The International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) issued their latest edition outlining the general requirements for the competence of testing and calibration laboratories, known as ISO/IEC 17025:2017. For food laboratories, ISO 17025 outlines how a competent laboratory should operate from framework and resource requirements to management and process systems. In essence, for a laboratory to generate accurate measurement results, it must build and engage an able structure for that testing. Proficiency testing is a necessary component of this formation.
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Food laboratories should be aware of how ISO 17025:2017 differs from its predecessor version of 2005. Somewhat similar to the risk-based approach adopted through the implementation of the Food Safety Modernization Act (FSMA), ISO 17025 applies what it calls risk-based “thinking” that integrates more flexibility and performance-based requirements in its 2017 edition. The updated version of the standard now aligns more closely with other relevant standards for the quality of medical laboratories (ISO 15189) and quality management (ISO 9001).
In order to monitor performance, laboratories under ISO 17025 must compare test results with results from other laboratories. There are two noted avenues for conducting this planned monitoring review: proficiency testing and other inter-laboratory comparisons. The purpose of proficiency testing, and other comparison practices, is to drive improvement in the quality and accuracy of measurements made within the laboratory.
ISO 17025 requires that data from these comparison exercises be analyzed and used to improve a laboratory’s functions. If the data show that test results register outside of predetermined criteria, a laboratory must address the variation and take action to prevent the performance and reporting of test results that are not fit for their intended purpose.
Already in Play
ISO 17025 is already referenced in federal regulation and guidance documents. In its final rule on accreditation of third-party certification bodies that conduct food safety audits, FDA noted a requirement to use a laboratory accredited under ISO/IEC 17025:2005 or another laboratory accreditation standard that provides at least a similar level of assurance for validity and reliability of analytical results. The agency’s draft guidance on the control of Listeria monocytogenes in ready-to-eat foods recommends taking action to ensure that a testing laboratory is knowledgeable, and suggests determining whether the laboratory is accredited to a standard such as ISO 17025.
The Food Safety and Inspection Service (FSIS), an agency with the USDA, accredits nonfederal analytical chemistry laboratories to analyze meat and poultry food products. This FSIS Accredited Laboratory Program recommends that participating laboratories follow standardizing procedures such as ISO 17025.
FSMA contains a provision for laboratory accreditation for the analyses of foods. Section 202 of the law calls for the development of model standards that laboratories must meet to be accredited. As FDA reviews existing standards for guidance, ISO 17025 may well become the basis for these model standards.
Laboratories that are accredited to the previous 2005 version of ISO 17025, while still valid, have three years to transition to the new version.
Proficiency Testing Providers
When it comes to externally provided proficiency testing services, ISO 17025 explains that these services must be suitable in support of the activities of the laboratory. One way to assess the competency of a proficiency testing provider for food laboratories is by its accreditation to ISO/IEC 17043:2010. ISO 17043 accreditation validates a proficiency testing provider’s technical competence and its operation of a quality management system.
For alternate inter-laboratory comparisons, laboratories would be well-served to have procedures for determining which external laboratories are appropriate for conducting the comparison service. Records should document the criteria used, services selected, and actions taken.
Under ISO 17025, laboratories must adopt a process for assessing their risks. Participating in proficiency testing provides an objective way to help laboratories detect and correct problems within a risk-based environment.
Stombler is director of the Food Laboratory Alliance and president of Auburn Health Strategies. Reach her at firstname.lastname@example.org.