Module H1
Conformity based on full quality assurance plus design examination
1. Conformity based on full quality assurance plus design examination is the conformity assessment procedure whereby
the manufacturer fulfils the obligations laid down in points 2 and 6, and ensures and declares on his sole responsibility
that the products concerned satisfy the requirements of the legislative instrument that apply to them.
2. Manufacturing
The manufacturer shall operate an approved quality system for design, manufacture and final product inspection and
testing of the products concerned as specified in point 3 and shall be subject to surveillance as specified in point 5.
The adequacy of the technical design of the products shall have been examined in accordance with 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 products 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,
— all relevant information for the product category envisaged,
— the documentation concerning the quality system,
— 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 products with the requirements of the legislative instrument that
apply to them.
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 design and product quality,
— the technical design specifications, including standards, that will be applied and, where the relevant harmonised
standards and/or technical specifications will not be applied in full, the means that will be used to ensure that
the essential requirements of the legislative instrument that apply to the products will be met,
— the design control and design verification techniques, processes and systematic actions that will be used when
designing the products pertaining to the product category covered,
— the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic
actions that will be used,
— the examinations and tests that will 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, qualification reports on the
personnel concerned, etc.,
— the means of monitoring the achievement of the required design and product 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 national standard that implements the relevant harmonised standard and/or
technical specifications.
In addition to experience in quality management systems, the auditing team shall have at least one member
experienced as an assessor in the relevant product field and product technology concerned, and knowledge of the
applicable requirements of the legislative instrument. The audit shall include an assessment visit to the manufacturer's
premises.
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.
3.6. 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.
4. Design examination
4.1. The manufacturer shall lodge an application for examination of the design with the notified body referred to in
point 3.1.
4.2. The application shall make it possible to understand the design, manufacture and operation of the product, and to
assess the conformity with the requirements of the legislative instrument that apply to it. It shall include:
— the name and address of the manufacturer,
— a written declaration that the same application has not been lodged with any other notified body,
— the technical documentation. The documentation shall make it possible to assess the product's conformity 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 and operation of the product. The technical documentation shall, wherever applicable, contain at least
the following elements:
— a general description of the product,
— conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,
— descriptions and explanations necessary for the understanding of those drawings and schemes and the
operation of the product,
— a list of the harmonised standards and/or other relevant technical specifications 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 requirements of the legislative instrument 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 supporting evidence for the adequacy of the technical design. This supporting evidence shall mention any
documents that have been used, in particular where the relevant harmonised standards and/or technical
specifications have not been applied in full, and shall include, where necessary, the results of tests carried out by
the appropriate laboratory of the manufacturer, or by another testing laboratory on his behalf and under his
responsibility.
4.3. The notified body shall examine the application, and where the design meets the requirements of the legislative
instrument that apply to the product it shall issue an EC design examination certificate to the manufacturer. The
certificate shall give the name and address of the manufacturer, the conclusions of the examination, the conditions (if
any) for its validity and the data necessary for identification of the approved design. The certificate may have one or
more annexes attached.
The certificate and its annexes shall contain all relevant information to allow the conformity of manufactured products
with the examined design to be evaluated, and to allow for in-service control, where applicable.
Where the design does not satisfy the applicable requirements of the legislative instrument, the notified body shall
refuse to issue a design examination certificate and shall inform the applicant accordingly, giving detailed reasons for
its refusal.
4.4. The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which
indicate that the approved design may no longer comply with the applicable requirements of the legislative
instrument, and shall determine whether such changes require further investigation. If so, the notified body shall
inform the manufacturer accordingly.
The manufacturer shall keep the notified body that has issued the EC design examination certificate informed of any
modification to the approved design that may affect the conformity with the essential requirements of the legislative
instrument or the conditions for validity of the certificate. Such modifications shall require additional approval —
from the notified body that issued the EC design examination certificate — in the form of an addition to the original
EC design examination certificate.
4.5. Each notified body shall inform its notifying authorities of the EC design examination certificates and/or any additions
thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying
authorities the list of certificates and/or any additions thereto refused, suspended or otherwise restricted.
Each notified body shall inform the other notified bodies of the EC design examination certificates and/or any
additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, of the
certificates and/or additions thereto which it has issued.
The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EC design
examination certificates and/or additions thereto. On request, the Commission and the Member States may obtain a
copy of the technical documentation and of the results of the examinations carried out by the notified body.
The notified body shall keep a copy of the EC design examination certificate, its annexes and additions, as well as the
technical file including the documentation submitted by the manufacturer until the expiry of the validity of the
certificate.
4.6. The manufacturer shall keep a copy of the EC design examination certificate, its annexes and additions together with
the technical documentation at the disposal of the national authorities for 10 years after the product has been placed
on the market.
5. Surveillance under the responsibility of the notified body
5.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the
approved quality system.
5.2. 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 as provided for by the design part of the quality system, such as results of analyses,
calculations, tests, etc.,
— the quality records as 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.
5.3. 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.
5.4. In addition, the notified body may pay unexpected visits to the manufacturer. 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.
6. Conformity marking and declaration of conformity
6.1. The manufacturer shall affix the required conformity marking set out in the legislative instrument, and, under the
responsibility of the notified body referred to in point 3.1, the latter's identification number to each individual product that satisfies the applicable requirements of the legislative instrument.
6.2. The manufacturer shall draw up a written declaration of conformity for each product model and keep it at the disposal
of the national authorities for 10 years after the product has been placed on the market. The declaration of conformity
shall identify the product model for which it has been drawn up and shall mention the number of the design
examination certificate.
A copy of the declaration of conformity shall be made available to the relevant authorities upon request.
7. The manufacturer shall, for a period ending at least 10 years after the product has been placed on the market, keep at
the disposal of the national authorities:
— the documentation concerning the quality system referred to in point 3.1,
— the change referred to in point 3.5, as approved,
— the decisions and reports of the notified body referred to in points 3.5, 5.3 and 5.4.
8. Authorised representative
The manufacturer's authorised representative may lodge the application referred to in points 4.1 and 4.2 and fulfil the obligations set out in points 3.1, 3.5, 4.4, 4.6, 6 and 7, on his behalf and under his responsibility, provided that theyare specified in the mandate.
