Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC (Text with EEA relevance)

Status:

This is the original version as it was originally adopted in the EU.
This legislation may since have been updated - see the latest available (revised) version

ANNEX IICONFORMITY ASSESSMENT PROCEDURES

Module AInternal production control

1.Internal production control is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 4, 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 to 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.Manufacturing

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured products with the technical documentation referred to in point 2 and with the requirements of the legislative instruments that apply to them.

4.Conformity marking and declaration of conformity

4.1.The manufacturer shall affix the required conformity marking set out in the legislative instrument to each individual product that satisfies the applicable requirements of the legislative instrument.

4.2.The manufacturer shall draw up a written declaration of conformity for a product model and keep it together with the technical documentation 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 for which it has been drawn up.

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

5.Authorised representative

The manufacturer's obligations set out in point 4 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

Module A1Internal production control plus supervised product testing

1.Internal production control plus supervised product testing is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3, 4, and 5, 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 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 contain, wherever applicable, 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.Manufacturing

4.Product checks

For each individual product manufactured, one or more tests on one or more specific aspects of the product shall be carried out by the manufacturer or on his behalf, in order to verify conformity with the corresponding requirements of the legislative instrument. At the choice of the manufacturer, the tests are carried out either by an accredited in-house body or under the responsibility of a notified body chosen by the manufacturer.

Where the tests are carried out by a notified body, the manufacturer shall, under the responsibility of the notified body, affix the notified body's identification number during the manufacturing process.

5.Conformity marking and declaration of conformity

5.1.The manufacturer shall affix the required conformity marking set out in the legislative instrument to each individual product that satisfies the applicable requirements of the legislative instrument.

5.2.The manufacturer shall draw up a written declaration of conformity for a product model and keep it together with the technical documentation 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 for which it has been drawn up.

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

6.Authorised representative

The manufacturer's obligations set out in point 5 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

Module A2Internal production control plus supervised product checks at random intervals

1.Internal production control plus supervised product checks at random intervals is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3, 4, and 5, 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 contain, wherever applicable, 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.Manufacturing

4.Product checks

At the choice of the manufacturer, either an accredited in-house body or a notified body, chosen by the manufacturer, shall carry out product checks or have them carried out at random intervals determined by the body, in order to verify the quality of the internal checks of the product, taking into account, inter alia, the technological complexity of the products and the quantity of production. An adequate sample of the final products, taken on site by the body before the placing on the market, shall be examined and appropriate tests as identified by the relevant parts of the harmonised standard and/or technical specifications, or equivalent tests, shall be carried out to check the conformity of the product with the relevant requirements of the legislative instrument.

The acceptance sampling procedure to be applied is intended to determine whether the manufacturing process of the product performs within acceptable limits, with a view to ensuring conformity of the product.

5.Conformity marking and declaration of conformity

5.1.The manufacturer shall affix the required conformity marking set out in the legislative instrument to each individual product that satisfies the applicable requirements of the legislative instrument.

5.2.The manufacturer shall draw up a written declaration of conformity for a product model and keep it together with the technical documentation 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 for which it has been drawn up.

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

6.Authorised representative

The manufacturer's obligations set out in point 5 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

Module BEC-type examination

1.EC-type examination is the part of a conformity assessment procedure in which a notified body examines the technical design of a product and verifies and attests that the technical design of the product meets the requirements of the legislative instrument that apply to it.

2.EC-type examination may be carried out in either of the following manners:

examination of a specimen, representative of the production envisaged, of the complete product (production type),
assessment of the adequacy of the technical design of the product through examination of the technical documentation and supporting evidence referred to in point 3, plus examination of specimens, representative of the production envisaged, of one or more critical parts of the product (combination of production type and design type),
assessment of the adequacy of the technical design of the product through examination of the technical documentation and supporting evidence referred to in point 3, without examination of a specimen (design type).

3.The manufacturer shall lodge an application for EC-type examination with a single notified body of his choice.

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,
the technical documentation. The technical documentation shall make it possible to assess the product's conformity with the applicable requirements of the legislative instrument 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 contain, wherever applicable, 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,
the specimens representative of the production envisaged. The notified body may request further specimens if needed for carrying out the test programme,
the supporting evidence for the adequacy of the technical design solution. This supporting evidence shall mention any documents that have been used, in particular where the relevant harmonised standards and/or technical specifications have not been applied in full. The supporting evidence shall include, where necessary, the results of tests carried out by the appropriate laboratory of the manufacturer, or by another testing laboratory on his behalf and under his responsibility.

4.The notified body shall:

For the product:

4.1.examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the product;

For the specimen(s):

4.2.verify that the specimen(s) have been manufactured in conformity with the technical documentation, and identify the elements which have been designed in accordance with the applicable provisions of the relevant harmonised standards and/or technical specifications, as well as the elements which have been designed without applying the relevant provisions of those standards;

4.3.carry out appropriate examinations and tests, or have them carried out, to check whether, where the manufacturer has chosen to apply the solutions in the relevant harmonised standards and/or technical specifications, these have been applied correctly;

4.4.carry out appropriate examinations and tests, or have them carried out, to check whether, where the solutions in the relevant harmonised standards and/or technical specifications have not been applied, the solutions adopted by the manufacturer meet the corresponding essential requirements of the legislative instrument;

4.5.agree with the manufacturer on a location where the examinations and tests will be carried out.

5.The notified body shall draw up an evaluation report that records the activities undertaken in accordance with point 4 and their outcomes. Without prejudice to its obligations vis-à vis the notifying authorities, the notified body shall release the content of that report, in full or in part, only with the agreement of the manufacturer.

6.Where the type meets the requirements of the specific legislative instrument that apply to the product concerned, the notified body shall issue an EC-type examination certificate to the manufacturer. The certificate shall contain the name and address of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity and the necessary data for identification of the approved type. The certificate may have one or more annexes attached.

The certificate and its annexes shall contain all relevant information to allow the conformity of manufactured products with the examined type to be evaluated and to allow for in-service control.

Where the type does not satisfy the applicable requirements of the legislative instrument, the notified body shall refuse to issue an EC-type examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.

7.The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved type may no longer comply with the applicable requirements of the legislative instrument, and shall determine whether such changes require further investigation. If so, the notified body shall inform the manufacturer accordingly.

The manufacturer shall inform the notified body that holds the technical documentation relating to the EC-type examination certificate of all modifications to the approved type that may affect the conformity of the product with the essential requirements of the legislative instrument or the conditions for validity of the certificate. Such modifications shall require additional approval in the form of an addition to the original EC-type examination certificate.

8.Each notified body shall inform its notifying authorities concerning the EC-type examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of certificates and/or any additions thereto refused, suspended or otherwise restricted.

Each notified body shall inform the other notified bodies concerning the EC-type examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning the certificates and/or additions thereto which it has issued.

The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EC-type examination certificates and/or additions thereto. On request, the Commission and the Member States may obtain a copy of the technical documentation and the results of the examinations carried out by the notified body. The notified body shall keep a copy of the EC-type examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer, until the expiry of the validity of the certificate.

9.The manufacturer shall keep a copy of the EC-type examination certificate, its annexes and additions together with the technical documentation at the disposal of the national authorities for 10 years after the product has been placed on the market.

10.The manufacturer's authorised representative may lodge the application referred to in point 3 and fulfil the obligations set out in points 7 and 9, provided that they are specified in the mandate.

Module CConformity to type based on internal production control

1.Conformity to type based on internal production control is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 3, and ensures and declares that the products concerned are in conformity with the type described in the EC-type examination certificate and satisfy the requirements of the legislative instrument that apply to them.

2.Manufacturing

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured products with the approved type described in the EC-type examination certificate and with the requirements of the legislative instrument that apply to them.

3.Conformity marking and declaration of conformity

3.1.The manufacturer shall affix the required conformity marking set out in the legislative instrument to each individual product that is in conformity with the type described in the EC-type examination certificate and satisfies the applicable requirements of the legislative instrument.

3.2.The manufacturer shall draw up a written declaration of conformity for a 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.

4.Authorised representative

The manufacturer's obligations set out in point 3 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

Module C1Conformity to type based on internal production control plus supervised product testing

1.Conformity to type based on internal production control plus supervised product testing is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 4, and ensures and declares on his sole responsibility that the products concerned are in conformity with the type described in the EC-type examination certificate and satisfy the requirements of the legislative instrument that apply to them.

2.Manufacturing

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured products with the type described in the EC-type examination certificate and with the requirements of the specific legislative instrument that apply to them.

3.Product checks

For each individual product manufactured one or more tests on one or more specific aspects of the product shall be carried out by the manufacturer or on his behalf, in order to verify conformity with the corresponding requirements of the legislative instrument. At the choice of the manufacturer, the tests shall be carried out either by an accredited in-house body or under the responsibility of a notified body, chosen by the manufacturer.

4.Conformity marking and declaration of conformity

4.1.The manufacturer shall affix the required conformity marking set out in the legislative instrument to each individual product that is in conformity with the type described in the EC-type examination certificate and satisfies the applicable requirements of the legislative instrument.

4.2.The manufacturer shall draw up a written declaration of conformity for a 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.

5.Authorised representative

The manufacturer's obligations set out in point 4 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

Module C2Conformity to type based on internal production control plus supervised product checks at random intervals

1.Conformity to type based on internal production control plus supervised product checks at random intervals is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 4, and ensures and declares on his sole responsibility that the products concerned are in conformity with the type described in the EC-type examination certificate and satisfy the requirements of the legislative instrument that apply to them.

2.Manufacturing

3.Product checks

At the choice of the manufacturer, either an accredited in-house body or a notified body, chosen by the manufacturer, shall carry out product checks or have them carried out at random intervals determined by the body, in order to verify the quality of the internal checks on the product, taking into account, inter alia, the technological complexity of the products and the quantity of production. An adequate sample of the final products, taken on site by the notified body before the placing on the market, shall be examined and appropriate tests as identified by the relevant parts of the harmonised standards and/or technical specifications, or equivalent tests, shall be carried out to check the conformity of the product with the relevant requirements of the legislative instrument. Where a sample does not conform to the acceptable quality level, the body shall take appropriate measures.

Where the tests are carried out by notified body, the manufacturer shall, under the responsibility of the notified body, affix the notified body's identification number during the manufacturing process.

4.Conformity marking and declaration of conformity

4.1.The manufacturer shall affix the required conformity marking set out in the legislative instrument to each individual product that is in conformity with the type described in the EC-type examination certificate and satisfies the applicable requirements of the legislative instrument.

4.2.The manufacturer shall draw up a written declaration of conformity for a 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.

5.Authorised representative

The manufacturer's obligations set out in point 4 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

Module DConformity to type based on quality assurance of the production process

1.Conformity to type based on quality assurance of the production process is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 5, and ensures and declares on his sole responsibility that the products concerned are in conformity with the type described in the EC-type examination certificate and satisfy the requirements of the legislative instrument that apply to them.

2.Manufacturing

The manufacturer shall operate an approved quality system for production, final product inspection and testing of the products concerned as specified in point 3, and shall be subject to surveillance as specified in point 4.

3.Quality system

3.1.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 of the approved type and a copy of the EC-type examination certificate.

3.2.The quality system shall ensure that the products are in conformity with the type described in the EC-type examination certificate and comply 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., and
the means of monitoring the achievement of the required product quality and the effective operation of the quality system.

3.3.The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2.

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 specifications.

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 3.1, fifth indent, 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.

3.4.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.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 3.2 or whether a 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.

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 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 quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.

4.3.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.

4.4.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.

5.Conformity marking and declaration of conformity

5.1.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 3.1, the latter's identification number to each individual product that is in conformity with the type described in the EC-type examination certificate and satisfies the applicable requirements of the legislative 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 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.

6.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 3.1,
the change referred to in point 3.5, as approved,
the decisions and reports of the notified body referred to in points 3.5, 4.3 and 4.4.

7.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, withdrawn or otherwise restricted, and, upon request, of quality system approvals which it has issued.

8.Authorised representative

The manufacturer's obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

Module D1Quality 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.

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.

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.

Module EConformity to type based on product quality assurance

1.Conformity to type based on product quality assurance is that part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 5, and ensures and declares on his sole responsibility that the products concerned are in conformity with the type described in the EC-type examination certificate and satisfy the requirements of the legislative instrument that apply to them.

2.Manufacturing

The manufacturer shall operate an approved quality system for final product inspection and testing of the products concerned as specified in point 3 and shall be subject to surveillance as specified in point 4.

3.Quality system

3.1.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, and
the technical documentation of the approved type and a copy of the EC-type examination certificate.

3.2.The quality system shall ensure compliance of the products with the type described in the EC-type examination certificate and with the applicable requirements of the legislative instrument.

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 examinations and tests that will be carried out after manufacture,
the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.,
the means of monitoring the effective operation of the quality system.

3.3.The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2.

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 3.1, fifth indent, 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.

3.4.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.The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system.

It shall notify the manufacturer of its decision. The notification shall contain 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 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 quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.

4.3.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.

4.4.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.

5.Conformity marking and declaration of conformity

5.1.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 3.1, the latter's identification number to each individual product that is in conformity with the type described in the EC-type examination certificate and satisfies the applicable requirements of the legislative 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 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.

6.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 3.1,
the change referred to in point 3.5, as approved,
the decisions and reports of the notified body referred to in points 3.5, 4.3 and 4.4.

7.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.

8.Authorised representative

Module E1Quality assurance of final product inspection and testing

1.Quality assurance of final product inspection and testing 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 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, and
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.

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 examinations and tests that will be carried out after manufacture,
the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.,
the means of monitoring 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.

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.

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

Module FConformity to type based on product verification

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 2, 5.1 and 6, and ensures and declares on his sole responsibility that the products concerned, which have been subject to the provisions of point 3, are in conformity with the type described in the EC-type examination certificate and satisfy the requirements of the legislative instrument that apply to them.

2.Manufacturing

3.Verification

A notified body chosen by the manufacturer shall carry out appropriate examinations and tests in order to check the conformity of the products with the approved type described in the EC-type examination certificate and with the appropriate requirements of the legislative instrument.

The examinations and tests to check the conformity of the products with the appropriate requirements shall be carried out, at the choice of the manufacturer either by examination and testing of every product as specified in point 4 or by examination and testing of the products on a statistical basis as specified in point 5.

4.Verification of conformity by examination and testing of every product

4.1.All products 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 EC-type examination certificate and with the appropriate requirements of the legislative instrument. In the absence of such a harmonised standard, the notified body concerned shall decide on the appropriate tests to be carried out.

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 product 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 product has been placed on the market.

5.Statistical verification of conformity

5.1.The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure the homogeneity of each lot produced, and shall present his products for verification in the form of homogeneous lots.

5.2.A random sample shall be taken from each lot according to the requirements of the legislative instrument. All products in a sample 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 ensure their conformity with the applicable requirements of the legislative instrument and to determine whether the lot is accepted or rejected. In the absence of such a harmonised standard, the notified body concerned shall decide on the appropriate tests to be carried out.

5.3.If a lot is accepted, all products of the lot shall be considered approved, except for those products from the sample that have been found not to satisfy the tests.

The notified body shall issue a certificate of conformity in respect to the examinations and tests carried out, and shall affix its identification number to each approved product or have it affixed under its responsibility.

The manufacturer shall keep the certificates of conformity at the disposal of the national authorities for 10 years after the product has been placed on the market.

5.4.If a lot is rejected, the notified body or the competent authority shall take appropriate measures to prevent that lot's being placed on the market. In the event of the frequent rejection of lots the notified body may suspend the statistical verification and take appropriate measures.

6.Conformity marking and declaration of conformity

6.1.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 3, the latter's identification number to each individual product that is in conformity with the approved type described in the EC-type examination certificate and satisfies the applicable requirements of the legislative 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 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.

If the notified body referred to in point 3 agrees and under its responsibility, the manufacturer may also affix the notified body's identification number to the products.

7.If the notified body agrees and under its responsibility, the manufacturer may affix the notified body's identification number to the products during the manufacturing process.

8.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 2 and 5.1.

Module F1Conformity based on product verification

1.Conformity based on product verification is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3, 6.1 and 7 and ensures and declares on his sole responsibility that the products concerned, which have been subject to the provisions of point 4, are in conformity with 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.

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.

3.Manufacturing

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured products with the applicable requirements of the legislative instrument.

4.Verification

A notified body chosen by the manufacturer shall carry out appropriate examinations and tests to check the conformity of the products with the applicable requirements of the legislative instrument.

The examinations and tests to check the conformity with those requirements shall be carried out, at the choice of the manufacturer, either by examination and testing of every product as specified in point 5, or by examination and testing of the products on a statistical basis as specified in point 6.

5.Verification of conformity by examination and testing of every product

5.1.All products shall be individually examined and appropriate tests, set out in the relevant harmonised standards and/or technical specifications, or equivalent tests, shall be carried out to verify conformity with the requirements that apply to them. In the absence of such a harmonised standard and/or technical specification the notified body concerned shall decide on the appropriate tests to be carried out.

5.2.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 product or have it affixed under its responsibility.

The manufacturer shall keep the certificates of conformity at the disposal of the national authorities for 10 years after the product has been placed on the market.

6.Statistical verification of conformity

6.1.The manufacturer shall take all measures necessary so that the manufacturing process ensures the homogeneity of each lot produced, and shall present his products for verification in the form of homogeneous lots.

6.2.A random sample shall be taken from each lot according to the requirements of the legislative instrument. All products in the sample shall be individually examined and appropriate tests set out in the relevant harmonised standards and/or technical specifications, or equivalent tests, to establish conformity with the requirements that apply to them, shall be carried out to determine whether the lot is accepted or rejected. In the absence of such a harmonised standard and/or technical specification the notified body concerned shall decide on the appropriate tests to be carried out.

6.3.If a lot is accepted, all products of the lot shall be considered approved, except for those products from the sample that have been found not to satisfy the tests.

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 product or have it affixed under its responsibility.

The manufacturer shall keep the certificates of conformity at the disposal of the national authorities for 10 years after the product has been placed on the market.

If a lot is rejected, the notified body shall take appropriate measures to prevent that lot being placed on the market. In the event of the frequent rejection of lots the notified body may suspend the statistical verification and take appropriate measures.

7.Conformity marking and declaration of conformity

7.1.The manufacturer shall affix the conformity marking set out in the legislative instrument, and, under the responsibility of the notified body referred to in point 4, 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.

If the notified body referred to in point 5 agrees and under its responsibility, the manufacturer may also affix the notified body's identification number to the products.

8.If the notified body agrees and under its responsibility, the manufacturer may affix the notified body's identification number to the products during the manufacturing process.

9.Authorised representative

Module GConformity based on unit verification

1.Conformity based on unit verification is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 5, and ensures and declares on his sole responsibility that the product concerned, which has been subject to the provisions of point 4, is in conformity with the requirements of the legislative instrument that apply to it.

2.Technical documentation

The manufacturer shall establish the technical documentation and make it available to the notified body referred to in point 4. 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.

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.

3.Manufacturing

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured product with the applicable requirements of the legislative instrument.

4.Verification

A notified body chosen by the manufacturer shall carry out appropriate examinations and tests, set out in the relevant harmonised standards and/or technical specifications, or equivalent tests, to check the conformity of the product with the applicable requirements of the legislative instrument, or have them carried out. In the absence of such a harmonised standard and/or technical specification the notified body concerned shall decide on the appropriate tests to be carried out.

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 the approved product, or have it affixed under its responsibility.

The manufacturer shall keep the certificates of conformity at the disposal of the national authorities for 10 years after the product has been placed on the market.

5.Conformity marking and declaration of conformity

5.1.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 4, the latter's identification number to each product that satisfies the applicable requirements of the legislative instrument.

5.2.The manufacturer shall draw up a written declaration of conformity 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 for which it has been drawn up.

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

6.Authorised representative

The manufacturer's obligations set out in points 2 and 5 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

Module HConformity based on full quality assurance

1.Conformity based on full quality assurance is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 5, and ensures and declares on his sole responsibility that the products concerned satisfy the requirements of the legislative instrument that apply to them.

2.Manufacturing

3.Quality system

3.1.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,
the technical documentation for one model of each category of products intended to be manufactured. 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.,
- test reports,
the documentation concerning the quality system, and
a written declaration that the same application has not been lodged with any other notified body.

3.2.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. That 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 design and product quality,
the technical design specifications, including standards, that will be applied and, where the relevant harmonised standards and/or technical specifications will not be applied in full, the means that will be used to ensure that the essential requirements of the legislative instrument that apply to the products will be met,
the design control and design verification techniques, processes and systematic actions that will be used when designing 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 on 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 satisfies the requirements referred to in point 3.2.

In addition to experience in quality management systems, the auditing team shall have at least one member experienced as an assessor 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 3.1, second indent, to verify the manufacturer's ability to identify the applicable 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 manufacturer or his authorised representative shall be notified of the decision.

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

3.4.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.The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system.

It shall notify the manufacturer of its decision. The notification shall contain 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 shall, for assessment purposes, allow the notified body access to the design, manufacture, inspection, testing and storage sites, and shall provide it with all necessary information, in particular:

the quality system documentation,
the quality records as provided for by the design part of the quality system, such as results of analyses, calculations, tests, etc.,
the quality records as provided for by the manufacturing part of the quality system, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.

4.3.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.

4.4.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 check the proper functioning of the quality system. It shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.

5.Conformity marking and declaration of conformity

5.1.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 3.1, the latter's identification number to each individual product that satisfies the applicable requirements of the legislative 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 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.

6.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 technical documentation referred to in point 3.1,
the documentation concerning the quality system referred to in point 3.1,
the change referred to in point 3.5, as approved,
the decisions and reports of the notified body referred to in points 3.5, 4.3 and 4.4.

7.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.

8.Authorised representative

Module H1Conformity based on full quality assurance plus design examination

1.Conformity based on full quality assurance plus design examination is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 6, and ensures and declares on his sole responsibility that the products concerned satisfy the requirements of the legislative instrument that apply to them.

2.Manufacturing

The manufacturer shall operate an approved quality system for design, manufacture and final product inspection and testing of the products concerned as specified in point 3 and shall be subject to surveillance as specified in point 5. The adequacy of the technical design of the products shall have been examined in accordance with point 4.

3.Quality system

3.1.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,
all relevant information for the product category envisaged,
the documentation concerning the quality system,
a written declaration that the same application has not been lodged with any other notified body.

3.2.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. This 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 design and product quality,
the technical design specifications, including standards, that will be applied and, where the relevant harmonised standards and/or technical specifications will not be applied in full, the means that will be used to ensure that the essential requirements of the legislative instrument that apply to the products will be met,
the design control and design verification techniques, processes and systematic actions that will be used when designing 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 on 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 satisfies the requirements referred to in point 3.2.

The manufacturer or his authorised representative shall be notified of the decision.

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

3.4.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.The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system.

It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

3.6.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.

4.Design examination

4.1.The manufacturer shall lodge an application for examination of the design with the notified body referred to in point 3.1.

4.2.The application shall make it possible to understand the design, manufacture and operation of the product, and to assess the conformity with the requirements of the legislative instrument that apply to it. It shall include:

the name and address of the manufacturer,
a written declaration that the same application has not been lodged with any other notified body,
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 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,
the supporting evidence for the adequacy of the technical design. This supporting evidence shall mention any documents that have been used, in particular where the relevant harmonised standards and/or technical specifications have not been applied in full, and shall include, where necessary, the results of tests carried out by the appropriate laboratory of the manufacturer, or by another testing laboratory on his behalf and under his responsibility.

4.3.The notified body shall examine the application, and where the design meets the requirements of the legislative instrument that apply to the product it shall issue an EC design examination certificate to the manufacturer. The certificate shall give the name and address of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity and the data necessary for identification of the approved design. The certificate may have one or more annexes attached.

The certificate and its annexes shall contain all relevant information to allow the conformity of manufactured products with the examined design to be evaluated, and to allow for in-service control, where applicable.

Where the design does not satisfy the applicable requirements of the legislative instrument, the notified body shall refuse to issue a design examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.

4.4.The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved design may no longer comply with the applicable requirements of the legislative instrument, and shall determine whether such changes require further investigation. If so, the notified body shall inform the manufacturer accordingly.

The manufacturer shall keep the notified body that has issued the EC design examination certificate informed of any modification to the approved design that may affect the conformity with the essential requirements of the legislative instrument or the conditions for validity of the certificate. Such modifications shall require additional approval — from the notified body that issued the EC design examination certificate — in the form of an addition to the original EC design examination certificate.

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

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

The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EC design examination certificates and/or additions thereto. On request, the Commission and the Member States may obtain a copy of the technical documentation and of the results of the examinations carried out by the notified body.

The notified body shall keep a copy of the EC design examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer until the expiry of the validity of the certificate.

4.6.The manufacturer shall keep a copy of the EC design examination certificate, its annexes and additions together with the technical documentation at the disposal of the national authorities for 10 years after the product has been placed on the market.

5.Surveillance under the responsibility of the notified body

5.1.The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

5.2.The manufacturer shall, for assessment purposes, allow the notified body access to the design, manufacture, inspection, testing and storage sites, and shall provide it with all necessary information, in particular:

the quality system documentation,
the quality records as provided for by the design part of the quality system, such as results of analyses, calculations, tests, etc.,
the quality records as provided for by the manufacturing part of the quality system, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.

5.3.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.

5.4.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 check the proper functioning of the quality system. It shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.

6.Conformity marking and declaration of conformity

6.1.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 3.1, the latter's identification number to each individual product that satisfies the applicable requirements of the legislative 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 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 and shall mention the number of the design examination certificate.

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

7.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 concerning the quality system referred to in point 3.1,
the change referred to in point 3.5, as approved,
the decisions and reports of the notified body referred to in points 3.5, 5.3 and 5.4.

8.Authorised representative

The manufacturer's authorised representative may lodge the application referred to in points 4.1 and 4.2 and fulfil the obligations set out in points 3.1, 3.5, 4.4, 4.6, 6 and 7, on his behalf and under his responsibility, provided that they are specified in the mandate.

TABLE: CONFORMITY ASSESSMENT PROCEDURES IN COMMUNITY LEGISLATION

Supplementary requirements which may be used in sectoral legislation.

Except for subclause 7.3 and requirements relating to customer satisfaction and continual improvement.

Except for subclauses 7.1, 7.2.3, 7.3, 7.4, 7.5.1, 7.5.2, 7.5.3 and requirements relating to customer satisfaction and continual improvement.

Except for requirements relating to customer satisfaction and continual improvement.

DESIGN

A.Internal production control

B.Type examination

G.Unit verification

H.Full quality assurance

EN ISO 9001:2000^d

Manufacturer

keeps technical documentation at the disposal of national authorities

Manufacturer submits to notified body

technical documentation
supporting evidence for the adequacy of the technical design solution
specimen(s), representative of the production envisaged, as required

Manufacturer

submits technical documentation

Manufacturer

operates an approved quality system for design
submits technical documentation

Notified body

ascertains conformity with essential requirements
examines technical documentation and supporting evidence to assess adequacy of the technical design
for specimen(s): carries out tests, if necessary
issues EC-type examination certificate

Notified body

carries out surveillance of the QS

Notified body

verifies conformity of design^a
issues EC-design examination certificate^a

PRODUCTION

C.Conformity to type

D.Production quality assurance

E.Product quality assurance

F.Product verification

EN ISO 9001:2000^b

EN ISO 9001:2000^c

Manufacturer

declares conformity with essential requirements
affixes required conformity marking

declares conformity with approved type
affixes required conformity marking

operates an approved quality system for production, final inspection and testing
declares conformity with approved type
affixes required conformity marking

operates an approved quality system for final inspection and testing
declares conformity with approved type
affixes required conformity marking

declares conformity with approved type
affixes required conformity marking

submits product
declares conformity
aAffixes required conformity marking

operates an approved QS for production, final inspection and testing
declares conformity
affixes required conformity marking

A1.

C1.

D1.

E1.

F1.

Accredited in-house body

declares conformity to essential requirements

or notified body

tests on specific aspects of the product^a

or notified body

tests on specific aspects of the product^a

affixes required conformity marking

affixes required conformity marking

affixes required conformity marking

Notified body

A2.

Product checks at random intervals^a

C2.

Product checks at random intervals^a

approves the QS
carries out surveillance of the QS

approves the QS
carries out surveillance of the QS

verifies conformity to essential requirements
issues certificate of conformity

verifies conformity to essential requirements
issues certificate of conformity

carries out surveillance of the QS

legislation.gov.uk

Search Legislation

Decision No 768/2008/EC of the European Parliament and of the CouncilShow full title

You are here:

What Version

Opening Options

More Resources

Legislation originating from the EU

This item of legislation originated from the EU

Status:

ANNEX IICONFORMITY ASSESSMENT PROCEDURES

Module AInternal production control

2.Technical documentation

3.Manufacturing

4.Conformity marking and declaration of conformity

4.1.The manufacturer shall affix the required conformity marking set out in the legislative instrument to each individual product that satisfies the applicable requirements of the legislative instrument.

5.Authorised representative

Module A1Internal production control plus supervised product testing

2.Technical documentation

3.Manufacturing

4.Product checks

5.Conformity marking and declaration of conformity

5.1.The manufacturer shall affix the required conformity marking set out in the legislative instrument to each individual product that satisfies the applicable requirements of the legislative instrument.

6.Authorised representative

Module A2Internal production control plus supervised product checks at random intervals

2.Technical documentation

3.Manufacturing

4.Product checks

5.Conformity marking and declaration of conformity

5.1.The manufacturer shall affix the required conformity marking set out in the legislative instrument to each individual product that satisfies the applicable requirements of the legislative instrument.

6.Authorised representative

Module BEC-type examination

1.EC-type examination is the part of a conformity assessment procedure in which a notified body examines the technical design of a product and verifies and attests that the technical design of the product meets the requirements of the legislative instrument that apply to it.

2.EC-type examination may be carried out in either of the following manners:

3.The manufacturer shall lodge an application for EC-type examination with a single notified body of his choice.

4.The notified body shall:

4.1.examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the product;

4.3.carry out appropriate examinations and tests, or have them carried out, to check whether, where the manufacturer has chosen to apply the solutions in the relevant harmonised standards and/or technical specifications, these have been applied correctly;

4.5.agree with the manufacturer on a location where the examinations and tests will be carried out.

9.The manufacturer shall keep a copy of the EC-type examination certificate, its annexes and additions together with the technical documentation at the disposal of the national authorities for 10 years after the product has been placed on the market.

10.The manufacturer's authorised representative may lodge the application referred to in point 3 and fulfil the obligations set out in points 7 and 9, provided that they are specified in the mandate.

Module CConformity to type based on internal production control

2.Manufacturing

3.Conformity marking and declaration of conformity

3.1.The manufacturer shall affix the required conformity marking set out in the legislative instrument to each individual product that is in conformity with the type described in the EC-type examination certificate and satisfies the applicable requirements of the legislative instrument.

4.Authorised representative

Module C1Conformity to type based on internal production control plus supervised product testing

2.Manufacturing

3.Product checks

4.Conformity marking and declaration of conformity

4.1.The manufacturer shall affix the required conformity marking set out in the legislative instrument to each individual product that is in conformity with the type described in the EC-type examination certificate and satisfies the applicable requirements of the legislative instrument.

5.Authorised representative

Module C2Conformity to type based on internal production control plus supervised product checks at random intervals

2.Manufacturing

3.Product checks

4.Conformity marking and declaration of conformity

4.1.The manufacturer shall affix the required conformity marking set out in the legislative instrument to each individual product that is in conformity with the type described in the EC-type examination certificate and satisfies the applicable requirements of the legislative instrument.

5.Authorised representative

Module DConformity to type based on quality assurance of the production process

2.Manufacturing

3.Quality system

3.1.The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the products concerned.

3.2.The quality system shall ensure that the products are in conformity with the type described in the EC-type examination certificate and comply with the requirements of the legislative instrument that apply to them.

3.3.The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2.

3.4.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.The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system.

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 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:

4.3.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.

5.Conformity marking and declaration of conformity

6.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:

7.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.

8.Authorised representative

Module D1Quality assurance of the production process

2.Technical documentation

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

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.