ANNEX B

Modules for conformity assessment

EC TYPE-EXAMINATION (MODULE B)

1. A notified body must ascertain and attest that a specimen, representative of the production envisaged, complies with the provisions of the international instruments that apply to it.

2. The application for the EC type-examination must be lodged by the manufacturer or his authorized representative established within the Community with a notified body of his choice. The application must include:
  — the name and address of the manufacturer and, if the application is lodged by the authorized representative, his name and address as well,
  — a written declaration that the same application has not been lodged simultaneously with any other notified body,
  — the technical documentation as described in point 3.
The applicant must place at the disposal of the notified body a specimen, representative of the production envisaged and hereinafter called ‘type’ (¹).
The notified body may request further specimens if needed for the test programme.

3. The technical documentation must make it possible to assess the product's compliance with the requirements of the relevant international instruments. It must, as far as is relevant for such assessment, cover the design, the building standard, manufacture, installation and functioning of the product in accordance with the description of technical documentation set down in the Appendix to this Annex.

4. The notified body must:
4.1. examine the technical documentation and verify that the type has been manufactured in accordance with the technical documentation;
4.2. perform the appropriate examinations and necessary tests or have them performed to check whether the requirements of the relevant international instruments have actually been met;
4.3. agree with the applicant the location where the examinations and necessary tests will be carried out.

5. Where the type meets the provisions of the relevant international instruments, the notified body must issue an EC type-examination certificate to the applicant. The certificate must give the name and address of the manufacturer, details of the equipment, the conclusions of the examination, the conditions of its validity and the necessary data for identification of the approved type. A list of the relevant parts of the technical documentation must be annexed to the certificate and a copy kept by the notified body. If a manufacturer is refused a type-certification, the notified body must give detailed reasons for that refusal. Where a manufacturer reapplies for type-approval for equipment for which a type-certificate has been refused, his submission to the notified body must include all relevant documentation, including the original test reports, the detailed reasons for the previous refusal and details of all modifications made to the equipment.

6. The applicant must inform the notified body that holds the technical documentation concerning the EC type-examination certificate of all modifications to the approved product, which must receive additional approval where such changes may affect compliance with the requirements or the prescribed conditions for use of the product. Such additional approval must be given in the form of an addition to the original EC type-examination certificate.

7. Each notified body must, on request, provide flag Member State administrations and the other notified bodies with the relevant information concerning the EC type-examination certificates and additions issued and withdrawn.

8. The other notified bodies may receive copies of the EC type-examination certificates and/or their additions. The Annexes to the certificates must be kept at the disposal of the other notified bodies.

9. The manufacturer or his authorized representative established within the Community must keep with the technical documentation copies of EC type-examination certificates and their additions for at least 10 years after the last product has been manufactured.

CONFORMITY TO TYPE (MODULE C)

1. A manufacturer or his authorized representative established within the Community must ensure and declare that the products concerned conform to type as described in the EC type-examination certificate and satisfy the requirements of the international instruments that apply to them. The manufacturer or his authorized representative established within the Community must affix the mark to each product and draw up a written declaration of conformity.

2. The manufacturer must take all measures necessary to ensure that the manufacturing process ensures that the manufactured products conform to type as described in the EC type-examination certificate and comply with the requirements of the international instruments that apply to them.

3. The manufacturer or his authorized representative established within the Community must keep a copy of the declaration of conformity for at least 10 years after the last product has been manufactured.

PRODUCTION-QUALITY ASSURANCE (MODULE D)

1. A manufacturer who satisfies the obligations of point 2 must ensure and declare that the products concerned conform to type as described in the EC type-examination certificate. The manufacturer or his authorized representative established within the Community must affix the mark to each product and draw up a written declaration of conformity. The mark must be accompanied by the identification symbol of the notified body responsible for surveillance as specified in point 4.

2. The manufacturer must operate an approved quality system for production, final-product inspection and testing as specified in point 3 and must be subject to surveillance as specified in point 4.

3. Quality system
3.1. The manufacturer must lodge an application for assessment of his quality system with a notified body of his choice for the products concerned. The application must include:
  — all relevant information for the product category envisaged,
  — the documentation concerning the quality system,
  — the technical documentation of the approved type and a copy of the EC type-examination certificate.
3.2. The quality system must ensure that the products conform to type as described in the EC type-examination certificate. All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. The quality-system documentation must permit a consistent interpretation of the quality programmes, plan, manuals and records. It must, in particular, include an adequate description of:
  — the quality objectives and the organizational structure, responsibilities and powers of the management with regard to product quality,
  — the 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 of the personnel concerned, etc.,
  — the means of monitoring the achievement of the required product quality and the effective operation of the quality system.
3.3. The notified body must assess the quality system to determine whether it satisfies the requirements laid down in point 3.2. It must presume compliance with those requirements in respect of quality systems that implement the relevant harmonized standard. The auditing team must have at least one member with experience of assessment in the product technology concerned. The assessment procedure must include a visit to the manufacturer's premises. The manufacturer must be notified of the decision. The notification must include the conclusions of the examination and the reasoned assessment decision.
3.4. The manufacturer must undertake to fulfil the obligations arising out of the quality system as approved and to uphold it so that it remains adequate and efficient. The manufacturer or his authorized representative established within the Community must keep the notified body that has approved the quality system informed of any intended updating of that quality system. The notified body must assess the modifications proposed and decide whether the modified quality system will still satisfy the requirements laid down in point 3.2 or whether a reassessment is required. The manufacturer must be notified of its decision. The notification must include 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 must allow the notified body access for inspection purposes to the locations of manufacture, inspection and testing and storage and must provide it with all necessary information, in particular:
  — the quality-system documentation,
  — the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.
4.3. The notified body must periodically carry out audits to make sure that the manufacturer maintains and applies the quality system and must provide the manufacturer with audit reports.
4.4. In addition, the notified body may pay unannounced visits to the manufacturer. During such visits the notified body may carry out tests or cause tests to be carried out to check that the quality system is functioning correctly, if necessary. The notified body must provide the manufacturer with a visit report and, if a test has taken place, with a test report.

5. The manufacturer must, for at least 10 years after the last product has been manufactured, keep at the disposal of the national authorities:
  — the documentation referred to in the second indent of the second paragraph of point 3.1,
  — the updating referred to in the second paragraph of point 3.4,
  — the decision and reports from the notified body referred to in the final paragraph of point 3.4, point 4.3 and point 4.4.

6. Each notified body must, on request, provide flag Member State administrations and the other notified bodies with the relevant information concerning the quality-system approvals issued and withdrawn.

PRODUCT-QUALITY ASSURANCE (MODULE E)

1. A manufacturer who satisfies the obligations of point 2 ensures and declares that the products concerned conform to type as described in the EC type-examination certificate. The manufacturer or his authorized representative established within the Community must affix the mark to each product and draw up a written declaration of conformity. The mark must be accompanied by the identification symbol of the notified body responsible for surveillance as specified in point 4.

2. The manufacturer must operate an approved quality system for final inspection and testing as specified in point 3 and must be subject to surveillance as specified in point 4.

3. Quality system
3.1. The manufacturer must lodge an application for assessment of his quality system for the products concerned with a notified body of his choice. The application must include:
  — all relevant information for the product category envisaged,
  — documentation concerning the quality system,
  — the technical documentation of the approved type and a copy of the EC type-examination certificate.
3.2. Under the quality system, each product must be examined and appropriate tests must be carried out in order to ensure its compliance with the relevant requirements of the international instruments. All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. That quality-system documentation must ensure common understanding of the quality programmes, plans, manuals and records. It must, in particular, include an adequate description of:
  — the quality objectives and the organizational structure, responsibilities and powers of the management with regard to product quality,
  — the examinations and tests that will be carried out after manufacture,
  — the means of monitoring the effective operation of the quality system,
  — the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.
3.3 The notified body must assess the quality system to determine whether it satisfies the requirements laid down in point 3.2. It must presume compliance with the requirements in respect of quality systems that implement the relevant harmonized standard. The auditing team must have at least one member with experience as an assessor in the product technology concerned. The assessment procedure must include an assessment visit to the manufacturer's premises. The manufacturer must be notified of the decision. The notification must include the conclusions of the examination and the reasoned assessment decision.
3.4. The manufacturer must undertake to fulfil the obligations arising out of the quality system as approved and to maintain it in an appropriate and efficient manner. The manufacturer or his authorized representative established within the Community must keep the notified body that has approved the quality system informed of any intended updating of that quality system. The notified body must evaluate the modifications proposed and decide whether the modified quality system will still satisfy the requirements laid down in point 3.2 or whether a reassessment is required. The manufacturer must be notified of its decisions. The notification must include 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 must allow the notified body access for inspection purposes to the locations of inspection, testing and storage and must provide it with all necessary information, in particular:
  — the quality-system documentation,
  — the technical documentation,
  — the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.
4.3. The notified body must periodically carry out audits to make sure that the manufacturer maintains and applies the quality system and must provide the manufacturer with audit reports.
4.4. In addition, the notified body may pay unannounced visits to the manufacturer. During such visits the notified body may carry out tests or cause tests to be carried out to check that the quality system is functioning correctly, if necessary. The notified body must provide the manufacturer with a visit report and, if a test has been carried out, with a test report.

5. The manufacturer must, for at least 10 years after the last product has been manufactured, keep at the disposal of the national authorities:
  — the documentation referred to in the third indent of the second paragraph of point 3.1,
  — the updating referred to in the second paragraph of point 3.4,
  — the decision and reports from the notified body referred to in the final paragraph of point 3.4, point 4.3 and point 4.4.

6. Each notified body must on request provide flag Member State administrations and the other notified bodies with the relevant information concerning the quality-system approvals issued and withdrawn.

PRODUCT VERIFICATION (MODULE F)

1. A manufacturer or his authorized representative established within the Community must check and attest that the products subject to point 3 conform to the type as described in the EC type-examination certificate.

2. The manufacturer must take all measures necessary to ensure that the manufacturing process ensures that the products conform to type as described in the EC type-examination certificate. He must affix the mark to each product and must draw up a declaration of conformity.

3. The notified body must carry out the appropriate examinations and tests in order to check that the product complies with the requirements of the international instruments either by examination and testing of every product as specified in point 4 or by examination and testing of products on a statistical basis, as specified in point 5, at the choice of the manufacturer.
3a. The manufacturer or his authorized representative established within the Community must keep a copy of the declaration of conformity for at least 10 years after the last product has been manufactured.

4. Verification by examination and testing of every product
4.1. All products must be individually examined and appropriate tests must be carried out in order to verify their conformity to type as described in the EC type-examination certificate.
4.2. The notified body must affix its identification symbol or cause it to be affixed to each approved product and draw up a written certificate of conformity relating to the tests carried out.
4.3. The manufacturer or his authorized representative established within the Community must ensure that he is able to supply the notified body's certificate of conformity on request to the flag Member State administration.

5. Statistical verification
5.1. The manufacturer must present his products in the form of homogeneous lots and must take all measures necessary to ensure that the manufacturing process ensures the homogeneity of each lot produced.
5.2. All products must be available for verification in the form of homogeneous lots. A random sample must be drawn from each lot. Products in a sample must be individually examined and appropriate tests must be carried out to ensure that they comply with the requirements of the international instruments which apply to them and to determine whether the lot is to be accepted or rejected.
5.3. In the case of accepted lots, the notified body must affix its identification symbol or cause it to be affixed to each product and must draw up a written certificate of conformity relating to the tests carried out. All products in the lot may be put on the market except those products from the sample which are found not to comply. If a lot is rejected, the notified body or the competent authority must take appropriate measures to prevent that lot's being put on the market. In the event of frequent rejection of lots the notified body may suspend statistical verification. The manufacturer may, under the responsibility of the notified body, affix the latter's identification symbol during the manufacturing process.
5.4. The manufacturer or his authorized representative established within the Community must ensure that he is able to supply the notified body's certificates of conformity on request to the flag Member State administration.

UNIT VERIFICATION (MODULE G)

1. The manufacturer must ensure and declare that the product concerned, which has been issued with the certificate referred to in point 2, complies with the requirements of the international instruments that apply to it. The manufacturer or his authorized representative established within the Community must affix the mark to the product and draw up a declaration of conformity.

2. The notified body must examine the individual product and carry out appropriate tests to ensure that it complies with the relevant requirements of the international instruments. The notified body must affix its identification number or cause it to be affixed to the approved product and must draw up a certificate of conformity concerning the tests carried out.

3. The aim of the technical documentation is to enable compliance with the requirements of the international instruments to be assessed and the design, manufacture and operation of the product to be understood.

FULL-QUALITY ASSURANCE (MODULE H)

1. A manufacturer who satisfies the obligations of paragraph 2 must ensure and declare that the products concerned comply with the requirements of the international instruments that apply to them. The manufacturer or his authorized representative established within the Community must affix the mark to each product and draw up a written declaration of conformity. The mark must be accompanied by the identification symbol of the notified body responsible for surveillance as specified in point 4.

2. The manufacturer must operate an approved quality system for design, manufacture, final-product inspection and testing as specified in point 3 and must be subject to surveillance as specified in point 4.

3. Quality system
3.1. The manufacturer must lodge an application for assessment of his quality system with a notified body.
The application must include:
  — all relevant information for the product category envisaged and
  — documentation concerning the quality system.
3.2. The quality system must ensure that the products comply with the requirements of the international instruments that apply to them. All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. The quality-system documentation must ensure common understanding of the quality policies and procedures such as quality programmes, plans, manuals and records. It must, in particular, include an adequate description of:
  — the quality objectives and the organizational structure, responsibilities and powers of the management with regard to product quality,
  — the technical design specifications, including standards, that will be applied and the assurance that the essential requirements of the international instruments that apply to the products will be met,
  — the design-control and design-verification techniques, processes and systematic actions that will be used in the design of 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 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 must assess the quality system to determine whether it satisfies the requirements laid down in point 3.2. It must presume compliance with the requirements in respect of quality systems that implement the relevant harmonized standard. The auditing team must have at least one member with experience as an assessor in the product technology concerned. The assessment procedure must include an assessment visit to the manufacturer's premises. The manufacturer must be notified of the decision. The notification must include the conclusions of the examination and the reasoned assessment decision.
3.4. The manufacturer must undertake to fulfil the obligations arising from the quality system as approved and to uphold it so that it remains adequate and efficient. The manufacturer or his authorized representative established within the Community must keep the notified body that has approved the quality system informed of any intended updating of that quality system. The notified body must evaluate the modifications proposed and decide whether the modified quality system will still satisfy the requirements laid down in point 3.2 or whether a reassessment is required. The manufacturer must be notified of its decisions. The notification must include the conclusions of the examination and the reasoned assessment decision.

4. EC 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 must allow the notified body access for inspection purposes to the locations of design, manufacture, inspection and testing and storage and must provide it with all necessary information, in particular:
  — the quality-system documentation,
  — the quality records as provided for in the design part of the quality system, such as the results of analyses, calculations, tests, etc.,
  — the quality records as provided for in the manufacturing part of the quality system, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.
4.3. The notified body must periodically carry out audits to make sure that the manufacturer maintains and applies the quality system and must provide the manufacturer with audit reports.
4.4. In addition the notified body may pay unannounced visits to the manufacturer. During such visits, the notified body may carry out tests or cause tests to be carried out to check that the quality system is functioning correctly, if necessary. The notified body must provide the manufacturer with a visit report and, if a test has been carried out, with a test report.

5. The manufacturer must, for at least 10 years after the last product has been manufactured, keep at the disposal of the national authorities:
  — the documentation referred to in the second indent of the second paragraph of point 3.1,
  — the updating referred to in the second paragraph of point 3.4,
  — the decision and reports from the notified body referred to in the final paragraph of point 3.4, point 4.3 and point 4.4.

6. Each notified body must, on request, provide flag Member State administrations and the other notified bodies with the relevant information concerning the quality-system approvals issued and withdrawn.

7. Design examination
7.1. The manufacturer must lodge an application for examination of the design with a single notified body.
7.2 The application must make it possible to understand the design, manufacture and operation of the product and to assess compliance with the requirements of international instruments. It must include:
  — the technical design specifications, including standards, that have been applied and
  — the necessary supporting evidence for their adequacy, in particular where the standards specified in Article 5 have not been applied in full. Such supporting evidence must include the results of tests carried out by an appropriate laboratory of the manufacturer's or on his behalf.
7.3. The notified body must examine the application and where the design complies with those provisions of the international instruments that apply it must issue an EC design-examination certificate to the applicant. The certificate must include the conclusions of the examination, the conditions of its validity, the data necessary for identification of the approved design and, if relevant, a description of the product's functioning.
7.4. The applicant must keep the notified body that has issued the EC design examination certificate informed of any modification to the approved design. Modifications to the approved design must receive additional approval from the notified body that issued the EC design-examination certificate where such changes may affect compliance with the relevant requirements of the international instruments or the prescribed conditions for use of the product. Such additional approval must be given in the form of an addition to the original EC design-examination certificate.
7.5. The notified bodies must, on request, provide flag Member State administrations and the other notified bodies with the relevant information concerning:
  — the EC design-examination certificates and additions issued and
  — the EC design-approvals and additional approvals withdrawn.

 

Appendix to Annex B

Technical documentation to be supplied by the manufacturer to the notified body

The provisions set down in this Appendix apply to all modules of Annex B.
The technical documentation referred to in Annex B must comprise all relevant data and means used by the manufacturer to ensure that equipment complies with the essential requirements relating to it. The technical documentation must make it possible to understand the design, manufacture and operation of the product, and must make it possible to assess compliance with the requirements of the relevant international instruments. The documentation must, so far as they are relevant to assessment, include:
— a general description of the type,
— conceptual-design, build standard and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,
— descriptions and explanations necessary for the understanding of those drawings and schemes, including the operation of the product,
— the results of design calculations made, impartial examinations carried out, etc.,
— impartial test reports,
— manuals for installation, use and maintenance.

Where appropriate, the design documentation must contain the following:
— attestations relating to the equipment incorporated in the appliance,
— attestations and certificates relating to the methods of manufacture and/or inspection and/or monitoring of the appliance,
— any other document that makes it possible for the notified body to improve its assessment.

 

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Footnote

 

(¹) A type may cover several versions of the product provided that the differences between the versions do not affect the level of safety or the other requirements concerning the performance of the product.