Microsoft Word - BYLAWS 9_26_10

OMB MEETING MATERIALS

153

Straw Man: This document is a starting point for future drafts and is not an approved document. Please do not distribute to laboratory staff for use.

General requirements for the competence of testing and calibration laboratories

1

Scope

"Where a laboratory claims accreditation or certification to a particular standard, or compliance with the requirements of a specific regulation, it is important to be clear as to which activities the accreditation, certification or compliance applies. The formal statement of the activities which have been accredited against ISO/IEC 17025 or certified against ISO 9001 is known as the ‘scope’" (CITAC/Eurachem Guide to Quality in Analytical Chemistry: An Aid to Accreditation ). Refer to ILAC guidance document: G18 04/2010, Guidelines for the Formulation of Scopes of Accreditation for Laboratories. Please note that the ILAC guidance document was under revision at the time this document was published. For most chemistry and microbiological 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 food, pharmaceuticals and dietary supplements such as FDA, Health Canada, and the Australian Therapeutic Goods Administration (TGA). 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. 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.

2

Normative references

A list of useful references is provided on the AOAC Web site ( www.aoac.org ) in the Publications and Resources section. This approach was chosen to ensure that the most current references are specified.

3

Terms and Definitions

4

General requirements

4.1

Impartiality

4.1.2 Conflict-of-interest agreements shall be established along with appropriate conflict of interest training programs for personnel. Training shall consist of initial and refresher training. The laboratory shall define a schedule for refresher training and renewal of conflict of interest agreements.

5

Structural requirements

5.7 a)

08/09/2018