1. Conformity Assesment Application Form
and Agreement (must be filled 2 copies)
3. Prepayment Receipt (3000 USD)
4. Technical File:
For Ec Type Examination
— a general type-description;
— design and manufacturing drawings and layouts of components, sub-assemblies, circuits, etc.;
— descriptions and explanations necessary for the understanding of said drawings and layouts and the operation of the product;
— a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the Directive where the standards referred to in Article 5 have not been applied;
— results of design calculations made, examinations carried out, etc.;
— test reports.
--- EC Decleration of Conformity
For Quality Assurance Notification :
— the quality objectives and the organizational structure, responsibilities and powers of the management with regard to equipment quality;
— the manufacturing, quality control and quality assurance techniques, processes and systematic actions which will be used;
— the examinations and tests which will be carried out before, during and after manufacture and the frequency with which they will be carried out;
— the quality records, such as inspection reports and test data, calibration data, reports on the qualifications of the personnel concerned, etc.;
— the means to monitor the achievement of the required equipment quality and the effective operation of the quality system.
It is firm's responsibility to give information about fundamental changing in firm system by means of Technical File Amendment Form
Please communicate with us for your questions and our fees.
Phone: 90 - 312 416 66 71
Fax: 90 - 312 416 62 82