Conjuntos funcionales (functional kits)

Evaluation of the definition and implementation of the internal procedures and guidelines, defined by the manufacturer, for the control of conformity of production provisions according to the regulatory acts affected by the granted “conjuntos funcionales”.

Procedure

After granting approvals via a “conjunto functional” by the Approval Authority, the manufacturer must carry out production controls and go through the first conformity of production audit one year later. Once the audit is done, a report with the conclusions is issued. If there are deviations, they must be solved and documentary evidence of this must be sent before the certificate can be issued. When the owners of the kits are manufacturers with a valid CoP certificate, this process can be included within a single joint process.

Request

If you need a Conformity of production certificate for “conjuntos funcionales” and have not reached us yet, you can write us on uca@ffii.es or call (+34) 91 684 22 01.

Fee

Depending on the typology of the kit, a documentary or on-site evaluation procedure can be established. On-site audits outside Spain will require the extra charge of trip and accommodation expenses for the audit team.

On-site Audit: 1730€ + VAT
Documentary Audit: 541€ + VAT