The AOAC INTERNATIONAL Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Food, Dietary Supplements, and Pharmaceuticals, An Aid to Interpretation of ISO/IEC 17025:2017 was created by the Analytical Laboratory Accreditation Criteria Committee (ALACC) to provide a section-by-section interpretation of requirements.
ALACC is a multinational group of experts from varied scientific disciplines and industries, and part of AOAC’s Technical Division for Laboratory Management (TDLM).
(ISBN 0-935584-86-2), Item 11545, is a softbound book, available for $188 per copy plus shipping.
A searchable PDF version, available through individual use and organizational licenses. [below to be formatted as a table when pricing is confirmed]
|Individual Use License||Item 11545||Member Rate: $188||Non-Member Rate: $209|
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A CRM is 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.
Reference: ISO Guide 80:2014, Guidance for the in-house preparation of quality control materials (QCMs)
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.
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 laboratory is required to audit the acquisition, transfer, and data storage process in the laboratory information management system (LIMS), along with access permissions for the various data to ensure only authorized personnel can access different parts of the LIMS.
Appendix A: Equipment in the 2018 AOAC Guidelines and if there is an acceptable alternative to measuring the mass of water as a means of verifying the accuracy of volumetric delivery devices: mechanical pipets, mechanical burets, and liquid dispensers.
An acceptable alternative to weighing the mass of liquid delivered by a bottle top dispenser would be through measuring the dispensed volume of liquid. It is up to the lab to ensure the alternative to weighing is suitable for its intended use.