ISO 17025:2005 Laboratory Accreditation CAP: Updates

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Presentation transcript:

ISO 17025:2005 Laboratory Accreditation CAP: Updates Erin Woodom-Coleman, Project Officer FDA Office of Partnerships February 2, 2016

ISO Team – Who Are We? Erin Woodom-Coleman OP – Human Food ISO Teresa Bills OP – Animal Food ISO Ruiqing Pamboukian, Ph.D. ORS – Human and Animal Food Host of ISO Assessors from ORS State primary testing laboratories

ISO CAP History ISO 17025:2005 Accreditation CAP (Food) Established in 2012 w/ 31 labs Expansion in 2015 w/ 6 new labs AFRPS CAP + ISO Option (Animal Food) Established in 2015 w/ 20 labs Anticipated expansion in the near future Build upon success w/ the first posting

Where Are We? – Original Labs Application Timeline Accreditation Achieved Under CAP Accredited Prior to CAP DEC. 2015 JAN. 2016 FEB. 2016 MAR. 2016 JUN 2016 AUG. 2016 AUG. 2019

Where Are We? – Original Labs Human Food ISO Application submission Preparing for assessments Addressing deficiencies Refining Sampling Agreements Enhancing scope (accredited labs)

Where Are We? – New Labs Human and Animal Food ISO Strengthening partnership with regulatory counterparts Desk Audits and Onsite Assessments Gap Analysis development Sampling Agreement brainstorming 1st model where laboratory and reg under one CAP

What’s Next? Original Labs 100% Accreditation Build and Expand Resources Scope of accreditation Sampling Agreement (joint effort) Blue Bell (SC) and Jeni’s Splendid (NE) New Labs (H/A Food) FTEs ISO Training Continue to build a quality management system

Congratulations! State Hygienic Lab Univ. of Iowa - Ankeny NE Dept. of Agriculture KS Dept. of Agriculture

Congratulations MD Dept. of Health and Mental Hygiene IN State Dept. of Health

Acknowledgements Manufactured Food and Animal Food Regulatory Programs MFRP Alliance AFDO AAFCO APHL

How to Reach Us Human Food/MFRPS ISO Erin Woodom-Coleman Erin.woodom-coleman@fda.hhs.gov (240)205-1606 Animal Food/AFRPS ISO Teresa Bills Teresa.bills@fda.hhs.gov (615)854-0019 ISO Technical Questions Ruiqing Pamboukian, Ph.D Ruiqing.pamboukian@fda.hhs.gov (301)796-8157