Offering accreditation services to food and pharmaceutical testing laboratories since 1998, A2LA is the most experienced food testing accreditation body in the US.
New Effective as of May 23, 2022, A2LA is the first accreditation body recognized to accredit laboratories under FDA’s Food Safety Modernization Act (FSMA) Laboratory Accreditation for Analyses of Foods (LAAF) Program. As of July 12, 2022 laboratories can now apply to approved accrediting bodies for an assessment to the LAAF requirements. For information regarding the FDA FSMA LAAF program, refer to the Frequently Asked Questions (FAQs).
A2LA’s Food and Pharmaceutical Testing Laboratory Accreditation Program encompasses laboratories that test products intended for human consumption and environmental samples related to foods or consumables. A2LA provides accreditation to food testing labs, dietary supplement testing labs, and other laboratories performing chemical and/or microbiological analyses in the examination of the following:
- Pharmaceuticals
- Food products
- Dietary Supplements
- Ingredients in the production of food
- In-process food samples
- Environmental samples pertinent to foods
- Final products
Some specifiers will require ISO/IEC 17025 plus the AOAC program guidelines, while others require only ISO/IEC 17025. Contact us to determine what standards your organization needs to be accredited to.
This specialty program is covered by the A2LA chemical and biological fields of testing.
Program Requirements
- ISO/IEC 17025 General Requirements for the Competence of Testing and Calibration Laboratories
- AOAC International Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Food, Dietary Supplements, and Pharmaceuticals—An Aid to the Interpretation of ISO/IEC 17025:2017*
- The AOAC guidelines (while considered a “guidance” document by AOAC) are used by A2LA as accreditation requirements, as they provide detailed criteria to aid in assessing the essential requirements for performing these types of analyses. The document also provides a section-by-section interpretation of the general ISO/IEC 17025 requirements as they apply to a life science laboratory and contains additional accreditation criteria found in the appendices.
- Appendix A discusses typical laboratory equipment and offers additional requirements on calibration, verification, and maintenance schedules
- Appendix B contains specific criteria for microbiology, including organisms, media, and reagents/kits
- Appendix C defines acceptance criteria for calibration data in chemistry
- Appendix D offers additional criteria on pharmaceutical products as it relates to cGMP requirements
- Appendix E offers specific criteria for dietary supplements, including validation, proficiency testing, and equipment
- The AOAC guidelines (while considered a “guidance” document by AOAC) are used by A2LA as accreditation requirements, as they provide detailed criteria to aid in assessing the essential requirements for performing these types of analyses. The document also provides a section-by-section interpretation of the general ISO/IEC 17025 requirements as they apply to a life science laboratory and contains additional accreditation criteria found in the appendices.
*The new LAAF rule incorporates some of the requirements contained in this document.