Directive 2014/68/EU of the European Parliament and of the CouncilShow full title

6. MODULE D1: QUALITY ASSURANCE OF THE PRODUCTION PROCESS

1. Quality assurance of the production process is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 4 and 7, and ensures and declares on his sole responsibility that the pressure equipment concerned satisfy the requirements of this Directive that apply to it.

2. Technical documentation

The manufacturer shall establish the technical documentation. The documentation shall make it possible to assess the conformity of the pressure equipment with the relevant requirements and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the product. The technical documentation shall, wherever applicable, contain at least the following elements:

• 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 those drawings and diagrams and the operation of the pressure equipment,

• a list of the harmonised standards the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet the essential safety requirements of this Directive where those harmonised standards have not been applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied,

• results of design calculations made, examinations carried out, etc., and

• test reports.

3. The manufacturer shall keep the technical documentation at the disposal of the relevant national authorities for 10 years after the pressure equipment has been placed on the market.

4. Manufacturing

The manufacturer shall operate an approved quality system for production, final product inspection and testing of the pressure equipment concerned as specified in point 5, and shall be subject to surveillance as specified in point 6.

5. Quality system

5.1. The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice for the pressure equipment concerned.

The application shall include:

• the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well,

• a written declaration that the same application has not been lodged with any other notified body,

• all relevant information on the pressure equipment type envisaged,

• the documentation concerning the quality system,

• the technical documentation referred to in point 2.

5.2. The quality system shall ensure compliance of the pressure equipment with the requirements of this Directive that apply to it.

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 shall permit a consistent interpretation of the quality programmes, plans, manuals and records.

It shall, in particular, contain an adequate description of:

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

• the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic measures that will be used, particularly the procedures used for the permanent joining of parts as approved in accordance with point 3.1.2 of Annex I,

• the examinations and tests that 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 concerning the qualifications or approvals of the personnel concerned, particularly those of the personnel undertaking the permanent joining of parts in accordance with point 3.1.2 of Annex I, etc.,

• the means of monitoring the achievement of the required product quality and the effective operation of the quality system.

5.3. The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 5.2. The elements of the quality system which conform to the relevant harmonised standard are presumed to comply with the corresponding requirements referred to in point 5.2.

In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the pressure equipment technology concerned, and the knowledge of the applicable requirements of this Directive. The audit shall include an assessment visit to the manufacturer’s premises.

The auditing team shall review the technical documentation referred to in point 2 in order to verify the manufacturer’s ability to identify the relevant requirements of this Directive and to carry out the necessary examinations with a view to ensuring compliance of the pressure equipment with those requirements.

The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned assessment decision.

5.4. 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.

5.5. The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system.

The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 5.2 or whether a reassessment is necessary.

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

6. Surveillance under the responsibility of the notified body

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

6.2. The manufacturer shall, for assessment purposes, allow the notified body access to the manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular:

• the quality system documentation,

• the technical documentation referred to in point 2,

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

6.3. The notified body shall 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 shall be such that a full reassessment is carried out every three years.

6.4. 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 shall be considered in the visit control system:

• the category of the pressure equipment,

• the results of previous surveillance visits,

• the need to follow up corrective action(s),

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

• significant changes in manufacturing organisation, policy or techniques.

During such visits the notified body may, if necessary, carry out product tests, or have them carried out, in order to verify that the quality system is functioning correctly. The notified body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.

7. CE marking and EU declaration of conformity

7.1. The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 5.1, the latter’s identification number to each individual pressure equipment that satisfies the applicable requirements of this Directive.

7.2. The manufacturer shall draw up a written EU declaration of conformity for each pressure equipment model and keep it at the disposal of the national authorities for 10 years after the pressure equipment has been placed on the market. The EU declaration of conformity shall identify the product model for which it has been drawn up.

A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.

8. The manufacturer shall, for a period ending 10 years after the pressure equipment has been placed on the market, keep at the disposal of the national authorities:

• the documentation referred to in point 5.1,

• the change referred to in point 5.5,

• the decisions and reports of the notified body referred to in points 5.5, 6.3 and 6.4.

9. Each notified body shall inform its notifying authorities of the quality system approvals issued or withdrawn, and shall periodically, or upon request, make available to its notifying authorities the list of quality system approvals refused, suspended or otherwise restricted.

Each notified body shall inform the other notified bodies of quality system approvals which it has refused, suspended, or withdrawn, and upon request, of quality system approvals which it has issued.

10. Authorised representative

The manufacturer’s obligations set out in points 3, 5.1, 5.5, 7 and 8 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.