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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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REFERENCE PROVISIONS FOR COMMUNITY HARMONISATION LEGISLATION FOR PRODUCTS
CONFORMITY ASSESSMENT PROCEDURES
Module A1 Internal production control plus supervised product testing
Module A2 Internal production control plus supervised product checks at random intervals
1 EC-type examination is the part of a conformity assessment procedure ...
2 EC-type examination may be carried out in either of the ...
3 The manufacturer shall lodge an application for EC-type examination with ...
4.1 examine the technical documentation and supporting evidence to assess the ...
4.2 verify that the specimen(s) have been manufactured in conformity with ...
4.3 carry out appropriate examinations and tests, or have them carried ...
4.4 carry out appropriate examinations and tests, or have them carried ...
4.5 agree with the manufacturer on a location where the examinations ...
5 The notified body shall draw up an evaluation report that ...
6 Where the type meets the requirements of the specific legislative ...
7 The notified body shall keep itself apprised of any changes ...
8 Each notified body shall inform its notifying authorities concerning the ...
9 The manufacturer shall keep a copy of the EC-type examination ...
10 The manufacturer's authorised representative may lodge the application referred to ...
Module C Conformity to type based on internal production control
Module C1 Conformity to type based on internal production control plus supervised ...
Module C2 Conformity to type based on internal production control plus supervised ...
Module D Conformity to type based on quality assurance of the production ...
1 Conformity to type based on quality assurance of the production ...
3.1 The manufacturer shall lodge an application for assessment of his ...
3.2 The quality system shall ensure that the products are in ...
3.3 The notified body shall assess the quality system to determine ...
3.4 The manufacturer shall undertake to fulfil the obligations arising out ...
3.5 The manufacturer shall keep the notified body that has approved ...
4 Surveillance under the responsibility of the notified body
4.1 The purpose of surveillance is to make sure that the ...
4.2 The manufacturer shall, for assessment purposes, allow the notified body ...
4.3 The notified body shall carry out periodic audits to make ...
4.4 In addition, the notified body may pay unexpected visits to ...
5.1 The manufacturer shall affix the required conformity marking set out ...
5.2 The manufacturer shall draw up a written declaration of conformity ...
6 The manufacturer shall, for a period ending at least 10 ...
7 Each notified body shall inform its notifying authorities of quality ...
Module D1 Quality assurance of the production process
1 Quality assurance of the production process is the conformity assessment ...
3 The manufacturer shall keep the technical documentation at the disposal ...
5.1 The manufacturer shall lodge an application for assessment of his ...
5.2 The quality system shall ensure compliance of the products with ...
5.3 The notified body shall assess the quality system to determine ...
5.4 The manufacturer shall undertake to fulfil the obligations arising out ...
5.5 The manufacturer shall keep the notified body that has approved ...
6 Surveillance under the responsibility of the notified body
6.1 The purpose of surveillance is to make sure that the ...
6.2 The manufacturer shall, for assessment purposes, allow the notified body ...
6.3 The notified body shall carry out periodic audits to make ...
6.4 In addition, the notified body may pay unexpected visits to ...
7.1 The manufacturer shall affix the required conformity marking set out ...
7.2 The manufacturer shall draw up a written declaration of conformity ...
8 The manufacturer shall, for a period ending at least 10 ...
9 Each notified body shall inform its notifying authorities of quality ...
Module E Conformity to type based on product quality assurance
1 Conformity to type based on product quality assurance is that ...
3.1 The manufacturer shall lodge an application for assessment of his ...
3.2 The quality system shall ensure compliance of the products with ...
3.3 The notified body shall assess the quality system to determine ...
3.4 The manufacturer shall undertake to fulfil the obligations arising out ...
3.5 The manufacturer shall keep the notified body that has approved ...
4 Surveillance under the responsibility of the notified body
4.1 The purpose of surveillance is to make sure that the ...
4.2 The manufacturer shall, for assessment purposes, allow the notified body ...
4.3 The notified body shall carry out periodic audits to make ...
4.4 In addition, the notified body may pay unexpected visits to ...
5.1 The manufacturer shall affix the required conformity marking set out ...
5.2 The manufacturer shall draw up a written declaration of conformity ...
6 The manufacturer shall, for a period ending at least 10 ...
7 Each notified body shall inform its notifying authorities of quality ...
Module E1 Quality assurance of final product inspection and testing
1 Quality assurance of final product inspection and testing is the ...
3 The manufacturer shall keep the technical documentation at the disposal ...
5.1 The manufacturer shall lodge an application for assessment of his ...
5.2 The quality system shall ensure compliance of the products with ...
5.3 The notified body shall assess the quality system to determine ...
5.4 The manufacturer shall undertake to fulfil the obligations arising out ...
5.5 The manufacturer shall keep the notified body that has approved ...
6 Surveillance under the responsibility of the notified body
6.1 The purpose of surveillance is to make sure that the ...
6.2 The manufacturer shall, for assessment purposes, allow the notified body ...
6.3 The notified body shall carry out periodic audits to make ...
6.4 In addition, the notified body may pay unexpected visits to ...
7.1 The manufacturer shall affix the required conformity marking set out ...
7.2 The manufacturer shall draw up a written declaration of conformity ...
8 The manufacturer shall, for a period ending at least 10 ...
9 Each notified body shall inform its notifying authorities of quality ...
Module F Conformity to type based on product verification
1 Conformity to type based on product verification is the part ...
4 Verification of conformity by examination and testing of every product
4.1 All products shall be individually examined and appropriate tests set ...
4.2 The notified body shall issue a certificate of conformity in ...
5.1 The manufacturer shall take all measures necessary so that the ...
5.2 A random sample shall be taken from each lot according ...
6.1 The manufacturer shall affix the required conformity marking set out ...
6.2 The manufacturer shall draw up a written declaration of conformity ...
7 If the notified body agrees and under its responsibility, the ...
Module F1 Conformity based on product verification
1 Conformity based on product verification is the conformity assessment procedure ...
5 Verification of conformity by examination and testing of every product
5.1 All products shall be individually examined and appropriate tests, set ...
5.2 The notified body shall issue a certificate of conformity in ...
6.1 The manufacturer shall take all measures necessary so that the ...
6.2 A random sample shall be taken from each lot according ...
7.1 The manufacturer shall affix the conformity marking set out in ...
7.2 The manufacturer shall draw up a written declaration of conformity ...
8 If the notified body agrees and under its responsibility, the ...
Module H Conformity based on full quality assurance
1 Conformity based on full quality assurance is the conformity assessment ...
3.1 The manufacturer shall lodge an application for assessment of his ...
3.2 The quality system shall ensure compliance of the products with ...
3.3 The notified body shall assess the quality system to determine ...
3.4 The manufacturer shall undertake to fulfil the obligations arising out ...
3.5 The manufacturer shall keep the notified body that has approved ...
4 Surveillance under the responsibility of the notified body
4.1 The purpose of surveillance is to make sure that the ...
4.2 The manufacturer shall, for assessment purposes, allow the notified body ...
4.3 The notified body shall carry out periodic audits to make ...
4.4 In addition, the notified body may pay unexpected visits to ...
5.1 The manufacturer shall affix the required conformity marking set out ...
5.2 The manufacturer shall draw up a written declaration of conformity ...
6 The manufacturer shall, for a period ending at least 10 ...
7 Each notified body shall inform its notifying authorities of quality ...
Module H1 Conformity based on full quality assurance plus design examination
1 Conformity based on full quality assurance plus design examination is ...
3.1 The manufacturer shall lodge an application for assessment of his ...
3.2 The quality system shall ensure compliance of the products with ...
3.3 The notified body shall assess the quality system to determine ...
3.4 The manufacturer shall undertake to fulfil the obligations arising out ...
3.5 The manufacturer shall keep the notified body that has approved ...
3.6 Each notified body shall inform its notifying authorities of quality ...
4.1 The manufacturer shall lodge an application for examination of the ...
4.2 The application shall make it possible to understand the design, ...
4.3 The notified body shall examine the application, and where the ...
4.4 The notified body shall keep itself apprised of any changes ...
4.5 Each notified body shall inform its notifying authorities of the ...
5 Surveillance under the responsibility of the notified body
5.1 The purpose of surveillance is to make sure that the ...
5.2 The manufacturer shall, for assessment purposes, allow the notified body ...
5.3 The notified body shall carry out periodic audits to make ...
5.4 In addition, the notified body may pay unexpected visits to ...
6.1 The manufacturer shall affix the required conformity marking set out ...
6.2 The manufacturer shall draw up a written declaration of conformity ...
7 The manufacturer shall, for a period ending at least 10 ...
TABLE: CONFORMITY ASSESSMENT PROCEDURES IN COMMUNITY LEGISLATION
2. Name and address of the manufacturer or his authorised representative:...
3. This declaration of conformity is issued under the sole responsibility...
4. Object of the declaration (identification of product allowing traceability. It...
5. The object of the declaration described above is in conformity...
6. References to the relevant harmonised standards used or references to...
7. Where applicable, the notified body ... (name, number) … performed...
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