In order for the National Safety Authority (i.e. the ORR in the UK) to be satisfied that they are in a position to authorise your programme to be placed into service (APIS), they need to be assured that the following can be demonstrated.
The programme has been defined with the technical scope and interfaces clearly defined;
Compliance to Technical Specifications for Interoperability and applicable National Standards has been demonstrated;
The system has been safety integrated;
Operational readiness;
Maintenance readiness;
This will need to be demonstrated in the Technical File that supports the EC Declaration of Verification (the ECDV-TF); not to be confused with the Notified Body and Designated Body Technical Files. The NoBo and DeBo Technical Files form part of the overarching ECDV-TF. From experience it is best (as with most things) to start preparing the ECDV-TF early in the process and then keeping it up to date as the project progresses. This can then be shown in meetings with the National Safety Authority in the build up to the Authorisation application to help build confidence and demonstrate that the submission is under control.
It is therefore vitally important that this is recognised early in the process and communicated to the project team so the importance of these activities can be understood. There is often a focus on ‘getting stuff built’ and evidence regarding Operational and Maintenance readiness not always given as much attention as is required.
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