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CE PROCEDURES

The technical file contains the following points;

General description of the product,

-Design drawings, information on products / production procedure,

- List of technical specifications and / or list of relevant directive specifications.

-Quality factor values ​​necessary for the product to meet the basic requirements stipulated in the relevant directive,

-Product test documents and reports, examinations

-Quality assurance system certificate and / or factory production control documentation (quality control plan, laboratory equipment list, production site flowchart, packaging and storage status, definition of product traceability (including market and storage), if any, prevent the product from mixing with external agents and other materials. measures, list of documents for production and product control, test method list)

-AT Certificate of Conformity

-AT declaration of conformity

- General Description of Product:

The product / product group must be identified with appropriate reference terms or symbols. The definition of the product is made according to the specifications specified in the technical specification, eg the structure, type of the product. serial number, standard number, procedures providing the standard, etc.

-Design Drawings, Information on Products / Production Procedure:

Designs of the manufacturing of the product, information regarding the production procedure, product type, content, manufacturing process and complication, production flow chart, sensitivity of the properties of the product to changes in manufacturing parameters, initial type test, conformity confirmation system value, factory production control must be specified in the technical file. The manufacturer must prepare and update the documents describing the factory production control system. The manufacturer's documentation work and related procedures must be appropriate to the product and manufacturing process. Procedures and instructions should be followed effectively. These studies and their results should be recorded. These results are used to correct any deviations, compensate for the effects of deviations, find solutions to any inconsistencies that arise, and, if necessary, review factory production control to eliminate the cause of the discrepancy. It is necessary to establish the necessary procedures to determine the compatibility of the product at appropriate stages, to identify and record the situations in which compliance cannot be achieved, and to determine the procedures necessary for the solution of the situations in which compliance is not achieved.

 

- List of Technical Specifications for the Product and / or List of Related Directive Specifications:

Manufacturers, CE In order to give details of how the marking should be applied to a product, the technical dossier should include a list of the technical specifications to which it is subject to the Directive or the other regulations to which it applies. Product / product group / class values ​​should be given as tables in the technical specification or referenced to an appropriate standard.

- Quality Factor Values ​​Required for the Product to Meet the Basic Requirements Stipulated in the Related Directive

Mechanical strength and stability, Safety in case of fire, Hygiene health environment,

Safety of use, Protection against noise,

In order to save energy and meet the heat preservation, the product must comply with the relevant standard values.

- Product Test Documents and Reports, Inspections:

Any test performed by the manufacturer and / or the Notified Body must be carried out and reported in accordance with the technical specifications. Test reports will be referenced to the samples. The responsibility for the sampling of the products to be tested lies with the manufacturer in accordance with the rules prescribed in the technical specification. The manufacturer is obliged to ensure that the samples represent the product to be placed on the market and to maintain satisfactory records thereof. The manufacturer may contact one or more notified laboratories. The manufacturer shall specify the tests, documents and reports concerning the product and the inspection documents and reports made on the product in the technical file. Documents and reports are issued under the name and responsibility of the notified body, which has always been kept as a supplier.

Quality Assurance System Certificate and / or Factory Production Control Documentation

The manufacturer shall prepare and update the documents describing the factory production control system he is applying. The manufacturer's documentation work and associated procedures must comply with the product and manufacturing process. For this;

  • Documented procedures and instructions for factory production control work shall be prepared in accordance with the requirements of the reference technical specification,
  • These procedures and instructions should be implemented effectively,
  • These studies and their results should be recorded,
  • These results should be used to review factory production control to correct any deviations, compensate for the effects of these deviations, find solutions to any inconsistencies that arise and, if necessary, eliminate the cause of the incompatibility.

Factory production control works;

  • Technical characteristics and verification of raw materials and components,
  • Controls and tests to be carried out during manufacture with a predetermined time interval,
  • This includes the verification works and tests to be carried out on the final product with a certain period of time that may be foreseen in the technical specification and may be adapted to the product and manufacturing conditions.

The manufacturer must have the necessary facilities, equipment and personnel to enable him to carry out the necessary verification procedures and tests, or have them available as necessary. The manufacturer is obliged to carry out all kinds of calibration, accuracy and accuracy measurements of the control, measurement or test equipment, whether or not he owns, in order to demonstrate the conformity of the product to the relevant technical specification and to keep them operational.

The tests shall be in accordance with the test plan and shall be carried out according to the methods specified in the technical specification. Depending on the compliance verification system adopted for the product or product family, initial type tests of the product may be carried out by the manufacturer itself, or such tests must be performed or verified by a notified body. If the control and test results indicate that the product does not meet the requirements (such as statistical change, etc.), the necessary corrective action should be taken immediately if the technical specification exceeds the limits permitted by the technical specification. If products are delivered without results, a procedure and registration must be maintained to notify customers. The manufacturer must prepare and maintain records that provide evidence that the product has been tested. The results of the factory product checks must be properly recorded by the manufacturer. Product description, date of manufacture, accepted test method, test results and acceptance criteria; it must be registered with the signature of the person responsible for the verification. For any control results that do not comply with the technical specifications, the corrective measures taken to correct the situation should be shown in the record.

It is the responsibility of the manufacturer or its representative to keep complete records of individual products or batches of products, including the relevant manufacturing details and specifications, and to whom those products or batches are first sold. The manufacturing details for individual products or batches of products should be easily identifiable and traceable. Anything that has been accepted for the product and which consists of the necessary provisions for verification of the factory production control and conformity confirmation to which the specification relates is of a mandatory nature. Certain characteristics of the manufacturing processes, the intended performance level of the product, must be adaptable to the requirements.

Certification

The firm, which provides auditing, supervision and certification services to internationally recognized standards, also provides periodic inspection, testing and control services.

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Mahmutbey Mh, Dilmenler Cd, No 2 
Bagcilar - Istanbul, TURKEY

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+90 532 281 01 42

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