Full Quality Assurance / Module H :

Approval as Pressure Equipment Manufacturer with a certified full quality Assurance system,
according the requirements within the European Pressure Equipment Directive 97/23/EC. -
Module H :
As in other European Directives, the PED allows the manufacturer to chose the approval
module, dependent on the classification of his product by category in accordance with Annex II
according to ascending level of hazard.
Module H is a stand-alone Module which includes an approved quality system for design,
manufacture, final inspection and testing. (full quality assurance)
Detailed information about the Modules, please see in the Directive 97/23/EC.
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 authorized
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 the 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 organizational 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 harmonized 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 fulfill the obligations arising out of the quality system
as approved and to ensure that it remains satisfactory and efficient.
The manufacturer, or his authorized 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 fulfills 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, reports 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 organization, policy or techniques.
During such visits the notified body may, if necessary, carry out or have carried out tests to
verify that the quality system is functioning correctly. The notified body must provide the
manufacturer with a visit report and, it a test has taken place, with a test report.
5. The manufacturer must, for a period of 10 years after the last of the pressure equipment has
been manufactured, keep a technical file at the disposal of the national authorities: