Machinery conformity assessment is a crucial process that not only facilitates the legal introduction of machinery into the European market but also ensures their safe and compliant operation. Regulations such as the Machinery Directive 2006/42/EC and Regulation 2023/1230/EU mandate that every machine undergoes this process before obtaining the CE marking.
While machinery conformity assessment can be conducted internally, it requires an in-depth understanding of numerous harmonized standards that imply compliance with legal requirements. For many companies, outsourcing this task to a specialized external firm is the best solution. Why? Because an independent auditor provides greater credibility and minimizes the risk of costly errors.
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When is Machinery Conformity Assessment Necessary?
Machinery conformity assessment is required in several key situations, and failing to conduct it can have serious consequences. Primarily, any new machine you plan to introduce to the EU market must meet the appropriate legal requirements. But what does “market introduction” actually mean? It encompasses not only the production and construction of machinery but also importing devices from outside the European Union or selling them. In these cases, you bear the responsibility for the conformity assessment process. You must ensure the machine has the CE marking and that the technical documentation is complete.
As a machine purchaser, it is your duty to verify that the machine you are buying has the correct CE marking. Failing to conduct proper verification can lead to serious legal, financial, and most importantly, safety risks.
Conformity assessment is equally important when modernizing production lines. Even if a machine previously had a CE marking, any significant change affecting its operation requires a reassessment. Introducing new components or modifications necessitates updating the technical documentation and conducting a new risk analysis.
The Process of Machinery Conformity Assessment
The machinery conformity assessment process consists of several key stages that must be meticulously executed to ensure the machine meets all legal requirements. The first step involves a risk analysis, which identifies potential hazards associated with using the machine. At this stage, necessary safety measures are determined to minimize accident risks.
A critical element of this process is selecting the appropriate harmonized standards. For instance, the standard PN-EN ISO 12100 is a type A harmonized standard, meaning it has a higher-level character compared to type B1, B2, and C standards, which are more detailed. Theoretically, one can declare compliance with the ISO 12100 standard alone, which may seem sufficient if the risk analysis shows all hazards have been properly identified and are acceptable. But this raises the question: Have we correctly interpreted the risks?
Relying solely on this standard can be both a good and bad strategy. Without experience, it is difficult to definitively assess whether any significant risk has been overlooked. Therefore, it is worth considering outsourcing the risk assessment to an external expert. Such a firm can provide additional assurance that no threat has been downplayed or overlooked.
If the risk analysis reveals that some hazards are unacceptable, then these risks can be managed using lower-level standards, such as B1 and B2 standards, which offer more detailed guidelines. Implementing additional protective measures, such as guards, safety curtains, or other systems, becomes necessary.
Common Problems and Mistakes
The most common issues in the machinery conformity assessment process arise from several key factors. The first is underestimating risks. Companies often fail to realize how a machine component might behave under various conditions. Automation of production brings not only benefits but also new risks. For example, how does the machine react to sudden stops or system failures? Lack of experience in machine safety and anticipating such scenarios can lead to serious accidents.
Another problem is lack of technical knowledge regarding available solutions that can mitigate risks. It is often not enough to apply any safety function—it must be the right safety function. For instance, when should a guard be fixed, and when should it be monitored? If a machine lacks guards and the only protection is a safety curtain, were stopping distance tests conducted to ensure the machine stops in time?
In the conformity assessment process, one must also not forget about residual risk. What has been done to minimize these risks? Every technical decision in this matter is significant, and incomplete analysis can lead to unacceptable hazards. Without adequate experience, it is challenging to fully identify all potential risks and select appropriate protective measures.
Costs and Consequences of Non-Compliance
Failing to properly conduct a machinery conformity assessment can lead to severe financial and legal consequences. When a machine does not meet the requirements, it must be adapted to essential requirements, which often means significant changes to production lines. This can be particularly problematic for machines imported from outside the EU, where standards may differ significantly. In such cases, modification costs can be enormous, especially if the manufacturer does not cooperate or refuses to take responsibility for non-compliance.
What then? Of course, one can opt for legal resolution, but until then, the machine cannot be legally used. Production line downtime means even greater losses, both financial and operational. Therefore, the risk associated with using non-compliant machines is enormous and can impact the entire business operation.
Choosing a Company for Conformity Assessment
Deciding to outsource machinery conformity assessment to an external company is a crucial step that can prevent serious legal and financial issues. So how do you choose the right partner for this process? Here are some key factors to consider:
- Experience and Specialization – Ensure the company has relevant experience in machinery conformity assessment and production lines, not just in theory but also in practical implementations. Does the company have experience working with machines similar to those you wish to assess?
- Knowledge of Harmonized Standards – A well-chosen partner must have a deep understanding of harmonized standards, such as PN-EN ISO 12100 and other detailed B1 and B2 standards, which help manage risks and protect against accidents.
- Comprehensive Approach – It is essential that the company offers full support—from risk analysis, through standard selection, to technical documentation preparation. You should receive not only a report but also specific solutions and recommendations for safety measures.
- References and Certifications – Check the company’s references and whether it holds certifications that confirm its competence in conducting machinery conformity assessments.
- Engineering Approach and Modernization Support – The best companies not only identify problems but also propose specific engineering solutions, which is rare. Additionally, they should be able to support you throughout the process and even physically modernize the machine.
FAQ: Machinery Conformity Assessment
Machinery conformity assessment is necessary when introducing new machines to the EU market, importing from outside the EU, selling, and during significant machine modernizations. In each of these situations, you must ensure the machine meets legal requirements and has the CE marking.
An external company specializes in harmonized standards and risk analysis, minimizing the risk of errors. It provides objectivity, saves time and resources that the company would otherwise need to allocate for training and internal analysis.
The most common mistakes include underestimating risks, lack of knowledge about available safety measures, and overlooking residual risk. Companies often fail to identify all hazards or improperly select safety functions.
Lack of assessment can result in costly machine modifications, production downtimes, legal sanctions, and threats to employee safety. Machines that do not meet requirements cannot be legally used.
When choosing a company, consider experience, knowledge of harmonized standards, comprehensive services, references, and the ability to support modernization. Companies like Engineering Shield Sp. z o.o. offer full support from analysis to implementing changes.