# Laboratory Accreditation Services for ISO 17025

Canonical: https://abierto.us/opportunities/75f40125r00021

- Solicitation number: 75F40125R00021
- Notice type: Sources sought
- Status: Awarded to American Association for Laboratory Accreditation
- Department: Department of Health and Human Services
- Agency: Food and Drug Administration
- Contracting office: FDA Office of Acq Grant SVCS (75F401)
- NAICS: 813920 Professional Organizations
- Product or service code: R420 Certifications and Accreditations for products and institutions other than educational institutions
- Place of performance: Atlanta, Georgia
- City: Atlanta. https://abierto.us/cities/atlanta-ga-1304000
- First posted: November 20, 2024
- Last posted: November 20, 2024
- SAM.gov: https://sam.gov/workspace/contract/opp/ec87440d174d43f89306a60d914d9225/view

## Description

In the past, FDA’s Regulatory laboratories operated under a variety of formal and informal quality management systems. All of these systems had the same aim – to assure the quality of laboratory results upon which regulatory decisions are made. However, these systems differed in their rigor and in the amount of independent oversight exercised.

A quality management system that is accredited to international standards (ISO/IEC 17025) enabled Laboratory managers to better maintain high quality laboratory operations, to more easily control resources, and to act with more confidence in meeting the needs of their customers and stakeholders. More effective operations result in greater regulatory impact and better consumer protection. Uniform laboratory procedures enhance data reliability and resource sharing with FDA domestic and international partners.

Through laboratory accreditation, FDA Regulatory laboratories maintain their reputation as a source of scientifically sound information and guidance. The accreditation process started in 2003 and FDA Regulatory laboratories undergo a full on-site assessment every two years depending upon the expiration of their Accreditation Certificate.

The objective of an accreditation assessment is to establish whether or not a laboratory complies with the accrediting body’s requirements for accreditation and can competently perform the types of tests or calibrations for which accreditation is sought. Accreditation is required to demonstrate compliance with additional criteria of the “AOAC International Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Food, Dietary Supplements, Pharmaceuticals, and Cannabis”.

The purpose of this contract is to have an independent, third-party Contractor perform the accreditation assessments and make the proper determinations and to identify any deficiencies.

## Award on USAspending

- Recipient: American Association for Laboratory Accreditation (UEI CG2ZJYF5W8X8)
- Contract: 75F40125P00018, purchase order
- Obligated: $104,380.00
- Competition: Competed Under SAP, 3 offers received
- Link: solicitation number 75F40125R00021 equals the FPDS solicitation identifier; same awarding office 75F401 (high confidence)
- Record: https://www.usaspending.gov/award/CONT_AWD_75F40125P00018_7524_-NONE-_-NONE-/


## Publications

- November 20, 2024: Sources sought, due December 2, 2024 at 10:00 AM EST. Notice 734a6fc02a414b699a52ef4a3df7e945. https://sam.gov/workspace/contract/opp/734a6fc02a414b699a52ef4a3df7e945/view
- November 20, 2024: Sources sought, due December 2, 2024 at 10:00 AM EST. Notice a065c51749af414885d543bf9ebf3959. https://sam.gov/workspace/contract/opp/a065c51749af414885d543bf9ebf3959/view
- November 20, 2024: Sources sought, due December 2, 2024 at 10:00 AM EST. Notice ec87440d174d43f89306a60d914d9225. https://sam.gov/workspace/contract/opp/ec87440d174d43f89306a60d914d9225/view

## Points of contact

- Amanda Edger, amanda.edger@fda.hhs.gov
- James Jenrette, james.jenretteiii@fda.hhs.gov, 3018377549

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Source: SAM.gov Contract Opportunities bulk extract and USAspending.gov award data. Confirm deadlines on SAM.gov before responding. Cite https://abierto.us/opportunities/75f40125r00021.