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ISO/IEC 17025 Accreditation Cooperative Agreement Program

ISO/IEC 17025 Accreditation Cooperative Agreement Program

What is the ISO/IEC 17025:2005 cooperative agreement?

ISO/IEC 17025 is one of the most important standards for calibration and testing laboratories, issued by the ISO (International Organization for Standardization) and the IEC (International Electrotechnical Commission).

ISO/IEC 17025:2005 specifies the general requirements for the competence to carry out tests and/or calibrations, including sampling. It covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods.

It is applicable to all organizations performing tests and/or calibrations. These include, for example, first-, second- and third-party laboratories, and laboratories where testing and/or calibration forms part of an inspection and product certification.

ISO/IEC 17025:2005 is applicable to all laboratories regardless of the number of personnel or the extent of the scope of testing and/or calibration activities. When a laboratory does not undertake one or more of the activities covered by ISO/IEC 17025:2005, such as sampling and the design/development of new methods, the requirements of those clauses do not apply.

ISO/IEC 17025:2005 is for use by laboratories in developing their management system for quality, administrative and technical operations. Laboratory customers, regulatory authorities and accreditation bodies may also use it in confirming or recognizing the competence of laboratories. ISO/IEC 17025:2005 is not intended to be used as the basis for certification of laboratories.

Compliance with regulatory and safety requirements on the operation of laboratories is not covered by ISO/IEC 17025:2005.

What is the intended goal of this cooperative agreement?

The goal of this cooperative agreement is for microbiological and chemical food analyses to be performed on behalf of state manufactured food regulatory programs conducted within the scope of an ISO/IEC 17025:2005 accredited laboratory. Its purpose is to advance the National Integrated Food Safety System (IFSS). This is accomplished by preparing the primary food testing laboratories for state manufactured food regulatory programs to achieve and maintain ISO/IEC 17025:2005 laboratory accreditation. Laboratories will also be prepared for accreditation enhancements.

Laboratory analyses from ISO/IEC 17025:2005 accredited labs will increase the analytical capacity for FDA and enhance efforts to protect the food supply. Data generated by recipient laboratories is housed in eLEXNET and is used by FDA in enforcement actions, surveillance, and responses to foodborne illness outbreaks. Laboratory accreditation also assists state manufactured food regulatory programs in achieving conformance with the Manufactured Food Regulatory Program Standards (MFRPS).

Who are the current awardees?

Map of Current Awardees for ISO/IEC 17025:2005 CAP

United States Map displaying 33 FDA funded ISO Accreditation states: AK, AL, CA, CO, CT*, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NY, NV, OH, OR, RI, SC, TN, TX, VA, VT, WA, WI, WV, WY

*Note: There are 34 state lab enrollees. Connecticut has two lab agencies with ISO accreditation cooperative agreements. 

ISO 17025 Accredited Cooperative Agreement Laboratories

Accrediting Body

Alaska Department of Environmental Conservation

A2LA

California Department of Public Health

PJLA

Connecticut Agricultural Experiment Station

A2LA

Connecticut Department of Public Health

AIHA

Division of Consolidated Laboratory Services (Virginia)

A2LA

Florida Department of Agriculture and Consumer Services

A2LA

Georgia Department of Agriculture

PJLA

Indiana State Department of Health 

ANAB

Kansas Department of Agriculture

ANAB

Kentucky Cabinet for Health and Family Services, Division of Laboratory Services

AIHA

Maryland Department of Health and Mental Hygiene

A2LA

Massachusetts State Public Health, Bureau of Infectious Disease and Laboratory Sciences

A2LA

Michigan Department of Agriculture and Rural Development

A2LA

Minnesota Department of Agriculture

PJLA

Mississippi University, State Chemical Laboratory

PJLA

Missouri Department of Health and Senior Services, State Public Health Laboratory

PJLA

Nebraska Department of Agriculture

A2LA

New York State Deptartment of Agriculture and Markets

A2LA

North Carolina Department of Agriculture and Consumer Services

A2LA

Ohio Department  of Agriculture

A2LA

Oregon Department of Agriculture, Laboratory Services

A2LA

Rhode Island State Department of Health, State Health Laboratories

ANAB

South Carolina Department of Health and Environmental Control, Bureau of Laboratories

A2LA

Tennessee Department  Of Agriculture, Technical Services Laboratory

PJLA

Texas Department of State Health Services, Laboratory Services Section

A2LA

The University of Iowa, State Hygienic Laboratory

AIHA

Vermont Department of Health Laboratory

A2LA

Washington State Deptartment of Agriculture

A2LA

West Virginia Department of Agriculture

A2LA

Wisconsin Department of Agriculture, Trade and Consumer Protection

A2LA


Unaccredited Cooperative Agreement Laboratories (Seeking)

Alabama Department of Public Health

Colorado Department of Public Health and Environment

Illinois Department of Public Health

Louisiana Office of Public Health Laboratory

Nevada State Public Health Laboratory

Wyoming Department of Agriculture


Website Links

American Association for Laboratory Accreditation (A2LA)
https://www.a2la.org/dirsearchnew/newsearch.cfm

AIHA Laboratory Accreditation Programs (AIHA-LAP)
http://apps.aiha.org/qms_aiha/public/pages/reports/publicScopeView.aspx?ProgramCode=39&Version=2

Perry Johnson Laboratory Accreditation (PJLA)
http://www.pjlabs.com/search-accredited-labs

ANSI-ASQ National Accreditation Board (ANAB)
http://search.anab.org/

Who may I contact for further information?

Specific questions on this program can be directed to the appropriate Office of Partnerships' contact within the Division of Partnership Investments and Agreements. Please visit the Office of Partnerships Contacts webpage to obtain a downloaded version of the staffing roster. 

General questions may be directed to the Office of Partnerships' general mailbox: op.feedback@fda.hhs.gov.