Module H
Conformity based on full quality assurance
1. 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 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 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,
— the technical documentation for one model of each category of products intended to be manufactured. 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.,
— 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 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. 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 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 specification.
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 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 the legislative instrument and to carry out the
necessary examinations with a view to ensuring compliance of the product 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 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.
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.
4.4. 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.
5. Conformity marking and declaration of conformity
5.1. 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.
5.2. 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.
A copy of the declaration of conformity shall be made available to the relevant authorities upon request.
6. 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 technical documentation referred to in point 3.1,
— 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, 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.
