There are many schemes to consider when thinking about compliance certification for different countries: CE certification for Europe, EAC certification for the Eurasian Economic Union, Manufacturing License and CCC marking for China, RMRS and Intergazcert certifications for Russia, CCoE certification for India, INMETRO Regulations for Brazil, the application of explosive atmospheres in accordance with ATEX, COMPEX or IECEx Directives, etc. How to optimally manage product compliance in accordance with local Laws without compromising product safety?
8 steps to conformity certification
If you desire to carry out a technical assessment for the compliance of your industrial products (machines, equipment, components), you should first consider the local laws, regulations and technical standards that regulate the conformity requirements of a specific country, as well as any distinctive characteristics related to each country or region. However, the process to obtain a declaration of conformity (or certification) consists of a series of steps which are common to many countries.
In general, a declaration (or certification) can be a simple self-declaration of conformity with a consequent affixing of the mark in the manufacturer’s name – for example the CE mark in the manufacturer’s name. In case the competences to carry out a complete, correct and truthful assessment are not enough, the risk you are taking can be enormous. The risk involved is high both for the manufacturer and the end user, especially in the event of accidents with severe consequences on the health of operators and end-users. The subject responsible for the declaration of conformity is indeed exposed to the risk connected to the use of unsafe products. As we know, liability is punishable by imprisonment. Many are the cases registered every year of accidents caused by the malfunctioning of products which had been unjustifiably marked as “compliant”.
The certification of conformity of an industrial product generally involves a complex process composed of a series of phases, which include the following steps:
Step #1. Basic Assessment: it is a 1st level assessment. It aims at analyzing the set of local laws and regulations that have an impact on the design, manufacture and delivery of the industrial product.
Step #2. Standard Assessment: it is a 2nd level assessment. Through a second evaluation it is possible to examine in closer detail local laws and regulations by analyzing the paragraphs containing the requirements applicable to the product.
Step #3. Compliance Matrix Assessment: The Compliance matrix is a data matrix that shows for each component, either purchased or manufactured, the laws and main rules that are applicable. From the intersection of the data indicated in the matrix, it is possible to start developing the necessary documentation to be submitted to receive an approval by local authorities. This documentation is also useful to complete the supply and draw up internal manufacturing specifications.
Step #4. Product Design: Product design must comply with local technical requirements. The conformity of each product feature represents an important guideline to be followed from the procurement phase. Multi-language specifications are later included in the installation and operation manuals.
Step #5. Product Verification: By means of product documentation, as well as tests and testing, it is possible to verify the developed design thanks to the support of an expert. The result of the carried-out tests is a technical report containing the list of applicable requirements which haven’t been fulfilled yet. The report details the requirements it refers to, as well as the list of components, the specifications of any non-compliant items; it also contains a dedicated section to the report on the detected issues. A correct report is usually accompanied by an additional document containing any possible actions to solve non-conformities.
Step #6. Management of Certification & Authorities: It is necessary to optimally manage the communication with authorities and certification bodies. These are responsible for the approval and issuing of certificates and marks, which are necessary to comply with the requirements of local standards. We will examine this point in the following paragraph.
Step #7. Issuing of Regulatory Documents: This phase will lead to the issuing of specific documentation required by the applicable requirements or authorities of the country where a declaration of conformity is needed. The list of documents that are necessary to comply with local standards varies depending on the country and product.
Step #8. Development of Installation and Operation Manuals: Delivering goods all over the world requires the supply of a specific set of documents to be made available in multiple languages. In this last preparatory phase, installation and operation manuals must be attached to the product for its correct marketing.
Our tips to simplify the certification process of an industrial machine
Firstly, we recommend keeping in mind the consequences that a lack of product compliance may cause and preventing any potential risks. In this regard, it is advisable to contact an expert in conformity certification who can help you prevent the risk. On the other hand, the management of the communication with authorities and certification bodies is particularly delicate. For this reason, it is of utter importance to seek help in native speaker technicians who can ensure a more effective communication.
Authorities, on the other hand, will be more willing to manage the process proactively, therefore reducing the points on the punch list and working on finalizing the certification process.
However, the protection of industrial machineries from potential risks is essential for end-users as well. It is recommended to verify the overall safety level of purchased products and make any necessary changes to restore the conformity of machineries and production lines being used.
Do you want to know more about the technical laws of a specific country and design your industrial products in compliance with the regulations and standards of a specific country or region?
Get in touch with our specialists! We provide support for technical design in compliance with local standards and laws in more than 50 different countries, including Russia, USA, Canada, Australia, Brazil, China, India and the United Arab Emirates. We support companies in obtaining both the EAC certification for the Eurasian Economic Union, thanks to our in-house Russian mother-tongue technicians, and the CE certification for manufacturers and end-users operating in the European market. We can affix the CE mark to the product in our name relieving manufacturers and end-user from being held liable for the product.
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