Which standard of ISO is to be followed for PCR testing?

20 January 2022 0 9K Report

We are working on Dengue PCR and now after consistent good results we want to offer it on commercial level. But before that we would like to adopt an ISO standard. We have GLPs in place and for management documentation we are following ISO 9001. Due to small funding I would like to buy only one document, so I need help taht which standrad should we follow? I was looking at ISO 15189:2012, ISO 20837:2006, ISO 13485:2016. Kindly suggest if any other should be followed.

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Science method

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