Optima® Check-In
Is your machine instruction manual actually compliant with ISO 20607?
Import your existing PDF or DOCX manual. Our assistant audits each criterion according to ISO 20607 and Regulation 2023/1230 and delivers an actionable compliance score in minutes.
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Why check the quality of your machine's instruction manual before 2027?
EU Regulation 2023/1230, which will apply from 20 January 2027, does not simply reconfirm the requirements of Machinery Directive 2006/42/EC. It profoundly modifies the obligations relating to instruction manuals: a digital format by default, continued accessibility throughout the machine's lifespan, and new requirements for connected machinery. A manual written in 2018, even if correct at the time, may today present compliance shortcomings without teams having realised it. Standards evolve, machines are modified, uses change, and the manual remains static.
«The manufacturer must ensure that the instructions for use accompany the machinery throughout its foreseeable lifetime and remain compliant with current requirements.
What an audit reveals: the most common shortcomings
In the instruction manuals audited by Optima AI, compliance gaps consistently focus on the same points:
- Incomplete safety instructions: not all residual risks identified in the risk analysis are reproduced in the manual
- Under-documented maintenance: servicing procedures too vague, intervals not specified, spare parts not referenced
- Partial operating modes: only the nominal mode is covered, setting, maintenance, or emergency modes are absent
- Decommissioning absent: the section on decommissioning and disposal is omitted or dealt with in a few lines
- Unsuitable language: the instructions are not available in the language of the country of marketing
What OPTIMA Check-In verifies: the ISO 20607 criteria
The sections audited in each notice
- Machine identification: description, serial number, manufacturer’s contact details, applicable declarations
- General description and intended use: functions, limits of use, reasonably foreseeable uses
- Safety information: general guidelines, PPE, hazard zones, warning signs, residual risks
- Transport, packaging, storage: masses, lifting points, environmental conditions
- Installation and commissioning: installation requirements, connections, pre-start-up checks
- Operation: procedures for all intended operating modes (nominal, adjustment, cleaning, emergency)
- Maintenance: preventative maintenance, access to maintenance areas, required qualifications, spare parts
- Troubleshooting: diagnosing common malfunctions, recommissioning procedures
- Decommissioning and disposal: dismantling, decontamination, sorting of materials
Instruction Manual and Regulation 2023/1230: what's new to incorporate
Beyond the structural requirements of ISO 20607, EU Regulation 2023/1230 introduces specific obligations which instructions drafted under the old Directive may not necessarily cover:
- Standard digital format: the notice must be provided in digital format, accessible via a link, QR code or online portal; the paper version is only sent upon request
- Long-term accessibility: the instruction manual must remain available for consultation throughout the machine’s service life, including in the event of a change of ownership
- Mandatory cybersecurity: for any machine with a digital interface or network connection, cybersecurity instructions must be included in the manual
- Collaborative robots: cobots require specific sections on adaptive human-machine interface and collaboration zones
- Strengthened multilingualism: the requirement to provide information in the language of the country of commissioning is retained and clarified
FAQ
Frequently asked questions about machine notice compliance audits
How to check if my instruction manual complies with ISO 20607?
Verifying that an instruction manual complies with ISO 20607 involves checking for the presence and quality of each mandatory section defined by the standard: identification, general description, safety, transport, installation, use, maintenance, troubleshooting and decommissioning. Each section must also cover the residual risks identified in the ISO 12100 risk assessment. OPTIMA Check-In automates this verification in a matter of minutes using your PDF or DOCX document.
What criteria does Optima Check-In check in my notice?
OPTIMA Check-In verifies the completeness and quality of each mandatory section according to ISO 20607 and EU Regulation 2023/1230: presence of machine identification information, coverage of all intended operating modes, completeness of safety instructions with regard to residual risks, quality of maintenance documentation, and for connected machines, presence of cybersecurity instructions introduced by Regulation 2023/1230. Each criterion is assigned a NON-COMPLIANCE level of CRITICAL, IMPORTANT, or MINOR.
What does the "IMPORTANT" statue in my report mean?
The IMPORTANT level indicates a notable discrepancy in your notice: the section is present but incomplete or insufficiently developed in relation to the regulatory requirements. This is not an immediately blocking discrepancy, but it exposes the manufacturer to risk in case of inspection or accident. In practice, IMPORTANT discrepancies constitute the list of priority works to be undertaken before the application of Regulation 2023/1230 in January 2027.
Your notice has a low compliance score, what are my options?
A low score precisely identifies the sections needing correction, and that's the information you need to prioritise. You have two options: manually revise the notice using the criterion-by-criterion report, or use OPTIMA Design to regenerate the missing sections based on existing functional and risk analyses. In either case, a new Check-In analysis validates the corrections made. This audit-correction-validation loop is at the heart of living compliance.
How long does a machine instruction notice audit take?
Manually, a full audit of a notice by a compliance expert takes between 4 and 8 hours depending on the complexity of the machine and the length of the document. With OPTIMA Check-In, the analysis is produced in a few minutes from the imported document. Human time is then focused on reading the report and deciding on the corrections to be made, rather than on the tedious process of reviewing the notice section by section.
What is the difference between Optima Check-In and Optima Conception?
These two tools address distinct but complementary needs. OPTIMA Check-In audits an existing instruction manual and identifies any compliance issues. OPTIMA Conception generates an ISO 20607-compliant instruction manual based on a functional analysis and a risk analysis. In an ideal compliance workflow, Check-In is used after Conception to validate the produced package leaflet, or upstream on an existing product portfolio to carry out a baseline assessment prior to the updates required by Regulation 2023/1230.
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