Cabinet of Ministers Regulations No. 290 in Riga on May 2, 2007. (pr. No 15) Amendment 26 Cabinet of 22 august 2006 rules no 673 "provision on metrological requirements measuring instruments" Issued in accordance with the law "on conformity assessment" and article 7 of the law "on a uniformity of measurements" the second paragraph of article 6 to make a Cabinet of 22 august 2006 rules no 673 "provision on metrological requirements measuring instruments" (Latvian journal, 2006, nr. 137) and to make the new version of annex 2 (annex). Prime Minister a. Halloween economic Minister j. Malcolm annex Cabinet on May 2, 2007.-Regulation No. 290 "annex 2 Cabinet of 22 august 2006 Regulation No. 673 of the conformity assessment procedures module A module I.. Declaration of conformity based on internal production control module-1 A conformity assessment procedure in accordance with the manufacturer complies with those rules and regulations on the requirements for certain measuring instruments (hereinafter the regulations) requirements and declares that the measuring tool meets these requirements. 2. the manufacturer shall perform the following obligations: 2.1 draw up technical documentation in accordance with this provision, 14, 15, 16, 17, 18 and 19 points the extent to evaluate the means of measuring compliance with the laws and requirements, including requirements for the design of measuring tools, production and operation; 2.2. ensuring consumer protection centre approach to this annex referred to in point 2.1. technical documentation for 10 years after the last measuring instrument manufacturing; 2.3. take all necessary measures to ensure compliance of the manufactured products of the measurement requirements of this regulation; 2.4. each measurement feature, which comply with the requirements of this regulation, must affix the CE marking and supplementary marking metrological; 2.5. for each type of measurement means draw up a declaration of conformity and ensure consumer protection Center approach for 10 years after the last measuring instrument manufacturing. The Declaration identifies the appropriate measuring tool. Each measuring instrument that is placed on the market, accompanied by a copy of the Declaration. If one user supplied a large batch of measuring instruments, measuring instruments of the party concerned or to add one mailing a copy of the Declaration. 3. The manufacturer's authorised representative fulfils this annex 2.2 and 2.5. the manufacturer's obligations set out in point. If the manufacturer or his authorized representative is not located in a Member State of the European Community, those obligations assume the person who places the measuring instrument on the market. II. module A1. Declaration of conformity based on internal production control and topped with product testing conducted by the notified body 4. module A1-the conformity assessment procedure whereby the manufacturer fulfils the legislation requirements and declares that the measuring tool meets these requirements. 5. the manufacturer shall perform the following obligations 5.1 establish technical documentation according to these rules 14, 15, 16, 17, 18 and 19 the requirements referred to in paragraph the extent to evaluate the means of measuring compliance with the laws and requirements, including requirements for the design of measuring tools, production and operation; 5.2. ensure consumer protection centre approach to this annex referred to in point 5.1. technical documentation for 10 years after the last measuring instrument manufacturing; 5.3. take all necessary measures to ensure compliance of the manufactured products of the measurement requirements of this regulation; 5.4. each measuring instrument that satisfies the requirements of this regulation, must affix the CE marking and supplementary marking, as well as metrological notified body identification number; 5.5. for each type of measurement means draw up a declaration of conformity and ensure consumer protection Center approach for 10 years after the last measuring instrument manufacturing. The Declaration identifies the appropriate measuring tool. Each measuring instrument that is placed on the market, accompanied by a copy of the Declaration. If one user supplied a large batch of measuring instruments, measuring instruments of the party concerned or to add one mailing a copy of the Declaration. 6. the manufacturer shall choose one of the notified bodies. The notified body shall perform the following obligations: 6.1. taking into account the features of measuring technological complexity and the volume of production, determines the frequency of the periodic tests and inspections of products or participate in product testing, to verify the internal checks of the product quality; 6.2. before inserting the product market and the finished product is also tested samples of the quantity in accordance with the provisions of the 4, 8, 9, 11 and 12, or equivalent tests, in order to assess the conformity of the means of measuring the requirements of this regulation; 6.3. If the proper documentation is not available, shall take a decision on the tests to be carried out; 6.4. If, in accordance with the results of testing the product does not meet the requirements of this regulation, shall take appropriate measures. 7. The manufacturer's authorised representative fulfils this annex 5.2 and 5.5 of the manufacturer's obligation in point. If the manufacturer or his representative is not located in a Member State of the European Community, those obligations assume the person who places the measuring instrument on the market. III. B module. Type evaluation (module B) 8-conformity assessment procedure that is part of the conformity assessment procedures in accordance with notified body examines the technical design of the measuring and declares that the technical design meets the legislative requirements. 9. Type of inspection shall be carried out using one of the following methods: 9.1. completed the planned means of measuring the sample testing; 9.2. the planned means of measurement of one or more critical examination of the components, as well as other means of measuring the conformity assessment of the components of the technical project, using this annex referred to in paragraph 10 of the technical documentation and supporting evidence; 9.3. the measurement of the technical evaluation of the project using this annex referred to in paragraph 10 of the technical documentation, as well as additional evidence (without the means of measuring the sample tests). A decision on the most appropriate method and then the models adopted required the notified body. 10. the manufacturer shall perform the following obligations: 10.1. Select one of the notified bodies and to submit it for examination of the application type. The application shall include: 10.1.1. manufacturer's name and address, but if the application is lodged by the authorised representative of the manufacturer, the authorised representative in addition to include the name and address; 10.1.2. a written declaration that the same application has not been lodged with another notified body; 10.1.3. technical documentation according to these rules 14, 15, 16, 17, 18 and 19 points the extent to evaluate the means of measuring compliance with the laws and requirements, including requirements for the design of measuring tools, production and operation; 10.2. the notified body shall provide the required planned measurement or its ingredients samples; 10.3. submit additional evidence for the ingredients of measuring compliance with the technical project, if the inspection is not required for the measurement of samples, as well as references to documents in accordance with these rules 4, 8, 9, 11 and 12 point (especially if they are not fully used) and, if necessary, submit to the laboratory of the manufacturer or on his behalf and on behalf of other laboratory testing results; 10.4. inform the notified body that holds the type certificate of the EC assessment-related technical documentation for all measurement features modifications which may affect the conformity with the essential and special requirements, as well as the validity of the certificate. Such modifications require extraordinary approval. The EC type-approval certificate of assessment is added as a supplement. The manufacturer's EC type assessment certificate, its annexes and additions with the technical documentation a copy of 10 years after the last measuring instrument manufacturing. 11. The notified body shall perform the following obligations: 11.1 in accordance with this annex 9.1. method referred to: 11.1.1 examine the technical documentation; 11.1.2. Verify samples that are made in accordance with the documentation and identify the elements which have been designed in accordance with the provisions of the 4, 8, 9, 11 and 12 of the documents referred to in paragraph; 11.1.3. identify the elements which are not designed in accordance with the provisions of the 4, 8, 9, 11 and 12 of the documents referred to in paragraph; 11.1.4. carry out appropriate inspections and testing or participate in checks to see whether the manufacturer has used the solutions in accordance with the provisions of the 4, 8, 9, 11 and 12 of the documents referred to in paragraph; 11.1.5. carry out appropriate inspections and testing or participate in the inspections carried out by the manufacturer, in order to assess whether the solution used by the manufacturer, if this provision is not applied to the 4, 8, 9, 11 and 12, the document referred to in the relevant legislation; 11.1.6. agree with the applicant the location where the examinations and tests carried out; 11.2. in accordance with this annex 9.2. test method referred to in the technical documentation and supporting evidence to assess the means of measuring compliance with the technical part of the project. 11.3. pursuant to this annex referred to in point 9.3 method checks the technical documentation to ensure that the manufacturer has adequate means to ensure consistent production; 11.4. the assessment report shall be drawn up. The report indicates that, in annex 11.1 11.2 and 11.3., and referred to the results obtained. The notified body must publish a report content (in part or in full), if agreed by the manufacturer; 11.5. If the technical design meets the requirements of this regulation, issue an EC type assessment certificate. The certificate of the manufacturer and its authorized representative (if any), name and address, the results of the examination, the conditions for validity of the certificate and the means of measuring the identification of necessary data. The certificate, you can add one or more attachments. Certificate and the annex contains all the information necessary to assess the measure conform to the approved type: 11.5.1. measuring type metrological characteristics; 11.5.2. measures the integrity of measurement (for example, sealing, identification of software); 11.5.3. information on other elements necessary for the identification of the means of measurement and Visual inspection of conformity; 11.5.4. any specific information necessary to verify the characteristics of the manufactured measuring instruments; 11.5.5. information to ensure compatibility with additional devices or other measuring instruments, if any; 11.6. the assessment report shall be drawn up and ensure consumer protection Center approach for the report; 7.3. immediately notify the consumer centres for: 11.7.1. issued EC type assessment certificates and their annexes; 11.7.2. issued EC type assessment certificate supplements and amendments; 11.7.3. withdrawn EC type assessment certificates; 11.8. the registry also maintains a technical documentation provided by the manufacturer until the certificate expires. 12. The manufacturer's authorised representative shall comply with paragraph 10 of this annex set out in the manufacturer's liability. If the manufacturer is not established in the European Community in the country and has no representation in the Member State of the European Community, on the preparation of the technical documentation and ensuring access to documentation is the responsibility of the person designated by the manufacturer. Vi. the C module. Declaration of conformity to type based on internal production control module 13 C-the conformity assessment procedure whereby the manufacturer fulfils the legislation requirements, ensures and declares that the measuring instruments concerned satisfy the EC type described in the certificate of the assessment and the requirements of this regulation. 14. the manufacturer shall perform the following obligations: 14.1. take all necessary measures to ensure that measuring instruments produced in compliance with the EC type described in the certificate of the assessment and the requirements of this regulation; 14.2. affix the CE marking and supplementary marking each of metrological measurement feature, which comply with the EC type described in the certificate of the assessment of the type and the requirements of these regulations; 14.3. each type of measurement means draw up a declaration of conformity and ensure consumer protection Center approach for 10 years after the last measuring instrument manufacturing. The Declaration identifies the appropriate measuring tool. Each measuring instrument that is placed on the market, accompanied by a copy of the Declaration. If one user supplied a large batch of measuring instruments, measuring instruments of the party concerned or to add one mailing a copy of the Declaration. 15. the authorised representative of the manufacturer in the performance of this annex set out in paragraph 14.3. the manufacturer's obligations. If the manufacturer or his authorized representative is not located in a Member State of the European Community, those obligations assume the person who places the measuring instrument on the market. V. module C1. Declaration of conformity to type based on internal production control and topped with a notified body product testing module C1-16. the conformity assessment procedure whereby the manufacturer fulfils the laws laid down, ensures and declares that the measuring instruments concerned satisfy the EC type described in the certificate of the assessment of the type and the requirements of these regulations. 17. the manufacturer shall perform the following obligations: 17.1. take all necessary measures to ensure that measuring instruments produced in compliance with the EC type described in the certificate of the assessment and the requirements of this regulation; 17.2. affix the CE marking and supplementary marking, as well as metrological notified body identification number to each measuring instrument that complies with the EC type described in the certificate of the assessment of the type and the requirements of these regulations; 17.3. for each type of measurement to draw up a declaration of conformity and ensure consumer protection Center approach for 10 years after the last measuring instrument manufacturing. The Declaration identifies the appropriate measuring tool. Each measuring instrument that is placed on the market, accompanied by a copy of the Declaration. If one user supplied a large batch of measuring instruments, measuring instruments of the party concerned or to add one mailing a copy of the Declaration. 18. The notified body: 18.1. taking into account the features of measuring technological complexity and the volume of production, determines the frequency of the periodic tests and inspections of products, or participate in the inspections carried out by the manufacturer in order to verify the quality of the internal checks of the product; 18.2. prior to insertion of the product market and the finished product is also tested samples of the quantity in accordance with the provisions of the 4, 8, 9, 11 and 12, or equivalent tests, in order to assess the conformity of the means of measuring the requirements of this regulation; 18.3. If the proper documentation is not available, shall take a decision on the tests to be carried out; 18.4. If, in accordance with the results of testing the product does not meet the requirements of this regulation, shall take appropriate measures. 19. the authorised representative of the manufacturer in the performance of this annex set out in paragraph 17.3. the manufacturer's obligations. If the manufacturer or his representative is not in the country of the European Community, those obligations assume the person who places the measuring instrument on the market. Vi. Module D. Declaration of conformity to type based on quality assurance of the production process module-20 D the conformity assessment procedure whereby the manufacturer: 20.1. fulfil appropriate laws, ensures and declares that the measuring instrument complies with the EC type described in the certificate of the assessment of the type and the requirements of these regulations; 20.2. implement and maintain an approved quality system for production, final product inspection and testing of measuring instruments concerned, as well as its monitoring. 21. the manufacturer shall perform the following obligations: 21.1. choose one of the notified bodies and submit the application for assessment of the quality system. The application shall include: 21.1.1. information about the planned means of measuring category; 21.1.2. documentation of the approved type of measurement, as well as the EC type assessment certificate copy; 21.1.3. the documentation concerning the quality system, as well as the EC type assessment certificate summary; 21.2. all elements of the quality system requirements and conditions that are imposed by the manufacturer shall be documented in a systematic, developing policies, procedures and instructions. The quality system documentation shall ensure appropriate quality programmes, plans, manuals and the interpretation of the Protocol. The compilation of dossiers in particular focus on the following aspects: 21.2.1. the quality objectives, the organisational structure, responsibilities and powers of the management with regard to product quality; 21.2.2. manufacturing process, quality management and quality assurance techniques, processes and systematic measures used; 21.2.3. inspection and testing to be completed before the production process, production process and beyond, as well as the frequency of inspections; 21.2.4. quality records, such as inspection reports, test and calibration data, personnel qualifications; 21.2.5. product quality monitoring and effective quality system management; 21.3. bound by the obligations arising from the quality system as approved and maintain it adequate and effective; 21.4. inform the notified body that has approved the quality system informed of any intended change of the quality system; 13.4. ensure the notified body to carry out the inspection approach for all manufacture, inspection, testing and storage sites and shall provide all the necessary information, in particular: 21.5.1. the quality system documentation; 21.5.2. the quality records, such as inspection reports, test and calibration data, qualification of the personnel involved; 21.6. affix the CE marking and supplementary marking, as well as metrological the relevant notified body identification number to each measuring instrument that complies with the EC type described in the certificate of the assessment of the type and the requirements of these regulations; 21.7. for each type of measurement means draw up a declaration of conformity and ensure consumer protection Center approach for 10 years after the last measuring instrument manufacturing. The Declaration identifies the appropriate measuring tool. Each measuring instrument that is placed on the market, accompanied by a copy of the Declaration. If one user supplied a large batch of measuring instruments, measuring instruments of the party concerned or to add one mailing a copy of the Declaration; 21.8.10 years after the last measuring instrument manufacturing ensures consumer protection centre approach: this annex 21.8.1.21.1.2. the documentation referred to in point; 21.8.2. information on changes to the quality system; 21.8.3. notified body's decisions and reports in accordance with this annex, 22.2, 21.4 and 22.4 22.5. section. 22. The notified body shall perform the following obligations: 22.1. evaluate the quality system to determine whether it meets this attachment point 21.2. requirements and applicable standards. Audit team members in addition to the qualifications of the quality management system in the evaluation of experienced metrology and measurement of concerned technologies, knowledge of the legislative requirements. The assessment procedure shall include the inspection (inspection) visit to the manufacturer's plant. Notified body of their decision on the results of inspection shall notify the manufacturer. The decision includes research findings and reasoning of the decision; 22.2. assess the modifications provided for by the manufacturer and shall decide whether the modified quality system complies with section 21.2. of this annex to the requirements or the need for re-evaluation. Notified body of their decision on the results of the evaluation shall notify the manufacturer. The decision shall contain the conclusions of the study; 22.3. the quality system monitoring to make sure that the manufacturer fulfils the obligations arising out of the approved quality system; 22.4. periodically carry out audits to make sure that the manufacturer maintains and applies the quality system. The audit report shall be submitted to the manufacturer; 22.5. can make unexpected manufacturer's inspection, to perform product testing or participate in the testing, the manufacturer to verify whether the quality system is functioning correctly. The notified body must provide the manufacturer with a report on the results of the inspection, but if it is done the testing, including test report; 22.6. ensure consumer protection centre, access to quality system approval or refusal to approve quality system, as well as immediate consumer centres informed of quality system approval. 23. The manufacturer's authorised representative shall comply with this annex, 21.8 21.7 21.4.,., and in paragraph 22.1 manufacturer. VII. Module D1. Declaration of conformity based on quality assurance of the production process module D1-24. the conformity assessment procedure whereby the manufacturer fulfils the laws obligations and declares that a measuring instrument satisfies the requirements. 25. the manufacturer shall perform the following obligations: 25.1. develop technical documentation according to these rules 14, 15, 16, 17, 18 and 19 points the extent to ensure the opportunity to assess the means of measuring compliance with the laws and requirements, including requirements for the design of measuring tools, production and operation; 25.2. ensure consumer protection centre approach to this annex referred to in paragraph 25.1. technical documentation for 10 years after the last measuring instrument manufacturing; 25.3. implement and maintain an approved quality system for production, final product inspection and testing of measuring instruments concerned, as well as its monitoring; 25.4. the notified body chosen and submitted the application for assessment of the quality system. The application shall contain: information about planned 25.4.1. measuring features category; 25.4.2. this annex 25.1. the technical documentation referred to in point a; 25.4.3. the documentation concerning the quality system; 25.5. the quality system shall ensure compliance of the means of measuring the normative requirements. All the elements of the quality system requirements and conditions applied by the manufacturer shall be documented in a systematic, developing policies, procedures and instructions. The quality system documentation shall ensure appropriate quality programmes, plans, manuals and the interpretation of the Protocol. When writing documentation, paying particular attention to the following aspects: 25.5.1. quality objectives, the organisational structure, responsibilities and powers of the management with regard to product quality; 25.5.2. manufacturing process, quality management and quality assurance methods; 25.5.3. inspection and testing to be carried out before and after the production process, production process and beyond, as well as the frequency of inspections; 25.5.4. quality records, such as inspection reports, test and calibration data, personnel qualifications; 25.5.5. product quality monitoring and effective quality system management; 15.9. bound by the obligations arising from the quality system as approved and maintain it adequate and effective; 25.7. inform the notified body which approved the quality system informed of any intended change of the quality system; 25.8. provides the notified body access for inspection of manufacture, inspection, testing and storage sites and shall provide all the necessary information, in particular: 25.8.1. the quality system documentation; 25.8.2. this annex 25.1. the technical documentation referred to in point a; 25.8.3. quality records, such as inspection reports, test and calibration data, qualification of the personnel involved; 16.1. affix the CE marking and supplementary marking the metrological and the relevant notified body identification number to each measuring instrument that satisfies the appropriate legislation; 25.10. draw up a declaration of conformity and ensure consumer protection Center approach for 10 years after the last measuring instrument manufacturing. The Declaration identifies the appropriate measuring tool. Each measuring instrument that is placed on the market, accompanied by a copy of the Declaration. If one user supplied a large batch of measuring instruments, measuring instruments of the party concerned or to add one mailing a copy of the Declaration; 25.11.10 years after the last measuring instrument manufacturing ensures consumer protection centre approach: 25.11.1. this annex 25.4.2. the documentation referred to in point; 25.11.2. information on changes to the quality system; 25.11.3. notified body's decisions and reports in accordance with this annex, 25.7 26.2, 26.4 and 26.5... 26. The notified body shall perform the following obligations: 26.1. evaluate the quality system to determine whether it corresponds to this annex referred to in paragraph 25.5. requirements and applicable standards. Audit team members in addition to the qualifications of the quality management system in the evaluation of the necessary experience in metrology and measurement of specific technologies, knowledge of the legislative requirements. The evaluation procedure shall include an inspection visit to the manufacturer's plant. Notified body of their decision on the results of inspection shall notify the manufacturer. The decision includes research findings and reasoning of the decision; 26.2. assess the modifications provided for by the manufacturer and shall decide whether the modified quality system complies with this paragraph in annex 25.5. requirements or need re-evaluation. The notified body shall communicate its decision to the manufacturer. The decision includes research findings and results of the evaluation thereof; 26.3. the quality system monitoring to make sure that the manufacturer fulfils the obligations arising out of the approved quality system; 26.4. periodically carry out audits to make sure that the manufacturer maintains and applies the quality system. The audit report shall be submitted to the manufacturer; 26.5. can make unexpected manufacturer's inspection-to perform product testing or participate in the testing, the manufacturer to verify whether the quality system is functioning correctly. The notified body must provide the manufacturer with a report on the results of the inspection, but if it is done the testing, including test report; 16.5. ensure consumer protection centre, access to quality system approval or refusal to approve the quality system and to immediately inform the consumer rights protection centre of quality system approval. 27. the authorised representative of the manufacturer in the performance of this annex, 25.4 25.7 25.2..,.,., 25.10 25.11., and 26.2 in. E module. The Declaration of conformity to type based on quality assurance of final product inspection and testing, inspection and testing 28. Module E-part of a conformity assessment procedure whereby the manufacturer fulfils the laws obligations and declares that a measuring instrument complies with the EC type described in the certificate of the assessment of the type and the requirements of these regulations. 29. the manufacturer shall perform the following obligations: 29.1. introduce, maintain and monitor the approved quality system for production, final product inspection and testing of measuring instruments concerned; 29.2. the notified body chosen and submitted the application for assessment of the quality system. The application shall contain: information about planned 29.2.1. measuring features category; 29.2.2. quality system documentation; 29.2.3. approved measuring type documentation, as well as the EC type assessment certificate copy; 29.3. the quality system shall ensure compliance of the means of measuring EC type assessment certificate to the type described in these rules and requirements. All the elements of the quality system requirements and conditions to be applied by the manufacturer, systematically documented in developing policies, procedures and instructions. The quality system documentation shall ensure appropriate quality programmes, plans, manuals and the interpretation of the Protocol. When writing documentation, paying particular attention to the following aspects: 29.3.1. quality objectives, the organisational structure, responsibilities and powers of the management with regard to product quality; 29.3.2. inspection and testing to be completed before the production process, production process and beyond, as well as the frequency of inspections; 29.3.3. quality records, such as inspection reports, test and calibration data, personnel qualifications; 29.3.4. product quality monitoring and effective quality system management; 29.4. bound by the obligations arising from the quality system as approved and maintain it adequate and effective; 29.5. inform the notified body that has approved the quality system informed of any intended change of the quality system; 29.6. provides the notified body access for inspection to the manufacture, inspection, testing and storage sites and shall provide all the necessary information, in particular: 29.6.1. quality system documentation; 29.6.2. quality records, such as inspection reports, test and calibration data, qualification of the personnel involved; 18.5. affix the CE marking and supplementary marking the metrological and the relevant notified body identification number to each measuring instrument that complies with the EC type described in the certificate of the assessment of the type and the requirements of these regulations; 29.8. for each type of measurement means draw up a declaration of conformity and ensure consumer protection Center approach for 10 years after the last measuring instrument manufacturing. The Declaration identifies the appropriate measuring tool. Each measuring instrument that is placed on the market, accompanied by a copy of the Declaration. If one user supplied a large batch of measuring instruments, measuring instruments of the party concerned or to add one mailing a copy of the Declaration; 29.9.10 years after the last measuring instrument manufacturing ensures consumer protection centre approach: this annex 29.2.2 29.9.1. the documentation referred to in point; 29.9.2. information on changes to the quality system; 29.9.3. notified body's decisions and reports in accordance with this annex, 30.2 29.5., 18.9. and 5. section. 30. The notified body shall perform the following obligations: 30.1. evaluate the quality system to determine whether it corresponds to this annex in 29.3 requirements as well as the quality system in compliance with the applicable standards. Audit team members in addition to the qualifications of the quality management system in the evaluation of experienced metrology and measurement of specific technologies, knowledge of the legislative requirements. The evaluation procedure shall include an inspection visit to the manufacturer's plant. Notified body of their decision on the results of inspection shall notify the manufacturer. The decision includes research findings and reasoning of the decision; 30.2. assess the modifications provided for by the manufacturer and shall decide whether the modified quality system complies with this section of annex 3. requirements or need re-evaluation. The notified body shall communicate its decision to the manufacturer. The decision includes research findings and results of the evaluation thereof; 30.3. carry out regular quality monitoring system to make sure that the manufacturer fulfils the obligations arising out of the approved quality system; 18.9. the periodic audits to make sure that the manufacturer maintains and applies the quality system. The audit report shall be submitted to the manufacturer; 5. you can take unexpected manufacturer's inspection-to perform product testing or participate in the testing, the manufacturer to verify whether the quality system is functioning correctly. The notified body must provide the manufacturer with a report on the results of the inspection, but if it is done the testing, including test report; 19.0. ensure consumer protection centre, access to quality system approval or refusal to approve the quality system and to immediately inform the consumer rights protection centre of quality system approval. 31. The manufacturer's authorised representative shall comply with this annex, 29.2 29.5 29.8 29.9.,., and 30.2. in point producer. IX. E1 module. Declaration of conformity based on quality assurance of final product inspection and testing module E1-32. the conformity assessment procedure whereby the manufacturer fulfils the legislation requirements and declares that the measuring tool meets these requirements. 33. the manufacturer shall assume the following responsibilities: 33.1. develop technical documentation according to these rules 14, 15, 16, 17, 18 and 19 the requirements referred to in paragraph the extent to evaluate the means of measuring compliance with the laws and requirements, including requirements for the design of measuring tools, production and operation; 33.2. ensure consumer protection Center to access the technical documentation for 10 years after the last measuring instrument manufacturing; 33.3. implement and maintain an approved quality system for production, final product inspection and testing of measuring instruments concerned, as well as its monitoring; 33.4. the notified body chosen and submitted the application for assessment of the quality system. The application shall contain: information about planned 33.4.1. the measuring tools category. 33.4.2. the documentation concerning the quality system; 33.4.3. this Annex 33.1. technical documentation referred to in subparagraph a; 33.5. the quality system shall ensure compliance of the means of measuring the normative requirements. All the elements of the quality system requirements and conditions to be applied by the manufacturer, systematically documented in developing policies, procedures and instructions. The quality system documentation shall ensure appropriate quality programmes, plans, manuals and the interpretation of the Protocol. When writing documentation, paying particular attention to the following aspects: 33.5.1. quality objectives, the organisational structure, responsibilities and powers of the management with regard to product quality; 33.5.2. manufacturing process, quality management and quality assurance methods; 33.5.3. inspection and testing to be completed before the production process, production process and beyond, as well as the frequency of inspections; 33.5.4. quality records, such as inspection reports, test and calibration data, personnel qualifications; 33.5.5. product quality monitoring and effective quality system management; 20.9. bound by the obligations arising from the quality system as approved and maintain it adequate and effective; 20.9. inform the notified body which approved the quality system informed of any intended change of the quality system; 33.8. provide the notified body access for inspection to the manufacture, inspection, testing and storage sites and shall provide all the necessary information, in particular: 33.8.1. information concerning the quality system documentation; 33.8.2. this Annex 33.1. technical documentation laid down in subparagraph a; 33.8.3. quality records, such as inspection reports, test and calibration data, qualification of the personnel involved; 21.1. affix the CE marking and supplementary marking the metrological and the relevant notified body identification number to each measuring instrument that satisfies the appropriate legislation; 33.10. draw up a declaration of conformity and ensure consumer protection Center approach for 10 years after the last measuring instrument manufacturing. The Declaration identifies the appropriate measuring tool. Each measuring instrument that is placed on the market, accompanied by a copy of the Declaration. If one user supplied a large batch of measuring instruments, the relevant measuring features lot or consignment shall be accompanied by one copy of the Declaration; 33.11.10 years after the last measuring instrument manufacturing ensures consumer protection centre approach: this Annex 33.11.1.33.4.2. the documentation referred to in point; 33.11.2. information on changes to the quality system; 33.11.3. notified body's decisions and reports in accordance with this annex, 20.9 20.8 20.8 21.3., and section. 34. The notified body shall assume the following responsibilities: 34.1. evaluate the quality system to determine whether it corresponds to this annex in 33.4.3 the requirements and applicable standards. Audit Group in addition to the qualifications of the quality management system in the evaluation of the necessary experience in metrology and measurement of specific technologies, knowledge of the legislative requirements. The evaluation procedure shall include an inspection visit to the manufacturer's plant. Notified body of their decision on the results of inspection shall notify the manufacturer. The decision includes research findings and reasoning of the decision; 21.3. assess the modifications provided for by the manufacturer and shall decide whether the modified quality system complies with the annex in this 33.5 requirements or need re-evaluation. The notified body shall communicate its decision to the manufacturer. The decision includes research findings and results of the evaluation thereof; 21.3. the quality system monitoring to make sure that the manufacturer fulfils the obligations arising out of the approved quality system; 21.4. periodically carry out audits to make sure that the manufacturer maintains and applies the quality system. The audit report shall be submitted to the manufacturer; 34.5. can make unexpected manufacturer's inspection-to perform product testing or participate in the testing, the manufacturer to verify whether the quality system is functioning correctly. The notified body must provide the manufacturer with a report on the results of the inspection, but if it is done the testing, including test report; 21.5. ensure consumer protection centre, access to quality system approval or refusal to approve the quality system and to immediately inform the consumer rights protection centre of quality system approval. 35. The manufacturer's authorised representative fulfils this annex., 20.8, 33.2, 33.10, 33.11 20.9.. and 21.3. in point producer. X. F module. The Declaration of conformity to type based on product verification 36. Module F-part of a conformity assessment procedure whereby the manufacturer fulfils the legislation requirements and declares that the measuring instruments covered by this annex, 38.1. the conditions referred to in (a), comply with the EC type described in the certificate of evaluation and relevant legislative requirements. 37. the manufacturer shall perform the following obligations: 37.1. take all necessary measures to ensure that measuring instruments produced conform to the approved type described in the EC type assessment certificate and with the requirements of legislation; 37.2. ensure consumer protection centre approach to compliance certificates for 10 years after the last measuring instrument certification; 37.3. take all with metrological characteristics of statistical compliance verification measures in order that the manufacturing process ensures the uniformity of each batch produced, and presented a uniform measuring instruments for verification of the lot; 37.4. affix the CE marking and supplementary marking each of metrological measurement feature, which conform to the approved type and the respective legislative requirements; 37.5. in measuring the type declaration of compliance and ensure consumer protection Center approach for 10 years after the last measuring instrument manufacturing. Each measuring instrument that is placed on the market, accompanied by a copy of the Declaration. If one user supplied a large batch of measuring instruments, measuring instruments of the party concerned or to add one mailing a copy of the Declaration; 23.4. in agreement with the notified body and its authority, you can attach the metering feature notified body identification number already during the production process. 38. The notified body shall perform the following obligations: 38.1. carry out appropriate inspections and testing or participate in the inspections carried out by the manufacturer and testing to assess the means of measuring compliance with the EC type described in the certificate of evaluation and relevant legislative requirements. Metrological characteristics examined and tested at the manufacturer's choice, checking and testing of each measurement product in accordance with this annex and section 37.1.38.2. or select samples from each batch at random in accordance with this annex and section 37.3 23.8.; 38.2. verify each of the metrological characteristics of measuring compliance: each measurement feature 38.2.1. inspection and tested separately according to these rules 4, 8, 9, 11 and 12 point or make equivalent tests to assess the metrological characteristics of measuring means of compliance with the requirements of this regulation. If the proper documentation is not available, the notified body shall take a decision on the tests to be carried out; 38.2.2. each approved measurement feature, issue the certificate of conformity and affix the identification number or empowered to do by other institutions; 23.8. check and test measurement tools using statistical procedures,-select samples from each batch at random in accordance with this annex, 23.9. order to determine whether the lot is accepted or rejected. Each selected measurement feature checks and tested separately in accordance with the provisions of the 4, 8, 9, 11 and 12, or equivalent tests, in order to assess the metrological characteristics of measuring means of compliance with the requirements of this regulation. If the documents are not available, the notified body shall take a decision on the tests to be carried out; 23.9. the statistical verification, provide: quality level 38.4.1. corresponding to 95 percent probability, not match the appropriate means of measurement is less than one percent; 38.4.2. quality levels that meet the five percent probability of not match appropriate measurement is less than seven percent; 38.5. If a lot is accepted, this batch of measuring instruments shall be considered approved, except for measuring features that did not meet the criteria for testing. The notified body shall issue a certificate of conformity and affix its identification number to each approved product or measuring empowered to do by other institutions; 24.0. If the consignment is rejected, the notified body shall take appropriate measures to prevent the placing on the market of the party. If similar cases recur repeatedly notified body repealed the statistical verification and take appropriate measures. 39. The manufacturer's authorised representative shall comply with this annex and 37.3 37.1. the manufacturer's obligations set out in point. XI. the F1 module. Declaration of conformity based on product verification module 40 F1-the conformity assessment procedure whereby the manufacturer fulfils the legislation requirements and declares that the measuring tool meets these requirements. 41. the manufacturer shall perform the following obligations: 25.5. develop technical documentation according to these rules 14, 15, 16, 17, 18 and 19 points the extent to evaluate the means of measuring compliance with the laws and requirements, including requirements for the design of measuring tools, production and operation; 41.2. ensure consumer protection Center to access the technical documentation for 10 years after the last measuring instrument manufacturing; 41.3. take all necessary measures to ensure the conformity of the manufactured instruments for measuring the relevant legislative requirements; 25.7. the manufacturer must take all the metrological characteristics of the compliance verification of statistical measures in order that the manufacturing process ensures the uniformity of each batch produced, and presented a uniform measuring instruments for verification of the lot; 25.8. ensure consumer protection centre approach to compliance certificates for 10 years after the last measuring instrument certification; 25.8. affix the CE marking and supplementary marking each of metrological measurement feature, which comply with the requirements of this regulation; 25.9. draw up a declaration of conformity of the measuring instrument, ensure consumer protection Center approach for 10 years after the last measuring instrument manufacturing. Each measuring instrument that is placed on the market, accompanied by a copy of the Declaration. If one user supplied a large batch of measuring instruments, measuring instruments of the party concerned or to add one mailing a copy of the Declaration; 41.8. in agreement with the notified body and its authority, you can attach the metering feature notified body identification number already during the production process. 42. The notified body shall perform the following obligations: 42.1. performing appropriate tests and testing or take part in the inspections carried out by the manufacturer, and tests to assess compliance with the appropriate means of measuring the normative requirements. Metrological characteristics examined and tested at the manufacturer's choice, checking and testing of each measurement product in accordance with this annex and paragraph 41.3 42.2. or selecting samples from each batch at random in accordance with this annex and section 25.7.26.3.; 26.2. verifies the conformity of the metrological characteristics, checking and testing of each measuring tool: 42.2.1. each measurement check feature and tested separately in accordance with the provisions of the 4, 8, 9, 11 and 12, or equivalent tests, in order to assess the metrological characteristics of measuring means of compliance with the requirements of this regulation. If the documents are not available, the notified body shall take a decision on the tests to be carried out; 42.2.2. issue a certificate of compliance for the examinations and testing, and affix the identification number to each approved product or measuring empowered to do by other institutions; 26.3. checks and tests the measuring features using statistical procedures,-select samples from each batch at random in accordance with this annex, paragraph 26.3. to determine whether the lot is accepted or rejected. Each selected measurement feature checks and tested separately in accordance with the provisions of the 4, 8, 9, 11 and 12, or equivalent tests, in order to assess the metrological characteristics of measuring means of compliance with the requirements of this regulation. If the documents are not available, the notified body shall take a decision on the tests to be carried out; 42.4. performing the statistical verification, provides: 42.4.1. level of quality corresponding to a probability of 95 percent of the matches, inadequate means of measuring less than one percent; 42.4.2. quality level corresponding to a five percent probability of not match appropriate measurement is less than seven percent; 26.4. If the batch is accepted, the means of measuring the lot shall be considered approved, except for measuring features that did not meet the criteria for testing. The notified body shall issue a certificate of conformity and affix its identification number to each approved product or measuring empowered to do by other institutions; 26.5. If a lot is rejected, the notified body shall take appropriate measures to prevent the placing on the market of the party. If similar cases recur repeatedly notified body repealed the statistical verification and take appropriate measures. 43. the authorised representative of the manufacturer in the performance of this annex and paragraph 41.3.25.7 in manufacturer's obligations. XII. G module. Declaration of conformity based on unit verification module G-44. the conformity assessment procedure whereby the manufacturer fulfils the legislation requirements and declares that the measuring instruments covered by this rule 4, 8, 9, 11 and 12, the conditions referred to in paragraph shall comply with the requirements of this regulation. 45. the manufacturer shall perform the following obligations: 45.1. develop technical documentation according to these rules 14, 15, 16, 17, 18 and 19 points the extent to evaluate the means of measuring compliance with the laws and requirements, including requirements for the design of measuring tools, production and operation; 45.2. ensure consumer protection Center to access the technical documentation for 10 years after the last measuring instrument manufacturing; 45.3. take all necessary measures to ensure the conformity of the manufactured instruments for measuring the relevant legislative requirements; 28.2. ensure consumer protection centre approach to compliance certificates for 10 years after the last measuring instrument certification; 28.3. affix the CE marking and supplementary marking each of metrological measurement feature, which comply with the relevant legislative requirements; 45.6. draw up a declaration of conformity of the measuring instrument, ensure consumer protection Center approach for 10 years after the last measuring instrument manufacturing. Each measuring instrument that is placed on the market, accompanied by a copy of the Declaration. If one user supplied a large batch of measuring instruments, measuring instruments of the party concerned or to add one mailing a copy of the Declaration. 46. The notified body shall perform the following obligations: 46.1. checks and testing are in accordance with the provisions of the 4, 8, 9, 11 and 12 to assess the adequacy of the means of measuring the requirements of this regulation; 28.7. If the documents are not available, the notified body shall take a decision on the tests to be carried out; 46.3. the certificate of conformity shall be issued for the examinations and testing, and affix the identification number to each approved product or measuring empowered to do other institutions. 47. the authorised representative of the manufacturer in the performance of this annex and paragraph 46 45.1. the manufacturer's obligations set out in paragraph 1. XIII. (H) module. Declaration of conformity based on full quality assurance module H-48. the conformity assessment procedure whereby the manufacturer fulfils the legislation requirements and declares that the measuring means for meeting the requirements of this regulation. 49. the manufacturer shall perform the following obligations: 30.5. implement and maintain monitored quality system approved for the design, production, final product inspection and testing of measuring instruments concerned, as well as its monitoring; 30.6. the notified body chosen be submitted in the application for the evaluation of the quality system. The application shall contain: information about planned 49.2.1. measuring features category; 49.2.2. the documentation concerning the quality system; 30.6. the quality system shall ensure compliance of the means of measuring the normative requirements. All the elements of the quality system requirements and conditions to be applied by the manufacturer, systematically documented in developing policies, procedures and instructions. The quality system documentation shall ensure appropriate quality programmes, plans, manuals and the interpretation of the Protocol. When writing documentation, paying particular attention to the following aspects: 49.3.1. quality objectives, the organisational structure, responsibilities and powers of the management with regard to product quality; 49.3.2. technical project specifications (also applicable standards) and the rules used for the execution of the essential requirements techniques, if these rules 4, 8, 9, 11 and 12 point those documents cannot be used in full; 49.3.3. design control and design verification techniques, processes and systematic measures in the design of the measuring instrument; 49.3.4. manufacturing process, quality management and quality assurance techniques, processes and systematic actions; 49.3.5. inspection and testing to be completed before the production process, production process and beyond, as well as the frequency of inspections; 49.3.6. quality records, such as inspection reports, test and calibration data, personnel qualifications; 49.3.7. monitoring tools needed to design and product quality and effective quality system management; 49. the commitments arising out of the approved quality system, and maintain the adequate and effective; 30.8. inform the notified body that has approved the quality system informed of any intended change of the quality system (notified body shall evaluate the modifications provided for by the manufacturer and shall decide whether the modified quality system complies with the annex in this 49.3 these requirements or require re-evaluation. The decision includes research findings and results of the evaluation. The notified body shall inform the manufacturer of its decision. 30.8. provides the notified body to carry out the inspection approach for all manufacture, inspection, testing and storage sites and shall provide all the necessary information, in particular: 49.6.1. the quality system documentation; 49.6.2. the quality records, such as inspection reports, test and calibration data, qualification of the personnel involved; 49.7. affix the CE marking and supplementary marking, as well as metrological notified body identification number to each measuring instrument that is in conformity with the requirements of these provisions; 49.8. each measurement type declaration of compliance and ensure consumer protection Center approach for 10 years after the last measuring instrument manufacturing. The Declaration identifies the appropriate measuring tool. Each measuring instrument that is placed on the market, accompanied by a copy of the Declaration. If one user supplied a large batch of measuring instruments, measuring instruments of the party concerned or to add one mailing a copy of the Declaration; 31.0.10 years after the last measuring instrument manufacturing ensures consumer protection centre approach: 49.9.1.49.2.2. of this annex the documentation referred to in point; 49.9.2. information about 30.8 of this annex. changes referred to in subparagraph; 49.9.3. this annex, 50.2 and 30.8. 50.3. the notified body referred to in the decisions and statements. 50. The notified body shall perform the following obligations: 50.1. evaluate the quality system to determine whether it corresponds to this annex in 49.3. requirements and applicable standards. Audit team members in addition to the qualifications of the quality management system in the evaluation of the experience required in the relevant means of measurement and metrological technology, knowledge of relevant laws and regulations. The evaluation procedure shall include an inspection visit to the manufacturer's plant. Notified body of their decision on the results of inspection shall notify the manufacturer. The decision shall contain the conclusions of the research and the reasons for the decision; 50.2. periodic audits to make sure that the manufacturer maintains and applies the quality system. The audit report shall be submitted to the manufacturer; 50.3. can make unexpected manufacturer's inspection-to perform product testing or participate in the testing, the manufacturer to verify whether the quality system is functioning correctly. The notified body must provide the manufacturer with an inspection report and, if tests have been carried out, the test report; 50.4. surveillance, make sure that the manufacturer fulfils the obligations arising out of the approved quality system; 50.5. ensure consumer protection centre, access to quality system approval or refusal to approve the quality system and to immediately inform the consumer rights protection centre of quality system approval. 51. The manufacturer's authorised representative shall comply with this annex, 30.8, 30.6 49.8 49.9. States and the obligations of the manufacturer. XIV. Module H1. Declaration of conformity based on full quality assurance with design and evaluation 52. Module H1-the conformity assessment procedure whereby the manufacturer fulfils the legislation requirements and declares that the measuring means for meeting the requirements of this regulation. 53. the manufacturer shall perform the following obligations: 53.1. manage and monitor the approved quality system for production, final product inspection and testing of the specific measuring and checking the technical design in accordance with this annex and 53.6 53.7 53.8.,. and 54; 33.1. the notified body chosen and submitted the application for assessment of the quality system. The application shall contain: information about planned 53.2.1. measuring features category; 53.2.2. documentation concerning the quality system; 53.3. the quality system shall ensure compliance of the means of measuring the normative requirements. All the elements, requirements, and conditions that are imposed by the manufacturer shall be documented in a systematic, developing policies, procedures and instructions. The quality system documentation shall ensure appropriate quality programmes, plans, manuals and the interpretation of the Protocol. When writing documentation, paying particular attention to the following aspects: 53.3.1. quality objectives, the organisational structure, responsibilities and powers of the management with regard to product quality; 53.3.2. technical project specifications (also applicable standards) and the practices employed in the provision of essential requirements, if these rules 4, 8, 9, 11 and 12 point those documents cannot be used in full; 53.3.3. design control and design verification techniques, processes and systematic measures for the design of the measuring instrument; 53.3.4. the production process, quality management and quality assurance techniques, processes and systematic actions; 53.3.5. inspection and testing to be completed before the production process, production process and beyond, as well as the frequency of inspections; 53.3.6. quality records, such as inspection reports, test and calibration data, personnel qualifications; monitoring means 53.3.7. required design and product quality and effective quality system management; 53.4. bound by the obligations arising from the quality system as approved and maintain it adequate and effective; 13. shall inform the notified body which approved the quality system informed of any intended change of the quality system. The notified body shall evaluate the modifications proposed and decide whether the modified quality system complies with this paragraph in annex 53.3. requirements or need re-evaluation. The decision includes research findings and results of the evaluation. The notified body shall inform the manufacturer of the decision; 53.6. the manufacturer shall submit an application for examination of the design with the notified body. The application enables you to understand the features of measuring design, production and operation, as well as allow the evaluation of conformity to the requirements of this regulation. The application shall contain the following information: 53.6.1. name and address of the manufacturer and, if the application is lodged by the authorised representative of the manufacturer, including its name and address; 53.6.2. a written declaration that the same application has not been submitted to another notified body; 53.6.3. technical documentation according to these rules 14, 15, 16, 17, 18 and 19 the requirements referred to in paragraph to the extent that provide the opportunity to assess the means of measuring compliance with the laws and requirements, including requirements for the design of measuring tools, production and operation; 53.6.4. the manufacturer shall provide further evidence of the conformity of measuring components of technical project under rules 4, 8, 9, 11 and 12 point requirements, especially if they are not fully used, and if necessary the manufacturer's laboratory or on its behalf and on behalf of other laboratory testing results; 53.7. inform the notified body that issued the EC design certificate of assessment of any major modifications to the approved design. If the modification may affect the conformity of the construction of these regulations the essential requirements or the conditions for validity of the certificate of measurement under the conditions of use of the funds, the notified body shall issue the additional approval. Additional confirmation is in addition to the original EC design assessment certificate; 53.8. the manufacturer or his authorised representative shall keep the EC design assessment, copies of the certificates, the annexes and additions with the technical documentation for 10 years after the last measuring instrument manufacturing. If the manufacturer or his representative is not in the country of the European Community, the technical documentation shall, on request, be produced to the person who is authorised by the manufacturer; is 53.9. provides the notified body access for inspection of design, manufacture, inspection, testing and storage sites, as well as provide all necessary information, in particular: 53.9.1. the quality system documentation; 53.9.2. the quality system of design quality provided for in section protocols, such as results of analyses, calculations and test results; 53.9.3. production quality system quality provided for in section records, such as inspection reports, test and calibration data, qualification of the personnel involved; 53.10. affix the CE marking and supplementary marking, as well as metrological notified body identification number to each measuring instrument that is in conformity with the requirements of these provisions; 53.11. in each of the measuring model of the Declaration of conformity and ensure consumer protection Center approach for 10 years after the last measuring instrument manufacturing. The declaration specifies the number of the certificate of design assessment. Each measuring instrument that is placed on the market, accompanied by a copy of the Declaration. If one user supplied a large batch of measuring instruments, measuring instruments of the party concerned or to add one mailing a copy of the Declaration; 53.12.10 years after the last measuring instrument manufacturing ensures consumer protection centre approach: 53.12.1. this annex 53.2.2. the documentation referred to in point; 53.12.2. information on changes made in this attachment 13.; 53.12.3.13. of this annex, and 54.4 54.3. notified body referred to in the decisions and statements. 54. The notified body shall perform the following obligations: 54.1. make sure that the manufacturer fulfils the obligations arising out of the approved quality system, as well as evaluate the quality system compliance with the applicable standards. Audit team members in addition to the qualifications of the quality management system in the evaluation of the experience required in the relevant means of measurement and metrological technology, knowledge of relevant laws and regulations. The evaluation procedure shall include an inspection visit to the manufacturer's plant. Notified body of their decision on the results of inspection shall notify the manufacturer. The decision includes research findings and reasoning of the decision; 54.2. examine the application and where the design meets the requirements of these regulations, issue to the manufacturer an EC design assessment certificate. The certificate shall contain the name and address of the manufacturer, testing, opinion, the conditions that apply to the certificate validity, and the approved means of measuring the data necessary for identification. The validity period is 10 years after the date of issue. Validity period can be renewed every 10 years. If the notified body shall take a decision on the refusal to issue a certificate of assessment of the design, it provides detailed reasons for the refusal. All relevant parts of the technical documentation shall be annexed to the certificate as an attachment. The certificate and its annexes provide all the necessary information for the evaluation and monitoring of compliance. If a feature of a correct measurement, documentation shall enable an assessment made of the metrological measurement in compliance with the design of the assessment. Documentation includes: 54.2.1. metrological characteristics of the project; 54.2.2. measures necessary for measuring the integrity of resources (sealing, identification of software); 54.2.3. information necessary for the measurement of another element of the project identification and Visual inspection of conformity; 54.2.4. any other specific information necessary for the verification of measuring instruments; 54.2.5. all necessary information to ensure the compatibility of auxiliary structures, if any, or other measuring instruments; 54.3. periodic audits to make sure that the manufacturer maintains and applies the quality system. The audit report shall be submitted to the manufacturer; 54.4. can make unexpected inspection by the manufacturer-to perform product testing, to participate in the testing, made by the manufacturer to verify whether the quality system is functioning correctly. The notified body must provide the manufacturer with an inspection report and, if tests have been carried out, the test report; 54.5. providing consumer protection Center to approach the quality system approval and denial list, as well as to immediately inform the consumer protection Centre about the EC design assessment certificate revocation or withdrawal of a quality system approval. 55. The manufacturer's authorised representative shall comply with this annex, 13, 33.1 53.11. and 53.12. manufacturer referred to in commitment. "
Economic Minister j. Malcolm