Laboratory Accreditation Services for ISO 17025
Closed Pre-Solicitation Posted
- Solicitation number
- 75F40125R00021
- Agency
-
FDA Office of Acquisition and Grant Services
Food and Drug Administration, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 813920 Professional Organizations
- PSC
- R420 Support- Professional: Certifications And Accreditations (Other Than Educ Or Info Tech C&A)
- Place of performance
- Atlanta, Georgia, United States
Notice details come from SAM.gov. Updated .
About this opportunity
The U.S. Food and Drug Administration (FDA) is seeking an independent, third-party contractor to perform accreditation assessments and identify any deficiencies to maintain ISO 17025 accreditation for its regulatory laboratories. The objective is to have a contractor with expertise in assessing chemical, biological, electrical, and mechanical testing laboratories conduct on-site assessments every two years to ensure the laboratories comply with accreditation requirements. The evaluation criteria include the contractor's technical approach, staffing and key personnel, and management approach, with confidence ratings assigned to each factor. Proposals are due by December 11, 2024, and the anticipated period of performance is January 1, 2025, to December 31, 2025.
This is not a set-aside contract, and the government has not provided the names of any potential incumbents or current contractors. The total estimated value of the contract has not been specified, but the pricing worksheet provides a detailed pricing structure for the base period and four option years, covering various laboratories, fringe benefits, overhead, other direct costs, and fee/profit. The NAICS code is 813920 for Professional Organizations, and the PSC code is R420-P for Support-Professional: Certifications and Accreditations.
Notice text
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.
Files
| File | Type | Posted |
|---|---|---|
| RFP_75F40125R00021.pdf | ||
| Attachment A - Pricing Worksheet.xlsx | XLSX spreadsheet | |
| Attachment 1 - Statement of Work.pdf |
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