- Latest available (Revised)
- Point in Time (09/07/2008)
- Original (As adopted by EU)
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)
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Version Superseded: 31/12/2020
Point in time view as at 09/07/2008.
There are currently no known outstanding effects for the Decision No 768/2008/EC of the European Parliament and of the Council, ANNEX II.
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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.
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.
A copy of the declaration of conformity shall be made available to the relevant authorities upon request.
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.
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.
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.
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.
A copy of the declaration of conformity shall be made available to the relevant authorities upon request.
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.
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.
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.
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.
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.
A copy of the declaration of conformity shall be made available to the relevant authorities upon request.
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.
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).
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.
For the product:
For the specimen(s):
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.
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.
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.
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.
A copy of the declaration of conformity shall be made available to the relevant authorities upon request.
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.
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.
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.
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.
A copy of the declaration of conformity shall be made available to the relevant authorities upon request.
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.
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.
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.
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.
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.
A copy of the declaration of conformity shall be made available to the relevant authorities upon request.
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.
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.
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.
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.
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.
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.
the quality system documentation,
the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.
A copy of the declaration of conformity shall be made available to the relevant authorities upon request.
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.
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.
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.
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 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.
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.
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.,
the means of monitoring the achievement of the required product quality and the effective operation of the quality system.
It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the national standard that implements the relevant harmonised standard and/or technical specification.
In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant 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.
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.
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.
A copy of the declaration of conformity shall be made available to the relevant authorities upon request.
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.
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.
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.
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.
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.
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 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.
It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the national standard that implements the relevant harmonised standard and/or technical specification.
In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant 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.
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.
the quality system documentation,
the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.
A copy of the declaration of conformity shall be made available to the relevant authorities upon request.
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.
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.
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.
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 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.
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.
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 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.
It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the national standard that implements the relevant harmonised standard and/or technical specification.
In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant 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.
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 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.
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.
A copy of the declaration of conformity shall be made available to the relevant authorities upon request.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 3 and 6.1.
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.
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.
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.
A copy of the declaration of conformity shall be made available to the relevant authorities upon request.
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.
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 4.
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.
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.
It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the national standard that implements the relevant harmonised standard and/or technical specification.
In addition to experience in quality management systems, the auditing team shall have at least one member 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.
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.
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.
A copy of the declaration of conformity shall be made available to the relevant authorities upon request.
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.
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.
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.
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.
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.
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.
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 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 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.
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.
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.
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.
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.
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.
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.
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.
A copy of the declaration of conformity shall be made available to the relevant authorities upon request.
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.
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.
a Supplementary requirements which may be used in sectoral legislation. | |||||||||||||
b Except for subclause 7.3 and requirements relating to customer satisfaction and continual improvement. | |||||||||||||
c 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. | |||||||||||||
d 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 9001:2000d | |||||||||||||
Manufacturer
| Manufacturer submits to notified body
| Manufacturer
| Manufacturer
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Notified body
| Notified body
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H1 | |||||||||||||
Notified body | |||||||||||||
PRODUCTION | C.Conformity to type | D.Production quality assurance | E.Product quality assurance | F.Product verification | |||||||||
EN ISO 9001:2000b | EN ISO 9001:2000c | ||||||||||||
A. | C. | ||||||||||||
Manufacturer | Manufacturer | Manufacturer | Manufacturer | Manufacturer | Manufacturer | Manufacturer | |||||||
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A1. | C1. | D1. | E1. | F1. | |||||||||
Accredited in-house body | Accredited in-house body | declares conformity to essential requirements | declares conformity to essential requirements | declares conformity to essential requirements | |||||||||
or notified body
| or notified body
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Notified body | Notified body | Notified body | Notified body | Notified body | |||||||||
A2.
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