Annex III requirement gap auditor

The problem this solves

Annex III of Regulation (EU) 2023/1230 is the list of essential health and safety requirements every machine placed on the EU market must satisfy. Teams work through it once, in a spreadsheet, by hand, and it is stale by the next design change. Run against the model instead, the answer is current every time, and the clauses nothing addresses stop being the ones nobody noticed.

How it works

For each applicable Annex III clause: does a requirement in this model satisfy it, and is it verified. Walks the essential health and safety requirements in numerical order, judges each clause satisfied, partial or not satisfied, drafts a requirement statement for every gap, and reports the requirements that satisfy no clause at all.

What you need to run it

Nothing beyond the connected model. The Annex III clause list is part of the workflow, because EU legislation is free to reuse; no ISO or IEC text is reproduced. Regulation (EU) 2023/1230 applies from 20 January 2027, and the technical file it requires is kept for ten years after the machine is placed on the market. This is a coverage check of the model against Annex III, not an assessment of conformity.

1. 01Optionally paste the confirmed list of applicable Annex III parts, which overrides the proposal the workflow makes in Step 2.
2. 02Optionally give the machine's Annex I category, if you know it, since an Annex I machine may require third-party conformity assessment.

Audit the requirements in the connected Dalus model against Annex III of Regulation (EU) 2023/1230, the essential health and safety requirements. Do not modify the model.

Step 1. Read the model: all requirements with customer ID, statement, type, priority, status, constraints, verifications and assigned systems; all hazards with severity, residual risk, assigned systems and mitigating requirements; all test cases with linked requirements and runs; all parts, connections and flows; and any states and transitions.

Step 2. Determine which parts of Annex III apply. Part 1 (general essential health and safety requirements) applies to all machinery. Add the additional parts for specific hazard categories where the machine warrants them: mobility, lifting, underground work, and lifting of persons. Justify each inclusion and exclusion in one sentence, grounded in a model element or in the machine type. Present this as a proposal the team must confirm, and say that a machine listed in Annex I may require third-party conformity assessment.

Step 3. Walk the applicable clauses of Annex III in numerical order. For each clause, report:
- Clause number and title, and a one-line restatement in your own words of what it obliges the manufacturer to do. Do not reproduce the Regulation's text at length.
- Requirements in the model that satisfy it, with customer ID and statement. Match on engineering meaning, not wording.
- Related hazards in the model that fall under the clause.
- Coverage: "satisfied", "partial", "not satisfied", or "not applicable" with rationale.
  satisfied: one or more requirements fully constrain what the clause obliges, with a measurable criterion.
  partial: a requirement addresses the topic but leaves part of the obligation unconstrained, or states no measurable criterion. Name exactly which part is unconstrained.
  not satisfied: the clause applies and nothing in the model addresses it.
- Verification: whether the satisfying requirements have a test case with a Passed run, or a declared analysis, inspection or demonstration with a description.
- Suggested requirement: for "not satisfied" and "partial", draft a requirement statement that would close the gap, specific, measurable and verifiable, and name the part or connection it should be assigned to and the hazard it would mitigate. Mark these clearly as suggestions, not model content.

Pay particular attention to clauses that models routinely miss: control system safety and reliability, protection against corruption of the control system, restart behaviour after a stop, stop functions and their categories, ergonomics and operator interaction, maintenance and isolation of energy sources, stability, and the additional obligations for mobile machinery and for machinery with self-evolving behaviour.

Step 4. Reverse check. List model requirements that satisfy no Annex III clause. For each, classify as internal design intent, customer-specific scope, or unclear purpose. Do not recommend removal.

Step 5. Findings, ranked:
- Applicable clauses "not satisfied" where a hazard in the model falls under them
- Other applicable clauses "not satisfied"
- Clauses "partial", ordered by how much is unconstrained
- Clauses satisfied but with no verification
- Requirements satisfying no clause

Step 6. Coverage summary at the top: clauses applicable, satisfied, partial, not satisfied, not applicable, and the percentage satisfied with verification.

Step 7. Provenance: the model element IDs behind every match.

Output: a findings report with the coverage summary first, then the clause-by-clause table in Annex III order, the reverse check, the ranked findings and provenance. Annex III clause titles may be quoted since EU legislation is free to reuse; do not reproduce text from any ISO or IEC standard. State that this is a coverage check of the model against Annex III and not an assessment of conformity, and that the applicable-parts proposal in Step 2 must be confirmed by the team.

What you get

Common questions