What is the ISO 17025 Standard

ISO 17025 is the international standard for laboratory competence, setting the benchmark for accuracy, reliability and consistency in testing and calibration laboratories. Developed by the International Organization for Standardization (ISO), this standard ensures that laboratories operate with scientific precision, validated methods and rigorous quality controls.

Why ISO Accreditation Matters

ISO 17025 accreditation is more than just a certification - it's a commitment to excellence in food safety and public health. For FSIS, this accreditation ensures that its laboratories meet the highest international standards for testing accuracy, reliability and consistency. Consumers trust that the food they purchase has been tested for safety. ISO accreditation serves to assure consumers that FSIS laboratories operate with the highest level of quality control, reinforcing confidence in the US food supply.

ISO accreditation is a vital component of FSIS' statutory mission to protect public health through science-based inspection of meat, poultry and egg products. By requiring laboratories to meet internationally recognized standards for testing accuracy, reliability, and consistency, ISO accreditation strengthens FSIS's ability to detect pathogens, chemical residues and other contaminants that pose risks to consumers. This accreditation supports FSIS' enforcement of the federal meat, poultry and egg acts by ensuring that laboratory data used in daily inspection and enforcement decisions is scientifically validated and independently verified. In today's complex food production environment, ISO accreditation not only ensures that public health protections remain strong, credible and responsive to emerging food safety challenges, but also ensures that the regulated industry is treated fairly.

FSIS laboratories analyze food and other samples for pathogens, chemical residues, veterinary pathology and other contaminants that could pose a risk to consumers. ISO accreditation guarantees that testing methods are scientifically validated, standardized and reproducible, reducing the risk of errors that could compromise food safety. FSIS inspection staff rely on laboratory results to make sound decisions about the safety and regulatory compliance of FSIS-regulated food products each day. These decisions are grounded in the principles of the Information Quality Act and support enforcement of key public health laws such as the Federal Meat Inspection Act, the Poultry Products Inspection Act and the Egg Products Inspection Act. Together these statutory frameworks ensure that the data underpinning regulatory decisions are scientifically valid, reliable and serve to protect consumers.

ISO accreditation is not a one-time achievement - it requires ongoing audits, evaluations and improvements. FSIS laboratories continuously refine their procedures, adopt new testing technologies and work to meet emerging food safety challenges.

By adhering to ISO 17025 standards, FSIS maintains a clear, documented and auditable process for laboratory testing. This ensures that decisions related to food safety are based on scientifically sound and independently verified data.

Current ISO Accreditations and Requirements

FSIS maintains ISO 17025 accreditation at three laboratories located in: Athens, Ga., St. Louis, Mo. and Albany, Calif. These laboratories have been accredited to the ISO 17025 standard since 2002.

To achieve and maintain ISO 17025 accreditation, FSIS laboratories must meet strict requirements in the following areas:

1. Proficiency Testing and Laboratory Competency
   • FSIS laboratories must demonstrate competency in the specific analyses they perform.
   • A proficiency testing program ensures that FSIS labs can accurately detect contaminants like pesticides and other chemical residues, Salmonella, Campylobacter, Listeria and E. coli STEC.
2. Comprehensive Documentation and Quality Assurance
   • FSIS laboratories maintain a detailed quality system containing standardized step-by-step work instructions to perform testing.
3. Regular Audits and Continuous Monitoring
   • An independent accrediting body assesses FSIS laboratories annually to verify compliance.
   • FSIS laboratories also undergo internal audits and quality checks to identify areas for improvement and potential noncompliance.

Maintaining Accreditation and Continuous Improvement

ISO 17025 accreditation requires ongoing commitment to quality, precision and scientific integrity. FSIS laboratories continuously work to maintain accreditation by adhering to compliance measures and adopting innovative improvements in food safety testing.

FSIS maintains ISO 17025 accreditation through annual assessments conducted by an external accrediting body, which evaluates laboratory procedures, documentation and testing accuracy. Any findings are addressed through corrective actions and process improvements. In advance of external auditing, the FSIS Laboratory Quality Assurance, Response and Coordination Staff conducts routine internal audits to proactively identify areas for improvement. These internal audits verify compliance with ISO 17025 standards and prepare the laboratory system for external audit success. FSIS' quality management system ensures that all processes remain up to date, are scientifically sound, and performed consistently. FSIS staff receive ongoing training in new testing methods, quality control procedures and ISO standards. Regular competency assessments ensure analysts maintain their proficiency in food safety testing.

FSIS laboratories adapt to emerging food safety challenges by continuously enhancing testing capabilities to detect new contaminants, pathogens and chemical residues. New analytical techniques and technologies are incorporated to improve accuracy and efficiency, such as reducing time to result. FSIS evaluates and refines testing methodologies to keep pace with scientific advancements. New methods undergo rigorous validation before being implemented in the accredited laboratories.

FSIS ISO Accreditation History

FSIS moved to obtain ISO 17025 accreditation after the USDA Office of Inspector General recommended the agency strengthen its quality assurance programs in Report No. 24601-1-Ch (June 2000). The audit stressed the need to ensure that all FSIS laboratories were in full compliance with applicable standards and consistently producing valid, scientifically supportable analytical results. In response, FSIS joined a pilot program with the Food and Drug Administration and several state and local public health partners. Recognizing the value of international standards in food safety testing, FSIS took proactive steps to align its laboratory operations with ISO 17025 standards. In 2002, FSIS successfully earned ISO 17025 accreditation. Over the years, FSIS has embraced continuous improvement by including advanced testing methods and adapting to emerging food safety threats.

Today, FSIS' world class laboratories stand as a model of scientific excellence, with ISO accreditation reinforcing the agency's commitment to public health and international food safety standards.