Medical Molecular Lab certification
i work in a medical diagnostic facility with imaging, physiotherapy and medical lab processes, now we have established a molecular lab, which iso certification can i get the molecular lab certified meanwhile we are currently we are certified to 9001:2015
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Always confirm with the relevant regulatory bodies. However, if the results of the tests are being used for medical diagnostic purposes then ISO 15189:2022 Medical Laboratories - Requirements for quality and competence is the standard to be accredited to. If the testing is for non-medical purposes (for example forensics or in some cases for trial purposes only), then ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories is the appropriate standard to be accredited.
For more information on ISO 17025, have a look at https://advisera.com/17025academy/what-is-iso-17025/
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Jun 14, 2023