OUR GOAL: COMPLIANT MACHINERY
What does Machine Compliance mean?
Verifying the conformity of a machine means ensuring that it complies with all the essential health and safety requirements laid down by current legislation. In Europe, this process has been governed by the Machinery Directive 2006/42/EC, which is currently in the process of transitioning to the new Machinery Regulation (EU) 2023/1230, introducing stricter requirements, including in the areas of digital technology and cybersecurity. In Switzerland, the regulatory framework is supplemented by the Machinery Ordinance (OMacch), which transposes European principles whilst adapting them to the national context, making conformity assessment a fundamental step for operating safely and in compliance with the law.
At SAECON, we support end-users and manufacturers throughout the conformity assessment process, right up to CE marking where required.
OUR SERVICES
We help ensure the safe and proper operation of machines and production lines
Regulatory framework assessment
The regulatory scenario is extensive and, at times, not easy to interpret. We offer our clients support in understanding which regulations are relevant to ensure that machinery complies with the rules and to safeguard the working environment. Machinery Directive 2006/42/EC, New Machinery Regulation 2023/1230, OMacch, Opi, PED, ATEX: a proper understanding of the regulatory framework enables compliant design and ensures that machinery complies with the relevant safety regulations.
Technical Documentation
The correct drafting of technical documentation plays a crucial role, as in the event of an accident or an inspection, these documents must be available and presented to the relevant authorities; they constitute essential evidence of the risk assessment carried out and the measures adopted to ensure safety, thereby protecting both the manufacturer and the employer. Well-structured documentation not only facilitates inspections but also helps to reduce legal liability and strengthen the company’s credibility.
Spare Parts Catalogue
Together with our Italian partner INSAFE, we have developed an innovative online spare parts catalogue that streamlines the ordering and supply of spare parts. With just a few clicks, you can order a spare part from anywhere in the world in a simple and intuitive way.
Risk assessment
Risk assessment is a structured process that enables the identification and analysis of hazards associated with the use of machinery, with a view to implementing effective preventive measures and ensuring safety at work. This process, as set out in the UNI EN ISO 12100:2010 standard, is based on an iterative approach to risk assessment and risk reduction.
CE Marking
The CE marking is not merely a ‘stamp’, but a process that guarantees compliance with quality and safety standards for machinery that has been designed, manufactured and placed on the market.
SAECON guides customers through this process, supporting manufacturers from the earliest stages of design, offering users the ability to monitor their machinery fleet and proposing adaptation plans to ensure compliance with regulatory standards. If necessary, we can oversee the entire adaptation process, right through to certifying the machinery.
On-line Portal for technical documentation
We provide our customers with the INSAFE® Portal, which allows them to conveniently access the technical documentation for their machinery online. But that’s not all! The Portal also enables users to monitor their maintenance schedule and access remote assistance videos to carry out routine procedures. It acts as an assistant that helps prevent machine downtime, with 24/7 access.
Is Third-Party Certification required to declare a machine compliant?
No.
There is no obligation to obtain accreditation or authorisation to certify the conformity of a machine.
The Machinery Directive 2006/42/EC, the OMACCH and the EU Machinery Regulation 2023/1230 do not provide for mandatory authorisation bodies to verify conformity.
The conformity of machinery is in fact derived from:
- the correct application of the Essential Safety Requirements;
- adequate risk analysis and mitigation;
- the preparation of compliant technical documentation.
SAECON operates in full compliance with technical standards, supporting:
- manufacturers, right from the design stages, to ensure products are compliant and safe when placed on the market;
- end-users, through technical audits of their machinery fleets, identifying critical issues and gaps to be addressed, and defining the necessary adaptation measures until full compliance is achieved.
Responsibility and protection:
A machine’s compliance is not a merely formal requirement, but a process involving specific legal and technical responsibilities.
The manufacturer is responsible for the design and placing on the market of a compliant product, while the employer is required to ensure that the equipment used remains safe throughout its entire life cycle.
A structured approach to machine safety enables you to:
- reduce the risk of accidents and plant shutdowns;
- demonstrate technical diligence in the event of inspections or legal disputes;
- protect the company from civil and criminal liability.
Relying on specialist expertise means not only achieving regulatory compliance, but also safeguarding the value of the business and the safety of people.