
Who declares aggregates and who assesses FPC?
Who declares aggregates and who assesses FPC?. Evidence, a conditional example and responsibility boundaries for this preparation purpose.
Scope and decision inputs
Separate manufacturer declaration and CE responsibilities from laboratory reports and any required third-party production-control assessment or certification.
Identify the actual system for the product and use. Do not assign every aggregate to system2+ or call every laboratory a notified certification body.
Conditional case and response
Hypothetical provider shows an accreditation logo and an FPC certificate, but the product scope and assigned task cannot be matched.
Check the actual notification and certificate scope, site and aggregate coverage. Accreditation or a logo alone does not prove the required designation.
Evidence outputs and responsible parties
Record who issues each output and who may decide an unresolved coverage question. A preparation contract must identify external decisions separately.
Kayra supports preparation and coordination; it does not assume the manufacturer’s declaration or the notified body’s certification decision.
Record responsibilities against each output
Create a responsibility list for the manufacturer’s declaration, laboratory reports and any required production-control assessment. Match each external task to the actual product, site and scope. Keep an unassigned decision visible in the preparation plan; a coordination contract does not transfer the manufacturer’s declaration responsibility or the body’s certification decision to Kayra.
Related service guides
- Aggregate CE: product scope, evidence and production control
- EN12620, EN13043, testing and aggregate FPC
- Aggregate CE workflow: resolve scope before declaring
- Aggregate CE preparation: compare provider outputs
- Aggregate CE records: link source, sample and declaration
- Aggregate CE cost and time: separate tasks and dependencies
- Verify aggregate declarations and FPC scope
- Aggregate changes and surveillance: maintain real coverage
- Aggregate assessment: inspect actual production control
- When does aggregate CE apply? Establish use and route
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Who declares aggregates and who assesses FPC? — Send the actual source, fraction, site, use and existing records to discuss the preparation outputs; external decisions remain with the responsible parties.