ANNEX 15 DECLARATION OF CONFORMITY BASED ON FULL QUALITY ASSURANCE AND TESTING OF CONSTRUCTION SOLUTIONS

1. "Declaration of conformity based on full quality assurance and testing structural solutions" is the process by which the conformity assessment manufacturer fulfills the obligations listed in this Annex and ensures and declares that the meter is in accordance with the relevant requirements of this Regulation.

Manufacturing
2. Manufacturer applies the approved quality system for design, manufacture and final inspection and testing standards as set out in Section 3, and it is applied to surveillance as specified in paragraph 5. The adequacy of the technical design of the measuring instrument shall have been examined according to the provisions of paragraph 4.

Quality system
3.1 The manufacturer shall submits a request for an assessment of the quality of the body for conformity assessment of your choice. The request shall include: all relevant information for the instrument category envisaged; the documentation concerning the quality system.

3.2 The quality system shall ensure compliance of the instruments with the appropriate requirements of this Regulation. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation must permit a consistent interpretation of the quality programmes, plans, manuals and records. It shall contain in particular an adequate description of: the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality; the technical specifications, including standards, that will be applied, and in cases where the appropriate harmonized standards and standardized documents are not fully implemented, and the funds will be used to ensure the application of the basic requirements of this Regulation concerning measures; the design control and design verification techniques, processes and systematic actions that will be used when designing the instruments pertaining to the instrument category covered; appropriate methods of production, quality control and quality assurance, processes and systematic actions that will be used; examinations and tests that will be carried out before, during and after manufacture, and their frequency;

quality records, such as. inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.. measures to monitor the achievement of the required quality structural solutions and products, as well as the effectiveness of the quality system.

3.3 Conformity assessment body assess the quality system to determine whether it meets the requirements of Item 3.2. Compliance with these requirements is assumed for those quality systems that comply with the provisions of the national standard that takes the appropriate harmonized standard, from the moment it was published. In addition to experience in quality management systems for independent assessment team has relevant experience on the field of metrology standards and measurments technology, and knowledge of the applicable requirements of this Regulation. The evaluation procedure includes a review of the manufacturer's facilities. The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the examination and the reasoned assessment decision. 3.4 The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient. 3.5 The manufacturer shall keep the notified body that has approved the quality system informed of any intended change of the quality system The notified body shall evaluate the changes proposed and decide whether the changed quality system will still satisfy the requirements referred to in paragraph 3.2 or whether a reassessment is required. Conformity assessment body shall notify its decision to the manufacturer. The notification shall contain the conclusions of the examination and the reasoned assessment decision. 3.6 Each notified body shall periodically review compliance by the agency responsible for metrology list of quality system approvals issued or refused, and shall notify the competent authority for metrology to withdraw approval of the quality system.

Design examination
4.1 The manufacturer shall lodge an application for examination of the design with the notified body referred to in item 3.1. 4.2 The application shall enable understanding of the design, manufacture and operation of the instrument, and shall enable assessment of conformity with the appropriate requirements of this Regulation. It shall include: the name and address of the manufacturer; a written declaration that the same application has not been lodged with any other notified body; the technical documentation as described in Article 10. The documentation shall enable assessment of the conformity of the instrument with the appropriate requirements of this

Regulation. It shall, as far as relevant for such assessment, cover the design and operation of the instrument; evidence suggests that all documents are used, especially when the appropriate harmonized standards and standardized documents are not fully implemented, and, if necessary, should be involved and the results of tests conducted in the respective labs or other testing laboratories in his name and under its responsibility. 4.3 Conformity assessment body to review the request and, if the structural and technical solutions meet the provisions of the Regulations applicable to the measure, the manufacturer shall issue a certificate of EU structural verification solutions. The certificate shall contain the name and address of the manufacturer, the conclusions of the examination, any conditions for its validity and the necessary data for identification of the approved instrument. 4.3.1 4.3.2 All relevant parts of the technical documentation shall be annexed to the certificate.. The certificate or its annexes shall contain all relevant information for conformity evaluation and in-service control. It shall to allow the evaluation of conformity of the manufactured instruments with the examined design regarding the reproducibility of their metrological performances, when they are properly adjusted using appropriate means, including: the metrological characteristics of the design of the instrument; measures required for ensuring the integrity of the instruments (sealing, identification of software ); information on other elements necessary for the identification of the instrument and to check its visualexternal conformity to the design; if appropriate, any specific information necessary to verify the characteristics of manufactured instruments; in the case of a sub-assembly, all necessary information to ensure the compatibility with other sub-assemblies or measuring instruments..

4.3.3 Conformity assessment body shall draw up a report on the verification of which is available to bodies responsible for metrology. Conformity assessment body may publish the content of the report in whole or in part, only with the consent of the manufacturer. 4.4 Manufacturer inform the notified body that issued the compliance certificate of EU structural verification solutions of any change approved structural solutions. Changes to the approved structural and technical solutions obtained additional approval body for conformity assessment issued by the EU certificate of verification of structural solutions, when such changes may affect conformity with the essential requirements of these Regulations, the conditions of validity of the certificate or the prescribed conditions for use benchmarks. This additional approval is given in the form of contributions original EU certificate of verification of structural solutions. 4.5 Each notified body shall periodically make available to the body in charge of metrology that designated it: EU design examination certificates and annexes issued; additions and amendments relating to certificates issued. Svako Tijelo za ocjenu usaglaenosti obavijetava Organ nadlenan za poslove metrologije o povlaenju EU uvjerenja o provjeri konstrukcionog rjeenja.

4.6 The manufacturer or his authorised representative shall keep a copy of the EU design examination certificate, its annexes and additions with the technical documentation for 10 years after the last measuring instrument has been manufactured. When neither the manufacturer nor his authorized representative is not registered in the EU, the obligation to make the technical documentation available on request shall be the responsibility of the person designated by the manufacturer.. Surveillance under the responsibility of the notified body 5.1 The purpose of surveillance is to make sure that the manufacturer fulfils the obligations arising out of the approved quality system.. 5.2 The manufacturer shall allow the notified body entrance for inspection purposes to the locations of design, manufacture, inspection, testing and storage, and shall provide it with all necessary information, in particular:: the quality system documentation; the quality records as foreseen by the design part of the quality system, such as results of analyses, calculations, tests, etc; the quality records as foreseen by the manufacturing part of the quality system, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc; 5.3 The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide an audit report to the manufacturer.. 5.4 Additionally, the notified body may pay unexpected visits to the manufacturer. During such visits the notified body may, if necessary, carry out product tests, or have them carried out under its responsibility, to verify that the quality system is functioning correctly. It shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report..

Written declaration of conformity

6.1 The manufacturer shall affix the CE marking, the supplementary metrology markin g and, under the responsibility of the notified body referred to in item 3.1, the latter's identification number to each measuring instrument that satisfies the appropriate requirements of this Regulation. 6.2 Izjava o usaglaenosti sastavlja se za svaki model mjerila i na raspolaganju je Organu nadlenom za poslove metrologije 10 godina od prestanka proizvodnje mjerila. Izjava o usaglaenosti identifikuje mjerila za koja je sastavljena. A copy of the declaration shall be supplied with each measuring instrument that is placed on the market. However, this requirement may be interpreted as applying to a batch or consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user. 7. Proizvoa 10 godina od prestanka proizvodnje mjerila uva i na raspolaganju je Organu nadlenom za poslove metrologije:

 the documentation referred to in 3.1, second indent; the change referred to in item 3.5, as approved; the decisions and reports of the notified body referred to in item 3.5, 5.3 and 5.4.

Authorised representative
8. The manufacturer's obligations contained in items 3.1, 3.5, 6.2 and 7 may be fulfilled, on his behalf and under his responsibility, by his authorised representative.