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Test validity for the regulatory bodies

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Guest user Created:   Jun 03, 2020 Last commented:   Jun 04, 2020

Test validity for the regulatory bodies

We have purchased two of the advisera kits to implement ISO 9001 and 17025. We are in the process of implementation, and in a couple of months, we hope to be ready to get accredited. In the meanwhile, we are performing several experiments following some of the ISO protocols. For example, to test the antiviral properties of certain products, we follow ISO 21702:2019. With our customers, we always make it very clear that we are not yet ISO accredited. Some have told us that this is no problem for them (they have been working with us in the past and are happy with our performance), as long as they can state that the product has been tested following that particular ISO. Now, my question is: will the tests that we perform (strictly following the ISO protocols) be valid for the regulatory bodies, even if we are not yet accredited?
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ISO 17025 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 17025 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Tracey Evans Jun 04, 2020

You asked if your laboratory's use of a internal Standard test method will be valid for the regulatory bodies, even if you are not accredited.

I am not in the position to comment on specific regulations (e.g. FDA GMP) and can only comment from an ISO 17025 implementation and accreditation point of view.  Performing a test is only a part of the overall management system requirements of ISO17025. The competency required to provide a consistently valid result is demonstrated through a number activities to meet the requirements of ISO 17025. Hence the importance of accreditation – the process of independent assessment and attestation to this competency.

I do not know what regulatory bodies you are referring to, nor the purpose of the test, i.e. type of product and application. Bear in mind the requirements may be different; for example if the test results were being used for quality control for a manufacturer, compared to studies for research or a product registration.  As the laboratory, your responsibility is to understand, define and document the requirements for the work you do.  Out of interest, I can mention that if the testing relates to alcohol-based hand sanitizer products during the COVID-19 pandemic; the FDA has issued a Temporary Policy for the preparation of certain products. See https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-temporary-policy-preparation-certain-alcohol-based-hand-sanitizer-products-during

I suggest you enquire as to the specific requirements of your customers (the use / purpose of the test result) and the requirements of their applicable regulatory bodies. ISO 17025:2017 clause 7.1 Review of requests, tenders and contracts and clause 7.2 Selection Verification and validation of methods are particularly relevant to your question. These are covered under section 09_Customer_Service and 10_Test_and_Calibration_Method in the ISO 17025 toolkit. https://advisera.com/17025academy/iso-17025-documentation-toolkit/

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Jun 03, 2020

Jun 04, 2020

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