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Key Facts: ISO Accreditation |
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FSIS has received ISO Standard 17025 accreditation for procedures
that the agency conducts at its three field service regulatory
laboratories, located in Athens, GA, St. Louis, MO and Alameda,
CA, and at its Microbial Outbreaks and Special Projects Branch
laboratory, located in Athens, GA.
ISO Standard 17025 was developed by the International Organization
for Standardization (ISO), which develops international agreements
on standards for various industries.
The American Association for Laboratory Accreditation (A2LA) is the
accrediting body for ISO Standard 17025 within the United States.
In addition to the FSIS laboratories, 17 Federal labs are ISO
accredited. These include laboratories for the U.S. Customs
Service, U.S. Army laboratories, and a USDA Agricultural
Marketing Service lab.
ISO Laboratory Accreditation Pilot Program
Accreditation encourages uniform laboratory practices and increases
credibility. FSIS began work with the Food and Drug Administration
(FDA) and state and local agencies, on a pilot project to
demonstrate that a variety of laboratories could receive
accreditation. In 1999, FSIS laboratory quality managers and
participants in the pilot program attended a week-long ISO
training course in Athens, GA.
FSIS Accreditation
In Sept. 2000, all FSIS laboratory employees were trained in ISO
procedures. Quality managers and supervisors received additional
training on ISO audits.
ISO accreditation requires full documentation of each procedure
in the laboratory. FSIS compiled a detailed quality manual and
recorded over 400 work instructions for every process used in
the laboratories.
In October and November 2001, the four FSIS laboratories were
audited by teams from A2LA. FSIS responded to and is taking
actions on issues cited in the review. Once all of the issues
are resolved for each laboratory, the A2LA Accreditation Council
reviews the audit report and the FSIS responses before rendering
a final decision on accreditation.
ISO Requirements
For a laboratory process to operate under ISO, a proficiency
testing program must be in place. A proficiency test checks
actual laboratory performance of a process.
FSIS has applied for ISO accreditation in analyses for pesticide
residues, sulfonamides, arsenic, moisture, fat, protein, sodium,
E. coli O157:H7, Salmonella, and Listeria.
These tests account for approximately 90% of the analyses that FSIS
conducts.
Maintaining Accreditation
In order to maintain accreditation, the FSIS quality manual and
work instructions must be constantly updated. Each laboratory
will also be audited by A2LA once a year, with an in-depth audit
occurring every other year. In addition, the FSIS Laboratory
Quality Assurance Division conducts annual and special audits
of the four FSIS laboratories.
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