{"id":4909,"date":"2021-01-13T16:12:09","date_gmt":"2021-01-13T16:12:09","guid":{"rendered":"https:\/\/emtem.key4web.it\/faq\/"},"modified":"2026-07-02T08:57:09","modified_gmt":"2026-07-02T08:57:09","slug":"faq","status":"publish","type":"page","link":"https:\/\/emtem.com\/en\/faq\/","title":{"rendered":"FAQ"},"content":{"rendered":"\t\t
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faq<\/h1>\t\t\t\t<\/div>\n\t\t\t\t
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HOME<\/a> –\u00a0 faq<\/a><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Machinery Directive Consulting<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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<\/path><\/svg><\/span><\/path><\/svg><\/span>To whom does the Machinery Directive 2006\/42\/EC apply?<\/span><\/path><\/svg><\/div>

It applies to manufacturers, authorized representatives, and importers<\/strong> who place machinery, partly completed machinery, interchangeable equipment, and lifting accessories on the European market. The regulation covers almost all industrial machinery and plants, including cases of those who internally assemble<\/strong> a production line, build a machine for own use<\/strong>, or carry out substantial modifications<\/strong> to existing plants. In these cases, the user assumes the same obligations as the manufacturer, including CE marking. <\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>What documents are required for the CE marking of a machine?<\/span><\/path><\/svg><\/div>

The following are required: a technical construction file, risk analysis according to EN ISO 12100, instructions for use in the user’s language, a CE declaration of conformity, and physical CE marking on the product.<\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>Is Directive 2006\/42\/EC still valid in 2026?<\/span><\/path><\/svg><\/div>

Yes, it is fully valid. It will be replaced by the Machinery Regulation (EU) 2023\/1230 starting from January 20, 2027. MTM Consulting also supports companies in the transition toward the new regulation. <\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>How long does the CE marking process for a machine take?<\/span><\/path><\/svg><\/div>

It depends on the complexity of the product. For standard machines, it ranges from 4 to 8 weeks; for complex machines, it can take 12-16 weeks. MTM provides a detailed work plan after the initial free analysis. <\/p>\n<\/div>\n\t\t\t\t\t<\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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ATEX Directive Consulting <\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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<\/path><\/svg><\/span><\/path><\/svg><\/span>What is the difference between ATEX Directive 2014\/34\/EU and Legislative Decree 81\/2008? <\/span><\/path><\/svg><\/div>

Directive 2014\/34\/EU concerns products placed on the market. Legislative Decree 81\/2008 (Title XI) concerns workplaces with explosion risks. MTM integrates both compliances into a single consultancy path. <\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>When is a notified body required for the ATEX Directive?<\/span><\/path><\/svg><\/div>

The intervention of a notified body is mandatory for Category 1 (Group II) and M1 (Group I)<\/strong> equipment. For Category 2<\/strong>, the obligation varies based on the nature of the product (electrical or non-electrical). For Category 3<\/strong>, the intervention of a notified body is never required, and the manufacturer can proceed independently with internal documentation. <\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>Must ATEX zoning be updated over time?<\/span><\/path><\/svg><\/div>

Yes. It must be reviewed whenever production processes, materials, or plant layouts change, or following structural modifications. MTM offers periodic review services. <\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>Must my existing plants be adapted to the ATEX Directive?<\/span><\/path><\/svg><\/div>

Plants must comply with the safety requirements of the Legislative Decree. 81\/2008. New equipment must be ATEX certified. MTM assesses the level of compliance and indicates priority corrective actions. <\/p>\n<\/div>\n\t\t\t\t\t<\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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Machinery Regulation <\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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<\/path><\/svg><\/span><\/path><\/svg><\/span>When does the Machinery Regulation (EU) 2023\/1230 become mandatory?<\/span><\/path><\/svg><\/div>

Regulation (EU) 2023\/1230<\/strong> will become mandatory from January 20, 2027<\/strong>, the date on which the previous Directive 2006\/42\/EC<\/strong> will be definitively repealed. Until that deadline, companies must continue to apply exclusively<\/strong> Directive 2006\/42\/EC. Currently, in fact, early voluntary application of the new Regulation for CE marking is not permitted. However, it is essential to use this transition period to adapt design and technical documentation<\/strong> to the new requirements. The goal is to be ready for January 20, 2027, when the transition to the new legislation will be immediate and without derogations. <\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>Do machines already certified under Directive 2006\/42\/EC need to be re-certified?<\/span><\/path><\/svg><\/div>

No.<\/strong> Products already placed on the market before January 20, 2027<\/strong> in compliance with Directive 2006\/42\/EC remain valid and do not require new interventions. However, all new machines<\/strong> placed on the market starting from January 20, 2027, must mandatory comply with Regulation (EU) 2023\/1230<\/strong>. MTM<\/strong> analyzes each situation case by case to guide its clients through the correct regulatory transition to maintain the CE compliance of your machines. <\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>Does Regulation 2023\/1230 also apply to machine control software with artificial intelligence?<\/span><\/path><\/svg><\/div>

Yes. The regulation introduces specific provisions for systems with machine learning that perform safety functions, requiring updated risk assessments and dedicated documentation. <\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>What is the gap analysis for the transition to Regulation 2023\/1230?<\/span><\/path><\/svg><\/div>

It is a comparative analysis between existing documentation (Directive 2006\/42\/EC) and the new requirements of Regulation 2023\/1230. It identifies what is missing, what needs to be updated, and the intervention priorities. <\/p>\n<\/div>\n\t\t\t\t\t<\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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PED Directive <\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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<\/path><\/svg><\/span><\/path><\/svg><\/span>Does the PED Directive also apply to pressure equipment assemblies?<\/span><\/path><\/svg><\/div>

Yes. It applies both to individual equipment and to assemblies, i.e., groups of pressure equipment assembled to form an integrated functional unit. <\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>What is the pressure threshold for the application of the PED Directive?<\/span><\/path><\/svg><\/div>

The directive applies to equipment with a maximum allowable pressure (PS) greater than 0.5 bar.<\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>When is a notified body required for the PED Directive?<\/span><\/path><\/svg><\/div>

For category II, III, and IV equipment, the involvement of a notified body is mandatory. For category I, the manufacturer can proceed independently. <\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>Must equipment imported from non-EU countries comply with PED?<\/span><\/path><\/svg><\/div>

Yes. Any pressure equipment falling within the application limits of the PED directive placed on the EU market must comply with Directive 2014\/68\/EU, regardless of the country of production. <\/p>\n<\/div>\n\t\t\t\t\t<\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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Machine Safety \"Pre-1996\"<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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<\/path><\/svg><\/span><\/path><\/svg><\/span>Must machines built before 1996 be CE marked?<\/span><\/path><\/svg><\/div>

No. If placed on the market before September 21, 1996, they are not subject to the Machinery Directive. However, they must comply with the minimum safety requirements of Annex V of the Legislative Decree. 81\/2008.<\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>Who is responsible for the adaptation of pre-1996 machines?<\/span><\/path><\/svg><\/div>

The employer is directly responsible. They must ensure that all machines in use are safe and comply with current legislation, regardless of the year of construction. <\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>What happens if a pre-1996 machine is not adapted?<\/span><\/path><\/svg><\/div>

The machine cannot be used. The company risks administrative sanctions, production halts, and, in the event of an accident, civil and criminal liability for the employer. <\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>Can I continue to use an old machine if I have it overhauled internally?<\/span><\/path><\/svg><\/div>

Internal overhauling is not sufficient without a formal risk assessment and the preparation of the technical documentation required by Annex V. MTM Consulting verifies compliance and prepares all necessary documentation.<\/p>\n<\/div>\n\t\t\t\t\t<\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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CE Marking HelpDesk<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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<\/path><\/svg><\/span><\/path><\/svg><\/span>How many queries can I send with the HelpDesk service?<\/span><\/path><\/svg><\/div>

Queries are unlimited for the entire duration of the subscription. There are no volume constraints: you can send one question or a hundred, the cost remains the same. <\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>How soon will I receive a response?<\/span><\/path><\/svg><\/div>

A response is guaranteed within 48 working hours from an MTM senior technician. For specific emergencies, it is possible to agree on specific priorities. <\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>Does the HelpDesk also cover the new Regulation (EU) 2023\/1230?<\/span><\/path><\/svg><\/div>

Yes. The service covers both the Machinery Directive 2006\/42\/EC and the new Regulation (EU) 2023\/1230, including all questions regarding the transition and the application of the new rules. <\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>Can I activate multiple Help Desk accounts for several users in my company?<\/span><\/path><\/svg><\/div>

Yes. It is possible to activate multiple accounts for different users. When contacting MTM, please indicate the number of accounts you wish to activate to receive the correct quote. <\/p>\n<\/div>\n\t\t\t\t\t<\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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Inspection of Newly Acquired Machinery<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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<\/path><\/svg><\/span><\/path><\/svg><\/span>When is it advisable to carry out an inspection on a new machine?<\/span><\/path><\/svg><\/div>

Before commissioning, ideally immediately after delivery. In this way, non-compliances can be identified before the machine is used, avoiding risks to workers and possible disputes with the supplier. <\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>Can a CE-marked machine have compliance issues?<\/span><\/path><\/svg><\/div>

Yes. CE marking is a presumption of compliance defined by the manufacturer. However, it is not an absolute guarantee of the absence of safety risks in every condition of use. It is the employer’s responsibility to ensure that the machine actually complies with essential safety requirements before making it available to workers and that it meets essential requirements in the specific context of use. <\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>What happens if non-compliances are found during the inspection?<\/span><\/path><\/svg><\/div>

MTM provides a technical report with the identified criticalities and proposes concrete solutions for adaptation. If the machine has not yet been formally accepted, the report also supports any disputes with the supplier. <\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>Is the inspection service available outside of Monza and Turin?<\/span><\/path><\/svg><\/div>

Yes. MTM Consulting operates throughout the Italian territory. Consultancy is also available remotely for an initial documentary analysis, followed by an on-site inspection when necessary. <\/p>\n<\/div>\n\t\t\t\t\t<\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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CE Marking for Medical Devices <\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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<\/path><\/svg><\/span><\/path><\/svg><\/span>Who is responsible for the CE marking of a medical device?<\/span><\/path><\/svg><\/div>

The manufacturer of the medical device is responsible for the CE marking and must ensure that the device meets all the requirements of Regulation (EU)<\/em> 2017\/745 before placing it on the market.<\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>Is a notified body always required for the CE marking of a medical device?<\/span><\/path><\/svg><\/div>

No. Class I devices can be self-certified. For classes IIa, IIb, and III, the involvement of a notified body accredited under Regulation (EU)<\/em> 2017\/745 is mandatory. <\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>What is the difference between the old Directive 93\/42\/EEC and the new Regulation (EU) 2017\/745?<\/span><\/path><\/svg><\/div>

Regulation (EU) <\/em>2017\/745 introduces more stringent requirements for clinical evaluation, post-market surveillance, and traceability (UDI code). All devices already certified under the old directive must be re-certified according to the new regulation. <\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>What is meant by UDI in medical devices?<\/span><\/path><\/svg><\/div>

The UDI (Unique Device Identifier) is a unique code mandatory for all medical devices placed on the EU market. It allows for the traceability of the device throughout the entire supply chain and must be registered in the European database EUDAMED. <\/p>\n<\/div>\n\t\t\t\t\t<\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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ErP Directive Consulting <\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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<\/path><\/svg><\/span><\/path><\/svg><\/span>To which products do the ErP Directive 2009\/125\/EC and Regulation (EU) 2024\/1781 apply?<\/span><\/path><\/svg><\/div>

They apply to all energy-related products that consume, produce, or transfer energy, or that have an indirect impact on energy use. This includes motors, pumps, fans, lighting products, heating appliances, and many others. <\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>How do I determine which ErP Regulation applies to my product?<\/span><\/path><\/svg><\/div>

Each product category has one or more specific implementing Regulations. MTM Consulting identifies the applicable regulation, analyzes the requirements in force, and supports the client in adaptation. Legislation is updated frequently: it is essential to verify the current version. <\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>Do the ErP Directive and the ESPR Regulation require CE marking?<\/span><\/path><\/svg><\/div>

Yes. Products subject to the ErP Directive and ESPR Regulation must bear the CE marking, which also includes compliance with the eco-design requirements of the applicable Regulation. The CE declaration of conformity must explicitly mention the ErP Directive or the ESPR regulation. <\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>What are the risks if the product does not meet ErP requirements?<\/span><\/path><\/svg><\/div>

The product can be withdrawn from the market by surveillance authorities. The manufacturer or importer risks significant administrative sanctions. In some countries, ErP requirements are verified through random market checks. <\/p>\n<\/div>\n\t\t\t\t\t<\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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Construction Products Regulation <\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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<\/path><\/svg><\/span><\/path><\/svg><\/span>Which products fall under the Construction Products Regulation (EU) 2024\/3110?<\/span><\/path><\/svg><\/div>

All products manufactured to be permanently incorporated into construction works fall under this: steel or concrete structures, waterproofing systems, fire doors, piping, insulation materials, electrical cables for building use, and many others.<\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>What is the Declaration of Performance (DoP)
required by the CPR?<\/span><\/path><\/svg><\/div>

It is the document by which the manufacturer declares the performance of the product in relation to its essential characteristics defined by the harmonized EN standard. It is not a declaration of conformity but a declaration of measured or calculated performances. <\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>Does the CPR always require a notified body?<\/span><\/path><\/svg><\/div>

It depends on the AVCP (Assessment and Verification of Constancy of Performance) system assigned to the product by the harmonized standard. For systems 1, 1+, and 2+, the involvement of a notified body is required. For systems 3 and 3+ (recently introduced), tests at accredited laboratories are sufficient, while for system 4, the manufacturer can proceed independently.<\/em><\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>Does the CPR CE marking guarantee that the product is safe?<\/span><\/path><\/svg><\/div>

No. The CPR CE marking indicates that the product’s performance has been declared according to the harmonized standard. It does not certify minimum performance. It is the designer of the work who must select products with performance suitable for the specific application. <\/p>\n<\/div>\n\t\t\t\t\t<\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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UKCA Marking <\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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<\/path><\/svg><\/span><\/path><\/svg><\/span>Since when has UKCA marking been mandatory in the United Kingdom?<\/span><\/path><\/svg><\/div>

The definitive obligation never came into effect. The transition was initiated on January 1, 2021, providing for a transition period that was extended several times until 2024. <\/p>\n

In May 2024, the British Government then decided to recognize CE marking indefinitely for many product categories, including machinery. CE machines are therefore accepted, and the use of UKCA remains an optional choice for manufacturers. <\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>Is CE marking still valid for the Northern Ireland market?<\/span><\/path><\/svg><\/div>

In many cases, yes. The Protocol\/Agreement on Northern Ireland provides that CE marking is accepted for various products. The regulatory situation is constantly evolving: MTM verifies applicability on a case-by-case basis. <\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>Can I use existing CE documentation for UKCA marking?<\/span><\/path><\/svg><\/div>

In part. CE technical documentation is a good starting point, but it must be adapted to UKCA requirements: UK reference standards, UKCA Declaration of Conformity and, if required, involvement of UK Approved Bodies instead of European notified bodies. <\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>Do I need an authorized representative in the United Kingdom for UKCA marking?<\/span><\/path><\/svg><\/div>

Manufacturers established outside the UK market <\/em>who place products on the GB market must designate a Responsible Person established in the UK territory. MTM can support in identifying the necessary responsible figures. <\/p>\n<\/div>\n\t\t\t\t\t<\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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Non-EU Import of Machinery <\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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<\/path><\/svg><\/span><\/path><\/svg><\/span> Who is responsible for the CE compliance of a machine imported from China?<\/span><\/path><\/svg><\/div>

The European importer. They do not assume the role of manufacturer unless they market the machine under their own brand or make substantial modifications to it, but they remain the party responsible for verifying safety requirements and the presence of the CE marking. <\/p>\n

The importer therefore has the obligation to verify that the non-EU manufacturer has prepared a correct and complete technical file, and to make it available to any control bodies that request it. <\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>Is the CE marking applied in China valid?<\/span><\/path><\/svg><\/div>

Not automatically. CE marking must result from a correct conformity assessment process. MTM Consulting verifies the documentation to ascertain whether the process was carried out correctly or if it is necessary to supplement or redo the documentation. <\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>What should I do if the imported machine does not have a complete technical file?<\/span><\/path><\/svg><\/div>

It is necessary to request the documentation from the supplier. If it is unavailable or incomplete, the importer must have a new technical file drawn up. MTM Consulting manages this process, including risk assessment and verification of EHSRs. <\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>Does the import of partly completed machinery require the same fulfillments?<\/span><\/path><\/svg><\/div>

Yes, but with its own specificities. Partly completed machinery does not receive CE marking but must be accompanied by assembly instructions and a declaration of incorporation. The importer is responsible for the correctness of these documents under the Machinery Directive. <\/p>\n<\/div>\n\t\t\t\t\t<\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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UNI EN ISO 9001:2015<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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<\/path><\/svg><\/span><\/path><\/svg><\/span>Who can be certified according to ISO 9001:2015?<\/span><\/path><\/svg><\/div>

Any company or entity, regardless of sector or size. The standard is designed to be flexible and adaptable to every type of organization, from small manufacturing firms to large service companies. <\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>Is ISO 9001 certification mandatory?<\/span><\/path><\/svg><\/div>

No, it is not mandatory by law. However, it is often requested by clients, in public and private tenders, or to access regulated markets. In many industrial sectors, it is considered a minimum requirement to qualify as a supplier. <\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>How long does ISO 9001 certification last?<\/span><\/path><\/svg><\/div>

The certification is valid for three years, but it must be maintained through annual surveillance audits conducted by the certification body. At the end of the three-year period, a renewal audit is performed. <\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>How much time is needed to obtain ISO 9001 certification?<\/span><\/path><\/svg><\/div>

It depends on the complexity of the organization and the starting level. On average, a complete certification project takes 3 to 6 months. MTM Consulting defines a personalized work plan after an initial analysis of the company situation. <\/p>\n<\/div>\n\t\t\t\t\t<\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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UNI EN ISO 14001:2015<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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<\/path><\/svg><\/span><\/path><\/svg><\/span>What is an Environmental Management System?<\/span><\/path><\/svg><\/div>

It is a structured set of practices and procedures that allows an organization to monitor, control, and improve its environmental performance, in compliance with current regulations and the objectives of its environmental policy.<\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>Is ISO 14001 certification mandatory?<\/span><\/path><\/svg><\/div>

No, it is voluntary. However, it is strongly recommended for companies that want to demonstrate a concrete commitment to sustainability, access public tenders and international markets, or qualify as suppliers for large companies with structured ESG policies. <\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>How much time is needed to implement an ISO 14001 EMS?<\/span><\/path><\/svg><\/div>

It depends on the company’s complexity and the starting level. On average, the process takes 3 to 6 months. MTM Consulting builds a personalized work plan after an initial analysis of the company’s environmental situation. <\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>Which sectors can adopt ISO 14001?<\/span><\/path><\/svg><\/div>

All sectors: manufacturing, construction, services, healthcare, transport, energy. The standard is designed to be flexible and adaptable to any organizational reality, regardless of size or type of activity. <\/p>\n<\/div>\n\t\t\t\t\t<\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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UNI EN ISO 45001:2023<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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<\/path><\/svg><\/span><\/path><\/svg><\/span>Is ISO 45001 mandatory by law?<\/span><\/path><\/svg><\/div>

No, it is a voluntary standard. However, it helps companies comply in a structured and verifiable way with the obligations provided for by the Legislative Decree. 81\/2008. In many cases, it is required to participate in public tenders, contracts, or to qualify as suppliers for large companies.<\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>What is the difference between ISO 45001 and OHSAS 18001?<\/span><\/path><\/svg><\/div>

ISO 45001:2023 has replaced OHSAS 18001 and its previous 2018 version, introducing a structure aligned with ISO 9001 and ISO 14001 (High Level Structure), greater attention to the organizational context, worker participation, and a proactive approach to risk prevention.<\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>Can ISO 45001 be integrated with ISO 9001 and ISO 14001?<\/span><\/path><\/svg><\/div>

Yes. The three standards share the same high-level structure (Annex SL), which makes them easily integrable into an integrated Quality-Environment-Safety management system. MTM Consulting designs integrated paths that optimize certification times and costs. <\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>How much time is needed to implement an ISO 45001 system?<\/span><\/path><\/svg><\/div>

It depends on the complexity of the organization and the starting point. On average, the process takes 3 to 6 months. MTM Consulting defines a tailored work plan after an initial analysis of the company situation. Write to info@emtem.com for an initial contact without obligation. <\/p>\n<\/div>\n\t\t\t\t\t<\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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Life Cycle Assessment <\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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<\/path><\/svg><\/span><\/path><\/svg><\/span>Which standards regulate an LCA study?<\/span><\/path><\/svg><\/div>

The LCA study is governed by the ISO 14040 standard, which defines principles and general structure, and by ISO 14044, which specifies technical and methodological requirements. If the study is aimed at an Environmental Product Declaration (in order to obtain an EPD), specific Product Category Rules (PCR) for the product category also apply. <\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>What is the difference between LCA and Carbon Footprint?<\/span><\/path><\/svg><\/div>

The LCA study evaluates all environmental impacts associated with a product’s life cycle: resource consumption, polluting emissions, land use, water consumption, and others. The carbon footprint is limited to quantifying greenhouse gas emissions. The carbon footprint is therefore a more focused version of the LCA, covering only one aspect of the overall environmental impact. <\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>Does the same LCA study apply to different products in the same range?<\/span><\/path><\/svg><\/div>

No. Even if the products belong to the same category, each LCA is contextual and depends on real data: supply chain, procurement, production processes, use, and disposal. The analysis must be carried out or adapted for each product or in the event of significant changes to the processes. <\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>Is it possible to focus the LCA study only on certain stages of the life cycle?<\/span><\/path><\/svg><\/div>

Yes. It is possible to define a partial scope of application (e.g., cradle-to-gate, or cradle-to-grave) depending on the specific objectives of the study. MTM Consulting helps define the most suitable approach for the company’s needs. <\/p>\n<\/div>\n\t\t\t\t\t<\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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Carbon Footprint <\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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<\/path><\/svg><\/span><\/path><\/svg><\/span>What does the carbon footprint measure?<\/span><\/path><\/svg><\/div>

The carbon footprint measures the greenhouse gas emissions generated by an activity, product, or organization. It is expressed in tons of CO\u2082 equivalent, a value that standardizes the climate-altering potential of all greenhouse gases into a single comparable indicator. <\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>What is the difference between Product and Organizational Carbon Footprint?<\/span><\/path><\/svg><\/div>

The Product Carbon Footprint (PCF) assesses emissions throughout the life cycle of a single product, according to the ISO 14067 standard. The Organizational Carbon Footprint (OCF) measures the total emissions of a company on an annual basis, according to the ISO 14064-1<\/em> standard and the GHG Protocol. <\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>Is it mandatory to calculate the carbon footprint?<\/span><\/path><\/svg><\/div>

It is not mandatory by law, but it is increasingly requested by international clients, supply chains of large companies, credit institutions with ESG policies, and public tenders. In many sectors, it is becoming a de facto requirement to qualify as a supplier. <\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>Which gases are included in the carbon footprint calculation?<\/span><\/path><\/svg><\/div>

All climate-altering gases defined by the Kyoto Protocol, including: carbon dioxide (CO\u2082), methane (CH\u2084), nitrous oxide (N\u2082O), hydrofluorocarbons (HFCs), perfluorocarbons (PFCs), and sulfur hexafluoride (SF\u2086). Each gas is converted into CO\u2082 equivalent based on its global warming potential (GWP). <\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>What is meant by Scope 1, 2, and 3 of the Organizational Carbon Footprint?<\/span><\/path><\/svg><\/div>

Scope 1 includes the company’s direct emissions (e.g., natural gas combustion, company fleet). Scope 2 includes indirect emissions related to purchased electricity and thermal energy. Scope 3 collects all other indirect emissions along the value chain, both upstream (suppliers) and downstream (use and end-of-life of products). <\/p>\n<\/div>\n\t\t\t\t\t<\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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Risk Assessment <\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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<\/path><\/svg><\/span><\/path><\/svg><\/span>Who is responsible for risk assessment?<\/span><\/path><\/svg><\/div>

The Employer is directly responsible for the risk assessment and the preparation of the DVR (Risk Assessment Document). This obligation is non-delegable, as established by Art. 17 of the Legislative Decree. 81\/2008. They may use external consultants for the drafting, but they always remain the responsible party.<\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>How often must the DVR be updated?<\/span><\/path><\/svg><\/div>

The DVR must be updated whenever working conditions change: new equipment, changes in processes, new tasks, or reports of new risks. In the absence of significant changes, a periodic update at least every 3 years is still recommended. <\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>Does the risk assessment also cover work
equipment?<\/span><\/path><\/svg><\/div>

Yes. The Employer must verify that the equipment is safe, suitable, and compliant with the legislation (Articles 70 and 71 of Legislative Decree 81\/2008). This also applies to CE-marked equipment, whose compliance does not exempt the Employer from the responsibility for correct and safe use. <\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>What sanctions are risked without the DVR?<\/span><\/path><\/svg><\/div>

The lack of the DVR or its inadequate drafting entails criminal sanctions for the Employer, with arrest from three to six months or an increasing fine depending on the type of violation. In the event of accidents, liability can be significantly aggravated. <\/p>\n<\/div>\n\t\t\t\t\t<\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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Machine Safety <\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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<\/path><\/svg><\/span><\/path><\/svg><\/span>Is CE-marked equipment always safe?<\/span><\/path><\/svg><\/div>

No. CE marking declares <\/em>compliance with the product directive, but the Employer must still verify the suitability, completeness of documentation, and safety of use of the equipment in their specific operational context, as provided for by Articles 70 and 71 of the Legislative Decree. 81\/2008.<\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>When does Annex V of Legislative Decree 81\/2008 apply? <\/span><\/path><\/svg><\/div>

Annex V applies to equipment made available to workers before the entry into force of the CE product directives, and therefore lacking CE marking. The Employer must verify its compliance with the minimum safety requirements and adapt it accordingly. <\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>Who is responsible for the maintenance of work equipment?<\/span><\/path><\/svg><\/div>

The Employer has the obligation to ensure that equipment is maintained in conditions of efficiency and safety through ordinary and extraordinary maintenance and periodic checks. All maintenance activities must be documented and preserved. <\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>What is needed to commission equipment in the company?<\/span><\/path><\/svg><\/div>

Every piece of equipment must be accompanied by a user manual, a CE declaration of conformity (or of incorporation for partly completed machinery), operating instructions in Italian, and documentation proving the training of operators. MTM Consulting verifies the completeness of the documentation and supports the updating of technical files. <\/p>\n<\/div>\n\t\t\t\t\t<\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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Manual Handling of Loads<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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<\/path><\/svg><\/span><\/path><\/svg><\/span>When is the assessment of risk from manual handling of loads mandatory?<\/span><\/path><\/svg><\/div>

It is mandatory whenever workers perform activities with loads that can cause biomechanical overload, even in potential form. It is an obligation provided for by Articles 167-170 of Legislative Decree 81\/2008 and must be included in the company DVR. <\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>What methods are used to assess manual handling?<\/span><\/path><\/svg><\/div>

The methods recognized by ISO 11228 standards are: NIOSH for lifting, Snook-Ciriello for pulling and pushing, and OCRA for repetitive movements of the upper limbs. The choice depends on the type of activity analyzed. <\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>What risks does incorrect handling entail?<\/span><\/path><\/svg><\/div>

The main risks are dorso-lumbar pathologies (hernias, discopathies, low back pain), musculoskeletal disorders of the upper limbs, chronic inflammation, and acute injuries. These can permanently reduce the worker’s ability to work and generate significant direct and indirect costs for the company. <\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>Must the assessment be updated over time?<\/span><\/path><\/svg><\/div>

Yes. Any change in tasks, equipment, handled loads, or space layout requires a new assessment. Periodic updating is also recommended, even in the absence of obvious changes, as a good management practice. <\/p>\n<\/div>\n\t\t\t\t\t<\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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ATEX Zoning <\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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<\/path><\/svg><\/span><\/path><\/svg><\/span>When is ATEX zoning mandatory?<\/span><\/path><\/svg><\/div>

It is mandatory in all workplaces where there is a risk of potentially <\/em>explosive atmospheres forming due to gases, vapors, mists, or combustible dusts – even just due to the presence of methane gas, forklifts, or UPS uninterruptible power supplies.<\/em> It is provided for by Title XI of Legislative Decree 81\/2008 and is fundamental for protecting the health and safety of workers. <\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>Who must perform the ATEX zoning of a workplace?<\/span><\/path><\/svg><\/div>

The Employer has the obligation to assess the risk and classify the areas. Zoning must be performed by a competent technician, and the result must be documented in the Explosion Protection Document. MTM Consulting offers complete technical support and drafts all mandatory documentation. <\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>What happens if the environmental conditions change?<\/span><\/path><\/svg><\/div>

If production processes, substances used, plant layout, or installed equipment change, the classification of ATEX zones must be updated. Furthermore, the ATEX CE compliance of all machines and plants present must be verified, as they may no longer be suitable for the new classification. <\/p>\n<\/div>\n\t\t\t\t\t<\/div>

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<\/path><\/svg><\/span><\/path><\/svg><\/span>Is ATEX zoning different from ATEX consultancy for CE marking?<\/span><\/path><\/svg><\/div>

They are two different but related aspects. ATEX OSH zoning concerns the classification of workplaces and the obligations of the Employer (Legislative Decree 81\/2008). ATEX consultancy for CE marking, on the other hand, concerns products (equipment) placed on the market (Directive 2014\/34\/EU). MTM Consulting specializes in both areas. <\/p>\n<\/div>\n\t\t\t\t\t<\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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request Information.<\/span><\/h3>\t\t\t\t<\/div>\n\t\t\t\t
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Do you need more information or want to understand how we can help you concretely?<\/span><\/p>

Fill out the form here: our team will contact you as soon as possible with a clear, precise response tailored to your needs.<\/span><\/p>

Whether it is consulting, a project, or a simple request, we are at your disposal to find the best solution together.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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    <\/span>\n\t\t\t<\/p>\n\t\t<\/div>\n\t<\/div>\n\t

    \n\t\t
    \n\t\t\t