FSIS has received ISO Standard 17025 accreditation for procedures
the agency conducts at its three field service regulatory
laboratories, located in Athens, GA, St. Louis, MO and Alameda,
CA, and its Food Emergency Response Network (FERN) 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.
There are a number of accrediting bodies for ISO Standard
17025 within the United States.
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.
In September 2000, 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 process used in
In October and November 2001, the four FSIS laboratories
were audited by a contracted accrediting body. FSIS responded
to issues cited in the review. Once all of the issues were
resolved for each laboratory, the accrediting body reviewed
the audit report and FSIS responses before rendering a final
decision on accreditation. Accreditation was granted and has
been continuous since then.
For a laboratory to operate under ISO accreditation, a proficiency
testing program or other suitable vehicle must be in place
for the analyses that the laboratory is accredited to perform.
A proficiency test checks actual laboratory performance of
a process. FSIS has ISO accreditation in analyses for pesticide
residues, sulfonamides, arsenic, moisture, fat, protein, salt,
E. coli O157:H7, Salmonella, and Listeria.
These tests account for approximately 90% of the analyses
that FSIS conducts.
In order to maintain accreditation, the FSIS quality manual
and work instructions must be constantly updated. Each laboratory
will also be audited by an accrediting body once a year, with
an on-site audit occurring every other year. In addition,
the FSIS Laboratory Quality Assurance Division conducts annual
and special audits of the four FSIS laboratories.