Almost all equipment operating in the factory is governed by laws and regulations regarding their construction, use, service and disposal. The selection of a specific directive and standard for a specific device can be difficult and laborious, and the uncertainties that may arise during the conformity assessment process effectively discourage entrepreneurs from taking care of safety issues and related formalities. We have many years of experience both in the construction and subsequent certification of machines, thanks to which they comply with the current legal regulations regarding a specific device or production line. Already at the design stage, we try to implement all the recommendations indicated in the Directives and standards harmonized with them, in order to avoid actions that hinder or prevent proper reception at the post-production stage.
The main groups of devices that are subject to EU regulations on declaring their compliance with directives and standards are listed below:
- MACHINES – Machine Directive MD 2006/42 / WE.
- ELECTRICAL EQUIPMENT – Low voltage directive LVD 2014/35 / EU, EMC directive 2014/30 / EU, Dangerous substances Directive RoHS II 2011/65 / EU, Ecodesign directive ECO 2009/125 / EC, Energy labeling regulation LAB 2017/1369 .
- TOYS – Toy Directive 2009/48 / EC.
- MEASURING INSTRUMENTS – Measurement Directive MID 2014/32 / UE
- YACHTS AND WATERBOARDS – Yacht Directive RCD 2013/53 / UE
- PERSONAL PROTECTIVE EQUIPMENT – PPE Regulation 2016/425 (new), PPE Directive 89/686 / EEC (old).
- PRESSURE EQUIPMENT – Pressure Equipment Directive PED 2014/68 / EU.
- RADIO DEVICES – RED Radio Directive 2014/53 / EU.
- CONSTRUCTION PRODUCTS – Construction Regulation CPR 305/2011
- MEDICAL DEVICES – Medical Directive 93/42 / EEC.
The first step towards declaring the conformity of a device is the appropriate classification of the device (scope and exclusions of the directive in question), as well as the determination of any harmonized standards for this device in accordance with the directive. Since a large part of enterprises in Poland use machines and devices manufactured in Poland before the entry of the EU Directive, obliging them to issue a declaration of conformity, we propose to adapt them to the applicable legal regulations (this is a necessary condition for the use of industrial equipment, and any deficiencies associated with it are fined ex officio!).
Some machines are assessed for compliance with the minimum requirements (manufactured before 2004 and not subjected to significant modernization since then – primarily no unauthorized changes to the control / security system). The remaining cases require the application of New Approach Directives, including the preparation of the Declaration of Conformity. This declaration is not only a certificate, but a number of factors that were met before it was issued. The declaration is, therefore, the culmination of the design of the device, the final confirmation that all structural elements have been manufactured in accordance with the instructions, and that the machine does not pose a threat to the user and the environment. Importantly, the Declaration is a form of commitment declaring that he has taken all steps to verify its correctness. It is therefore important not to have the document itself, but strict compliance of the machine with the declared directives and standards.
General requirements for all devices in order to issue a declaration of conformity are:
- Product identification number (model, type, serial number)
- Name and address of the manufacturer or authorized representative.
- A statement that the declaration is issued under the sole responsibility of the manufacturer.
- Product identification data enabling its traceability.
- All EU harmonization regulations that the product must meet – they are determined individually for each device)
- Name and identification number of the notified body, if it has participated in the conformity assessment procedure (if it is required to assess the conformity of a given device, e.g. pressure vessels are subject to UDT control).
- All additional information that may be required, if applicable.
- Date and place of issue of the declaration as well as the signature and position of the authorized person.
The manufacturer of the device is responsible for issuing the declaration of conformity, but the user is responsible for its correctness. Therefore, it is worth checking the basis on which the manufacturer declared the compliance of the device and whether it provided complete documentation. NOTE – according to EU regulations, we become the manufacturer of the device as users if we make major modifications to it or mark it with our own logo. An example of the transfer of producer responsibility to the user is any interference in the machine control systems that changes or affects the operating parameters. Connecting new safety circuits, integrating the line with a new device, integrating safety circuits (e.g. stopping the first device after stopping the second one) – everything was defined as a modification that obliges the user to issue a new declaration of conformity and take over the manufacturer’s obligations.
An important stage in the production of the device is a risk analysis, which consists in showing at the design stage the risks posed by the machine, as well as their early elimination by means of design measures and elimination of the remaining risk (residual risk) through the use of additional shields or personal protection of operators. It is important that a large group of machines has predefined safety measures that must be met in order to declare compliance with the directives (so-called harmonized standards). Acting on the basis of these provisions, we can be sure that the machine was made in accordance with the legal standards guaranteeing the most effective solutions proposed by the legislative body – the European Parliament.
Some machines require an audit of a certified body, but for the vast majority of them, an assessment by the Internal Production Control is sufficient. The research aims to confirm the design assumptions in practice. These include strength tests, electromagnetic field tests, electrical equipment tests, etc. The method of testing and presentation of results are assessed individually for each machine and / or its components.
Preparation of technical documentation is another, very important step, without which certification is not possible at all. Depending on the needs, the technical documentation in the form of instructions should cover the following issues:
- GENERAL DESCRIPTION – basic information about production, technical data, photos, models, applications, etc.,
- TECHNICAL working DRAWINGS, created precisely so that it is possible to make a product based on these drawings at any time in the future. – electric, pneumatic, hydraulic SCHEMES – if our device contains such components,
- DESCRIPTIONS AND EXPLANATIONS necessary to understand the technical drawings and diagrams mentioned above,
- LIST OF HARMONIZED STANDARDS that the manufacturer used in the conformity assessment process, applied in whole or in parts,
- DESCRIPTION OF SOLUTIONS adopted by the manufacturer in order to meet the essential requirements – if he did not apply harmonized standards in the conformity assessment process (NOT RECOMMENDED!)
- RESULTS OF CALCULATIONS made by the manufacturer to ensure the safety of a given solution used in the product (e.g. strength results, etc.)
- TEST REPORTS confirming the fulfillment of the essential requirements or their parts. These can be reports from the manufacturer or from external (e.g. supplier or test body) reports.
- PRODUCTION PROCEDURES if the product is produced in a non-unit (serial) manner. Production procedures must pay attention to how the product is produced, how it is inspected, how it is packed, from which components from which suppliers, etc.
The above information must be included in the manufacturer’s documentation, but it is not always provided to the end user – it contains a lot of information treated as the know-how of the design company and it is our contract with the supplier that we need to receive this type of information. On the other hand, the absolute obligation of the manufacturer is to provide the equipment with the instruction manual, the components of which are briefly presented below:
- GENERAL DESCRIPTION in which we include basic information about the production, technical data, photos, models, applications, etc.,
- CONTACT DETAILS OF THE MANUFACTURER, i.e. full name and full address at which the manufacturer can be contacted.
- APPLIED DIRECTIVES AND NORMS that were used by the manufacturer in the conformity assessment,
- APPLICATION ACCORDING TO THE PURPOSE – a very important element in which it is necessary to precisely describe what type of work can be performed with the product,
- WARNINGS CONCERNING FORBIDDEN USES which the manufacturer provides, that may happen and cause injury to the user,
- RESIDUAL RISK DESCRIPTION – if there is such risk, users should be informed in the operating manual so that they are aware of the risks associated with the use of the product,
- TECHNICAL DATA of the device, dimensions, etc. We apply this requirement, if applicable – ie in the case of machines, electrical and pressure devices, personal protective equipment.
- USE – description of activities related to the safe use of the product,
- ADJUSTMENT description of activities related to the safe regulation of the product (if applicable),
- REPAIR description of activities related to the safe repair of the product (if applicable),
- MAINTENANCE description of activities related to the safe maintenance of the product (if applicable),
- CLEANING description of activities related to the cleaning of the product (if applicable),
- TRANSPORT description of activities related to the safe transport of the product (if applicable),
- DISASSEMBLY description of the activities related to the disassembly of the product (if applicable),
- SPECIFICATION OF SPARE PARTS which the manufacturer expects that during the life of the product it will be necessary to replace it with new ones,
- EXPECTED FAULTS – a document informing the user what to do when the product does not work as intended.
- MODEL OF THE NAMEPLATE placed on the device
- DRAWINGS of the device.
The last step to correctly issue a Declaration of Conformity is to correctly mark the machine with the CE mark, in accordance with the specification and regulations. The labeling requirements are strictly defined and are regulated by the directive. The most important elements are:
- CE mark (next to the manufacturer’s name),
- manufacturer’s name and his full address,
- product name,
- Type, serial number (if used),
- Basic, relevant technical data.
Only after fulfilling all the above steps, we can proceed to issue the Declaration of Conformity. Of course, there are many indirect factors deciding on each of the steps, but in the material below we wanted to introduce you to how to create documentation and declare compliance, with an emphasis on machines.
The correct model of the declaration of conformity and its content is also strictly regulated by the regulations. The only document appropriate for the CE marking is the Declaration of Conformity. The common “certificates of conformity”, certificates of conformity “and their variations are not sufficient, even if they coincide with the document described in the Directive. On their basis, no action can be taken to bring the product into legal use.
Declaration should contain at least:
- TITLE EC or EU DECLARATION OF CONFORMITY, depending on the applied directive),
- MODEL TRADE NAME – the name must be very specific, so that we know exactly which product is subject to a given declaration of conformity on the basis of the declaration,
- NAME AND ADDRESS OF THE MANUFACTURER – if the manufacturer is located outside the EEA, the declaration of conformity should also include the name and address of the authorized representative, if one was appointed.
- European DIRECTIVES / REGULATIONS what the product meets
- HARMONIZED NORMS/STANDARDS that the product meets
- DECLARATION that this DoC is issued under the sole responsibility of the manufacturer.
- PLACE AND DATE OF ISSUE
- NAME, SURNAME, POSITION AND SIGNATURE of the person authorized to sign the declaration of conformity.
As you can see, the described process is long and requires a huge amount of data that must be collected and processed in order to obtain a product that can be legally marketed and operate, for example, in our factory.
We offer assistance in passing each stage of certification, we collect the necessary documentation even for machines already in operation that require re-certification. We conduct the case step by step, providing our clients with comprehensive information on the progress, requirements, legal possibilities, as well as solutions to problems related to the construction or even technical documentation. We are able to carry out successful certification wherever legally possible. We are looking for cost-effective solutions to additionally increase the attractiveness of our service. We invite you to consult with us on issues related to the Declaration of Conformity. We are convinced that together we will find a solution to every problem!
TAGS: declaration of conformity, CE, machine certification, adaptation of machines to essential requirements, adaptation of machines to minimum requirements, CE for machines, machine marking, machine documentation, machine directive 2006/42 / EC, low voltage directive 2014/35 / EU, tool directive 2009 / 104 / EC, Pressure Equipment Directive 2014/68 / EU, machine manual, risk assessment, machine modernization, safety, machine safety systems, machine protection, fencing of safety zones, safety audits.