Module H

Module H

Conformity based on full quality assurance

Conformity based on full quality assurance is a conformity assessment procedure whereby the manufacturer fulfills the obligations laid down in points 2 and 5 and, under its sole responsibility, ensures and declares that the products concerned meet the requirements of the legislative instrument applicable to them.

2.	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 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 submitted by an authorized representative, also the representative’s name and address,

— technical documentation for one model of each category of products to be manufactured; the technical documentation shall include, where applicable, 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,

— 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 that products comply with the requirements of the legal instrument applicable to them.

All documents, requirements, and regulations used by the manufacturer must be systematically and orderly documented in the form of written policies, procedures, and instructions. This 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,

— the 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 in question,

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 transposing 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 assessing 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 audit team shall review the technical documentation referred to in the second indent of point 3.1 to verify that the manufacturer is capable of identifying the relevant requirements of the legal instrument and carrying out the necessary reviews to ensure the product’s conformity with those requirements.

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

The notification shall 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 Section 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.

Surveillance under the responsibility of the notified body

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

4.2

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 part of the quality system relating to design, e.g., results of analyses, calculations, tests, etc.,

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

4.3	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.

4.4	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

5.1	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.

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 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 has been drawn up.

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 technical documentation referred to in point 3.1,

— the documentation relating to the quality system 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 sections 3.5, 4.3, and 4.4.

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.

8.	Authorized Representative The manufacturer’s obligations set forth in sections 3.1, 3.5, 5, and 6 may be fulfilled on its behalf and under its responsibility by its authorized representative, provided they are specified in the mandate.