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We are an ISO17025 accredited laboratory in South Africa. Our accreditation system states that we must have a complete schedule of all the tests we perform attached to our accreditation in order for the test to be covered by the accreditation.
This accreditation suits our routine TDM laboratory well, as tests do not change often. This type of accreditation does not however, suit our PK laboratory as we continually develop novel assays for pharmacokinetic studies, and under the current authority, we need to apply for the accreditation of every test developed.
Does any other laboratory have this problem? And how did you solve it? Our current accreditation authority is loathe to accept "technique accreditation" for a clinical laboratory.
Division of Clinical Pharmacology
University of Cape Town
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