Factory Production Control Certification

The certification process begins with the submission of an application together with the required technical documentation. Upon acceptance of the application, an assessment of the Factory Production Control system and an inspection of the manufacturing facility are carried out.

During the initial inspection, the manufacturing organization, personnel, production processes, equipment, incoming material inspection, testing facilities, and the overall implementation of the Factory Production Control system are evaluated to verify compliance with the applicable requirements.

If non-conformities are identified during the assessment, the manufacturer is notified in writing and is required to implement corrective actions within the specified timeframe. Failure to address the non-conformities adequately may result in the suspension or withdrawal of the certificate.

Following a successful assessment, the Notified Body issues a Certificate of Conformity of the Factory Production Control System (System 2+). The certificate entitles the manufacturer to issue a Declaration of Performance (DoP) and to affix the CE marking to the products covered by the certificate.

After certification, the Notified Body performs periodic surveillance to verify the continued compliance and effective operation of the Factory Production Control system and to ensure that product performance remains consistent with the applicable technical specifications.

In years when no surveillance inspection is scheduled, the manufacturer submits an annual declaration confirming whether any significant changes have occurred in the manufacturing process or the Factory Production Control system.

If the manufacturer intends to certify additional products or expand the scope of the existing certificate, an application for extension may be submitted. The Notified Body carries out the necessary assessment before extending the certification scope.

The manufacturer is responsible for maintaining the Factory Production Control system and for informing the Notified Body of any planned changes that could affect the characteristics or conformity of the certified products.