Barbara J. Baker, MPH
Washington State Department of Agriculture
Microbiology Laboratory
 Microbiology
Laboratory
◦ Program Manager
◦ Quality Assurance Officer
◦ Administrative Assistant
◦ Technical Supervisor
 5 Microbiologists
 1.5 Laboratory Support Staff
 WSDA
Food / Feed Safety Program
 FDA
◦ FERN MCAP
◦ ISO
◦ RRT
◦ BSE
 Routine
RTE surveillance
(including Retail Raw Milk
products)
 Environmental testing at Cheese
and Retail Raw Milk Producers
 Investigations / Outbreaks
 FDA FERN – MCAP Laboratory
Regulatory testing for FDA
Laboratory certified by FDA-LQAB
for testing dairy and water samples
for NCIMS
oFDA triennial on-site evaluations
o7 analysts are FDA-certified for dairy
testing
Laboratory Evaluations of Industry
Laboratories – 2 LEOs
 Test
Ruminant Feed for Prohibited
Materials
 Test Animal Feed / Food Processing
Waste for Pathogens
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Based on your business, determine which
accreditation body you want to work with –
we use A2LA
Purchase and read the Standard for ISO
17025:2005
Contract with an ISO 17025:2005 trainer to
train all of your staff
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Request assistance from your accrediting
body on obtaining materials to help develop
your Quality System – e.g., purchase the
checklist
Research other laboratory’s Quality Manuals
Develop your Quality Manual
◦ Policy Statement – what you intend to do
◦ About 25-30 pages
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Begin creating Procedures
◦ Describe how to support your Laboratory’s policies
◦ ~30 laboratory-wide system procedures you will
need
◦ Use the checklist to make sure you meet all the
requirements
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Start with your Document Control Procedure
Consider hiring an ISO 17025:2005
consultant to help you thru the process
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Stay in touch with your accrediting
organization to ensure you have all the pieces
in place prior to applying for accreditation
This whole process can take as short as 1
year or as long as 5 years
April 25, 2011
Internal audit completed by ISO contractor/
Laboratory QA auditor-in-training
August 15, 2011
Applied for accreditation with the American
Association of Laboratory Accreditation (A2LA)
October 26-27, 2011
A2LA audit occurred – Laboratory responded to
the four minor deficiencies identified during the
audit
December 22, 2011
ISO 17025:2005 accreditation achieved
November 7, 2012
A2LA surveillance assessment, accreditation
reaffirmed December 5 2012
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Have a dedicated Quality Assurance position
in your Laboratory
You are not alone – “don’t reinvent the wheel”
If you have the funds, hire a consultant to
assist you
Do not put too many procedures under scope
during the first year
It will make your Laboratory better and help
you continuously improve
Be patient….
Barbara Baker, Program Manager
WSDA Microbiology Laboratory
(360) 586-3645
bbaker@agr.wa.gov