ISO/IEC 17025 – Documents and Resources

Manual

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

MA 2100, Accreditation Manual for Laboratory-Related Activities

Accreditation Requirements

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

AR 2250, ISO/IEC 17025 Testing Laboratories

AR 2251, ISO/IEC 17025 Calibration Laboratories

AR 2257, ISO/IEC 17025 Sampling Organizations

AR 2259, ISO/IEC 17025 Dimensional Measurement Laboratories

Supplemental Accreditation Requirements

Voluntary add-on programs designed to meet the needs of industry, regulatory, and sector-specific requirements. These requirements are applied in addition to a ISO/IEC 17025 accreditation.

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

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

SR 2414, Supplemental Accreditation Requirements: DAGCAP

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

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

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

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

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

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

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

SR 2427, Supplemental Accreditation Requirements: VCCI Council Accreditation Program

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

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

SR 2430, Supplemental Accreditation Requirements: ILAC G7 Horseracing Laboratories

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

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)

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 Accreditation Requirements: FDA Lab Accreditation for Analyses of Foods (LAAF) Accreditation Program

SR 2441, Supplemental Accreditation Requirements: Field Evaluation Body Accreditation Program

Technical Accreditation Requirements

Mandatory and field-specific requirements enacted to strengthen the technical validity of calibration laboratory (non-forensic) accreditations. These requirements are applied in addition to a ISO/IEC 17025 accreditation.

TR 2501, Technical Accreditation Requirements: Scale and Balance Calibrations

TR 2508, Technical Accreditation Requirements: Wideband Infrared Thermometer Calibrations

TR 2509, Technical Accreditation Requirement: Surface Plate Calibrations

TR 2510, Technical Accreditation Requirements: Durometer Calibrations

Administrative Process Rules

Defines ANAB requirements as related to the accreditation process.

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

PR 2301, Accreditation Status

PR 2303, Assessment Activities

PR 2305, Delays Caused by the Customer

PR 2307, Multiple Location Accreditation

PR 2308, Transfer of Accreditation

PR 2310, Fees and Travel

PR 2311, Flexible Scopes of Accreditation (non-forensic)

PR 2316, Remote Assessment Activities

Client Notifications

FM 2830, Client Notification – Administrative Change Request – This form is to be used by organizations that wish to request and/or provide notification of a change to location(s) including the name in which accreditation is held, authorized contacts, contact details, legal entity, Tax ID number. Where key personnel have changed, please complete the technical change request.

FM 2831, Client Notification – Technical Change Request – This form is to be used by organizations that wish to request and/or provide notification of a change to location(s), key personnel, scope of accreditation and unsatisfactory PT/ILC results.

Guidance Documents

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

GD 2701, Guidance on Corrective Action and Cause Analysis

GD 2702, Guidance on Interpolation and Extrapolation of Calibration Data

GD 2703, Guidance on Purchasing and Evaluating Calibrations

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)

GD 2708, Guidance on Purchasing and Evaluating Reference Materials

Scopes of Accreditation

Defines the requirements for the development and drafting of scopes of accreditation for ISO/IEC 17025 accreditations.

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

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

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

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