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Memoire during your transition assessments. This could be used as a gap analysis tool or as an aide Records and examples that address the additional requirements. It a useful tool for analysing your progress prior to booking a transition assessment. It is not an exhaustive checklist, but contains summary statements of most of theĬompletion of this form is not mandatory and does not need to form part of the transition process. This document allows you to detail how you intend to meet the additional requirements of the new standard, so should be The standard or transitioning from ISO 13485:2003 / EN ISO 13485:2012. BSI is committed to ensuring a smooth assessment for all clients wishing to certify to ISO 13485:2016, whether you are new to
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