Module B (production) is always followed by other modules by which the conformity of the pressure equipment to the approved EU-type is demonstrated. A notified body examines specimen of a type and verifies and attests that it meets the requirements of the PED that apply to it by issuing an EU-type examination certificate.
Module E – 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 EU-type. A notified body assesses the quality system.
The idea behind module E is similar to the one under module D: both are based on a quality system and follow module B. Their difference is that the quality system under module E aims to ensure the quality of the final product, while the quality system under module D aims to ensure the quality of the whole production process (that includes the manufacturing part and the test of final product). E is thus similar to module D without the provisions relating to the manufacturing process
This module combination is suitable for pressure equipments categories I, II, and III.
Module B
EU-TYPE EXAMINATION – Production type
1. EU-type examination — production type is the part of a conformity assessment procedure in which a notified body examines the technical design of the pressure equipment and verifies and attests that the technical design of the pressure equipment meets the requirements of this Directive.
2. EU-type examination — production type shall consist of an assessment of the adequacy of the technical design of the pressure equipment through examination of the technical documentation and supporting evidence referred to in point 3, plus examination of a specimen, representative of the production envisaged, of the complete pressure equipment.
3. The manufacturer shall lodge an application for EU-type examination with a single notified body of his choice.
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,
- the technical documentation. The technical documentation shall make it possible to assess the conformity of the pressure equipment with the applicable requirements of this Directive 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 contain, wherever applicable, 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.,
- test reports,
- information concerning the tests provided for in manufacture,
- information concerning the qualifications or approvals required under points 3.1.2 and 3.1.3 of Annex I,
- the specimens representative of the production envisaged.
The specimen may cover several versions of the pressure equipment provided that the differences between the versions do not affect the level of safety.
The notified body may request further specimens if needed for carrying out the test programme;
- the supporting evidence for the adequacy of the technical design solution. This supporting evidence shall mention any documents that have been used, in particular where the relevant harmonised standards have not been applied in full. The supporting evidence shall include, where necessary, the results of tests carried out by the appropriate laboratory of the manufacturer applying other relevant technical specifications, or by another testing laboratory on his behalf and under his responsibility
4. The notified body shall:
4.1 examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the pressure equipment and the manufacturing procedures.
In particular, the notified body shall:
- assess the materials where these are not in conformity with the relevant harmonised standards or with a European approval for pressure equipment materials, and check the certificate issued by the material manufacturer in accordance with point 4.3 of Annex I,
- approve the procedures for the permanent joining of pressure equipment parts, or check that they have been previously approved in accordance with point 3.1.2 of Annex I,
- verify that the personnel undertaking the permanent joining of pressure equipment parts and the non-destructive tests are qualified or approved in accordance with points 3.1.2 or 3.1.3 of Annex I.
4.2 verify that the specimen(s) have been manufactured in conformity with the technical documentation and identify the elements which have been designed in accordance with the applicable provisions of the relevant harmonised standards as well as the elements which have been designed using other relevant technical specifications without applying the relevant provisions of those standards.
4.3 carry out appropriate examinations and necessary tests to check whether when the manufacturer has chosen to apply the solutions in the relevant harmonised standards, these have been applied correctly.
4.4 carry out appropriate examinations and necessary tests to check whether, where the solutions in the relevant harmonised standards have not been applied, the solutions adopted by the manufacturer applying other relevant technical specifications meet the corresponding essential safety requirements of this Directive.
4.5 agree with the manufacturer on a location where the examinations and tests will be carried out.
5. The notified body shall draw up an evaluation report that records the activities undertaken in accordance with point 4 and their outcomes. Without prejudice to its obligations vis-à-vis the notifying authority, the notified body shall release the content of that report, in full or in part, only with the agreement of the manufacturer.
6. Where the type meets the requirements of this Directive, the notified body shall issue an EU-type examination certificate – production type to the manufacturer. Without prejudice to point 7, the certificate shall be valid for 10 years and be renewable and shall contain the name and address of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity and the necessary data for identification of the approved type.
A list of the relevant parts of the technical documentation shall be annexed to the certificate and a copy kept by the notified body.
The certificate and its annexes shall contain all relevant information to allow the conformity of manufactured pressure equipment with the examined type to be evaluated and to allow for in-service control.
Where the type does not satisfy the applicable requirements of this Directive, the notified body shall refuse to issue an EU-type examination certificate – production type and shall inform the applicant accordingly, giving detailed reasons for its refusal. Provision shall be made for an appeals procedure.
7. The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved type may no longer comply with the applicable requirements of this Directive, and shall determine whether such changes require further investigation. If so, the notified body shall inform the manufacturer accordingly.
The manufacturer shall inform the notified body that holds the technical documentation relating to the EU-type examination certificate – production type of all modifications to the approved type that may affect the conformity of the pressure equipment with the essential safety requirements of this Directive or the conditions for validity of the certificate. Such modifications shall require additional approval in the form of an addition to the original EU- type examination certificate – production type.
8. Each notified body shall inform its notifying authority concerning the EU-type examination certificates – production type and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of certificates and/or any additions thereto refused, suspended or otherwise restricted.
Each notified body shall inform the other notified bodies concerning the EU-type examination certificates – production type and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning the certificates and/or additions thereto which it has issued.
The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU-type examination certificates – production type and/or additions thereto. On request, the Commission and the Member States may obtain a copy of the technical documentation and the results of the examinations carried out by the notified body. The notified body shall keep a copy of the EU-type examination certificate – production type, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer, until the expiry of the validity of the certificate.
9. The manufacturer shall keep a copy of the EU-type examination certificate – production type, its annexes and additions together with the technical documentation at the disposal of the national authorities for 10 years after the pressure equipment has been placed on the market.
10. The manufacturer’s authorised representative may lodge the application referred to in point 3 and fulfil the obligations set out in points 7 and 9, provided that they are specified in the mandate.
Module E
CONFORMITY TO TYPE BASED ON PRESSURE EQUIPMENT QUALITY ASSURANCE
1. Conformity to type based on pressure equipment quality assurance is that part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 5, and ensures and declares on his sole responsibility that the pressure equipment concerned is in conformity with the type described in the EU-type examination certificate and satisfies the requirements of this Directive that apply to it.
2. Manufacturing
The manufacturer shall operate an approved quality system for the final product inspection and testing of the pressure equipment concerned as specified in point 3 and shall be subject to surveillance as specified in point 4.
3. Quality system
3.1 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 of the approved type and a copy of the EU-type examination certificate.
3.2 The quality system shall ensure compliance of the products with the type described in the EU-type examination certificate and with the applicable requirements of this Directive.
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 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, reports concerning the qualifications or approvals of the personnel concerned, particularly those of the personnel undertaking the permanent joining of parts and the non-destructive tests in accordance with points 3.1.2 and 3.1.3 of Annex I,
- the means of monitoring 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 point 3.2. 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 3.1, fifth indent, 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.
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 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 3.2 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.
4. Surveillance under the responsibility of the notified body
4.1 The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.
4.2 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,
- the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications 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 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.
4.4 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 actions,
- 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.
5. CE marking and EU declaration of conformity
5.1 The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 3.1, the latter’s identification number to each individual pressure equipment that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements of this Directive.
5.2 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.
6. 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 3.1,
- the change referred to in point 3.5, as approved,
- the decisions and reports from the notified body which are referred to in points 3.3, 3.5, 4.3 and 4.4.
7. 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.
