What does the conformity assessment procedure according to Category III Module H include?

Manufacturing

The manufacturer operates an approved quality assurance system for the design, manufacturing, final acceptance, and testing of pressure equipment and is subject to monitoring by a notified body.

Quality Assurance System

The manufacturer must apply to a notified body of their choice for the assessment of their quality assurance system for the relevant pressure equipment. The application should include the following:

• Name and address of the manufacturer (and, if applicable, the authorized representative)
• The technical documentation for a model of each type of the pressure equipment to be manufactured:
  • A general description of the pressure equipment;
  • Designs, manufacturing drawings, and plans of components, subassemblies, circuits, etc.;
  • Descriptions and explanations necessary to understand these drawings and plans as well as the functioning of the pressure equipment;
  • A list of which harmonized standards have been fully or partially applied and a description of how the essential safety requirements of this directive were met in the areas where these harmonized standards were not applied; in the case of partially applied harmonized standards, these parts will be indicated in the technical documentation;
  • The results of the design calculations, tests, etc.;
  • The test reports.
• The documentation regarding the quality assurance system and
• A written declaration that the same application has not been submitted to any other notified body.

The quality assurance system ensures compliance of the pressure equipment with the applicable requirements of the relevant directive. The manufacturer must ensure that the considered elements, requirements, and regulations are systematically and properly assembled. This is to ensure that the quality assurance programs, plans, manuals, and reports are uniformly interpreted.

They must particularly contain an adequate description of the following points:

• Quality objectives as well as the organizational structure, responsibilities, and authorities of management regarding design and product quality;
• Technical design specifications, including the applied standards;
• Techniques for controlling the development and testing of the development outcome, procedures, and systematic measures applied during the development of the pressure equipment belonging to the relevant product category
• The corresponding manufacturing, quality control, and quality assurance techniques, applied procedures, and systematic measures, particularly the approved working methods for the execution of permanent connections
• Investigations and tests conducted before, during, and after manufacturing, indicating their frequency;
• The quality-related records, such as test reports, qualification or approval of involved personnel, etc.
• Means by which the achievement of the required development and pressure equipment quality as well as the effective operation of the quality assurance system are monitored.

The notified body assesses the quality assurance system to determine whether the specified requirements are fulfilled.

In addition to experience with quality management systems, at least one member of the audit team must have experience as an evaluator in the relevant pressure equipment field and the corresponding pressure equipment technology and knowledge of the applicable requirements of the relevant directive. The audit also includes a control visit to the manufacturing site. The audit team reviews the technical documentation to ensure that the manufacturer is capable of recognizing the applicable requirements of the relevant directive and performing the necessary tests to ensure compliance of the pressure equipment with these requirements.

The manufacturer commits to fulfilling the obligations associated with the approved quality assurance system and ensuring that the system is always operated properly and efficiently.
The manufacturer keeps the notified body informed of all planned changes to the quality assurance system. The body assesses the planned changes and decides whether the modified quality assurance system still meets the specified requirements or whether a reevaluation is necessary.

Monitoring under the Responsibility of the Notified Body

The monitoring is intended to ensure that the manufacturer fulfills the obligations associated with the approved quality assurance system properly.
The manufacturer grants the notified body access to the development, manufacturing, acceptance, testing, and storage facilities for evaluation and provides all necessary documents, particularly:

• The documentation regarding the quality assurance system;
• Quality-related records designated for the development area, such as results of analyses, calculations, or tests;
• Quality-related records designated for the manufacturing area, such as inspection reports, test data, or reports on the qualification of employees working in this area.

The notified body conducts regular audits to ensure that the manufacturer maintains and applies the quality assurance system.

Furthermore, the notified body may make unannounced visits to the manufacturer, taking into account the following factors:

• Category of the pressure equipment;
• Results of previous control visits;
• Required tracking of corrective actions;
• Any special conditions attached to the approval of the system;
• Significant changes in manufacturing organization, manufacturing concepts, or techniques.

During these visits, the notified body may, if necessary, conduct product tests to check the proper functioning of the quality assurance system.

CE Marking and EU Declaration of Conformity:

The manufacturer must attach the CE marking to each pressure device, provided the directive requires it, and under the responsibility of the mentioned notified body, their identification number.
Additionally, a written EU Declaration of Conformity is issued for a model of the pressure equipment and kept available for the national authorities for ten years along with the technical documentation after the pressure equipment has been put on the market. It must be clearly recognizable from the EU Declaration of Conformity for which pressure equipment it has been issued.
A copy of the EU Declaration of Conformity will be made available to the competent authorities upon request.

The documents to be maintained by the manufacturer are particularly:

• The technical documentation
• The documentation regarding the quality assurance system
• The approved modifications
• The decisions and reports of the notified body

The EU Declaration of Conformity must contain the following information:

1. Pressure device or assembly (product, type, batch, or serial number)
2. Name and address of the manufacturer and, if applicable, their authorized representative
3. The sole responsibility for the issuance of this Declaration of Conformity lies with the manufacturer
4. Subject of the declaration (designation of the pressure device or assembly for traceability; it may include a picture if necessary for the identification of the pressure device or assembly):
   1. Description of the pressure device or assembly;
   2. Applied conformity assessment procedures;
   3. In the case of assemblies, a description of the pressure devices from which the assembly consists, as well as the applied conformity assessment procedures.
5. The subject of the declaration as described above meets the relevant harmonization legislative requirements of the European Union:
6. Indication of the relevant harmonized standards applied, or indication of other technical specifications for which conformity is declared:
7. If applicable, the name, address, and number of the notified body that performed the conformity assessment, the number of the issued certificate, and reference to the EU type examination certificate (type sample), the EU type examination certificate (prototype), the EU design examination certificate, or the conformity certificate.
8. Additional information:

• Signed for and on behalf of:
• (Place and date of issue)
• (Name, position) (Signature)
• (If applicable: Information about the signer authorized to sign the declaration legally for the manufacturer or their authorized representative)