Achieving Excellence in Regulatory Science - ISO 17025 Laboratory Accreditation
Fisheries and Oceans Canada staff at three diagnostic laboratories share their journey towards ISO 17025 accreditation. Achieving accreditation to these international standards provides trading partners and Canadians with confidence in Canada’s diagnostic testing and management of aquatic animal health.
Transcript
As part of the National Aquatic Animal Health Program; Fisheries and Oceans Canada is responsible for providing sound diagnostic testing for infectious aquatic animal diseases of national and international concern for wild and farmed fin fish, molluscs, and crustaceans. These diagnostic results help ensure the protection of our wild and captured fish, aquaculture industry, and trade with international partners. Testing takes place in three labs across the country that have recently received their ISO 17025 accreditation; the Pacific Biological Station in Nanaimo, British Columbia; the Freshwater Institute in Winnipeg, Manitoba; and the Gulf Fisheries Centre in Moncton, New Brunswick.
As Canada is a member of the World Trade Organization, these labs - and the diagnostic tests they perform - must meet standards established by the world Organization for Animal health. These standards are known as ISO 17025 and the process of becoming accredited is highly complex. The National Aquatic Animal Health Program is co-delivered by Fisheries and Oceans Canada and the Canadian Food Inspection Agency (or CFIA).
Derek Williams (Quality Manager, Aquatic Animal Health Laboratory, Pacific Biological Station)
We're part of the National Animal Aquatic Health Program and CFIA is the lead and Fisheries and Oceans Canada does the diagnostic testing for them. So they are the ones that enforce the regulations and they are the ones that go and do the sampling, they send the samples to us, we do the testing and report the results to them.
Anne Veniot (National Manager, National Aquatic Animal Health, Laboratory System)
Whether it's samples from an aquaculture site in Canada or from wild fish in a river through surveillance, the results we are producing are accurate, and they are reliable. And so we can speak with confidence and we can provide our results to the Canadian food inspection agency and they can be confident that when they are making a call on a disease that is based on sound science and sound diagnostic results.
Mark Higgings (Section Head, Aquatif Animal Health Laboratory, Pacific Biological Station)
The diagnostic testing has not changed but to meet these international guidelines we need to have a sound diagnostic process in place.
Suzanne Richardson (National Laboratory Accreditation, Coordinator)
The ISO 17025 has two main sections: there's the management requirements and the technical requirements. On the technical side of the requirements, you’re basically looking at the traceability and the quality of everything that touches the samples.
So from the time the sample is received at the lab to the time you actually output your diagnostic results... including storage and disposal. It has to be done so that you can trace beyond all reasonable doubt the sample from each one of those steps...
Derek Williams (Quality Manager, Aquatic Animal Health Laboratory, Pacific Biological Station)
Essentially, you are starting from the ground up, you have to create procedures for almost everything you do. You have to create a policy which applies to all those procedures, you have to create a framework, for conducting internal audits, for analyzing the data that you produce, for doing a review of all your work and another framework for continually improving your process.
Sunita Khatkar (Section Head, Aquatic Animal Health Laboratory, Freshwater Institute)
It is not a big shift in how we do things, it's about making sure our quality assurance and quality control activities are part of our process, not a separate activity.
Derek Williams (Quality Manager, Aquatic Animal Health Laboratory, Pacific Biological Station)
The main underlying theme of ISO 17025 standard is continuous improvement and that just means that you're constantly improving the effectiveness of your system.
Erin Burns-Flett (Quality Manager, Aquatic Animal Health Laboratory, Freshwater Institute)
They want to see evidence of your continuous improvement, so when new staff come on they have all the training... that's pretty rigorous, it's very well documented, it's everything from reading operating procedures that's a starting point, to actual practical on-the-bench work, where you're observed and you run test samples.
Sunita Khatkar (Section Head, Aquatic Animal Health Laboratory, Freshwater Institute)
Once they demonstrate that proficiency, then they have been authorized to perform a specific task.
Anne Veniot (National Manager, National Aquatic Animal Health, Laboratory System)
It's really a way of doing business, it's a way of operating that we've come to adopt in our system, to make it stronger and really have those reliable results that we need for a diagnostic program.
Mark Higgings (Section Head, Aquatif Animal Health Laboratory, Pacific Biological Station)
To put this in place, it's taken almost ten years and so to actually reach the end of the road has been just a huge joy and relief.
Derek Williams (Quality Manager, Aquatic Animal Health Laboratory, Pacific Biological Station)
So once you get accredited, it's kind of like getting on a train that you don't get off. So it starts and it doesn't stop and you just have to keep working and keep getting better and then they keep coming and finding more work for you to do but again, as long as you keep focused on improving your system and improving the quality of your results, it's all worthwhile.
Fisheries and Oceans Canada
For more information, visit: www.dfo-mpo.gc.ca
© Her Majesty the Queen in Right of Canada, 2016
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