The Design and Development Register runs on the Company Workspace. Original drawings and test reports are kept in a folder on your computer, and the register holds only the results of each stage and the evidence locations (names and content are encrypted with a different key for each company, while numbers, dates, statuses and scores are left as they are so they can be aggregated).
Design and Development Register: design and development under ISO 9001 8.3 · ISO 13485 7.3 · ISO 21001 8.3 · ISO 50001 8.2 as operational data

For each design project, enter the result, completion date, approving position and evidence location of each stage (planning, inputs, outputs, review, verification, validation, transfer). The project closes only when review, verification, validation and transfer are "conforming" (or "not applicable" with a reason). Design changes are linked by the CH- number of the Change Management Register, and the ISO 13485 design file list can be downloaded as Excel. IATF 16949 projects use the APQP of the IATF 16949 Core Tools as it is. Stage deadlines appear in the Operations Calendar.

  1. ① ProjectSet the product, project, standard and responsible position, and the default stages are set up.
  2. ② Stage recordsEnter the result, completion date, approving position and evidence location for each stage.
  3. ③ Design changesRequest them in the Change Management Register and link them by CH- number.
  4. ④ ClosureWhen review, verification, validation and transfer are in place, the approver closes the project.
Principles we follow: Evidence originals stay in your folder and only the location is recorded. A stage with a recorded result is not deleted. Positions are used instead of personal names. Clauses that could not be verified against the original text are marked "To be confirmed". Data is not used for AI training.

My design and development register

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