Achieving Excellence in Regulatory Science
Fisheries and Oceans Canada’s National Aquatic Animal Health Laboratories Attain International Accreditation
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Safeguarding Canada’s reputation for high-quality fish and seafood—as well as the livelihoods of those who work in the industry—depends on the ability to deliver accurate, reliable, and consistent test results for detecting aquatic animal diseases.
Ongoing growth in the global trade of wild and farmed fish and seafood products brings with it increased risk of transferring aquatic pathogens (disease-causing agents) from one place to another. While these pose no risk to human health, they have the potential to be devastating to wild fisheries and aquaculture operations by affecting the ability of infected marine species to grow, reproduce, or survive.
In recent years, staff at three diagnostic laboratories in the Fisheries and Oceans Canada National Aquatic Animal Health Laboratory System (NAAHLS) have been working diligently to develop formal quality management systems to meet ISO 17025 requirements. ISO 17025 (general requirements for the competence of testing and calibration laboratories) encompasses detailed specifications for laboratories that perform diagnostic testing, established by the International Organization for Standardization (ISO).
Since Canada is a member of the World Trade Organization (WTO), NAAHLS labs and the diagnostic tests they perform must meet standards established by the World Organization for Animal Health (OIE). Achieving accreditation to these international standards provides our trading partners with confidence in Canada’s diagnostic testing and management of aquatic animal health. Sound diagnostic testing enables the Canadian Food Inspection Agency (CFIA) to attest to the health status of Canada’s fish and seafood exports, and to ensure that imports from other countries pose no risk of transferring infectious aquatic pathogens to Canada. Testing also supports surveillance of the presence or absence of pathogens in various locations across the country, and is part of investigations into reports of disease.
“The accreditation of NAAHLS laboratories is good because it indicates the labs have a quality management system in place, and have the capacity and competence to manage and conduct specific diagnostic tests,” says Anne Veniot, a Fisheries and Oceans Canada biologist and national manager of the NAAHLS. “That provides confidence in test results for trading partners that import Canadian fish and seafood products, and for those involved in protecting aquatic animal health.”
“Accreditation is a way of formally capturing everything the lab does on a day-to-day basis by documenting it in a standard format,” says Veniot. The lab staff began preparing years before an application for accreditation was submitted by developing and documenting the lab’s quality management and technical systems and assessing them through internal audits to ensure they are working properly. The two systems operate together to ensure full traceability of the samples it receives for diagnostic testing.
“The management system is a very detailed description of every aspect of how labs operate, including the roles and responsibilities of all staff, communications with partners and clients, and standard operating procedures and protocols for all lab activities including the management of forms, records and other documents used to track samples from collection to final test results,” says Veniot. “The technical system concerns how the tests are performed, and the procedures and protocols in place to ensure they are operating correctly and are suitable for their intended purpose.” It can take anywhere from two to five years to validate each diagnostic test. Once validated, the performance of a test is monitored on an ongoing basis to ensure it continues to provide accurate and precise results.
Each lab must also document and record its formal training program, which any new staff must undergo. Training can involve many steps including reading about and observing operating procedures, performing procedures while under supervision, and carrying them out independently followed by a performance evaluation.
Once these systems have been established, documented, and tested, the lab applies for accreditation to the Standards Council of Canada (SCC), which does an initial review of the documentation prior to conducting a detailed on-site audit of lab operations. Accreditation is only granted once laboratories address findings from the audit.
Successful completion of the first audit and receiving accreditation is a major milestone, however sustaining a lab’s status requires ongoing vigilance. To maintain accreditation, labs must be audited again on the one-year anniversary of the first SCC audit, and every other year after that.
Benefits of accreditation
The accreditation of NAAHLS laboratories has a wide range of benefits, including it:
- demonstrates the laboratories’ capacity and competence to manage and carry out specific activities;
- provides those who rely on the laboratory for testing—including Fisheries and Oceans Canada, the CFIA, industry stakeholders, members of the public, and trading partners—with confirmation that the way the lab operates and the tests it performs meet international standards, providing confidence in its test results;
- provides sound diagnostic testing to inform regulations and management decisions related to aquatic animal diseases; and
- supports the export of fish and seafood products from Canada, and imports from other countries.
“In September 2014, the NAAHLS lab at the Freshwater Institute became the first to receive ISO 17025 accreditation,” says Veniot. “Followed by the lab at the Pacific Biological Station on February 28, 2016 and the lab at the Gulf Fisheries Centre on June 15, 2016.” Quality management to maintain excellence in regulatory science is an on-going process to which the staff at NAAHLS laboratories are committed.
“Accreditation to the ISO 17025 standard shows that our National Aquatic Animal Health Laboratories can hold up to scrutiny, and that Canada has a solid regulatory diagnostic foundation for the care and protection of Canada’s wild fish and seafood industry,” says Veniot.
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