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Doctor Operating CT Scanner

Audits

As part of the routine work, and managing regulatory processes, QA-Base team will guide and support the client with all issues and compliances with internal and external Audits.

QA-Base team will monitor and guide for improvements all internal processes, training and performances of all activities in the client's organization in order to prepare them for external Audits from the different NB and according to the relevant ISO standards they need to comply with, and with any requirements the CE/FDA will need in order to approve the related standards.

Internal Audits will be prepared and managed by QA-Base team, will perform them internal and give points for improvement in order to fully comply with the external Audits, and in order to pass the Audits in the best and easiest way.

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** all documentation related to the above processes will be the customer property and will be implemented in the customer IT/ database system.

Part of the document will be:

Quality manual and policy, document related to ISO9001, ISO 13485, or other required ISO/ standards, document related to CE/ FDA/ CFDA/ AMAR etc, training documents, management review documents, paperwork related to internal and external audits, etc.

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