Directive 2004/22/EC of the European Parliament and of the Council (repealed)Show full title

ANNEX E U.K. DECLARATION OF CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF FINAL PRODUCT INSPECTION AND TESTING

1. ‘Declaration of conformity to type based on quality assurance of final product inspection and testing’ is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in this Annex and ensures and declares that the measuring instruments concerned are in conformity with the type as described in the EC-type examination certificate and satisfy the appropriate requirements of this Directive. U.K.

Manufacturing U.K.

2. The manufacturer shall operate an approved quality system as specified in paragraph 3 for final product inspection and testing of the measuring instrument concerned and shall be subject to surveillance, as specified in paragraph 4. U.K.

Quality system U.K.

3.1. The manufacturer shall lodge an application for assessment of the quality system with a notified body of his choice. U.K.

The application shall include:

• all relevant information for the instrument category envisaged;

• the documentation concerning the quality system;

• the technical documentation of the approved type and a copy of the EC-type examination certificate.

3.2. The quality system shall ensure compliance of the instruments with the type as described in the EC-type examination certificate and the appropriate requirements of this Directive. U.K.

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 examinations and tests that will be carried out after manufacture;

• the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.;

• the means to monitor the effective operation of the quality system.

3.3. The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in paragraph 3.2. It shall presume conformity with these requirements in respect of a quality system that complies with the corresponding specifications of the national standard that implements the relevant harmonised standard, from the moment its references have been published. U.K.

In addition to experience in quality management systems, the auditing team shall possess appropriate experience in the relevant field of metrology and instrument technology, and knowledge of the applicable requirements of this Directive. The evaluation procedure shall include an inspection visit to the manufacturer's premises.

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. U.K.

3.5. The manufacturer shall keep the notified body that has approved the quality system informed of any intended change of the quality system. U.K.

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 re-assessment is required.

It shall notify its decision to the manufacturer. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

Surveillance under the responsibility of the notified body U.K.

4.1. The purpose of surveillance is to make sure that the manufacturer fulfils the obligations arising out of the approved quality system. U.K.

4.2. The manufacturer shall allow the notified body entrance for inspection purposes to the locations of inspection, testing and storage, and shall provide it with all necessary information, in particular: U.K.

• the quality system documentation;

• the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.

4.3. 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. U.K.

4.4. 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, 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. U.K.

Written declaration of conformity U.K.

5.1. The manufacturer shall affix the ‘CE’ marking, the supplementary metrology marking and, under the responsibility of the notified body referred to in paragraph 3.1, the latter's identification number to each measuring instrument that is in conformity with the type as described in the EC-type examination certificate and satisfies the appropriate requirements of this Directive. U.K.

5.2. A declaration of conformity is drawn up for each instrument model and shall be kept at the disposal of the national authorities for 10 years after the last instrument has been manufactured. It shall identify the instrument model for which it was drawn up. 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. U.K.

6. The manufacturer shall, for 10 years after the last instrument has been manufactured, keep at the disposal of the national authorities: U.K.

• the documentation referred to in the second indent of paragraph 3.1;

• the change referred to in the second subparagraph of paragraph 3.5, as approved;

• the decisions and reports from the notified body which are referred to in paragraph 3.5, final subparagraph, paragraph 4.3 and paragraph 4.4.

7. Each notified body shall periodically make available to the Member State that designated it the list of quality system approvals issued or refused, and shall immediately inform the Member State that designated it of the withdrawal of a quality system approval. U.K.

Authorised representative U.K.

8. The manufacturer's obligations contained in paragraphs 3.1, 3.5, 5.2 and 6 may be fulfilled, on his behalf and under his responsibility, by his authorised representative. U.K.