MACHINERY DIRECTIVE (Direttiva 2006/42/CE)
WHAT WE GIVE YOU
DirettivE 2006/42/CE - Complete Technical File for Machinery and Partly Completed Machinery - We Guarantee 100% Compliance
- Risk Assessment;
- PLr design and PL verification according to the technical standard UNI EN ISO 13849;
- Technical File (Technical File for Partly Completed Machiinery);
- Instruction Manual (Assembly Instruction for Partly Completed Machiinery);
- Facsimile of the Declaration of Conformity (facsimile of the Declaration of Incorporation for Partly Completed Machiinery);
- Facsimile of the CE Plate;
- Noise Measurement and Related Reporting;
- Electrical Safety Testing and Related Reports;
- Design and implementation of production control systems;
- Assistance in relationships with Notified Bodies (for Annex IV machinery).
D.Lgs. 81/2008
- Risk Assessment Document according to Annex V for existing machinery and equipment for which the Machinery Directive does not apply;
- Operator's Manual;
- Machinery Cards.
Training - See also Course Catalog
We offer a Modular THREE days course that can be attended in the classroom or at the customer's office. - See also Course Catalog.
WHO IS IT FOR
This service is for:
- Machinery and/or plant manufacturers;
- Any company in any sector that uses machines and/or facilities.

mtm consulting s.r.l. – SPECIALISTS IN MACHINERY DIRECTIVE
mtm consulting s.r.l. It is the market leader for machine safety. Possesses specific skills and in-depth on legislation for the protection of equipment and risk assessment.
mtm consulting s.r.l. not only saves time and money to its customers, but also responsible for the creation of documentation for CE marking, such as the technical file and SAFETY report, and for the drafting of the Declaration of Conformity.
The staff of mtm consulting s.r.l. It operates throughout the country by providing information and training to date to CE standards.
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WHAT ARE THE ADVANTAGES OF WORKING WITH mtm consulting s.r.l.
Here are just some of the benefits:
- involving early on mtm consulting LTD compliance with legislation can be planned and implemented as an integral part of every company project - CE marking, SAFETY reports, ...;
- all potential problems are identified early stage when legislative compliance can be integrated into the project;
- legislative compliance means pragmatism and commercial competitiveness avoiding anything that is not value-added;
- our professionals have a constant open access to any type of questions related to European Standards;
- any need to test their pre-compliance is identified from an early stage and included in the timing and in the project budget;
- the involvement of third parties such as for example notified bodies is planned, managed, and programmed as and when required;
- mtm consulting s.r.l. responsible for setting up documentation for the CE marking, such as the technical file and SAFETY report, and for the drafting of the Declaration of Conformity for manufacturers and authorised Representatives;
- for manufacturers, mtm consulting s.r.l. acts as a "Responsible Person in the Community" - "authorised representative" or as a "person authorized to compile the technical file";
- available services tailored to our clients such as: training courses or seminars as well as providing customized software to specific needs.
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mtm consulting s.r.l. SUPPORTS ITS CLIENTS IN ALL STEGES FOR CE MRKING
Here are just a few ways in which we can support:
- providing advice, training courses and seminars;
- performing inspections and controls;
- performing risk assessment;
- ensuring compliance with the essential safety requirements;
- constituting the technical file;
- drawing up the Declaration of Conformity;
- acting as your Authorised Representative in the European Union.
To the suppliers / manufacturers and the agents in the European Union mtm consulting s.r.l. is acting as a "person authorized to compile the technical file".
To the suppliers / manufacturers outside the European Union mtm consulting s.r.l. is acting as an "Authorised Representative" keeping a copy of the technical file.
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CONFORMITY TO OBLIGATORY REGULATIONS
mtm consulting s.r.l. in order to ensure that all manufacturers comply with regulatory obligations:
- accepts responsibility for the creation of documentation for CE Marking by acting as "Person authorized to compile the technical file" for manufacturers and the agents residing in the Community;
- It accepts responsibility for the creation of documentation for CE Marking by acting as "Authorized Representative" for manufacturers who reside outside the Community;
- performs periodic annual audits with its customers in order to verify and ensure continuous compliance with regulatory requirements;
- performs audits at suppliers of its customers in order to verify the correct application of the Machinery Directive before the machine is delivered and installed;
- shall arrange for all the tests and the pre-conformance testing necessary to verify compliance with the applicable rules;
- shall involve third parties such as for example notified bodies where this is necessary;
- offers training courses and seminars over the supply of customized software according to specific needs;
- provides to perform translation of texts in language;
- provides the design of guards;
- performs noise detection emitted by machinery and equipment;
- performs the electrical safety tests.
In order to offer a service that is the best possible mtm consulting s.r.l. makes use of resources which are distinguished by the large professional preparation in multiple fields (technology, electronics, ...) to which mtm consulting s.r.l. offers professional development based on the continuing education required, however, to offer a value-added service to its customers.
In carrying out its activities mtm consulting s.r.l. uses the most advanced software available in the market.
Through continuous technological updating mtm consulting s.r.l. It is able to provide its customers not only documents in paper form, but also in digital form ready for any type of use (printing press for the realization of the manuals).
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ADDITIONAL SERVICES
For manufacturers
mtm consulting s.r.l. advises manufacturers of machines and plants in terms of:
- support in performing the risk assessment (technical file or the relevant technical documentation);
- draw up the EC Declaration of Conformity or Declaration of Incorporation as applicable;
- draft of the instruction manual or the instructions for assembly;
- translation of the manual in the language of the destination country of the machine;
- realization of cd, with multimedia and hypertext navigation, the documentation provided or existing company;
- design protections;
- noise detection emitted by machinery and equipment;
- electrical safety tests.
The most important phase of the construction of a machine is undoubtedly that of design during which the specifications must be properly defined to which it must respond, but also the protection devices that interact with the functional organs of the same.
For the users
Often the user is in possession of plants "irreplaceable" and "custom" which, however, does not possess any kind of technical documentation. What we offer is:
- Machine safety analysis and identify the steps required to put in security;
- design protection;
- drafting of the necessary technical documentation (of integration documents);
- translation of texts in language;
- noise detection emitted by machinery and equipment;
- electrical safety tests.
It also does not happen to often be in the position of having to buy a new car or a new plant, or to have to / want it to sell, rather than to give or take charge of equipment by way of loan. Each of the above mentioned situations require the application of a specific documentation. Also, sometimes, it is better to rid the plant, but also in this case it is necessary to make some special considerations.
For importers
Often the importer is in possession of installations of which however does not have the complete technical documentation and necessary to be able to sell within the European Community. What we offer is:
- Machine safety analysis and identify the steps required to put in security;
- design protection;
- drafting of the necessary technical documentation (of integration documents);
- translation of texts in language;
- noise detection emitted by machinery and equipment;
- electrical safety tests.
For those who are planning or conducting a new production site (both in Italy and abroad)
The construction of a new production site is a complex project that requires to be handled with care and professionalism. A not unimportant aspect is related to the production plant construction: the purchase, installation start-up of the plants. In this context mtm consulting s.r.l. offers the following services:
- analysis of the types of machines and installations;
- analysis of the documentation provided or made available by suppliers;
- support during purchase and contract with suppliers;
- compiling the technical documents required if several machines are integrated into a single complex system or line;
- drafting of all the operations required to use the machines and equipment;
- any design of protections;
- translation of texts in language;
- noise detection emitted by machinery and equipment;
- electrical safety tests;
- support during the testing phase.
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CE AUDIT
The Legislative Decree no. 626/94 had a simplistic view of the CE Marking. That is to say that the end user only had to test for the presence of the CE Marking machines. With the Legislative Decree no. 81/2008 is a fundamental innovation was made. Namely that the burden of verifying that a machine conforms to the Machinery Directive is the end user.
In order to ensure full compliance with each machine must be checked after installation and before being put into use in order to assess their safety. The inspection, if conducted properly, should carry out all aspects of machine safety, and on the CE marking.
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CE AUDIT – THE SOLUTION
The solution is to check compliance with the Essential Safety Requirements (RES) when buying new equipment.
The RES include questions such as:
- the equipment must comply with European directives?
- to achieve compliance with European specific European standards are to be applied?
- it is required Declaration of Conformity?
- the CE marking may appear on the equipment?
- it is required a manual of use and maintenance in compliance with the Machinery Directive requirements?
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AREAS BEEING AUDITED
Here is the list of the main areas that need to be audited:
- documentation, manulai, etc .;
- drawings: electrical, pneumatic, hydraulic, etc .;
- hardware;
- environmental audits;
- control systems;
- software;
- calibration, the machine parameters;
- security control systems;
- manual handling of loads;
- dangers;
- ergonomic evaluation;
- maintenance and cleaning procedures;
- need for education and training.
There are many reasons why a company finds that an audit before the purchase is not feasible and that for reasons of: staff, time availability, the need for expertise or a mix of the three.
mtm consulting s.r.l. performs audits for its customers by releasing a comprehensive report that includes any area of problems and the corrective action.
The legislation on the health and safety of workers in the workplace requires that you adhere to the risk assessment for each affiché equipment can be used without the user is exposed to risks.
The risk assessment must be carried out:
- after installation and before starting up the first time all equipment;
- after all equipment has deteriorated which may prejudice the safe use;
- at predetermined intervals;
- qualvota each time that exceptional circumstances.
The results of these evaluations should be documented and maintained.
mtm consulting s.r.l. ensures compliance with current legislation as well as offering specific training courses.
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THESE ARE JUST SOME OF THE QUESTIONS THAT WOULD NEED TO ARISE
In order to ensure the equipment to comply to the same RES it should be subjected to a security audit before it is shipped by the supplier. This audit covers only the safety aspects. Often the customer upon receipt of delivery check that it complies with the order and performs a quality audit and engineering.
Combining the two audits would result in a cost advantage. Any problems may arise when the equipment is still by the supplier and could be resolved directly in the equipment installation phase at the customer.
Evidently make changes after sending the equipment is significantly more challenging than doing it at the design stage, this is why you need to anticipate the safety audit.
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PROJECT MANAGEMENT FOR THE INSTALLATION OF COMPLEX MACHINERY
Taking into account the definition of the car as a whole Directive Machinery factory could be considered as a complex set of machines and therefore subject to the Machinery Directive.
Even when the whole complex of machines is made by the end user and will never put on the market shall apply the obligations to draw up the Technical File, the Declaration of Conformity and to affix to the Declaration of Conformity.
They can be identified two different scenarios.
1) New machinery
Two or more machines are combined to make a new one. Each machine is accompanied by the Declaration of Conformity or Incorporation. The Machinery Directive requires a "person responsible" to ensure that the set of the two machines is in accordance with the Directive itself and is safe. Practically this means to make the assessment of risks, ensure compliance with the essential safety requirements, produce a technical file and affix the CE Marking.
2) Existing machinery
Two or more machines are combined to make a new one. Each machine is previously in the application of the Machinery Directive. The Machinery Directive requires a "person responsible" to ensure that the set of the two machines is in accordance with the Directive itself and is safe. Practically this means to make the assessment of risks, ensure compliance with the essential safety requirements, produce a technical file and affix the CE Marking.
In both cases, or even in mixed cases mtm consulting s.r.l. is able to assist its clients in all phases required for CE Marking.
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STEPS TO BE ABLE TO CE MARK A MACHINERY
The steps to be able to CE mark a machine are:
- make a risk assessment;
- evaluate the essential safety requirements;
- produce the technical file;
- draw up the Declaration of Conformity;
- affix the CE Marking.
For many machines (excluding those listed nell'Alegato IV of the Directive) the manufacturer can make a self-declaration. For machines listed in Annex IV is necessary instead the intervention of a Notified Body even though the Directive 2006/42 / EC allows a manufacturer the road of self-certification if the same manufacturer fully guarantee the correspondence with the standard type C applicable (of course this applies only in cases where there is a rule of type C and the same applies covers all applicable Essential Safety Requirements).
mtm consulting s.r.l. regularly works with renowned Notified Bodies and is able to support its customers in dealing with them.
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THE NEW MACHINERY DIRECTIVE (Directive 2006/42/CE)
The need of the Machinery Directive stems from both the growing market of machines in the European Community and by the increasing need to focus on the health and safety of workers who use them.
The decisions they need to make companies are the two following:
- we have sufficient internal resources and sufficient expertise to carry out the assessment of the risks and take any corrective actions?
- we are able to stay current, informed and compliant?
Responding to these two simple questions every company is able to decide whether it is necessary and convenient to take the outsourcing.
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WHAT ARE THE MAJOR CHANGES MADE BY DIRECTIVE 2006/42/EC TO THE PREVIOUS DIRECTIVE 98/37/EC
The non-exhaustive list of the main differences between the two Directives are:
- on the Declaration of Conformity must bear the name of the "person authorized to compile the technical file".
- Manufacturers outside the European Union are obliged to give a written mandate to a "Mandatory" in the Community.
- The scope is expanded. In addition to machinery and partly completed machinery in the field of application you are also interchangeable equipment, safety components, lifting accessories, chains, ropes and straps and the removable mechanical transmission devices.
- They have changed many Essential Safety Requirements (RES) and many are in addition to previous ones. The major changes include: ergonomics, control positions, lighting, manual controls, the machine start-up, the machine's stability, security systems, operating instructions in addition to special specifications for the food and cosmetic industries and pharmaceuticals.
- from December 29, 2009 will be marketed and put into service only Mark machines under the new Directive 2006/42/EC (the previous Directive 98/37/EC no longer in force).
- the machines in series manufacturers, to continue to market its equipment / machines, will have to verify compliance with all of the new RES Directive 2006/42/EC.
- all certificates of EC type examinations must be checked in order to confirm your compliance with the new Directive 2006/42/EC
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NEW MACHINERY DIRECTIVE (DIRECTIVE 2006/42/EC) - ARE YOU ALREADY COMPLIANT?
The new Machinery Directive shall enter into force 29 December 2009 without providing for a transitional period. That's why all companies should schedule it to come into force well in advance.
In many parts of the Directive have been made radical changes. All those involved in the application of the Directive are to verify compliance with the new features and the essential safety requirements including those which take into account the control systems.
In order to help businesses of any size to verify their compliance with the Directive it is crucial from definitions. For example, the definition of machine includes "an assembly, fitted with or intended to be fitted with a drive system other than human or animal effort, consisting of linked parts or components, of which at least one mobile, which are joined together for an application well determined ". Also interchangeable equipment is defined as a "device that, after the commissioning of a machine or a tractor, is assembled with that machinery or tractor by the operator himself in order to change its function or attribute a new function in so far as this equipment is not a tool".
Another imported definition is that of partly completed machinery which are defined as those "assembly which is almost machinery but which, alone, are not able to perform a specific application. A drive system is partly completed machinery. Partly completed machinery is only intended to be incorporated or assembled with other machinery or other partly completed machinery or equipment, thereby forming machinery to which this Directive ".
It is also to be noted as fall within the definition of machine also sets of multiple machines that are managed by a control system as if they were a single set - for example a production line.
The scope is expanded. In addition to machinery and partly completed machinery in the field of application you are also interchangeable equipment, safety components, lifting accessories, chains, ropes and straps and the removable mechanical transmission devices.
Obviously the safety and health of workers in the workplace is the primary goal of the employer when a new machine is installed: But do not forget that the Machinery Directive specifies certain obligations that are sometimes very strict and in addition to those the regulations for health and safety in the workplace.
All European Directives are transposed into Italian and often provide a range of sanctions that can be criminal and / or administrative or financial.
In Italy the Directive 2006/42/EC was implemented by Legislative Decree no. 17/2010 which provides for penalties applicable to infringements of national provisions transposing the Directive as well as taking all necessary measures for its implementation. Sanctions are, as required by the Directive, effective, proportionate and dissuasive”
Therefore, care must be taken to ensure compliance with the Directive. This means fulfilling the following four points:
- be able to demonstrate conformity with the essential safety requirements;
- make a proper and comprehensive risk analysis;
- properly prepare the Declaration of Conformity or Declaration of Incorporation;
- affix the CE marking on the machines.
It should be noted that the Directive does not only refer to a single unit, but also involves the processes and systems. If therefore you have been made a complex set, as for example a production line, integrating between them more existing machines also have in fact been made a new machine and then the whole will conform to the Machinery Directive.
Similarly changing the performance or intended use of a machine or a complex set you configure the construction of a new machine that must comply with the Machinery Directive.
The changes to the essential safety requirements made by the new Directive are too numerous to be listed here. The major changes include: ergonomics, control positions, lighting, manual controls, the machine start-up, the machine's stability, security systems, operating instructions in addition to special specifications for the food and cosmetic industries and pharmaceuticals.
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NEED TO BE COMPLIANT
There are also changes regarding the Declaration of Conformity. The "person authorized to compile the technical file" should be established within the European Community. Where necessary the Declaration of Conformity must include any other applicable Directives. It is also no longer expected a specific declaration for safety components.
There are of course many other aspects of the new Machinery Directive which is vital that every organization occur in order to have guaranteed compliance with the Directive itself. It is also, however, it points out that there are many other fundamental standards to ensure compliance of a machinery.
The standard 954-1 Safety of machinery - Safety-related parts of control systems will be replaced by EN ISO 13849-1 at the end of 2011 (further extended from December 2010). The designers of control systems can then choose to apply EN ISO 13849-1 or EN / IEC 62061 to ensure compliance with the Machinery Directive.
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THE STANDARD EN ISO 13849-1
EN ISO 13849-1 uses a four-step process for the design of control systems related to security:
- perform risk analysis (using the EN ISO 12100);
- for each identified risk, define the level of performance (Performace Level or PL);
- define the architecture of the system consistent with the PL;
- validate the design to verify that they meet the requirements emerged in the process of risk analysis.