Implementation Roadmap

Manufacturer onboarding shall establish that a participating organization can produce, identify, document, inspect, and support System05 Products within a declared scope.

Onboarding shall address:

organizational identity and responsibility;

authorized Product families;

technical-document control;

material and Supplier management;

process capability;

tooling and measurement;

inspection and calibration;

Product identity and traceability;

Nonconformity and corrective action;

cybersecurity and data integrity;

support, recall, and lifecycle obligations.

Manufacturers shall receive the applicable Specifications, Interface artifacts, reference specimens, validation suites, and change notifications.

Participation shall not require disclosure of unnecessary proprietary internal technology. However, information essential to safety, Compatibility, verification, maintenance, and replacement shall remain available.

Initial onboarding may use provisional or limited manufacturing status.

System05 marketplace presence, payment of fees, or completion of administrative registration shall not establish manufacturing Conformance.

Manufacturers shall report material changes affecting released Products and shall not continue using withdrawn Specifications or expired qualifications.

Withdrawal or failure of a manufacturer shall trigger defined Product-support, replacement, and Building-risk management procedures.