1. Experiences of a Newly Accredited Laboratory
Barbara J. Baker, MPH
Washington State Department of Agriculture
Microbiology Laboratory

2. WSDA Laboratory Displaying Certificate

3. Who are we? Microbiology Laboratory Program Manager
Quality Assurance Officer
Administrative Assistant
Technical Supervisor
5 Microbiologists
1.5 Laboratory Support Staff

4. Who are our Customers? WSDA Food / Feed Safety Program FDA FERN MCAP
ISO
RRT
BSE

5. Food Testing
Routine RTE surveillance (including Retail Raw Milk products)
Environmental testing at Cheese and Retail Raw Milk Producers
Investigations / Outbreaks
FDA FERN – MCAP Laboratory

6. Dairy Testing Regulatory testing for FDA
Laboratory certified by FDA-LQAB for testing dairy and water samples for NCIMS
FDA triennial on-site evaluations
7 analysts are FDA-certified for dairy testing
Laboratory Evaluations of Industry Laboratories – 2 LEOs

7. Feed Testing Test Ruminant Feed for Prohibited Materials
Test Animal Feed / Food Processing Waste for Pathogens

8. Steps to achieving ISO 17025:2005
Based on your business, determine which accreditation body you want to work with – we use A2LA
Purchase and read the Standard for ISO :2005
Contract with an ISO 17025:2005 trainer to train all of your staff

9. 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 pages

10. 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

11. 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

12. ISO 17025:2005 Accreditation 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

13. Lessons Learned
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….

14. Contact Information
Barbara Baker, Program Manager WSDA Microbiology Laboratory (360)