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:
Conformity based on full quality assurance is the 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 satisfies the requirements of this Directive that
apply to it.
2.      Manufacturing
The manufacturer shall operate an approved quality system for design, manufacture, final product
inspection and testing of the pressure equipment 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,
—      the technical documentation for one model of each type of pressure equipment intended to be
manufactured. 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.,
—      test reports,
—      the documentation concerning the quality system, and
—      a written declaration that the same application has not been lodged with any other notified body.
3.2.   The quality system shall ensure compliance of the pressure equipment with the requirements of this
Directive that 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. That
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 design and product quality,
—      the technical design specifications, including standards, that will be applied and, where the
relevant harmonised standards will not be applied in full, the means that will be used to ensure
that the essential requirements of this Directive that apply to the pressure equipment will be
met,
—      the design control and design verification techniques, processes and systematic actions that will
be used when designing the pressure equipment, pertaining to the product type covered,
particularly with regard to materials in accordance with point 4 of Annex I,
—      the corresponding manufacturing, quality control and quality assurance techniques, processes
and systematic actions that will be used, particularly the procedures for the permanent joining
of parts as approved in accordance with point 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
points 3.1.2 and 3.1.3 of Annex I, etc.,
—      the means of monitoring the achievement of the required design and pressure equipment
quality and 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 experienced as assessor in the 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, second indent, to
verify the manufacturer’s ability to identify the applicable 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 manufacturer or his authorised representative shall be notified of the decision. 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 design,
manufacture, inspection, testing and storage sites and shall provide it with all necessary information,
in particular:
—      the quality system documentation,
—      the quality records provided for by the design part of the quality system, such as results of
analyses, calculations, tests, etc.,
—      the quality records provided for by the manufacturing part of the quality system, such as
inspection reports and test data, calibration data, qualification reports on 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 shall provide the manufacturer with an audit report. The frequency of
periodic audits shall 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 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 check the proper functioning of the quality system. It 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 item of pressure equipment that
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 pressure
equipment 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 technical documentation referred to in point 3.1,
—      the documentation concerning the quality system referred to in point 3.1,
—      the change referred to point 3.4, as approved,
—      the decisions and reports of the notified body referred to in points 3.3, 3.4, 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.
8.      Authorised representative
The manufacturer’s obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled by his authorised
representative, on his behalf and under his responsibility, provided that they are specified in the
mandate.