Module H1

Module H1

Conformity based on full quality assurance plus design review

Conformity based on full quality assurance plus design examination is a conformity assessment procedure whereby the manufacturer fulfills the obligations laid down in points 2 and 6 and, under its sole responsibility, ensures and declares that the products concerned meet the requirements of the legislative instrument applicable to them.

Manufacturing

The manufacturer shall operate an approved quality system for the design, manufacture, final inspection, and testing of the products in question in accordance with point 3 and shall be subject to surveillance in accordance with point 5. The adequacy of the technical design of the products shall be reviewed in accordance with point 4.

Quality System

3.1

The manufacturer shall lodge an application for assessment of its quality system for the products concerned with a notified body of its choice.

The application shall include:

— the name and address of the manufacturer, and, if the application is lodged by an authorized representative, also the name and address of the representative,

— all relevant information regarding the intended product category,

— documentation concerning the quality system,

— a written declaration that the same application has not been submitted to another notified body.

3.2

The quality system must ensure the conformity of the products with the requirements of the applicable legal instrument.

All documents, requirements, and regulations used by the manufacturer must be systematically and coherently documented in the form of written policies, procedures, and instructions. The quality system documentation must allow for a consistent interpretation of quality-related programs, plans, manuals, and records.

The quality system documentation must include

in particular, an adequate description

— quality objectives and the organizational structure, responsibilities, and authorities of management regarding design and product quality,

— technical design specifications, including the standards that will be applied, and, where the relevant harmonized standards or technical specifications are not applied in full, a description of the means that will be used to ensure compliance with the essential requirements of the legislative instrument applicable to the products,

— design control and verification methods, the procedures and systematic activities to be used in the design of products belonging to the relevant product category,

— the corresponding methods, procedures, and systematic activities to be used in manufacturing, inspection, and quality assurance,

— the examinations and tests to be carried out before, during, and after manufacture, specifying their frequency,

— quality records, such as inspection reports, test records, calibration records, reports on the qualifications of 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 meets the requirements referred to in point 3.2.

It shall presume conformity with these requirements for those elements of the quality system that correspond to the relevant specifications of the national standard implementing the relevant harmonized standard or technical specification.

The audit team must have experience with quality management systems, and at least one member must have experience in evaluating the relevant product field and the technology of the products in question, as well as knowledge of the relevant requirements of the legal instrument. The audit includes an assessment visit to the manufacturer’s premises.

The decision shall be notified to the manufacturer or its authorized representative.

The notification must contain the conclusions of the audit and the reasoned assessment decision.

3.4	The manufacturer undertakes to fulfill the obligations arising from the quality system as approved and to maintain it so that it remains adequate and effective.

3.5

The manufacturer shall inform the notified body that approved the quality system of any intended change to the quality system.

The notified body shall assess the proposed changes and decide whether the modified quality system will continue to meet the requirements set out in point 3.2 or whether a new assessment is necessary.

The notified body shall notify the manufacturer of its decision. The notification shall contain the conclusions of the review and the reasoned assessment decision.

3.6

Each notified body shall inform its notifying authorities of the quality system approvals it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities a list of quality system approvals it has refused, suspended, or otherwise restricted.

Each notified body shall inform the other notified bodies of the quality system approvals it has refused, suspended, or withdrawn, and, upon request, of the quality system approvals it has issued.

Design review

4.1	The manufacturer shall submit an application for design review to the notified body referred to in clause 3.1.

4.2

The application shall enable an understanding of the design, manufacture, and operation of the product and shall enable an assessment of conformity with the requirements of the applicable regulatory instrument. The application shall include:

— the name and address of the manufacturer,

— a written declaration that the same application has not been submitted to another notified body,

— technical documentation. The documentation shall enable the assessment of the product’s conformity with the relevant requirements and shall include an appropriate analysis and assessment of risks. The technical documentation must refer to the relevant requirements and, to the extent necessary for the assessment, cover the design and operation of the product. The technical documentation must contain, where relevant, at least the following elements:

—

— a general description of the product,

— conceptual design and manufacturing drawings and diagrams of components, subassemblies, circuits, etc.,

— descriptions and explanations necessary for understanding these drawings and diagrams and the operation of the product,

— a list of harmonized standards or other relevant technical specifications published in the Official Journal of the European Union and applied in full or in part, and a description of the solutions adopted to meet the essential requirements of the legislative instrument where such harmonized standards have not been applied; in the case of partially applied harmonized standards, the technical documentation shall specify the parts that have been applied,

— results of design calculations, tests carried out, etc.,

— test reports,

— supporting evidence of the adequacy of the technical design solution. This supporting evidence must refer to all documents that have been used, particularly where the relevant harmonized standards or technical specifications have not been applied in full, and, where necessary, include the results of tests carried out by the manufacturer’s appropriate laboratory or by another testing laboratory on his behalf and under his responsibility.

4.3

The notified body shall examine the application and, if the design meets the requirements of the legislative instrument applicable to the product, issue an EC design examination certificate to the manufacturer. The certificate shall contain the name and address of the manufacturer, the conclusions of the examination, the conditions of validity of the certificate (if any), and the data necessary to identify the approved design. One or more annexes may be attached to the certificate.

The certificate and its annexes shall contain all relevant information necessary to assess whether the manufactured products conform to the examined design and, where applicable, to carry out in-service inspections.

If the design does not meet the relevant requirements of the legislative instrument, the notified body shall refuse to issue a design examination certificate and shall inform the applicant accordingly, providing detailed reasons for the refusal.

4.4

The notified body shall ensure that it is kept informed of any changes in the generally acknowledged state of the art that would indicate that the approved design may no longer comply with the relevant requirements of the legislative instrument, and shall determine whether such changes require further investigation. If they do, the notified body shall inform the manufacturer.

The manufacturer shall inform the notified body that issued the EC design examination certificate of any changes to the approved design that may affect conformity with the essential requirements of the legislative instrument or the conditions for the validity of the certificate. Such changes must be subsequently approved by the notified body that issued the EC design examination certificate in the form of an addendum to the original EC design examination certificate.

4.5

Each notified body shall inform its notifying authorities of the EC design examination certificates or additions thereto that it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities a list of certificates or additions thereto that it has refused, suspended, or otherwise restricted.

Each notified body shall inform the other notified bodies of the EC design examination certificates or additions thereto which it has refused, suspended, or otherwise restricted, and, upon request, also of the certificates or additions thereto which it has issued.

The Commission, the Member States, and other notified bodies may, upon request, receive a copy of the EC design examination certificates or their addenda. The Commission and the Member States may, upon request, receive a copy of the technical documentation and the results of the examinations carried out by the notified body.

Until the expiry of the EC design examination certificate, the notified body shall keep a copy of that certificate, its annexes, and amendments, as well as the technical documentation file, including the documentation submitted by the manufacturer.

4.6	The manufacturer shall keep a copy of the EC design examination certificate, its annexes, and amendments, together with the technical documentation, for the benefit of the national authorities for a period of ten years after the product has been placed on the market.

Surveillance under the responsibility of the notified body

5.1	The purpose of surveillance is to ensure that the manufacturer duly fulfills the obligations arising from the approved quality system.

5.2

For the purposes of assessment, the manufacturer shall allow the notified body access to the premises designated for design, manufacture, inspection, testing, and storage, and shall provide it with all necessary information, in particular:

— the quality system documentation,

— the quality records required in the design part of the quality system, e.g., results of analyses, calculations, tests, etc.,

— quality records required by the manufacturing part of the quality system, e.g., inspection reports, test records, calibration records, reports on the qualifications of the personnel concerned, etc.

5.3	The notified body shall conduct periodic audits to ensure 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 unannounced visits to the manufacturer. During these visits, the notified body may, if necessary, carry out or have carried out product tests to verify that the quality system is functioning properly. The notified body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.

Conformity Marking and Declaration of Conformity

6.1	The manufacturer shall affix the required conformity marking set forth in the legal instrument and, under the responsibility of the notified body referred to in point 3.1, the identification number of that body to each individual product that meets the relevant requirements of the legal 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 a period of ten years after the product has been placed on the market. The declaration of conformity shall identify the product model for which it was drawn up and shall include the number of the design examination certificate.

A copy of the declaration of conformity shall be made available to the competent authorities upon request.

The manufacturer shall, for the purposes of the national authorities, keep the following for a period of at least ten years from the date the product was placed on the market:

— the quality system documentation referred to in point 3.1,

— the information on the change referred to in point 3.5, as approved,

— the decisions, reports, and records of the notified body referred to in points 3.5, 5.3, and 5.4.

Authorized Representative

The manufacturer’s authorized representative may submit the application referred to in sections 4.1 and 4.2 and, on behalf of the manufacturer and under the manufacturer’s responsibility, fulfill the obligations set out in sections 3.1, 3.5, 4.4, 4.6, 6, and 7, provided they are specified in the mandate.