The management of non-conforming products is definitely essential within any Quality Management System based on ISO 13485:2016 and FDA regulation; having a fully compliant NC Procedure and Non-conformance Report template (in word) is of great importance to avoid the release of non-conforming device and maintained quality, safety and efficacy of the device on the markets. A solid NC process to identify, segregate and investigate product deviation is one the pillar of manufacturing process for a regulated environment.
The process follows a specific well defined flow, that starts from the identification of the problem through root-cause identification and evaluation of the impact and the need of any advisory notice. Important decisions need then to be taken about product disposition and the possibility to use or discard the non-conforming product.
Moreover, an impact assessment on the deviation shall always be performed, taking in consideration the risk management process, to ensure that the decisions to be taken during this process are always commensurate to risk.
Here at QualityMedDev we show a Non-conformance Report template fully editable in word that can be used to document the non-conformity records. , fully compliant with ISO 13485 and FDA regulations 21 CFR 820.
Do not hesitate to download the product!
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