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  1. (Revised) 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).

    Question: When can an expired CRM be used?

    Answer: A CRM is an RM characterized by a metrologically valid procedure for one or more specified properties, accompanied by a reference material certificate that provides: 1) the value of the specified property, 2) its associated uncertainty, and 3) a statement of metrological traceability. When A CRM expires it loses a link to its uncertainty and traceability but still may be sufficiently homogeneous and stable with respect to one or more of its specified properties. Thus, a CRM that has passed its expiration date can still be used as a QC or as an RM if it is used in a manner that does not require the application of these two lost attributes as long as it is evaluated and re-qualified for suitability.

    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.