OMB Winter Mtg.-February 5-6, 2015

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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. "Where a laboratory claims compliance against, or certification or accreditation to, a particular standard, it is important to be clear to what this compliance, certification, or accreditation applies. The formal statement of the activities that have been certified against ISO 9001, or accredited against ISO/IEC 17025 is known as the "scope." ISO 9000 and GLP require only a brief description of the activities covered, but with ISO/IEC 17025, a detailed description of the specific work covered by the accreditation is usually required." [ CITAC/Eurachem Guide to Quality in Analytical Chemistry: An Aid to Accreditation (2002)] Refer to the ILAC document: G18 04/2010, Guidelines for the Formulation of Scopes of Accreditation for Laboratories. 1.1 For most testing laboratories, all requirements found in this document are essential in obtaining accreditation. This document covers testing by standard methods that are internationally and nationally recognized such as AOAC INTERNATIONAL, U.S. Food and Drug Administration (FDA), U.S. Pharmacopeia (USP), European Pharmacopeia (EP), U.S. Department of Agriculture (USDA), International Union of Pure and Applied Chemistry (IUPAC), International Commission for Microbiological Specifications for Foods (ICMSF), Health Canada ,Compendium of Methods for the Microbiological Examination of Foods (CMMEF), International Organization for Standardization (ISO), new methods, and laboratory developed methods. This document is intended to provide guidance consistent with regulatory bodies having jurisdiction over dietary supplements such as FDA, Health Canada, and the Therapeutic Goods Administration (TGA). “The validation of a standard or collaboratively studied methods should not be taken for granted, no matter how impeccable the method’s pedigree, the laboratory should satisfy itself that the degree of validation of a particular method is adequate for the required purpose, and that the laboratory is itself able to verify any stated performance criteria.” [ CITAC/Eurachem Guide to Quality in Analytical Chemistry: An Aid to Accreditation (2002)] A laboratory may use an in-house method that has demonstrated superior performance or utilizes more modern technology, and has been adequately validated as defined in this document. However, methods of analysis that are specified in law or regulation shall be followed in accordance with those requirements. Performance in proficiency testing programs for the analytes in question, where reasonably available, will be a required element in determining whether or not such analyses can be accredited 1.2 Because both sampling and methods are critical components of an analytical assessment, the testing laboratory shall note whether other parties conducting portions of this procedure are operating under this document. In addition, this document specifically addresses proficiency in the execution of test methods and is not generally intended for research and/or product development laboratories, unless specified by a customer and/or proficiency scheme for application to a test method critical to these functions. 1.4 This document is for the implementation of laboratory management systems. It covers all analytical laboratories, including those associated with companies, government agencies, trade organizations, academic and independent laboratories. It is not intended for calibration laboratories. 1.5 Although compliance with regulatory and safety requirements is not generally part of accreditation, compliance with all applicable regulatory, safety, and chemical hygiene requirements is expected as a part of the laboratory’s quality system. The safety of all personnel is a responsibility of management. The proper handling and disposal of reagents, solvents, microbials, tissue, etc., is a societal safety issue as well as a