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 Technical Supervisor 5 Microbiologists 1.5 Laboratory Support Staff

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

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

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

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

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 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

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 5 2012

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….

Contact Information Barbara Baker, Program Manager WSDA Microbiology Laboratory (360) 586-3645 bbaker@agr.wa.gov