Experiences of a Newly Accredited Laboratory
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Experiences of a Newly Accredited Laboratory Barbara J. Baker, MPH Washington State Department of Agriculture Microbiology Laboratory
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Experiences of a Newly Accredited Laboratory. Barbara J. Baker, MPH Washington State Department of Agriculture Microbiology Laboratory. WSDA Laboratory Displaying Certificate. Who are we?. Microbiology Laboratory Program Manager Quality Assurance Officer Administrative Assistant - PowerPoint PPT Presentation
Transcript of Experiences of a Newly Accredited Laboratory
Experiences of a Newly Accredited
LaboratoryBarbara J. Baker, MPH
Washington State Department of AgricultureMicrobiology Laboratory
WSDA Laboratory Displaying Certificate
Who are we?Microbiology Laboratory
◦Program Manager◦Quality Assurance Officer◦Administrative Assistant◦Technical Supervisor
5 Microbiologists 1.5 Laboratory Support Staff
WSDA Food / Feed Safety ProgramFDA
◦FERN MCAP◦ISO◦RRT◦BSE
Who are our Customers?
Food TestingRoutine RTE surveillance (including Retail Raw Milk products)
Environmental testing at Cheese and Retail Raw Milk Producers
Investigations / OutbreaksFDA FERN – MCAP Laboratory
Regulatory testing for FDALaboratory certified by FDA-LQAB for testing dairy and water samples for NCIMSoFDA triennial on-site evaluationso7 analysts are FDA-certified for dairy
testingLaboratory Evaluations of Industry Laboratories – 2 LEOs
Dairy Testing
Test Ruminant Feed for Prohibited Materials
Test Animal Feed / Food Processing Waste for Pathogens
Feed Testing
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
Steps to achieving ISO 17025:2005
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
Steps to achieving ISO 17025:2005
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 Start with your Document Control Procedure Consider hiring an ISO 17025:2005
consultant to help you thru the process
Steps to achieving ISO 17025:2005
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
Steps to achieving ISO 17025:2005
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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
ISO 17025:2005 Accreditation
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….
Lessons Learned
Barbara Baker, Program ManagerWSDA Microbiology Laboratory(360) [email protected]
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