Quality System Assurance Support (BS EN 13485)

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A hospital trust contacted AVM for support because of an adverse inspection that threatened the continuation of registration. AVM attended the site and was then able to write a new quality system manual and introduce key SOPs.

Once these had been implemented, AVM carried out an internal audit. The result meant the trust was able to close all non-conformities and transitioned to 13485:2016 successfully.

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