​Summer 2016

​APHL and US FDA are helping labs achieve ISO/IEC accreditation with a variety of tools and resources.

Gloved hand holds grains for testing

In just four years, nine state and local public health laboratories have either achieved accreditation to the ISO/IEC 17025:2005 standard for the first time or expanded the scope of their accreditation. The force behind this surge in accreditations is a five-year cooperative agreement between APHL and the US Food and Drug Administration (FDA) designed to advance the quality of laboratory practice under the Food Safety Modernization Act (FSMA).

The Arizona State Public Health Laboratory (AZ SPHL) earned ISO/IEC 17025:2005 accreditation in 2015 with resources and support from APHL, and AZ SPHL funding. Other public health laboratories have received dedicated federal funding for ISO/IEC 17025:2005 accreditation. Since 2012, APHL has collaborated with the FDA, the Association of Food and Drug Officials, and the Association of American Feed Control Officials to help state and local food and feed testing laboratories on their journey toward ISO 17025 accreditation.

According to Kathryn Wangsness, MHA, chief of the Office of Laboratory Services at the AZ SPHL, APHL resources helped greatly in earning accreditation for her laboratory. “I think we would have eventually gotten there, but we were able to become ISO accredited much more quickly. Access to accredited laboratories and seeing how other labs interpreted the ISO standard were crucial to our success.”

Wangsness and her Quality Assurance team signed up for as many ISO-related trainings and webinars as possible on the APHL Accreditation Training Resources page. She notes, “Most of them were free, which helped us get more training than we would have otherwise!” APHL also sponsors travel for members attending related conferences and trainings. When Wangsness had enough funds to send only one person to an ISO training, “I reached out to APHL, and they gave us funding for another person to attend that training.”

The APHL ISO/IEC 17025:2005 Accreditation site houses a members-only resources page, which contains sample documents to assist laboratories with ISO standard compliance. Instead of starting from scratch on the many documents required under ISO, Wangsness was able to edit documents from the repository to fit her laboratory’s needs. A public resource page is also available with links to conference presentations and information about the value of accreditation.

If a laboratory is not slated to receive federal funding for accreditation, APHL connects it with an experienced ISO 17025 consultant. In Wangsness’ words, this is “the icing on the cake!” The consultant helps in every part of the application process—reviewing documents, performing inventory checks and gap analyses and conducting on-site reviews. “Having the consultant walk through the laboratory, providing her perspective, was invaluable. It was extremely helpful to have access to someone who had already gone through the process and was so knowledgeable about the ISO standard.”

Wangsness acknowledges that, while the ISO accreditation process isn’t easy, it does strengthen the quality of laboratory practice. She has three pieces of advice for laboratories looking to achieve accreditation:

  1. Purchase the ISO 17025 Standard. It’s difficult to know how to comply to the standard if you can’t quickly reference it.
  2. Start working on anything that your procurement system requires to go out for bid. This can be an arduous task for some states and can slow down the ISO process.
  3. Utilize APHL resources. Sign up for the discussion board, look at the posted resources and utilize the available free trainings and webinars. They can help point you in the right direction.

For more information, please contact Robyn Pyle, MS, specialist, Food Safety, 240.485.2732, robyn.pyle@aphl.org