ISO 9001 - EN 46001
Notification Body
T_V
The ISO 9001 certification represents the greatest acknowledgment
for a company quality systems and the EN 46001 is the specific
set of rules required for the production of "Medical
Devices”.
The notification body renews the certification every 3 years
after an investigated and repeated analysis of the fulfilment,
the observance and the improvement of all the whole quality
procedures in use. Every year a control audit is carried out
in order to check the update of the internal procedures according
to the new rules relating to Quality.
Following the audit, the approval and the authorization of
the Notification Body, the quality certification allows Soleko
to affix the CE mark to its products, essential for the sale
of the Medical devices including the whole Soleko production.
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