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Ce Certifications

The CE marking indicates conformity of the product to European product legislation.

The CE mark is an abbreviation of 'Conformity European' and the meaning in the literature is 'European Conformity', conforming to European Norms. The CE marking indicates that a product or group of products is in conformity with the essential requirements established by the European Union for the protection of health, safety, environment and consumers and referred to as "product directives". Products do not carry the CE marking; can not be entered into the European Union countries, so CE marking can be defined as an "industrial product passport" allowing products to freely circulate in the European Union domestic market.

The CE marking is a sign that is a passport for a product with warranty as well as a declaration of warrant of the manufacturer, which must be used in the Turkish domestic market as of January 1, 2004, providing free circulation of the product within the EU.

CE Mark is not a quality mark. CE Mark is not a trademark taken from any place but is attached to the product / package / related document by the manufacturer. The CE marking must be in the following format. The proportions should be preserved if the CE marking is expanded or collapsed. The CE Mark demonstrates that the product has been produced and certified in accordance with the EU's New Approach Directives. In other words, it is a sign that the product has the minimum safety requirementst in terms of human health, life and property safety, animal and plant life and health, environment and consumer protection.

The manufacturer is responsible for presenting a product covered by the New Approach directives to the market as CE Marked. However, the importer has to fulfill this responsibility if the manufacturer or the authorized representative of the manufacturer is not in the European Union. In other words, the importer has to guarantee that the imported products conform to EU norms.

CE CERTIFICATION CONSULTANCY SERVICE 

The CE mark must be in accordance with the directive or directives that are required by the product to be purchased. Once the directive or directives have been established, the standard or standards within the scope of the product directive or directives shall be established. The EU Member State where the product can be sold is determined whether the applicable national rules related to the product are available in the country / countries.

In the scope of the Directive or Directives, aRoad Map is reviewed and the most appropriate Road Map is selected. (In order to reach the CE mark in each Directive, there is a Road Map required for the manufacturer to follow). Within the scope of the Directive or Directives, the most appropriate Module (Conformity Assessment Method Intended to Determine Suitability of Essential Requirements) is selected. (8 Particle Base Modules and their 8 Particle Variants may form combinations with each other in order to be able to form a complete conformity assessment procedure.) As a general rule, a product throughout the design and production phase is subject to evaluation in accordance with the modality of suitability evaluation).

It is determined whether the product is a risky group product. The most appropriate certification bids are obtained from the notified body if the product is in a risks group.

It is controlled whether the product is produced in compliance with the standards.

Risk analysis of the product's mechanical, electrical and constructed construction is done. As a result of risk analysis, there may be a small number of changes that may be related to safety of the product. The final product will be determined after the meetings with our experts in this field and the technical staff of the firm.

If the product is to be tested under the standard or standards an accredited offer shall be obtained from a test establishment (Domestic or Foreign) for the best results.

Trainings required about standards or standards to be applied at manufacturing phase are given by technical personnel by the expert persons.

Work orders that will comply with the standards of Production to be applied in production are prepared and if there is a Quality Management System applied to the company, these work orders are added to the Quality Management System Procedures and the most efficient application is ensured.

Product assembly, commissioning, final user and maintenance manuals provide directives and Standards 

Labeling and Marking of Products are Made in accordance with the Directives and Standards.

Technical File of the Product is prepared. Technical File is all the technical information and reports related to the product that should be stored for 10 years with the producer. This is the file where the reports are prepared. Preparations should be made as indicated in the Directives and Standards.

Product CE Declaration Prepared. (The Declaration that the Declaration Producer Produces the Product in the Specified Directive and Standards). CE mark is attached to the product.

CE Marking is a health and safety mark in the European Union's "New Approach" framework established in 1985 to provide free movement of goods. It is intended to use a uniform EU mark indicating compliance with EU directives instead of the different conformity markings used throughout the EU.

The CE mark indicates compliance with the European Union's New Approach Directives, indicating that the product on which it is affixed is healthy and safe in terms of human, animal and environment. It is not possible for a product falling under one or several of the New Approach Directives, which now number about 25, to enter the EU market without carrying the CE Mark. To prove compliance with the New Approach Directives, manufacturers have a great deal of ability to manufacture in compliance with the harmonized standards of the directives. While it is not compulsory to comply with the standards, if the production conforms to the standards, it is encouraged that the producer assumes compliance with the standards.

CE mark; Is not a symbol of quality but a sign that the product to which it is affixed is a sign that it meets all the requirements of the relevant regulation and that it provides free movement of goods among the Member Countries of the European Union.

The "CE" conformity mark consists of the initials "CE" with the following shape: 

If the "CE" conformity mark is reduced or enlarged, it must stick to the proportions given in the above drawing provided

Following the "CE" conformity mark, the identification number of the notified body performing the transactions must be included. For example, for TSE; it is "CE 1783". 

In the following table, the CE marking is placed between the required directives,

- All new products produced in Member Countries or third countries,

- Used or second-hand products imported from third countries,

- Substantially differentiated products subject to the provisions of the Directives as if they were new products,

CE marking is required.

 

New Approach Regulations Requiring CE Marking;

1. Low Voltage Devices

2. Simple pressure vessels

3. Gas Burning Devices

4. New Hot Water Boilers

5. Electromagnetic Compatibility

6. Machines

7. Explosives for civil use

8. Non-Automatic Weighing Instruments

9. Equipment Used in Explosive Atmospheres

10. Elevators

11. Pressure Equipment

12. Active Emplanted Medical Devices

13. Medical Devices

14. in Vitro Diagnostic Medical Devices

15. Toys

16. Travel Boats

17. Construction Materials

18. Personal Protection Devices

19. Radio and Telecommunication Terminal Equipment

20. Vehicles moving on the cable for passenger transport

21. Measuring Instruments

 

 

"CE" SIGNAL PROTECTION PROCEDURES

1- Directive / directives related to the product are determined.

2- If so, harmonized standards are established.

3- The combination of module or modules is selected.

4- Determine whether a notified body is required.

5. Following the conformity assessment, the declaration of conformity and, if necessary, other documents are prepared.

6- Technical file is prepared and maintained.

7. "CE" mark is affixed on the product and / or on its packaging and accompanying document, and it is submitted to the market. 

UNLAWFUL USE OF CE MARK

In case of nonconformity with the regulations, the manufacturer of the product or its authorized representative established in Turkey shall ensure that the product complies with the provisions of the CE marking of conformity and shall terminate this violation. In the event of non-compliance, the Ministry shall take all necessary measurements to restrain or prohibit the supply of such goods to the market, to withdraw from the market, and to prohibit the use of the elevator, within the authority granted to it by law.

NEW APPROACH AND MODULAR SYSTEM

The directives in the "New Approach" do not contain much technical detail and the general rules that the manufactured goods must comply with according to the goods groups are determined. In addition, it is ensured that goods eligible for "Basic Requirements" are in free circulation.

The directives are prepared according to the intended use of the products, not the products itself.  Thus, products that have similar functions are grouped together and provided "minimum security" conditions for multiple products with a single directive.

Since 1990, a "modular" understanding has been implemented in the CE marking system.

The main objective of the modular approach is to determine the conformity assessment methods, the characteristics of the products and the risk ratios they take.

In the case of the Building Materials Regulations, fulfillment of the Essential Requirements of the New Approach Regulations of the product is ensured by fulfilling the requirements in the Annex ZA of the Harmonized Standard covered by the product.

In the Building Materials Regulation, instead of the Modular Approach, an approach called Conformity Verification Systems is mentioned. 

 

 

Conformity Verification Systems;

SYSTEM 1+ / 1

I) Documentation of the conformity of the product of an approved Notification Body:

(A) Duties of the manufacturer:

(1) Factory Production Control (FPC)

(2) Subsequent experiments carried out by the manufacturer of samples taken from the factory in accordance with a predetermined test plan

(B) Duties of the Notified Body:

(3) Product Initial Type Experiments

(4) Initial inspection of Factory and Factory Production Control

(5) Continuous surveillance, evaluation and approval of Factory Production Control

(6) Probably, the test samples from the factory (for System 1+)

SYSTEM 2+ / 2

(Ii) Declaration of product conformity by the manufacturer (1st alternative)

(A) Duties of the manufacturer:

(1) Product Initial Type Tests

(2) Factory Production Control

(3) Routine tests carried out by the manufacturer of samples taken from the factory according to a predetermined test plan

(B) Duties of the Notified Body:

(4) Documentation of the factory production control plant and factory production control based on an initial inspection

(5) probably, test samples from the factory (for System 2+)

SYSTEM 3

(Ii) Declaration of product conformity by the manufacturer (2nd alternative)

(A) Tasks of the Producer:

(1) Factory Production Control

(B) Duties of the Notified Body:

(2) Product Initial Type Experiments by an approved laboratory (reports must be from Notified Laboratories only)

 

SYSTEM 4

(Iii) Declaration of product conformity by the manufacturer (3rd alternative)

(A) Duties of the manufacturer:

(1) Product Initial Type Tests

(2) Factory Production Control

(B) Duties of the Notified Body: _____________________________

 

CONFORMITY ASSESSMENT MODULES

Module A: Internal Production Control

Module B: TypeExamination

Module C: Type Compliance Statement

Module D: Production Quality Assurance

Module E: Product Quality Assurance Module F: Product Verification

Module G: Unit Verification

Module H: Full Quality Assurance

Module A: Internal Control of Production In this stage, which includes design and production stages, the manufacturer declares conformity of the product to the relevant directives and prepares technical documents explaining its design, production and use.

There is no need for a notified body.

Module B: EC Type Examination in this module, which covers only the design phase, is usually used in conjunction with the declaration of conformity. In the framework of this module, which does not require CE marking, the notified body tests the product sample in accordance with the relevant directive.

Module C: Type Compliance Statement in this module for production stage is not sufficient by itself and represents a stage after the EC Type Examination Module (Module B). This module, which is used to prove that the product meets the requirements of the relevant directive, affixes the CE marking to the manufacturer's product and declares conformity.

Module D: Manufacturing Quality Assurance covers the production phase and follows Module B. It includes the testing and approval process by an approved body. The process it follows is similar to the production, installation and after sales service coverage of ISO 9000 (formerly ISO 9002). It foresees the establishment of a quality assurance system for the production process. The final product inspection and testing is carried out by the manufacturer.

Module E: Product Quality Assurance covers the production phase and follows Module B. It includes the stage of testing and approval by an approved body. The process it follows is similar to that of ISO 9000 (last ISO 9003) with the latest checks and tests' purchase + packaging + after sales service [no production]. It foresees the establishment of a quality assurance system for the production process. The final product inspection and testing is carried out by the manufacturer.

Module F: Product Validation in this module, which is only for the production phase, is usually used in conjunction with Module B. The CE marking is affixed to the product, together with the written conformity document in the module within which the approved body checks compliance with the product technical documentation or the specifications of the type examination.

Module G: Unit Verification In the context of this module, which covers design and production stages, the product, must bear the CE marking on the basis of the notified body, the product's compliance with the relevant directives and the tests carried out.

Module H: Full Quality Assurance For the application of this module which is related to both design and production phases, the existence of quality management system [ISO 9000 design + development + production + facility + after sales service scope (TS EN ISO 9001)] is checked by an approved institution. This is where the design is not fully compatible with the harmonized standards; whether it conforms to the provisions of the design regulation.

CE MARKING AND TSE DOCUMENT 

The CE mark indicates compliance with the European Union's New Approach Directives, which indicates that the product affixed on it is environmentally safe. A product can enter more than one New Approach Directive and the CE Mark attached to the product by fulfilling the necessary requirements indicate that the product complies with all of these directives. Compliance with the Directive means meeting the essential requirements of the directives by following the relevant conformity assessment procedures outlined in the directives. These basic requirements foresee the requirements for product safety. However, the basic requirements do not directly address the requirements for product performance characteristics and quality. Therefore, CE Marking is aimed at the safety of products and aims mainly to free circulation within the European Union. However, the TSE Product Certification is carried out in accordance with the safety conditions stipulated in the standards in the directives, as well as the performance and quality criteria, together with the adequacy of the production site. For this reason, TSE Certified product is not only safer but also assures consumers in terms of performance and quality. For this reason, product documentation should not be considered as an alternative to CE marking. The most obvious demonstration is that product certification activities that are not CE marking all over the European Union countries are continuously increasing. The product documentation services that our institute has launched in 1964 and continues uninterruptedly until today are of great importance to our consumers both in terms of our industry. 

WHAT IS THE RELATIONSHIP BETWEEN THE CE MARKET QUALITY MANAGEMENT REQUESTS?

There is no direct relationship between CE marking and Quality Management Systems (TS EN ISO 9001). CE marking indicates that any product is designed and manufactured in accordance with European Union New Approach Directives and the relevant harmonized European Standards. It is seen that Quality Management Systems are required for some product groups in the modular system.