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. Leads with the ten findings that matter most, then walks the essential health and safety requirements in numerical order, judging each clause satisfied, partial, out of model scope or not satisfied. It drafts requirement statements for the gaps that carry a hazard, and reports the requirements that satisfy no clause at all.

What you need to run it

The connected model, and nothing you have to buy: Annex III is public law, free to read on EUR-Lex and free to reuse, and 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. 01Paste or attach the Annex III text. The run works without it, but with it every clause is walked against the current wording rather than from recall.
2. 02Optionally paste the confirmed list of applicable Annex III parts, which overrides the proposal the workflow makes in Step 2.
3. 03Optionally 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. Top findings. The ten findings that matter most, two sentences each, in plain language, no clause number in the first sentence.

Step 4. 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.
  partial, out of model scope: the clause obliges things a system model does not hold (marking, instructions, materials certification, production acceptance testing). Report it, but exclude it from the coverage percentage.
  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: draft statements only where a hazard in the model falls under the clause, maximum fifteen, ranked by hazard severity; for the rest, name the gap without drafting. Every drafted statement is specific, measurable and verifiable, and names 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.

Check the state machine against every clause about stopping, starting and restarting. Report any operating state from which a required transition is missing.

Step 5. 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 6. 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 7. Coverage summary: clauses applicable, satisfied, partial, partial out of model scope, not satisfied, not applicable, and the percentage of applicable in-scope clauses satisfied.

Step 8. Provenance: the model element IDs behind every match. End with a compact table of clause number, coverage and matched requirement IDs, so two runs can be compared directly.

Output: a findings report with the top findings first, then the coverage summary, 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