Certification CE, Module D1Quality assurance of the production process

Module D1
Quality assurance of the production process
1. Quality assurance of the production process is the conformity assessment procedure whereby the manufacturer fulfils
the obligations laid down in points 2, 4 and 7, and ensures and declares on his sole responsibility that the products
concerned satisfy the requirements of the legislative instrument that apply to them.
2. Technical documentation
The manufacturer shall establish 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, manufacture 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.
3. The manufacturer shall keep the technical documentation at the disposal of the relevant national authorities for
10 years after the product has been placed on the market.
4. Manufacturing
The manufacturer shall operate an approved quality system for production, final product inspection and testing of the
products concerned as specified in point 5, and shall be subject to surveillance as specified in point 6.
5. Quality system
5.1. 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,
— a written declaration that the same application has not been lodged with any other notified body,
— all relevant information for the product category envisaged,
— the documentation concerning the quality system,
— the technical documentation referred to in point 2.
5.2. 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. The 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 product quality,
— 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 product quality and the effective operation of the
quality system.
5.3. The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in
point 5.2.
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 with
experience of evaluation 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 2 in order to verify the
manufacturer's ability to identify the relevant 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 decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the
reasoned assessment decision.
5.4. 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.
5.5. 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 5.2 or whether 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.
6. Surveillance under the responsibility of the notified body
6.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the
approved quality system.
6.2. The manufacturer shall, for assessment purposes, allow the notified body access to the manufacture, inspection,
testing and storage sites and shall provide it with all necessary information, in particular:
— the quality system documentation,
— the technical documentation referred to in point 2,
— the quality records, such as inspection reports and test data, calibration data, qualification reports on the
personnel concerned, etc.
6.3. 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.
6.4. 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 verify that the quality system is
functioning correctly. The notified body shall provide the manufacturer with a visit report and, if tests have been
carried out, with a test report.
7. Conformity marking and declaration of conformity
7.1. 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 5.1, the latter's identification number to each individual product
that satisfies the applicable requirements of the legislative instrument.
7.2. 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.
8. 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 referred to in point 5.1,
— the change referred to in point 5.5, as approved,
— the decisions and reports of the notified body referred to in points 5.5, 6.3 and 6.4.
9. 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.
10. Authorised representative
The manufacturer's obligations set out in points 3, 5.1, 5.5, 7 and 8 may be fulfilled by his authorised representative,
on his behalf and under his responsibility, provided that they are specified in the mandate