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Arena PLM to become the new centralized PLM/Change Control and Documentation Control system. BOM, Quality Incidentes/CAPA to be included in a separate module. -
Arena system expected to be implemented for the Invisalign QMS as per the Global QMS strategy -
Hold preparatory sessions with site leadership and relevant stakeholders to gather the relevant information and prepare the meeting efficiently -
Meeting performed at least yearly in order to verify the effectiveness of the Quality Management System. -
Full QMS scope audit carried out by the Global organization in order to demonstrate conformity to Internaltional Standards, Regulations and Align Internal Policies and Procedures -
Site processes must be cycled as per the risk assessment performed in advance and according to the Global/Corporate guidelines (currently once per year) -
New integrated scorecard for the site to be released with the Global KPIs. Potentially, Treat scorecards can be reviewed specifically -
Still unknown. Depending on the global certification strategy, Treat organizations in EMEA may undergo the Dekra External Audit process based on their risk assessment.
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All the site Internal Audits need to be completed in order to assess the new Audit Schecule for 2023 -
In order to improve planning and added value to QMS processes in the EMEA Treat organizations, Quality Planning for 2023 should be completed at least 15 days before the year end to allow coordination between different sites and reporting to the Global organizaiton
