ISO 12100 · Safety of machinery and the EU Machinery Regulation
ISO 12100 and Machinery Regulation compliance for machinery that is safe by design.
Machine builders, integrators and plants that modify their own equipment need to show that hazards were found and risks reduced before anyone stands next to the machine. Sterling's expert and experienced consultants set up the risk assessment method, the design review records and the technical file routine with your engineers. We help our clients put it into practice and prove it.
- Fixed scope, one proposal: consulting, Effivity software, Sterling Academy access and internal auditor training, as applicable to your standard, in one proposal
- A team of expert and experienced consultants who link machinery risk assessment with your quality and safety management systems
- The Sterling Promise: 100% on-time completion, 100% success, 8,100+ client engagements. Sterling does not certify, approve or CE-mark machinery; the manufacturer declares conformity and designated bodies assess where the law requires
8,100+ client engagements in 60+ countries.
Why manufacturers choose Sterling
What it is
What is ISO 12100 and how does it relate to the Machinery Regulation?
ISO 12100 is the ISO standard "Safety of machinery: General principles for design: Risk assessment and risk reduction". ISO describes it as setting basic terminology, principles and a methodology for achieving safety in the design of machinery, with a procedure for identifying hazards, estimating risks and eliminating or reducing them across the machine's life. It is also the base on which more specific machinery safety standards, type-B and type-C, are built.
In the European Union, the law on machinery is Regulation (EU) 2023/1230, published on EUR-Lex. CEN-CENELEC publishes guidance on the relationship between EN ISO 12100 and the Machinery Directive the Regulation follows. Manufacturers use the ISO 12100 method to structure the risk assessment the EU framework expects.
Current edition. ISO lists ISO 12100:2010 as the published edition, last reviewed and confirmed in 2022, and shows it will be replaced by ISO/DIS 12100.3, now under development. Confirm the dates of application of Regulation (EU) 2023/1230 for your products on EUR-Lex before you plan.
Who it is for
Who needs ISO 12100 and Machinery Regulation compliance?
Anyone who designs, builds, integrates or places machinery on the market meets the question sooner or later. Four starting points are common:
- You export machinery to the EU. Distributors and customers ask for the risk assessment behind the declaration and the CE mark.
- A customer's safety team is reviewing your design. Plant buyers want to see how hazards were identified and which measures reduced them.
- You integrate or modify lines. Combining machines or changing a guard can change the risk picture and the paperwork.
- An incident or near miss exposed gaps. The design review and risk records did not show why a measure was chosen.
The aim is safer machines and design records that explain every decision, not a thicker file.
Requirements
What are the main ISO 12100 requirements?
The lines below follow ISO's own summary of the standard. The obligations of the Machinery Regulation are set by the Regulation itself; Sterling's work maps them to your products at title level, and your legal advisers confirm how they apply.
- Terminology and principles: a shared vocabulary and principles for safety in machinery design.
- Hazard identification: finding the hazards across the machine's life cycle.
- Risk estimation: judging each risk on a consistent basis.
- Eliminating hazards or reducing risk: choosing and applying measures, and checking the result.
- Documentation and verification: recording the risk assessment and risk reduction and verifying them.
- Scope limits: risks to domestic animals, property and the environment are outside the standard.
What does useful machinery safety evidence look like?
A risk assessment for each machine family, traced to design decisions, guard and control choices, user information and test results, plus a controlled technical file that is updated when the design changes. We set up these records in Effivity so every revision keeps its reasoning.
Your engagement
What your ISO 12100 engagement includes
Sterling works on the method and the management system behind machinery safety: how risk assessment is done, reviewed, recorded and kept current. Your design engineers keep ownership of the technical solutions.
Scope, gap analysis and plan
Across your machine families and markets, with owners and dates.
Risk assessment procedure
An ISO 12100-based method, templates and review rules built with your engineers.
Effivity ISO & GRC software
Risk records, design reviews and changes in Effivity, included at no additional cost.
Training for everyone
Internal auditor training as applicable, and preferential Sterling Academy access with complimentary awareness training for your people.
Internal audit
Design and technical file routines audited, with findings closed on evidence.
Readiness for reviews
Records organised for customers, notified bodies and market surveillance authorities.
Sterling does not certify, CE-mark or give legal advice. Conformity is declared by the manufacturer, and designated bodies and authorities act as the Regulation provides.
Often combined with
Standards organisations pair with ISO 12100
- CE markingCE marking compliance support for manufacturers: EU rules, technical files, declaration of conformity and quality systems.
- EN 1090EN 1090 certification for steel and aluminium fabricators: factory production control, welding, execution records and support through the notified body's audit.
- EN 71 / ASTM F963EN 71 and ASTM F963 toy safety compliance for manufacturers: product and market mapping, material control, test planning and records that keep lots conforming.
- EU Cyber Resilience ActCyber Resilience Act compliance and requirements for products with digital elements: categories, reporting since September 2026 and CE marking by December 2027.
- EU MDR 2017/745EU MDR compliance consulting for CE marking: QMS, technical documentation, traceability and post-market surveillance prepared for your notified body.
- IEC 61508IEC 61508 compliance support for E/E/PE safety-related systems: functional safety management, lifecycle records, SIL evidence and assessment readiness.
Effivity · ISO and GRC software, included in every engagement
How Effivity helps you fulfil, automate and simplify the requirements of ISO 12100 and the Machinery Regulation.
Every Sterling ISO 12100 engagement includes Effivity, the ISO and GRC automation platform built by the Sterling group and used in 50+ countries. Your consultant configures the workspace within the agreed scope, so documents, risk assessments, design reviews, audits, nonconformities, engineering changes, training records and management review live in one place, the system runs in daily work and the assessor or customer auditor reviews a live system rather than a binder. Sterling consulting clients get their Effivity subscription included with the engagement, at no additional cost.
Context, scope and interested parties
The scope statement, the internal and external issues and the interested parties are kept in one register and reviewed on a schedule, so the context stays current as the business changes instead of being rewritten before each audit.
Policy, roles and objectives
The policy, the responsibilities and the objectives with their measures, owners and dates live where the people who own them work; progress is reported from the system, not from a separate spreadsheet.
Risks and opportunities
A risk and opportunity register with owners, actions and review dates; treatments tracked to closure and brought to management review automatically.
Competence, awareness and documented information
Training and competence records for every person, linked to Sterling Academy; documents with versions, approvals and distribution, so the current version is the only one in use.
Design, risk assessment and change
Risk assessments per machine, design review actions, engineering change requests and technical file revisions, each with an owner, a date and its record created as the work is done.
Monitoring, internal audit and management review
Audit programmes, findings and follow-up; KPIs on live dashboards; a management review that records its inputs, decisions and actions.
Nonconformity, complaints and corrective action
Raised, investigated and closed with root cause and the evidence that the action worked; recurring issues visible to management before they become a finding.
Your own processes, forms and reports
Forms, fields, workflows and reports adapted to how you work, without code; legal and customer requirements tracked to the processes they affect.
What this means at a review
Customers, notified bodies and authorities ask why a hazard was treated the way it was, which revision was released and who approved it. In Effivity each answer is a screen with dates, owners and evidence attached. After the programme, Sustain™ keeps the same workspace running, so every new design follows the same method.
In your engagement
- Subscription included with the engagement, at no additional cost
- Configured by your Sterling consultant within the agreed scope
- Your documents, records and registers migrated, not retyped
- Admin and user training for your team
- Modules for QMS, EMS, OHSMS, ISMS and more when you integrate other standards
Sterling Academy · Machinery safety e-learning
Build machinery safety awareness across design, production and service.
Sterling Academy delivers e-learning for the whole workforce and for the people who run the system: video lessons with practice checkpoints, a final exam and a numbered Certificate of Completion for each learner, verifiable online. Sterling consulting clients benefit from preferential course access and special pricing through their Sterling consultant, including complimentary awareness training for their people as part of the engagement.
- Awareness for designers, assemblers and service engineers on how risk assessment shapes their work
- Practitioner learning for the people who run design reviews
- Internal auditor training for the people who will audit the system, as applicable to your standard, as part of the engagement
- Learner progress by department and a training status report for your reviewers
- New hires trained as they arrive, so competence evidence stays current
- A Sterling consultant reachable when a learner needs one
Keep exploring
Explore more about ISO 12100
ISO 12100 resources
Services for ISO 12100
Why Sterling
Want ISO 12100 and Machinery Regulation compliance that holds up? Come to Sterling.
Machine builders already run design, quality and after-sales processes. We connect risk assessment to them, so the method is used on every project and the records explain every choice.
Management systems in 60+ countries since 2003
Systems implemented for manufacturers, integrators, contractors and service firms across every region we serve, with offices in 21 countries and one engagement team accountable wherever you operate.
All-inclusive proposal
Consulting, Effivity, training and Academy access in one proposal, with any third-party fees identified separately. No surprises, ever.
A system your people can use
Fewer documents and more control: procedures, records and software connected to the work on the floor, so machinery safety evidence is produced as the job is done.
Expert and experienced consultants
Consultants who have advised on management systems across sectors and countries since 2003 and who build the machinery safety side of your system properly the first time.
The Sterling Promise
What the Sterling Promise means for your machinery safety programme
We stay with you until the agreed ISO 12100 and Machinery Regulation outcome is achieved, supporting implementation, preparation and the closure of review findings. Practical delivery, included software and employee learning turn the investment into lasting capability.
The engagement identifies the standard, the legislation in scope, the outcome and responsibilities. Your organisation supplies accurate information, keeps ownership of design decisions and its declaration of conformity, and puts the agreed controls into use. Designated bodies and authorities reach their own conclusions. Sterling does not give legal advice.
FAQs
Frequently asked questions about ISO 12100
Can a company be certified to ISO 12100?
No. ISO 12100 is a design and risk assessment standard, not a certifiable management system standard. What you can show is a sound, documented risk assessment for each machine, and a management system that makes sure it is done every time.
Is ISO 12100 the same as the Machinery Regulation?
No. ISO 12100 is a voluntary international standard; Regulation (EU) 2023/1230 is European Union law on machinery. CEN-CENELEC publishes guidance on how EN ISO 12100 relates to the Machinery Directive that the Regulation follows.
Does Sterling prepare the declaration of conformity?
No. The manufacturer issues its declaration and applies the marking; designated bodies assess where the law requires it. Sterling builds the risk assessment method, the records and the review routine that support your declaration, and your legal advisers confirm the obligations that apply.
Keep exploring
More on ISO 12100 and related standards
More in Product compliance & functional safety
Talk to a consultant
Plan your ISO 12100 and Machinery Regulation compliance with confidence.
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