⌦ TRANSITIONAL AND ⌫ FINAL PROVISIONS
3. MODULE D1: Quality assurance of the production process
The manufacturer's obligations set out in points 2.3.1, 2.3.5, 2.5 and 2.6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
3.5.1. The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the instruments concerned.
The application shall include:
(a) the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well;
(b) a written declaration that the same application has not been lodged with any other notified body;
(c) all relevant information for the instrument category envisaged;
(d) the documentation concerning the quality system;
(e) the technical documentation referred to in point 3.2.
3.5.2. The quality system shall ensure compliance of the instruments with the requirements of this Directive 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:
(a) the quality objectives and the organisational structure, responsibilities and powers of the management with regard to instrument quality;
(b) the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used;
(c) the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out;
(d) the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.;
(e) the means of monitoring the achievement of the required instrument quality and the effective operation of the quality system.
3.5.3. The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.5.2.
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 instrument field and instrument technology concerned, and knowledge of the applicable requirements of this Directive. The
audit shall include an assessment visit to the manufacturer's premises. The auditing team shall review the technical documentation referred to in point 3.2 in order to verify the manufacturer's ability to identify the relevant requirements of this Directive and to carry out the necessary examinations with a view to ensuring compliance of the instrument 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.
3.5.4. 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.
3.5.5. 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 3.5.2 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.
3.6. Surveillance under the responsibility of the notified body
3.6.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.
3.6.2. 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:
(a) the quality system documentation;
(b) the technical documentation referred to in point 3.2;
(c) the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.
3.6.3. 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.
3.6.4. 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.
3.7. Conformity marking and declaration of conformity
3.7.1. The manufacturer shall affix the CE marking and the inscriptions provided for in point 1 of Annex III, and, under the responsibility of the notified body referred to in point 3.5.1, the
latter's identification number to each individual instrument that satisfies the applicable requirements of this Directive.
3.7.2. The manufacturer shall draw up a written declaration of conformity for each instrument model and keep it at the disposal of the national authorities for 10 years after the instrument has been placed on the market. The declaration of conformity shall identify the instrument 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.
3.8. The manufacturer shall, for a period ending at least 10 years after the instrument has been placed on the market, keep at the disposal of the national authorities:
(a) the documentation referred to in point 3.5.1;
(b) the change referred to in point 3.5.5, as approved;
(c) the decisions and reports of the notified body referred to in points 3.5.5, 3.6.3 and 3.6.4.
3.9. 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.
3.10. Authorised representative
The manufacturer's obligations set out in points 3.3, 3.5.1, 3.5.5, 3.7 and 3.8 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
2009/23/EC (adapted) 34. EC ⌦ MODULE F: Conformity to type based on product ⌫ verification
2009/23/EC
3.1. EC verification is the procedure whereby the manufacturer or his authorised representative established within the Community ensures and declares that the instruments which have been checked in accordance with point 3.3 are, where applicable, in conformity with the type described in the EC type-examination certificate and that they satisfy the requirements of this Directive.
3.2. The manufacturer shall take all necessary measures in order that the manufacturing process ensures conformity of the instruments, where applicable, with the type as described in the EC type-examination certificate and with the requirements of this Directive which apply to them. The manufacturer or his authorised representative established within the Community shall affix the ‘CE’ conformity marking to each instrument and draw up a written declaration of conformity.
3.3. The notified body shall carry out the appropriate examinations and tests in order to check the conformity of the product to the requirements of this Directive by examination and testing of every instrument, as specified in point 3.5.
3.4. For instruments not subject to EC type-approval, the documents relating to the design of the instrument, as set out in Annex III, must be accessible to the notified body should the latter so request.
3.5. Verification by checking and testing of each instrument
3.5.1. All instruments shall be individually examined and appropriate tests, as set out in the relevant harmonised standards referred to in Article 6(1), or equivalent tests, shall be carried out in order to verify their conformity, where applicable, with the type as described in the EC type-examination certificate and the requirements of this Directive.
3.5.2. The notified body shall affix, or cause to be affixed, its identification number on each instrument the conformity of which to requirements has been established, and shall draw up a written certificate of conformity relating to the tests carried out.
3.5.3. The manufacturer or his authorised representative shall ensure that he is able to supply the notified body’s certificates of conformity on request.
new
4.1. Conformity to type based on product verification is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 4.2, 4.5.1 and 4.6, and ensures and declares on his sole responsibility that the instruments concerned, which have been subject to the provisions of point 4.3, are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of this Directive that apply to them.
4.2. Manufacturing
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured instruments with the approved type described in the EU-type examination certificate and with the requirements of this Directive that apply to them.
4.3. Verification
A notified body chosen by the manufacturer shall carry out appropriate examinations and tests in order to check the conformity of the instruments with the approved type described in the EU-type examination certificate and with the appropriate requirements of this Directive.
The examinations and tests to check the conformity of the instruments with the appropriate requirements shall be carried out by examination and testing of every instrument as specified in point 4.4.
4.4. Verification of conformity by examination and testing of every instrument
4.4.1. All instruments shall be individually examined and appropriate tests set out in the relevant harmonised standard(s) and/or technical specifications, or equivalent tests, shall be carried out in order to verify conformity with the approved type described in the EU-type examination certificate and with the appropriate requirements of this Directive.
In the absence of such a harmonised standard, the notified body concerned shall decide on the appropriate tests to be carried out.
4.4.2. The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out, and shall affix its identification number to each approved instrument or have it affixed under its responsibility.
The manufacturer shall keep the certificates of conformity available for inspection by the national authorities for 10 years after the instrument has been placed on the market.
4.5. Conformity marking and declaration of conformity
4.5.1. The manufacturer shall affix the CE marking and the inscriptions provided for in point 1 of Annex III, and, under the responsibility of the notified body referred to in point 4.3, the latter's identification number to each individual instrument that is in conformity with the approved type described in the EU-type examination certificate and satisfies the applicable requirements of this Directive.
4.5.2. The manufacturer shall draw up a written declaration of conformity for each instrument model and keep it at the disposal of the national authorities, for 10 years after the instrument has been placed on the market. The declaration of conformity shall identify the instrument 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.
If the notified body referred to in point 4.3 agrees and under its responsibility, the manufacturer may also affix the notified body's identification number to the instruments.
4.6. If the notified body agrees and under its responsibility, the manufacturer may affix the notified body's identification number to the instruments during the manufacturing process.
4.7. Authorised representative
The manufacturer's obligations may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. An authorised representative may not fulfil the manufacturer's obligations set out in points 4.2 and 4.5.1.