The manufacturer operates a product quality (= production quality without the manufacturing part) assurance system for final product inspection and testing in order to ensure conformity to the PED requirements. The notified body assesses the quality system.
The idea behind module E1 is similar to the one under module D1: both are based on a quality system. Their difference is that the quality system under module E1 aims to ensure the quality of the final product, while the quality system under module D1 aims to ensure the quality of the whole production process (that includes the manufacturing part and the test of final product). E1 is thus similar to module D1 without the provisions relating to the manufacturing process.
This module is suitable for pressure equipments categories I, and II.
Module E1
QUALITY ASSURANCE OF FINAL PRESSURE EQUIPMENT INSPECTION AND TESTING
1. Quality assurance of final pressure equipment inspection and testing 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 technical 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 pressure equipment. 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 the 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 the final product inspection and testing of the pressure equipment 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, and
- 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.
Under the quality system, each item of pressure equipment shall be examined and appropriate tests as set out in the relevant standard(s) referred to in Article 12, or equivalent tests, and particularly final assessment as referred to in point 3.2 of Annex I, shall be carried out in order to ensure its conformity with the requirements of this Directive which 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 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 after manufacture,
- 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,
- the means of monitoring 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.
It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant harmonised standard.
In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant pressure equipment field and pressure equipment technology concerned, and 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 required.
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 on 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 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 item of 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 pressure equipment 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, as approved,
- the decisions and reports of the notified body referred to in points 5.3, 5.5, 6.3 and 6.4.
9. Each notified body shall inform its notifying authorities of 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.
