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Draft 6. Note: This document is a draft suggestion only and is not an approved document. Please do not distribute to laboratory staff for use.

Acknowledgments

AOAC INTERNATIONAL Analytical Laboratory Accreditation Criteria Committee (ALACC) The criteria were revised under the leadership of: David J. Fall, Covance Laboratories Inc., USA, Chair of the ALACC Heidi Phillips, Chair of the ALACC Chemistry Subcommittee Michael Brodsky, Brodsky Consulting, USA, Chair of the ALACC Microbiology Subcommittee

Sumit Sen, U.S. Food and Drug Administration, USA, Chair of the ALACC Pharmaceutical Subcommittee Dr. Yan-Bo Yang, BioPharm Development, USA, Chair of the Dietary Supplement Subcommittee The names of ALACC Subcommittee members who participated in the revision process are available on the AOAC Web site at www.aoac.org . AOAC Introduction AOAC INTERNATIONAL Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Food, Dietary Supplements, and Pharmaceuticals, An Aid to Interpretation of ISO/IEC 17025:2005 provides detailed criteria to aid in assessing the essential requirements for performing these types of analyses. This document closely follows ISO/IEC 17025 and provides a section-by-section interpretation of the general ISO/IEC 17025 requirements. For those sections of ISO/IEC 17025 that are self-explanatory and sufficiently focused on testing laboratories, no further comment was deemed necessary. AOAC welcomes recommendations for revisions from its practitioners. These recommendations will be reviewed by ALACC to determine if a clarification is required. However, in order to expedite the review, submit these in the form of Yes/No type questions. Such clarifications will be posted on the AOAC Web site ( www.aoac.org ) in the Accreditation Section under Frequently Asked Questions (FAQ). Some quotes are taken from CITAC/Eurachem Guide to Quality in Analytical Chemistry: An Aid to Accreditation (2002). This material is reproduced with permission of the authors. AOAC Background The International Organization for Standardization (ISO) issued in May 2005 the second edition of ISO/IEC 17025, “General requirements for the competence of testing and calibration laboratories.” This ISO/IEC Standard provides requirements for testing and calibration laboratories to establish management systems to help ensure the acquisition of consistent and reliable laboratory data. Because ISO/IEC 17025 is intended to apply to both calibration and testing laboratories, it is, by necessity, broad. However, ISO/IEC 17025 competently and succinctly presents management requirements for these laboratories. Regulatory Bodies, in the background to the Current Good Manufacturing Practices regulations, present a regulatory philosophy that provides for appropriate application of this Standard to regulated laboratories. Consistent with that philosophy and the needs of testing laboratories, this document provides more precise direction on how to meet the Standard requirements to help avoid interpretation differences. This approach is consistent with that of regulatory bodies and the need for establishing more definitive applications for specific fields. Many regulatory bodies have demonstrated their acceptance of and the applicability of ISO/IEC 17025 by achieving accreditation of their own testing laboratories, as well as by being actively involved in maintenance of ISO/IEC 17025 standard. General Requirements for the Competence of Testing and Calibration Laboratories 1. Scope