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-  the name and address of the manufacturer and the location of the pressure equipment,    
 -  a written declaration to the effect that a similar application has not been lodged with another notified body,    
 -  technical documentation.

     3. The technical documentation must enable the conformity of the pressure equipment with the requirements of the Directive which apply to it to be assessed and the design, manufacture and operation of the pressure equipment to be understood.

The technical documentation must contain:

 -  a general description of the pressure equipment,    
 -  conceptual design and manufacturing drawings and diagrams of components, sub-assem blies, 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,    
 -  appropriate details relating to the approval of the manufacturing and test procedures and of the qualifications or approvals of the personnel concerned in accordance with sections 3.1.2 and 3.1.3 of Annex I.

     4. The notified body must examine the design and construction of each item of pressure equipment and during manufacture perform appropriate tests as set out in the relevant standard(s) referred to in Article 5 of the Directive, or equivalent examinations and tests, to ensure its conformity with the requirements of the Directive which apply to it.

In particular the notified body must:

 -  examine the technical documentation with respect to the design and the manufacturing procedures,    
 -  assess the materials used 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 section 4.3 of Annex I,    
 -  approve the procedures for the permanent joining of parts or check that they have been previously approved in accordance with section 3.1.2 of Annex I,    
 -  verify the qualifications or approvals required under sections 3.1.2 and 3.1.3 of Annex I,    
 -  carry out the final inspection referred to in section 3.2.1 of Annex I, perform or have performed the proof test referred to in section 3.2.2 of Annex I, and examine the safety devices, if applicable.

    4.1. The notified body must affix its identification number or have it affixed to the pressure equipment and draw up a certificate of conformity for the tests carried out. This certificate must be kept for a period of ten years.

    4.2. The manufacturer, or his authorised representative established within the Community, must ensure that the declaration of conformity and certificate of conformity issued by the notified body can be made available on request.

Module H (full quality assurance)
     1. This module describes the procedure whereby the manufacturer who satisfies the obligations of section 2 ensures and declares that the pressure equipment in question satisfies the requirements of the Directive which apply to it. The manufacturer, or his authorised 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 4.

     2. The manufacturer must implement an approved quality system for design, manufacture, final inspection and testing as specified in section 3 and be subject to surveillance as specified in section 4.

     3. Quality system

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

The application must include:

 -  all relevant information concerning the pressure equipment in question,    
 -  the documentation concerning the quality system.

    3.2. The quality system must ensure compliance of the pressure equipment 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 procedural and quality measures such as programmes, plans, manuals and records.

It must contain in particular an adequate description of:

 -  the quality objectives and the organisational structure, responsibilities and powers of the management with regard to the quality of the design and to product quality,    
 -  the technical design specifications, including standards that will be applied and, where the standards referred to in Article 5 are not applied in full, the means that will be used to ensure that the essential requirements of the Directive which apply to the pressure equipment will be met,    
 -  the design control and design verification techniques, processes and systematic measures that will be used when designing the pressure equipment, particularly with regard to materials in accordance with section 4 of Annex I,    
 -  the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic measures that will be used, particularly the procedures 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 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 and the non-destructive tests in accordance with sections 3.1.2 and 3.1.3 of Annex I,    
 -  the means of monitoring the achievement of the required pressure equipment design and quality and the effective operation of the quality system.

    3.3. The notified body must assess the quality system to determine whether it satisfies the requirements referred to in 3.2. The elements of the quality system which conform to the relevant harmonised standard are presumed to comply with the corresponding requirements referred to in 3.2.

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.

    3.4. The manufacturer must undertake to fulfil the obligations arising out of the quality system as approved and to ensure that it remains satisfactory and efficient.

The manufacturer, or his authorised representative established within the Community, must inform the notified body that 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 3.2 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.

     4. Surveillance under the responsibility of the notified body

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

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

 -  the quality system documentation,    
 -  the quality records provided for in the design part of the quality system, such as results of analyses, calculations, tests, etc.,    
 -  the quality records provided for in the manufacturing part of the quality system, such as inspection reports and test data, calibration data, report concerning the qualifications of the personnel concerned, etc.

    4.3. 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.

    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 must 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,    
 -  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 or have carried out tests to veriy 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.

     5. 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:

 -  the documentation referred to in the second indent of the second subparagraph of 3.1;    
 -  the adjustments referred to in the second subparagraph of 3.4;    
 -  the decisions and reports from the notified body which are referred to in the last subparagraph of 3.3, the last subparagraph of 3.4, and in 4.3 and 4.4.

     6. 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 it has issued.

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

Module H1 (full quality assurance with design examination and special surveillance of the final assessment)
     1. In addition to the requirements of module H, the following apply:

(a) the manufacturer must lodge an application for examination of the design with the notified body;

(b) the application must enable the design, manufacture and operation of the pressure equipment to be understood, and enable conformity with the relevant requirements of the Directive to be assessed.

     It must include:

 -  the technical design specifications, including standards, which have been applied,    
 -  the necessary supporting evidence for their adequacy, in particular where the standards referred to in Article 5 have not been applied in full. This supporting evidence must include the results of tests carried out by the appropriate laboratory of the manufacturer or on his behalf;

(c) the notified body must examine the application and where the design meets the provisions of the Directive which apply to it issue an EC design-examination certificate to the applicant. The certificate must contain the conclusions of the examination, the conditions for its validity, the necessary data for identification of the approved design and, if relevant, a description of the functioning of the pressure equipment or accessories;

(d) the applicant must inform the notified body that has issued the EC design-examination certificate of all modifications to the approved design. Modifications to the approved design must receive additional approval from the notified body that issued the EC design-examination certificate where they may affect conformity with the essential requirements of the Directive or the prescribed conditions for use of the pressure equipment. This additional approval must be given in the form of an addition to the original EC design-examination certificate;

(e) each notified body must also communicate to the other notified bodies the relevant information concerning the EC design-examination certificates it has withdrawn or refused.

     2. Final assessment as referred to in section 3.2 of Annex I is subject to increased surveillance in the form of unexpected visits by the notified body. In the course of such visits, the notified body must conduct examinations on the pressure equipment.



SCHEDULE 5 Regulations 2(2), 7(3)(c), 8(3)(a)(iii)


(Annex VI to the Pressure Equipment Directive)


CE MARKING

     1. The CE marking shall consist of the initials "CE" taking the following form:

     2. If the CE marking is reduced or enlarged the proportions given in the above graduated drawing must be respected.

     3. The various components of the CE marking must have substantially the same vertical dimension, which may not be less than five millimetres.



SCHEDULE 6 Regulations 7(3)(d), 8(3)(a)(iv)


(Annex VII to the Pressure Equipment Directive)


EC DECLARATION OF CONFORMITY

The EC declaration of conformity must contain the following particulars:

 -  name and address of the manufacturer or of his authorised representative established within the Community,    
 -  description of the pressure equipment or assembly,    
 -  conformity assessment procedure followed,    
 -  in the case of assemblies, description of the pressure equipment constituting the assembly, and the conformity assessment procedures followed,    
 -  where appropriate, name and address of the notified body which carried out the inspection,    
 -  where appropriate, a reference to the EC type-examination certificate, EC design-exam ination certificate or EC certificate of conformity,    
 -  where appropriate, name and address of the notified body monitoring the manufacturer's quality assurance system,    
 -  where appropriate, the references of the harmonised standards applied,    
 -  where appropriate, other technical standards and specifications used,    
 -  where appropriate, the references of the other Community Directives applied,    
 -  particulars of the signatory authorised to sign the legally binding declaration for the manufacturer or his authorised representative established within the Community.

SCHEDULE 7 Regulation 17


EUROPEAN APPROVAL FOR MATERIALS

     1. The notified body shall determine and perform, or arrange for the performance of, the appropriate inspections and tests to certify the conformity of the types of material with the corresponding requirements of these Regulations, and in the case of materials recognised as being safe to use before 29th November 1999, the notified body shall take account of the existing data when certifying such conformity.

     2. The notified body shall not issue a European approval for materials until it has:

(a) informed the Member States and the Commission by sending them the appropriate information;

(b) allowed a period of three months to elapse in order that a member State or the Commission may refer the matter to the Standing Committee set up by Article 5 of Directive 98/34/EC;

(c) taken into account, where appropriate, the opinion of the Committee and the comments submitted.

     3. A copy of the European approval for pressure equipment materials shall be sent to the member States, the notified bodies and the Commission.

     4. The materials used for the manufacture of pressure equipment conforming with European approvals for materials, the references of which have been published in the Official Journal of the European Communities, shall be presumed to conform to the applicable essential requirements of Schedule 2.

     5. The notified body which issued the European approval for pressure equipment materials shall withdraw that approval if it finds that it should not have been issued if the type of materials is covered by a harmonised standard and shall immediately inform the other member States, the notified bodies and the Commission of any withdrawal of an approval.