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