internal audits of laboratory information management systems shall be conducted at least once per accreditation cycle.

    Question: What information is required to satisfy this requirement?

    Answer: The laboratory is required to audit the acquisition, transfer and data storage process in the LIMS, along with permissions for access to the various data to ensure only authorized personnel can access the different parts of the LIMS.