Directive 97/23/EC of the European Parliament and of the Council (repealed)Dangos y teitl llawn

Module E1 (product quality assurance) U.K.

1. This module describes the procedure whereby the manufacturer who satisfies the obligations of section 3 ensures and declares that the pressure equipment satisfies the requirements of the Directive which apply to it. The manufacturer, or his authorized representative established within the Community, must affix the CE marking to each item of pressure equipment and draw up a written declaration of conformity. The CE marking must be accompanied by the identification number of the notified body responsible for surveillance as specified in section 5. U.K.

2. The manufacturer must draw up the technical documentation described below. U.K.

The technical documentation must enable an assessment to be made of the conformity of the pressure equipment with the requirements of the Directive which apply to it. It must, as far as is relevant for such assessment, cover the design, manufacture and operation of the pressure equipment and contain:

• a general description of the pressure equipment,

• conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc.,

• descriptions and explanations necessary for an understanding of the said drawings and diagrams and the operation of the pressure equipment,

• 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.

3. The manufacturer must operate an approved quality system for the final pressure equipment inspection and testing as specified in section 4 and be subject to surveillance as specified in section 5. U.K.

4. Quality system U.K.

4.1. The manufacturer must lodge an application for assessment of his quality system with a notified body of his choice. U.K.

The application must include:

• all relevant information on the pressure equipment concerned,

• the documentation concerning the quality system.

4.2. Under the quality system, each item of pressure equipment must be examined and appropriate tests as set out in the relevant standard(s) referred to in Article 5, or equivalent tests, and particularly final assessment as referred to in section 3.2 of Annex I, must be carried out in order to ensure its conformity with the requirements of the Directive which apply to it. All the elements, requirements and provisions adopted by the manufacturer must 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. U.K.

It must contain in particular an adequate description of:

• the quality objectives and the organizational structure, responsibilities and powers of the management with regard to the quality of the pressure equipment,

• the procedures used for the permanent joining of parts as approved in accordance with section 3.1.2 of Annex I,

• the examinations and tests to be carried out after manufacture,

• the means of monitoring the effective operation of the quality system,

• the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications or approvals of the personnel concerned, particularly those of the personnel undertaking the permanent joining of parts in accordance with section 3.1.2 of Annex I.

4.3. The notified body must assess the quality system to determine whether it satisfies the requirements referred to in 4.2. The elements of the quality system which conform to the relevant harmonized standard are presumed to comply with the corresponding requirements referred to in 4.2. U.K.

The auditing team must have at least one member with experience of assessing the pressure equipment technology concerned. The assessment procedure must include an inspection visit to the manufacturer's premises.

The decision must be notified to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision. Provision must be made for an appeals procedure.

4.4. The manufacturer must undertake to discharge the obligations arising from the quality system as approved and to ensure that it remains satisfactory and efficient. U.K.

The manufacturer, or his authorized representative established within the Community, must inform the notified body which has approved the quality system of any intended adjustment to the quality system.

The notified body must assess the proposed changes and decide whether the modified quality system will still satisfy the requirements referred to in 4.2 or whether a reassessment is required.

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

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

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

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

• the quality system documentation,

• the technical documentation,

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

5.3. The notified body must carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and provide the manufacturer with an audit report. The frequency of periodic audits must be such that a full reassessment is carried out every three years. U.K.

5.4. In addition the notified body may pay unexpected visits to the manufacturer. The need for such additional visits, and the frequency thereof, will be determined on the basis of a visit control system operated by the notified body. In particular, the following factors must be considered in the visit control system: U.K.

• the category of the equipment,

• the results of previous surveillance visits,

• the need to follow up corrective action,

• special conditions linked to the approval of the system, where applicable,

• significant changes in manufacturing organization, policy or techniques.

During such visits the notified body may, if necessary, carry out or have carried out tests to verify that the quality system is functioning correctly. The notified body must provide the manufacturer with a visit report and, if a test has taken place, with a test report.

6. The manufacturer must, for a period of ten years after the last of the pressure equipment has been manufactured, keep at the disposal of the national authorities: U.K.

• the technical documentation referred to in section 2,

• the documentation referred to in the second indent of 4.1,

• the adjustments referred to in the second paragraph of 4.4,

• the decisions and reports from the notified body which are referred to in the last paragraph of 4.3, the last paragraph of 4.4 and in 5.3 and 5.4.

7. Each notified body must communicate to the Member States the relevant information concerning the quality system approvals which it has withdrawn and, on request, those is has issued. U.K.

Each notified body must also communicate to the other notified bodies the relevant information concerning the quality system approvals it has withdrawn or refused.