Conformity to Europe with CE or Turkish equivalent includes mandatory conditions for health, safety, environment and consumer protection for certain products with the New Approach Directives, which started to be removed from 1985. So, a product with CE marking is an indicator of compliance to the conditions set out in the EU Directive in terms of life and goods safety of people, animals and plants, not related to quality. For example, a flyer can not fly well, although it is suitable for life and safety of goods. So the quality may not be good.

 

The manufacturer is responsible for the introduction of products to the market as CE marked (in line), the CE mark is exported to the product. This mark of the manufacturer has presented various alternatives to the product:

 

Low-risk products : Many products are located in low-risk product groups in terms of safety. Therefore, after making the manufacturer's conformity assessment, a statement publishes; the product indicates that the mandatory safety, health, environmental and consumer protection standards. It is necessary to organize this declaration in accordance with the norm.

 

High risk products : It is not enough to declare the manufacturer for these products. In this case, products must be tested by approved organizations (notified body). As a result of the review of the approved organization, the manufacturer can put the CE mark into the product. All system and units manufactured to be used in the last product are manufacturers to integrate with a file and declaration that belongs to components and components in accordance with the relevant directive (name). Organizations that produce parts or components to the integration cannot hit CE mark on their products.

 

WHAT IS CE CERTIFICATE?

The CE Mark was initially used as head letters of “Conformity Européenne” words, which means “conformity conforms to European norms” in French, since 1995, “Conformity European” expression has been used as “conformity compatibility”. When CE certificate is issued, the product is subjected to tests. These tests vary according to the type of product.

 

CE Marking is the conformity mark consisting of “CE” letters. CE Compliance Sign is applied to products organized by European Union with health, safety and environmental protection laws. The CE Compliance Sign is applied to the products entering the scope of the New Approach Directives (Technical regulations). CE Compliance Sign is mandatory for manufacturers who want to market their products in Europe Market. Otherwise, it is impossible to manufacture and sell products in this market. The products that do not comply with technical regulations (responsives) cannot be included in the European Union in member countries markets. If the product meets the requirements of the directive and carries CE Conformity Sign, these countries will not bring ban and limitations in the introduction of the product to the market or to the consumer. So CE Compliance Sign is a passport of a product in Europe.

If not otherwise specified in the relevant technical arrangement, it consists of at least 5 mm neck “CE” letters. For this point, it can be reduced or enlarged, depending on the specified proportions and shape. The product or data sheet are discussed. If the product is not possible by its structure, the label, packaging, and the related technical arrangement required to have any documents with the product. Visible, readable and irreplaceable. CE conformity mark is discussed at the end of production control phase. Other markings that will be misleaded about the meaning and shape of the CE conformity mark.

 

HOW TO GET CE CERTIFICATE?

It can be said that the products with CE marking provide a certain safety assurance for the living. How to take the “CE Mark” is indicated in the directive of the products that are located in how to trade the product. Since products are presented to the market as CE marked, the manufacturer is responsible for the introduction of CE mark to the product. This mark of the manufacturer has been presented various alternatives to the product. At the same time, CE Certificate is a sign that is required to comply with the new approach directives of the European Union. This entry is mandatory and the European Union will be presented to the market of member countries. The products can be considered to be a passport that should have a nevi to be able to walk freely in European markets.

 

WHY CE CERTIFICATE?

High speed-growing technology, increasing competition environment and the need to produce quality for reasons such as user awareness has increased today. Documentation of product quality and reliability has been subject to consumer terms. There are many documents used in documenting product safety. One of these documents is CE certificate. The European Union has adopted a new standardization policy for some challenges experienced. At the beginning of these challenges, each member of the European Union had different standards from the country. Countries that can not find the necessary terms and compliance in the product that a member of the European Union is exported to another country according to their rules and standards were not able to get these products and have not been able to trade healthy among countries. This To eliminate problems, close to each other products are collected under a category and the necessary safety conditions and standards have been determined. In general, these criteria are based on the environment, human and animal health, safety and consumer protection. Detailed technical conditions that determine the quality of the product are determined by CEN and CENELEC firms.

 

WHAT IS MASK CE CERTIFICATE?

Masks vary depending on functions. Recently revealed SARS, Coronavirus, Ebola, which is one of the increasingly increasing products of its use and importance. These masks are classified as dust mask, surgical mask, welding mask, respiratory mask according to the places where the general purpose is to clean the left air.

 

Masks with CE marking can be subjected to CE-documented masks. Having CE mark on a mask shows that the mask is possible in the European Economic Area (AEA) circulation and sales. It is also a sign that this mask is suitable for safety, health and environmental protection standards. In addition to CE marking for circulation and sale in AEA of surgical masks, EN 14683 Standard must also provide requirements. EN 14683 Standard; They can be explained as Requirements and Test Methods for Medical Face Masks.

Standard surgical masks can be defined as a barrier that limits the passage of an infectious agent (or disease) between mouth, nose and jaw, medical devices, hospital staff and patient. Masks are tested as a final product and classified in 4 classes according to the results obtained from these tests.

 

As EN Quality Consultancy Services, we support in the test and technical file preparation process required for Mask CE Certificate. The tests, technical file preparation and clinical trial that must be made in Approved Organizations are completed simultaneously during this time and we perform your certification process. Contact us immediately to get detailed information about all these processes that need to follow sensitive and well.

 

WHAT IS CE CERTIFICATES?

In the European market, CE Compliance Sign is a kind of commercial passport for the product and allows products to walk freely between 28 European countries and countries with EU mutual recognition agreement. For the entire European Economic Area, there are only one legislation and basic requirements to comply with the products. In this field, national laws lost validity and collected under one legislation. Therefore, products do not have to comply with different national regulations. Different legislations of the country and different conditions sought to bring an additional cost to the manufacturer. With the help of new Approach Directives or CE directives, the adaptation of national laws and directives and mutual recognition of technical standards is provided, so the manufacturer does not have to shape products for different markets. This is also the manufacturer reduces costs. Safety levels of all products were arranged with the help of directives during compliance operations. Compliance with current basic requirements has made the product safer in terms of the user, the damage and liability cases are also reduced.

 

WHAT IS THE PRODUCT CONCEPTABLE BUSINESS?

CE Compliance Sign is required only in countries within the European Economic Area (EEA). The European Economic Area consists of 25 member countries of the European Union of Austria, Belgium, Danimarka, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands,Portekiz, Spain, Sweden, UK, Czech Republic, Estonia, Hungary, Malta, Lithuania, Latvia, South Cyprus Greek Cutting, Poland, Slovakia and Slovenia from three countries; Iceland, Norway and Liechtenstein.

 

EU DIGITAL FOR STONE PRODUCTS

• Low voltage devices Low voltage equipment (73/23/EEC; 93/68/EEC)
• Simple pressure vessels Simple pressure vessels (87/404/EEC;90/488/ EEC; 93/68/EEC)
• Gas collar tools Gas appliances (90/396/EEC; 93/68/EEC)
• Hot water boilers Hot water boilers (92/42/EEC; 93/68/EEC)
• Electromagnetic compatibility Electromagnetic compatibility (89/336/ EEC; 92/31/EEC; 93/68/EEC)
• Machines (98/37/ EC)
• explosives for civil use Civilians (93/15/EEC)
• Non-automatic weighing tools Non-automatic explosive (90/384/EEC; 93/68/EEC)
• Equipment and protection systems used in explosive environments for use in adverse disaster atmospheres (94/9/EC)
• Elevator Lifts (95/16/ EEC
• Freezers Household electric refrigerators, Freezers and Banquets (96/57/ EC)
• Regulation Pressure vessels Pressure equipment (97/23/EC)
• Noise reduction in the environment from the equipment used outdoors in the environment for use outdoors (2000/14)
•  Energy efficiency in fluorescent lamps Energyefficiency requirements for ballast for auxiliary lighting (2000/55/EC)
• Active medical devices that can be placed in the body Active implantable devices (90/385/EEC; 93/42/EEC; 93/68/EEC)
•  Medical devices Medical devices (93/42/EEC; 98/79/ EC)
• In vitro medical diagnostic devices In vitro diagnostic medical devices (98/79/ EC)
•  Toys Toys (88/378/ EEC; 93/68/EEC)
• Recreational craft for sightseeing purposes (94/25/ EC)
•  Marine Contractor Trip Boats Regulation Construction materials Construction products (89/106/ EEC; 93/68/EEC)
• Personal protection equipment Personal protective equipment (89/686/ EEC; 93/68/EEC; 93/95/EEC; 96/58/EEC)
• Radio and telecommunications terminal devices Radio and telecommunications terminal equipment (99/5/EC)
• Vehicles moving on passenger transport cable Cableway installations designed to carry persons (2000/9/ EC)

 

CE SUPPLY WORKING PRODUCT TEST DOES IT WORK?

The European Commission has developed several standard conformity assessment methods for the control of products. This is called “Modular System”. Modules that can be used for each directive are set within the directive. Manufacturer can choose one of different modules. The producers of low-risk products can determine and declare the products with control and testing that they will carry the necessary conditions. According to European standards, high-risk products should be tested and documented by test and certification bodies (Noteified Body).

 

HOW TO READ THE CE TECHNICAL DOES?

The technical file is related to previous preparation operations in testing by approved institutions of the conditions specified in new approach directives. These directives make the manufacturer the obligation to create a technical file with information that proves the direct requirements of the product.

 

The technical file in some directives is one of the tools of the conformity assessment of the product in the framework of the market surveillance in which member states. In this context, the intervention of a third person or a approved institution is not concerned. The eligibility declaration of the renunciation is sufficient. When the product goes into the market, the technical file is offered to the national authorities when requested by the manufacturer or authorized representative.

 

In Directives, the technical file is only one of the tools in a certain conformity assessment process, which is carried out by entering the work of a third person (induced institution). The content of the technical file under the first purpose contains the necessary processes to prove compliance with the quality of the product and technically product; if the manufacturer has been produced in accordance with the harmonized standards, if the manufacturer has never been obeyed or partially complied with the basic requirements specified directly. The technical file should be maintained to be submitted to the audit of authorized organizations with 10 years from the manufacture of the final product unless otherwise specified in the relevant technical regulations.

             

 Basic technical data regarding compliance assessment operations:

• The name, address and product detection of the manufacturer,
• List of harmonized standards applied by the manufacturer, explanations of the solutions adopted to meet the basic requirements of the technical regulation, where these standards are not applied or implemented,
• Description of the product,
• If necessary, instructions for use of the product,
• If necessary, the detailed plan of the product

 

MODULES USED IN CE BUSINESS

Modules or conformity assessment procedures are important in CE compliance mark application. The application includes all kinds of activities for testing, inspection and documenting compliance to the relevant technical regulation of this activity product, which is referred to as “conventional evaluation process”.

 

In the CE marking system, modular understanding of conformity assessment methods, characteristics of products and the risk rates it carries is applied. Modular Approach is a modular system created for legislation preparation, the application of modules for determining the directives related to the design and production phase of the product. Modules covering various risk groups from A to H classify the product according to the degree of danger. Module A (production Internal Control): This module covers design and manufacturing phases. A technique file that explains the design, manufacturing and use of the manufacturer should be prepared and edit a conformity statement by verifying that the product provides the basic requirements determined in the directives. Unless otherwise specified in the related technical regulation of the manufacturer, the last Since the production of the product, it should retain the technical file prepared to be submitted to the audit of authorized organizations for at least 10 years.

 

Module Aa: In addition to this module A, this module contains one of the following complementary elements. The tests related to the specifications of the product for each manufactured product are made by the manufacturer or on the manufacturer. These tests are made by the manufacturer in the responsibility of a approved organization selected by the manufacturer and the approved organization ID number is discussed in the production phase in the responsibility of the approved organization. The approved organization selected by the manufacturer makes or built product controls at random intervals. The approved organization tests and examinations the basic requirements that the samples received in accordance with the finished products in the production place expressing the relevant technical regulations.

 

Module B (AB Type Review): This module, which only covers the design stage, is often not used alone. Used with one of C, D, E and F modules.36 According to this module, the manufacturer sends a prototype, representing the planned product of the production, to a approved enterprise, to control the compliance of the basic safety requirements. The approved organization makes necessary reviews on the sent prototype and if it detects compliance with the basic safety requirements, the applicant arranges the EU Type Inspection Certificate. If the approved organization is not suitable for product security requirements, the EU Type Review Document refuses editing and informs the applicant in writing with the report prepared in detail the reasons for rejection.

 

Module C (Typical Declaration): This module for production stage is used together with B module. The manufacturer declares and warrants that the product will produce in accordance with the type described in the EU type inspection document, the CE mark is discussed in each product. In this module, some technical regulations may be required by an approved organization or random product controls in the responsibility of the approved organization.

 

Module D (Production Quality Assurance):It covers production stage and follows B module. The manufacturer predicts the establishment of a quality assurance system with production, plant and service stages. The manufacturer declares and warrants compliance statement and CE marking in accordance with the type defined in the EU Type Review Certificate. The manufacturer and selected approved organization is documented by production and finished product audits and approved organization.

 

Module E (Product Quality Assurance): It predicts the establishment of a quality assurance system with final inspection and experiments. The producer conducts the test and experiments of the final product within the quality system installed. After applying the quality system for production, the manufacturer demands the audit of the approved organization selected. The approved organization gives compliance certificate by checking the quality system together with the EU Type Review. The manufacturer organizes a conformity declaration, discusss CE mark.

 

Module F (Product Verification): Only used with this module B module for production stage. A approved organization is the CE mark of the product along with a written conformity certificate in this module, which only controls the product's technical documents and the definition in type review.

 

Module G (One Verification): This module, covering both design and production stages, is often used for small productions, according to order or small diameter. The manufacturer prepares a technical file with the design and production stages of the product. The approved organization makes necessary examinations to determine the requirements specified in technical regulations. The producer prepares the written eligibility declaration and compliments the CE mark.

 

Module H (Full Quality Assurance): The H module, which predicts the implementation of the full quality assurance system, includes design and manufacturing stages. According to the module, it should be installed and approved a quality assurance system, which includes the manufacturer, design, production, facility and service stages. Quality assurance system ensures compliance with the requirements specified in the relevant technical regulations of the products. The manufacturer compliments CE mark on each product and organizes written eligibility declaration.

 

WHAT IS THE ROAD OF CE WORKING?

The following are:

 

• First, the New Approach Directives entered the produced product are determined.
•  If the product does not enter the scope of the New Approach Directives, there is no obligation to carry the CE mark of the product.
• If the complaint is available, the directives are provided and the safety/emnity specified in the directives on the product are determined.
• There are EU Harmonize standards for technical matters related to the product. 9 The conformity assessment method (Module) is determined to determine the basic requirements of the product in the New Approach Directive.
•  It is determined that the product does not need to apply to the Approved Organization for the detection of compliance to the basic requirements.
• In order to ensure compliance assessment processes are completed, all required tests and conformity criteria are worked together with a Approved Organization to be completed.
• Other information and documents requested in directives with technical file are stored. 9 Following the evaluation of conformity, the Declaration of Conformity and the required supporting evidence are prepared, on the product, label, packaging or “CE” mark to accompany the accompanying document is presented to the market after correctly.

 

What is the Needed Information?

 CE mark is an official sign that must be in all EU countries. The sign proves that the product can be placed without any restrictions in the market, the basic requirements of the product and/or manufacturer have carried out the conformity assessment studies of the manufacturer or third parties. The basic requirements of the CE marking is all related. If the product is covered by different directives, the mark on the product indicates that all these directives are satelliteed. The person responsible for the transportation of the mark on the product must supply the satellite to all directives. The mark should not declare which the product is produced in accordance with the directive or standard. This type of information should be included in test reports and compliance documents.

 

In addition to the CE marking, the last two digits of the year are carried out. Since the CE mark declares compliance with the legislation, they protect European standards and national signs validity. However, compliance signs of national standards do not specify compliance with the legislation of unity. In accordance with the law number 4703, administrative fines are applied to companies that provide non-secure products to the market by making production illegally and also provide information to the public about these products to the manufacturer and undertake the costs revealed here, withdrawal of products from the market is brought in obligations such as disposal of these products when necessary.

CE Certification Services

 

Product Review and Reporting by Machine Safety Regulation

 

Integration of Electrical Safety Testing Machines (EN 60204-1)

 

Technical File Review

 

Use Guide Review

 

Risk Analysis and Evaluation Review

 

Open Trainings for General Participation

 

Compliance Certification of Machines (Certificate of Conformity)

 

Certified Institution Services with Our Solution Partners

 

INFORMATION ABOUT MANAGEMENT

 

Scope of Regulation

 

The regulation covers the conformity assessment of components and safety elements used in machinery and machinery.