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Documents and requirements for application and maintenance of accreditation for ISO/IEC 17025 calibration and testing laboratories, dimensional measurement, and sampling organizations.

Page Contents

Applications

Manual

Accreditation Requirements

Supplemental Accreditation Requirements

Technical Accreditation Requirements

Administrative Process Rules

Guidance Documents

Scopes of Accreditation

Other Documents

Change Notifications


Applications

Manual

MA 2100, Accreditation Manual for Laboratory-Related Activities

Explains the operational activities and responsibilities of ANAB and its customers (excluding forensics and management systems certification bodies).

Accreditation Requirements

AR 2250, ISO/IEC 17025 Testing Laboratories

Defines accreditation requirements for ISO/IEC 17025 testing laboratories (non-forensic). To be used in conjunction with MA 2100 (see Manuals above). Additional supplemental program-specific documents may apply.

AR 2251, ISO/IEC 17025 Calibration Laboratories

Defines accreditation requirements for ISO/IEC 17025 calibration laboratories (non-forensic). To be used in conjunction with MA 2100 (see Manual above).

AR 2257, ISO/IEC 17025 Stand Alone Sampling Organizations

Defines accreditation requirements for ISO/IEC 17025 stand alone sampling organizations (non-forensic). To be used in conjunction with MA 2100 (see Manuals above). Additional supplemental program-specific documents may apply.

AR 2259, ISO/IEC 17025 Dimensional Measurement Laboratories

Defines accreditation requirements for ISO/IEC 17025 dimensional measurement laboratories (non-forensic). To be used in conjunction with MA 2100 (see Manual above).

Supplemental Accreditation Requirements

SR 2044, Supplemental Accreditation Requirements: TNI Field Sampling and Measurement Organization (FSMO)

SR 2401, Supplemental Accreditation Requirements: ANSI/NCSL Z540-1 Calibration Laboratories

SR 2402, Supplemental Accreditation Requirements: ANSI/NCSL Z540.3, Subclause 5.3, Calibration Laboratories

SR 2406, Supplemental Accreditation Requirements: Construction Material Testing ISO/IEC 17025 NACLA Accreditation Program

SR 2407, Supplemental Accreditation Requirements: Cannabis Testing Laboratory and Sampling Accreditation Program

SR 2412, Supplemental Accreditation Requirements: FCC Recognition of Accredited Testing Laboratories

Defines supplemental requirements for accreditation and designation of testing laboratories under the Federal Communications Commission (FCC) Office of Engineering.

SR 2413, Supplemental Accreditation Requirements: Energy Star Laboratory Accreditation Program

Defines supplemental requirements for accreditation of laboratories to the requirements of the EPA Energy Star program.

SR 2414, Supplemental Accreditation Requirements: DAGCAP

Defines supplemental requirements for accreditation of laboratories to the requirements of the DoD Advanced Geophysical Accreditation Classification Program (DAGCAP). Also see DoD information about this program.

SR 2416, Supplemental Accreditation Requirements: Food, Dietary Supplements, and Pharmaceuticals Testing Laboratory Accreditation Program (AOAC)

Defines supplemental requirements for accreditation to Food, Dietary Supplements, and Pharmaceuticals Testing Laboratory Accreditation Program requirements for labs performing chemical and/or microbiological analyses in the examination of food, dietary supplements, and pharmaceutical ingredients used in production, in-process samples, environmental samples, and final products.

SR 2417, Supplemental Accreditation Requirements: AAFCO Feed Testing Laboratory Accreditation Program

Defines supplemental requirements for accreditation to AAFCO Feed Testing Laboratory Accreditation Program requirements.

SR 2418, Supplemental Accreditation Requirements: U.S. EPA Drinking Water Cryptosporidium Testing Laboratory Accreditation Program

SR 2419, Supplemental Accreditation Requirements: TNI Non-Governmental Accreditation Body Environmental Laboratory Accreditation Program

Defines supplemental requirements for accreditation to the NELAC Institute (TNI) Non-Governmental Accreditation Body (NGAB) Environmental Laboratory Accreditation Program (ELAP) requirements.

SR 2420, Supplemental Accreditation Requirements: DoD Environmental Laboratory Accreditation Program

Defines supplemental requirements for accreditation of laboratories to the requirements of the Department of Defense Environmental Laboratory Accreditation Program (DoD ELAP).

SR 2421, Supplemental Accreditation Requirements: EPA National Lead Laboratory Accreditation Program

Defines supplemental requirements for accreditation of laboratories to the requirements of the EPA National Lead Laboratory Accreditation Program (NLLAP).

SR 2424, Supplemental Accreditation Requirements: EPA TSCA Title VI Formaldehyde Program

Defines supplemental requirements for accreditation of laboratories to the requirements of the EPA Toxic Substances Control Act (TSCA) Title VI Formaldehyde Program.

SR 2425, Supplemental Accreditation Requirements: Consumer Product Safety Commission Testing Accreditation Program

Defines supplemental requirements for accreditation to CPSC Testing Accreditation Program.

SR 2427, Supplemental Accreditation Requirements: VCCI Council Accreditation Program

Defines supplemental requirements for accreditation of laboratories to the requirements of the VCCI Council Accreditation Program.

SR 2428, Supplemental Accreditation Requirements: Project 25 Conformity Assessment Program for Testing Laboratories

Defines supplemental requirements for accreditation of laboratories to the requirements of the Project 25 Conformity Assessment Program (P25 CAP).

SR 2429, Supplemental Accreditation Requirements: Laboratories Performing Detection of Suspect/Counterfeit Parts Under AS6171

Defines supplemental requirements for laboratories performing detection of suspect/counterfeit parts under the specific requirements of AS6171.

SR 2430, Supplemental Accreditation Requirements: ILAC G7 Horseracing Laboratories

Defines supplemental requirements for horseracing laboratories accredited to ISO/IEC 17025.

SR 2431, Supplemental Accreditation Requirements: U.S.-Mexico Telecom Program

Defines supplemental requirements for third-party telecom testing laboratories seeking NIST designation to Mexico.

SR 2432, Supplemental Accreditation Requirements: Good Laboratory Practices for Nonclinical Laboratory Studies, CFR Part 58, Subparts A-F and J (2011)

SR 2433, Supplemental Accreditation Requirements: DOE Consolidated Audit Program - Accreditation Program (DOECAP-AP)

Defines supplemental requirements for accreditation of laboratories for the U.S Department of Energy Consolidated Audit Program (DOECAP).

SR 2435, Supplemental Accreditation Requirements: ISED Recognition of Accredited Testing Laboratories

SR 2437, Supplemental Accreditation Requirements: Basic Safety and Essential Performance of Medical Devices

SR 2438, Supplemental Accreditation Requirements: Biocompatibility Testing of Medical Devices

SR 2440, Supplemental Requirements: FDA Lab Accreditation for Analyses of Foods (LAAF) Accreditation Program

Defines supplemental requirements for accreditation of laboratories for the US Food and Drug Administration (FDA) Laboratory Accreditation for Analyses of Foods (LAAF) program.

Technical Accreditation Requirements

TR 2501, Technical Accreditation Requirements ISO/IEC 17025 Calibration Laboratories (Non-Forensic) - Scales and Balances

TR 2508, Technical Accreditation Requirements: Estimation of Uncertainty for Calibration of Wideband Infrared Thermometers

TR 2509, Surface Plate Calibrations

TR 2510 Durometer Calibrations

Administrative Process Rules

PR 1018, Policy on Use of ANAB Accreditation Symbols and Claims of Accreditation Status

PR 2301, Accreditation Status

Applies to all customers and provides definitions and specific administrative process for accreditation statuses.

PR 2303, Assessment Activities

The assessment process determines the customer’s compliance with the requirements of the relevant accreditation standards, ANAB accreditation requirements, and any supplemental requirements, and the technical competence to the scope of accreditation. Various activities are used, both on-site and remotely, to evaluate conformance. Assessment activities include all locations where key activities of the customer are performed.

PR 2305, Delays Caused by the Customer

Defines the process when, for whatever reason, a customer delays the accreditation process during the application or assessment stage, and applies to all applicant and accredited customers.

PR 2307, Multi-Site Accreditation

Defines ANAB's process to determine, apply, manage, and accredit multiple-facility organizations (main, satellite, and temporary), mobile, and on-site conformity assessment services of the customer.

PR 2308, Transfer of Accreditation

Defines ANAB's process when an accredited customer seeks to transfer accreditation to ANAB.

PR 2310, Fees and Travel

Defines assessment fees ANAB charges customers and the required travel requirements for ANAB assessors and technical experts.

PR 2316, Remote Assessment Activities

Defines requirements and makes recommendations for conducting remote assessments.

Guidance Documents

GD 2700, Guidance on Reporting Uncertainty of Measurement for Calibration Laboratories

Provides guidance on uncertainty requirements for ANAB-accredited laboratories that perform calibrations.

GD 2701, Guidance on Corrective Action and Cause Analysis

Establishes guidelines, clarifications, and recommendations for specific ISO/IEC 17025 requirements, and specific policies and instructions as defined by ANAB.

GD 2702, Guidance on Interpolation and Extrapolation of Calibration Data

Provides guidance on interpolation and extrapolation of calibration data as related to calculating measurement uncertainties and the expression of those uncertainties on the customer’s scope of accreditation and any accredited calibration or testing reports.

GD 2703, Guidance on Purchasing and Evaluation Calibrations

Provides general accreditation guidance for accredited customers to purchase calibrations that are fit for their intended purpose.

GD 2704, Guidance on Internal Audits for Laboratories

GD 2705, Guidance on Management Review for Laboratories

GD 2706, Guidance on Writing Standard Operating Procedures

GD 2707, Guidance on Uncertainty of Measurement for Testing Laboratories (non-forensic)

This document provides guidance on ISO/IEC 17025:2017 uncertainty requirements for ANAB accredited laboratories that perform testing.

Scopes of Accreditation

PR 2350, Preparing a Draft Scope of Accreditation for ISO/IEC 17025 Testing Laboratories

To assist in drafting scopes of accreditation and to clarify ILAC guidance documents and ANAB requirements, while helping standardize formats across the range of potential ISO/IEC 17025 accredited tests.

FM 2850, ISO/IEC 17025 Testing Scope Template (contact ANAB)

FM 2864, ISO/IEC 17025 FCC Testing Scope Template (contact ANAB)

FM 2865, ISO/IEC 17025 ILI CanNaLAP Testing Scope Template (contact ANAB)

PR 2351, Preparing a Draft Scope of Accreditation for ISO/IEC 17025 Calibration Laboratories

To assist in drafting scopes of accreditation and to clarify ILAC guidance documents and ANAB requirements, while helping standardize formats across the range of potential accredited calibrations in the sphere of ISO/IEC 17025 accredited operations.

FM 2880, ISO/IEC 17025 Calibration Scope Template (contact ANAB)

PR 2357, Preparing a Draft Scope of Accreditation for ISO/IEC 17025 Stand Alone Sampling Organizations

To assist in drafting scope of accreditation and to clarify ILAC guidance documents and ANAB requirements, while helping standardize formats across the range of potential accredited sampling organizations.

FM 2869, ISO/IEC 17025 Stand Alone Sampling Organization Scope Template (contact ANAB)

PR 2360, Preparing a Draft Scope of Accreditation for ISO/IEC 17025 Dimensional Measurement Laboratories

To assist in drafting scopes of accreditation and to clarify ILAC guidance documents and ANAB requirements, while helping standardize formats across the range of potential ISO/IEC 17025 accredited dimensional measurements.

FM 2882, ISO/IEC 17025 Dimensional Measurement Scope Template (contact ANAB)

Other Documents

Change Notifications

FM 2830, Client Notification 

Used by customers to notify ANAB of any organizational changes, such as change of name, ownership, location, contact information, management, key personnel, accounting information, unsatisfactory PT/ILC, or scope of accreditation.