The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019

(b) The following influence quantities shall be considered in relation with electromagnetic environments:
- — voltage interruptions;
- — short voltage reductions;
- — voltage transients on supply lines and/or signal lines;
- — electrostatic discharges;
- — radio frequency electromagnetic fields;
- — conducted radio frequency electromagnetic fields on supply lines and/or signal lines;
- — surges on supply lines and/or signal lines.

(1) Other influence quantities to be considered, where appropriate, are: - — voltage variation; - — mains frequency variation; - — power frequency magnetic fields; - — any other quantity likely to influence in a significant way the accuracy of the instrument. (1) When carrying out the tests as envisaged in these Regulations, the following points shall apply: (1) Basic rules for testing and the determination of errors Essential requirements specified in paragraphs 1.1 and 1.2 shall be verified for each relevant influence quantity. Unless otherwise specified in the appropriate instrument-specific Schedule, these essential requirements apply when each influence quantity is applied and its effect evaluated separately, all other influence quantities being kept relatively constant at their reference value. Metrological tests shall be carried out during or after the application of the influence quantity, whichever condition corresponds to the normal operational status of the instrument when that influence quantity is likely to occur. (1) Ambient humidity (a) According to the climatic operating environment in which the instrument is intended to be used either the damp heat-steady state (non-condensing) or damp heat cyclic (condensing) test may be appropriate. (b) The damp heat cyclic test is appropriate where condensation is important or when penetration of vapour will be accelerated by the effect of breathing. In conditions where non-condensing humidity is a factor the damp-heat steady state is appropriate. (2) The application of the same measurand in a different location or by a different user, all other conditions being the same, shall result in the close agreement of successive measurements. The difference between the measurement results shall be small when compared with the MPE. (3) The application of the same measurand under the same conditions of measurement shall result in the close agreement of successive measurements. The difference between the measurement results shall be small when compared with the MPE. (4) A regulated measuring instrument shall be sufficiently sensitive and the discrimination threshold shall be sufficiently low for the intended measurement task. (5) A regulated measuring instrument shall be designed to maintain an adequate stability of its metrological characteristics over a period of time estimated by the manufacturer, provided that it is properly installed, maintained and used according to the manufacturer's instruction when in the environmental conditions for which it is intended. (6) A regulated measuring instrument shall be designed to reduce as far as possible the effect of a defect that would lead to an inaccurate measurement result, unless the presence of such a defect is obvious. (7) (7) A regulated measuring instrument shall have no feature likely to facilitate fraudulent use, whereas possibilities for unintentional misuse shall be minimal. (7) A regulated measuring instrument shall be suitable for its intended use taking account of the practical working conditions and shall not require unreasonable demands of the user in order to obtain a correct measurement result. (7) The errors of a utility measuring instrument at flows or currents outside the controlled range shall not be unduly biased. (7) Where a regulated measuring instrument is designed for the measurement of values of the measurand that are constant over time, the regulated measuring instrument shall be insensitive to small fluctuations of the value of the measurand, or shall take appropriate action. (7) A regulated measuring instrument shall be robust and its materials of construction shall be suitable for the conditions in which it is intended to be used. (7) A regulated measuring instrument shall be designed so as to allow the control of the measuring tasks after the instrument has been placed on the market and put into use. If necessary, special equipment or software for this control shall be part of the instrument. The test procedure shall be described in the operation manual. When a regulated measuring instrument has associated software which provides other functions besides the measuring function, the software that is critical for the metrological characteristics shall be identifiable and shall not be inadmissibly influenced by the associated software. (8) (8) The metrological characteristics of a regulated measuring instrument shall not be influenced in any inadmissible way by the connection to it of another device, by any feature of the connected device itself or by any remote device that communicates with the regulated measuring instrument. (8) A hardware component that is critical for metrological characteristics shall be designed so that it can be secured. Security measures foreseen shall provide for evidence of an intervention. (8) Software that is critical for metrological characteristics shall be identified as such and shall be secured. Software identification shall be easily provided by the regulated measuring instrument. Evidence of an intervention shall be available for a reasonable period of time. (8) Measurement data, software that is critical for measurement characteristics and metrologically important parameters stored or transmitted shall be adequately protected against accidental or intentional corruption. (8) For utility measuring instruments the display of the total quantity supplied or the displays from which the total quantity supplied can be derived, whole or partial reference to which is the basis for payment, shall not be able to be reset during use. (9) (9) A regulated measuring instrument shall bear the following inscriptions: (a) manufacturer's name, registered trade name or registered trade mark; (b) information in respect of its accuracy; and, where applicable: (c) information in respect of the conditions of use; (d) measuring capacity; (e) measuring range; (f) identity marking; (g) number of the type examination certificate or the design examination certificate; (h) information whether or not additional devices providing metrological results comply with the provisions of these Regulations on legal metrological control. (9) An instrument of dimensions too small or of too sensitive a composition to allow it to bear the relevant information shall have its packaging, if any, and the accompanying documents required by the provisions of these Regulations suitably marked. (9) The instrument shall be accompanied by information on its operation, unless the simplicity of the regulated measuring instrument makes this unnecessary. Information shall be easily understandable and shall include where relevant: (a) rated operating conditions; (b) mechanical and electromagnetic environment classes; (c) the upper and lower temperature limit, whether condensation is possible or not, open or closed location; (d) instructions for installation, maintenance, repairs, permissible adjustments; (e) instructions for correct operation and any special conditions of use; (f) conditions for compatibility with interfaces or regulated measuring instruments. (9) Groups of identical regulated measuring instruments used in the same location or used for utility measurements do not necessarily require individual instruction manuals. (9) Unless specified otherwise in an instrument-specific Schedule, the scale interval for a measured value shall be in the form 1 × 10ⁿ, 2 × 10ⁿ, or 5 × 10ⁿ, where n is any integer or zero. The unit of measurement or its symbol shall be shown close to the numerical value. (9) A material measure shall be marked with a nominal value or a scale, accompanied by the unit of measurement used. (9) The units of measurement used and their symbols shall be in accordance with the relevant enactments on units of measurement and their symbols. (9) All marks and inscriptions required under any requirement shall be clear, non-erasable, unambiguous and non-transferable. (10) (10) Indication of the result shall be by means of a display or hard copy. (10) The indication of any result shall be clear and unambiguous and accompanied by such marks and inscriptions necessary to inform the user of the significance of the result. Easy reading of the presented result shall be permitted under normal conditions of use. Additional indications may be shown provided they cannot be confused with the metrologically controlled indications. (10) In the case of hard copy the print or record shall also be easily legible and non-erasable. (10) A regulated measuring instrument for direct sales trading transactions shall be designed to present the measurement result to both parties in the transaction when installed as intended. When critical in case of direct sales, any ticket provided to the consumer by an ancillary device not complying with the appropriate requirements of these Regulations shall bear appropriate restrictive information. (10) Whether or not a regulated measuring instrument intended for utility measurement purposes can be remotely read it shall in any case be fitted with a metrologically controlled display accessible without tools to the consumer. The reading of this display is the measurement result that serves as the basis for the price to pay. (11) (11) A regulated measuring instrument other than a utility measuring instrument shall record by a durable means the measurement result accompanied by information to identify the particular transaction, when: (a) the measurement is non-repeatable; and (b) the regulated measuring instrument is normally intended for use in the absence of one of the trading parties. (11) Additionally, a durable proof of the measurement result and the information to identify the transaction shall be available on request at the time the measurement is concluded. (12) A regulated measuring instrument shall be designed so as to allow ready evaluation of its conformity with the appropriate requirements of these Regulations. SCHEDULE 1B (1) Internal production control plus supervised instrument checks at random intervals is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 2, 3, 4, and 5, and ensures and declares on his sole responsibility that the regulated measuring instruments concerned satisfy the requirements of these Regulations that apply to them. (2) The manufacturer shall establish the technical documentation set out in regulations 44 and 45. The documentation shall make it possible to assess the instrument'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 instrument. (3) The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured instruments with the technical documentation referred to in paragraph 2 and with the requirements of these Regulations that apply to them. (4) At the choice of the manufacturer, either an accredited in-house body or an approved body, chosen by the manufacturer, shall carry out instrument 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 instrument, taking into account, inter alia, the technological complexity of the instruments and the quantity of production. An adequate sample of the final regulated measuring instruments, 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 designated standard, and/or normative document, and/or equivalent tests set out in other relevant technical specifications, shall be carried out to verify the conformity of the instruments with the relevant requirements of these Regulations. In the absence of a relevant designated standard or normative document, the accredited in-house body or approved body concerned shall decide on the appropriate tests to be carried out. In those cases where a relevant number of instruments in the sample do not conform to an acceptable quality level, the accredited in-house body or approved body shall take appropriate measures. Where the tests are carried out by an approved body, the manufacturer shall, under the responsibility of the approved body, affix the approved body's identification number during the manufacturing process. (5) (5) The manufacturer shall affix the UK marking and the M marking set out in these Regulations to each individual instrument that satisfies the applicable requirements of these Regulations. (5) The manufacturer shall draw up a written declaration of conformity for an instrument model and keep it together with the technical documentation at the disposal of the market surveillance authorities for 10 years after the instrument has been placed on the market. The declaration of conformity shall identify the instrument for which it was drawn up. A copy of the declaration of conformity shall be made available to the market surveillance authorities upon request. A copy of the declaration of conformity shall be supplied with each regulated measuring instrument that is placed on the market. However, this requirement may be interpreted as applying to a batch or consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user. (6) The manufacturer's obligations set out in paragraph 5 may be fulfilled by his authorised representative, on his behalf and under his responsibility provided that they are specified in the mandate. (1) ‘Type examination’ is the part of a conformity assessment procedure in which an approved body examines the technical design of an instrument and verifies and attests that the technical design of the instrument meets the requirements of these Regulations that apply to it. (2) Type examination may be carried out in either of the following manners: (a) examination of a specimen, representative of the production envisaged, of the complete regulated measuring instrument (production type), (b) assessment of the adequacy of the technical design of the instrument through examination of the technical documentation and supporting evidence referred to in paragraph 3, plus examination of specimens, representative of the production envisaged, of one or more critical parts of the instrument (combination of production type and design type); (c) assessment of the adequacy of the technical design of the instrument through examination of the technical documentation and supporting evidence referred to in paragraph 3, without examination of a specimen (design type). The approved body decides on the appropriate manner and the specimens required. (3) The manufacturer shall lodge an application for type examination with a single approved body of his choice. The application shall include: (a) the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well; (b) a written declaration that the same application has not been lodged with any other approved body; (c) the technical documentation set out in regulations 44 and 45. The technical documentation shall make it possible to assess the instrument's conformity with the applicable requirements of these Regulations 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 instrument. The application shall in addition contain, wherever applicable: (d) the specimens, representative of the production envisaged. The approved body may request further specimens if needed for carrying out the test programme; (e) 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 designated standards, and/or normative documents have not been applied in full. The supporting evidence shall include, where necessary, the results of tests carried out in accordance with other relevant technical specifications by the appropriate laboratory of the manufacturer, or by another testing laboratory on his behalf and under his responsibility. (4) The approved body shall: For the instrument: (4) examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the instrument; For the specimen(s): (4) verify that the specimen(s) have been manufactured in conformity with the technical documentation and identify the elements which have been designed in accordance with the applicable provisions of the relevant designated standards and/or normative documents, as well as the elements which have been designed in accordance with other relevant technical specifications; (4) carry out appropriate examinations and tests, or have them carried out, to check whether, where the manufacturer has chosen to apply the solutions in the relevant designated standards and normative documents, these have been applied correctly; (4) carry out appropriate examinations and tests, or have them carried out, to check whether, where the solutions in the relevant designated standards, and/or normative documents have not been applied, the solutions adopted by the manufacturer applying other relevant technical specifications meet the corresponding essential requirements of these Regulations; (4) agree with the manufacturer on the location where the examinations and tests will be carried out. For the other parts of the regulated measuring instrument: (4) examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the other parts of the regulated measuring instrument. (5) The approved body shall draw up an evaluation report that records the activities undertaken in accordance with paragraph 4 and their outcomes. Without prejudice to its obligations vis-à-vis the Secretary of State, the approved body shall release the content of that report, in full or in part, only with the agreement of the manufacturer. (6) Where the type meets the requirements of these Regulations, the approved body shall issue a type examination certificate to the manufacturer. That certificate shall contain the name and address of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity and the necessary data for identification of the approved type. The type examination certificate may have one or more annexes attached. The type examination certificate and its annexes shall contain all relevant information to allow the conformity of manufactured regulated measuring instruments with the examined type to be evaluated and to allow for in-service control. In particular, to allow the conformity of manufactured instruments to be evaluated with the examined type regarding the reproducibility of their metrological performances, when they are properly adjusted using appropriate means, content shall include: - — the metrological characteristics of the type of instrument; - — measures required for ensuring the integrity of the instruments (sealing, identification of software, etc.); - — information on other elements necessary for the identification of the instruments and to check their visual external conformity to type; - — if appropriate, any specific information necessary to verify the characteristics of manufactured instruments. The type examination certificate shall have a validity of 10 years from the date of its issue, and may be renewed for subsequent periods of 10 years each. Where the type does not satisfy the applicable requirements of these Regulations, the approved body shall refuse to issue a type examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal. (7) The approved body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved type may no longer comply with the applicable requirements of these Regulations, and shall determine whether such changes require further investigation. If so, the approved body shall inform the manufacturer accordingly. (8) The manufacturer shall inform the approved body that holds the technical documentation relating to the type examination certificate of all modifications to the approved type that may affect the conformity of the instrument with the essential requirements of these Regulations or the conditions for validity of that certificate. Such modifications shall require additional approval in the form of an addition to the original type examination certificate. (9) Each approved body shall inform the Secretary of State concerning the type examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to the Secretary of State the list of such certificates and/or any additions thereto refused, suspended or otherwise restricted. The other approved bodies and the Secretary of State may, on request, obtain a copy of the type examination certificates and/or additions thereto. On request, the Secretary of State may obtain a copy of the technical documentation and the results of the examinations carried out by the approved body. The approved body shall keep a copy of the 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 that certificate. (10) The manufacturer shall keep a copy of the type examination certificate, its annexes and additions together with the technical documentation at the disposal of the market surveillance authorities for 10 years after the instrument has been placed on the market. (11) The manufacturer's authorised representative may lodge the application referred to in paragraph 3 and fulfil the obligations set out in paragraphs 8 and 10, provided that they are specified in the mandate. (1) Conformity to type based on quality assurance of the production process is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 2 and 5, and ensures and declares on his sole responsibility that the regulated measuring instruments concerned are in conformity with the type described in the type examination certificate and satisfy the requirements of these Regulations that apply to them. (2) The manufacturer shall operate an approved quality system for production, final product inspection and testing of the regulated measuring instruments concerned as specified in paragraph 3 and shall be subject to surveillance as specified in paragraph 4. (3) (3) The manufacturer shall lodge an application for assessment of his quality system with an approved body of his choice, for the regulated measuring instruments concerned. The application shall include: (a) the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well, (b) a written declaration that the same application has not been lodged with any other approved body, (c) all relevant information for the instrument category envisaged; (d) the documentation concerning the quality system; (e) the technical documentation of the approved type and a copy of the type examination certificate. (3) The quality system shall ensure that the regulated measuring instruments are in conformity with the type described in the type examination certificate and comply with the requirements of these Regulations that apply to them. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records. It shall, in particular, contain an adequate description of: (a) the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality; (b) the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used; (c) the examinations and tests that will be carried out before, during, and after manufacture, and the frequency with which they will be carried out; (d) the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned; (e) the means of monitoring the achievement of the required product quality and the effective operation of the quality system. (3) The approved body shall assess the quality system to determine whether it satisfies the requirements referred to in paragraph 3.2. It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant designated standard. In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant instrument field and instrument technology concerned, and knowledge of the applicable requirements of these Regulations. The audit shall include an assessment visit to the manufacturer's premises. The auditing team shall review the technical documentation referred to in paragraph 3.1(e), to verify the manufacturer's ability to identify the relevant requirements of these Regulations and to carry out the necessary examinations with a view to ensuring compliance of the instrument with those requirements. The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned assessment decision. (3) The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient. (3) The manufacturer shall keep the approved body that has approved the quality system informed of any intended change of the quality system. The approved body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in paragraph 3.2 or whether a re-assessment is necessary. It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision. (4) (4) The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system. (4) The manufacturer shall, for assessment purposes, allow the approved body access to the manufacture, inspection, testing and storage sites, and shall provide it with all necessary information, in particular: (a) the quality system documentation; (b) the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned. (4) The approved body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report. (4) In addition, the approved body may pay unexpected visits to the manufacturer. During such visits the approved body may, if necessary, carry out instrument tests, or have them carried out, in order to verify that the quality system is functioning correctly. The approved body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report. (5) (5) The manufacturer shall affix the UK marking and the M marking set out in these Regulations and, under the responsibility of the approved body referred to in paragraph 3.1, the latter's identification number to each individual regulated measuring instrument that is in conformity with the type described in the type examination certificate and satisfies the applicable requirements of these Regulations. (5) The manufacturer shall draw up a written declaration of conformity for each instrument model and keep it at the disposal of the market surveillance authorities for 10 years after the instrument has been placed on the market. The declaration of conformity shall identify the instrument model for which it has been drawn up. A copy of the declaration of conformity shall be made available to the market surveillance authorities upon request. A copy of the declaration of conformity shall be supplied with each regulated measuring instrument that is placed on the market. However, this requirement may be interpreted as applying to a batch or consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user. (6) The manufacturer shall, for a period ending 10 years after the instrument has been placed on the market, keep at the disposal of the market surveillance authorities: (a) the documentation referred to in paragraph 3.1, (b) the information relating to the change referred to in paragraph 3.5, as approved; (c) the decisions and reports from the approved body referred to in paragraphs 3.5, 4.3 and 4.4. (7) Each approved body shall inform the Secretary of State of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to the Secretary of State the list of quality system approvals refused, suspended or otherwise restricted. (8) The manufacturer's obligations set out in paragraphs 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. (1) Quality assurance of the production process is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 2, 4 and 7, and ensures and declares on his sole responsibility that the regulated measuring instruments concerned satisfy the requirements of these Regulations that apply to them. (2) The manufacturer shall establish the technical documentation set out in regulations 44 and 45. The documentation shall make it possible to assess the instrument'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 instrument. (3) The manufacturer shall keep the technical documentation at the disposal of the market surveillance authorities for 10 years after the instrument has been placed on the market. (4) The manufacturer shall operate an approved quality system for production, final product inspection and testing of the regulated measuring instruments concerned as specified in paragraph 5 and shall be subject to surveillance as specified in paragraph 6. (5) (5) The manufacturer shall lodge an application for assessment of his quality system with an approved body of his choice, for the measuring instruments concerned. The application shall include: (a) the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well; (b) a written declaration that the same application has not been lodged with any other approved body; (c) all relevant information for the instrument category envisaged; (d) the documentation concerning the quality system; (e) the technical documentation referred to in paragraph 2. (5) The quality system shall ensure compliance of the regulated measuring instruments with the requirements of these Regulations that apply to them. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records. It shall, in particular, contain an adequate description of: (a) the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality; (b) the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used; (c) the examinations and tests that will be carried out before, during, and after manufacture, and the frequency with which they will be carried out; (d) the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned; (e) the means of monitoring the achievement of the required product quality and the effective operation of the quality system. (5) The approved body shall assess the quality system to determine whether it satisfies the requirements referred to in paragraph 5.2. It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant designated standard. In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant instrument field and instrument technology concerned, and knowledge of the applicable requirements of these Regulations. The audit shall include an assessment visit to the manufacturer's premises. The auditing team shall review the technical documentation referred to in paragraph 2 in order to verify the manufacturer's ability to identify the relevant requirements of these Regulations and to carry out the necessary examinations with a view to ensuring compliance of the instrument with those requirements. The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned assessment decision. (5) The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient. (5) The manufacturer shall keep the approved body that has approved the quality system informed of any intended change of the quality system. The approved body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in paragraph 5.2 or whether a re-assessment is necessary. It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision. (6) (6) The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system. (6) The manufacturer shall, for assessment purposes, allow the approved body access to the manufacture, inspection, testing and storage sites, and shall provide it with all necessary information, in particular: (a) the quality system documentation; (b) the technical documentation referred to in paragraph 2; (c) the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned. (6) The approved body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report. (6) In addition, the approved body may pay unexpected visits to the manufacturer. During such visits the approved body may, if necessary, carry out instrument tests, or have them carried out, in order to verify that the quality system is functioning correctly. The approved body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report. (7) (7) The manufacturer shall affix the UK marking, the M marking set out in these Regulations, and, under the responsibility of the approved body referred to in paragraph 5.1, the latter's identification number to each individual regulated measuring instrument that satisfies the applicable requirements of these Regulations. (7) The manufacturer shall draw up a written declaration of conformity for each instrument model and keep it at the disposal of the market surveillance authorities for 10 years after the instrument has been placed on the market. The declaration of conformity shall identify the instrument model for which it has been drawn up. A copy of the declaration of conformity shall be made available to the market surveillance authorities upon request. A copy of the declaration of conformity shall be supplied with each regulated measuring instrument that is placed on the market. However, this requirement may be interpreted as applying to a batch or consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user. (8) The manufacturer shall, for a period ending 10 years after the instrument has been placed on the market, keep at the disposal of the market surveillance authorities: (a) the documentation referred to in paragraph 5.1; (b) the information relating to the change referred to in paragraph 5.5, as approved; (c) the decisions and reports of the approved body referred to in paragraphs 5.5, 6.3 and 6.4. (9) Each approved body shall inform the Secretary of State of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to the Secretary of State the list of quality system approvals refused, suspended or otherwise restricted. (10) The manufacturer's obligations set out in paragraphs 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. (1) Conformity to type based on instrument quality assurance is that part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 2 and 5, and ensures and declares on his sole responsibility that the regulated measuring instruments concerned are in conformity with the type described in the type examination certificate and satisfy the requirements of these Regulations that apply to them. (2) The manufacturer shall operate an approved quality system for final product inspection and testing of the regulated measuring instruments concerned as specified in paragraph 3 and shall be subject to surveillance, as specified in paragraph 4. (3) (3) The manufacturer shall lodge an application for assessment of his quality system with an approved body of his choice, for the regulated measuring instruments concerned. The application shall include: (a) the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well; (b) a written declaration that the same application has not been lodged with any other approved body; (c) all relevant information for the instrument category envisaged; (d) the documentation concerning the quality system; (e) the technical documentation of the approved type and a copy of the type examination certificate. (3) The quality system shall ensure compliance of the regulated measuring instruments with the type described in the type examination certificate and with the applicable requirements of these Regulations. 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: (a) the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality; (b) the examinations and tests that will be carried out after manufacture; (c) the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned; (d) the means of monitoring the effective operation of the quality system. (3) The approved body shall assess the quality system to determine whether it satisfies the requirements referred to in paragraph 3.2. It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant designated standard. In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant instrument field and instrument technology concerned, and knowledge of the applicable requirements of these Regulations. The audit shall include an assessment visit to the manufacturer's premises. The auditing team shall review the technical documentation referred to in paragraph 3.1(e), in order to verify the manufacturer's ability to identify the relevant requirements of these Regulations and to carry out the necessary examinations with a view to ensuring compliance of the instrument with those requirements. The decision shall be notified to the manufacturer. The notification shall contain the conclusions of audit and the reasoned assessment decision. (3) The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient. (3) The manufacturer shall keep the approved body that has approved the quality system informed of any intended change to the quality system. The approved body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in paragraph 3.2 or whether a re-assessment is necessary. It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision. (4) (4) The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system. (4) The manufacturer shall, for assessment purposes, allow the approved body access to the manufacture, inspection, testing and storage sites, and shall provide it with all necessary information, in particular: (a) the quality system documentation; (b) the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned. (4) The approved body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report. (4) In addition, the approved body may pay unexpected visits to the manufacturer. During such visits the approved body may, if necessary, carry out instrument tests, or have them carried out, in order to verify that the quality system is functioning correctly. The approved body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report. (5) (5) The manufacturer shall affix the UK marking, the M marking set out in these Regulations, and, under the responsibility of the approved body referred to in paragraph 3.1, the latter's identification number to each individual instrument that is in conformity with the type described in the type examination certificate and satisfies the applicable requirements of these Regulations. (5) The manufacturer shall draw up a written declaration of conformity for each instrument model and keep it at the disposal of the market surveillance authorities for 10 years after the instrument has been placed on the market. The declaration of conformity shall identify the instrument model for which it has been drawn up. A copy of the declaration of conformity shall be made available to the market surveillance authorities upon request. A copy of the declaration of conformity shall be supplied with each regulated measuring instrument that is placed on the market. However, this requirement may be interpreted as applying to a batch or consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user. (6) The manufacturer shall, for a period ending 10 years after the instrument has been placed on the market, keep at the disposal of the market surveillance authorities: (a) the documentation referred to in paragraph 3.1; (c) the information relating to the change referred to in paragraph 3.5, as approved; (c) the decisions and reports of the approved body referred to in paragraphs 3.5, 4.3 and 4.4. (7) Each approved body shall inform the Secretary of State of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to the Secretary of State the list of quality system approvals refused, suspended or otherwise restricted. (8) The manufacturer's obligations set out in paragraphs 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. (1) Quality assurance of final instrument inspection and testing is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 2, 4 and 7, and ensures and declares on his sole responsibility that the regulated measuring instruments concerned satisfy the requirements of these Regulations that apply to them. (2) The manufacturer shall establish the technical documentation set out in regulations 44 and 45. The documentation shall make it possible to assess the instrument'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 instrument. (3) The manufacturer shall keep the technical documentation at the disposal of the market surveillance authorities for 10 years after the instrument has been placed on the market. (4) The manufacturer shall operate an approved quality system for final product inspection and testing of the regulated measuring instruments concerned as specified in paragraph 5 and shall be subject to surveillance as specified in paragraph 6. (5) (5) The manufacturer shall lodge an application for assessment of his quality system with the approved body of his choice, for the regulated measuring instruments concerned. The application shall include: (a) the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well; (b) a written declaration that the same application has not been lodged with any other approved body; (c) all relevant information for the instrument category envisaged; (d) the documentation concerning the quality system; (e) the technical documentation referred to in paragraph 2. (5) The quality system shall ensure compliance of the regulated measuring instruments with the requirements of these Regulations that apply to them. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. The quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records. It shall, in particular, contain an adequate description of: (a) the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality; (b) the examinations and tests that will be carried out after manufacture; (c) the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned; (d) the means of monitoring the effective operation of the quality system. (5) The approved body shall assess the quality system to determine whether it satisfies the requirements referred to in paragraph 5.2. It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant designated standard. In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant instrument field and instrument technology concerned, and knowledge of the applicable requirements of these Regulations. The audit shall include an assessment visit to the manufacturer's premises. The auditing team shall review the technical documentation referred to in paragraph 2 in order to verify the manufacturer's ability to identify the relevant requirements of these Regulations and to carry out the necessary examinations with a view to ensuring compliance of the instrument with those requirements. The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned assessment decision. (5) The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient. (5) The manufacturer shall keep the approved body that has approved the quality system informed of any intended change to the quality system. The approved body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in paragraph 5.2 or whether a re-assessment is necessary. It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision. (6) (6) The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system. (6) The manufacturer shall, for assessment purposes, allow the approved body access to the manufacture, inspection, testing and storage sites, and shall provide it with all necessary information, in particular: (a) the quality system documentation; (b) the technical documentation referred to in paragraph 2; (c) the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned. (6) The approved body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report. (6) In addition, the approved body may pay unexpected visits to the manufacturer. During such visits the approved body may, if necessary, carry out instrument tests, or have them carried out, in order to verify that the quality system is functioning correctly. The approved body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report. (7) (7) The manufacturer shall affix the UK marking, the M marking set out in these Regulations, and, under the responsibility of the approved body referred to in paragraph 5.1, the latter's identification number to each individual regulated measuring instrument that satisfies the applicable requirements of these Regulations. (7) The manufacturer shall draw up a written declaration of conformity for each instrument model and keep it at the disposal of the market surveillance authorities for 10 years after the instrument has been placed on the market. The declaration of conformity shall identify the instrument model for which it has been drawn up. A copy of the declaration of conformity shall be made available to the market surveillance authorities upon request. A copy of the declaration of conformity shall be supplied with each regulated measuring instrument that is placed on the market. However, this requirement may be interpreted as applying to a batch or consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user. (8) The manufacturer shall, for a period ending 10 years after the instrument has been placed on the market, keep at the disposal of the market surveillance authorities: (a) the documentation referred to in paragraph 5.1, (b) the information relating to the change referred to in paragraph 5.5, as approved; (c) the decisions and reports from the approved body referred to in paragraphs 5.5, 6.3 and 6.4. (9) Each approved body shall inform the Secretary of State of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to the Secretary of State the list of quality system approvals refused, suspended or otherwise restricted. (10) The manufacturer's obligations set out in paragraphs 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. (1) Conformity to type based on product verification is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 2, 5.1 and 6, and ensures and declares on his sole responsibility that the regulated measuring instruments concerned, which have been subject to the provisions of paragraph 3, are in conformity with the type described in the type examination certificate and satisfy the requirements of these Regulations that apply to them. (2) The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured regulated measuring instruments with the approved type described in the type examination certificate and with the requirements of these Regulations that apply to them. (3) An approved body chosen by the manufacturer shall carry out the appropriate examinations and tests, or have them carried out, to verify the conformity of the instruments with the type as described in the type examination certificate and the appropriate requirements of these Regulations. The examinations and tests to verify the conformity of the regulated measuring instruments with the appropriate requirements shall be carried out, at the choice of the manufacturer, either by examination and testing of every instrument as specified in paragraph 4, or by examination and testing of the regulated measuring instruments on a statistical basis as specified in paragraph 5. (4) Verification of conformity by examination and testing of every instrument (4) All regulated measuring instruments shall be individually examined and appropriate tests set out in the relevant designated standard(s) and/or normative documents, and/or equivalent tests set out in other relevant technical specifications, shall be carried out in order to verify their conformity with the approved type described in the type examination certificate and with the appropriate requirements of these Regulations. In the absence of a designated standard or normative document, the approved body concerned shall decide on the appropriate tests to be carried out. (4) The approved 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 instrument or have it affixed under its responsibility. The manufacturer shall keep the certificates of conformity available for inspection by the market surveillance authorities for 10 years after the instrument has been placed on the market. (5) (5) The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure the homogeneity of each lot produced, and shall present his regulated measuring instruments for verification in the form of homogeneous lots. (5) A random sample shall be taken from each lot according to the requirements of paragraph 5.3. All regulated measuring instruments in a sample shall be individually examined and appropriate tests set out in the relevant designated standard(s) and/or normative document(s), and/or equivalent tests set out in other relevant technical specifications, shall be carried out in order to verify their conformity with the type described in the type examination certificate and with the applicable requirements of these Regulations, and to determine whether the lot is accepted or rejected. In the absence of such designated standard or normative document, the approved body concerned shall decide on the appropriate tests to be carried out. (5) The statistical procedure shall meet the following requirements: The statistical control will be based on attributes. The sampling system shall ensure: (a) a level of quality corresponding to a probability of acceptance of 95 %, with a non-conformity of less than 1 %; (b) a limit quality corresponding to a probability of acceptance of 5 %, with a non-conformity of less than 7 %. (5) If a lot is accepted, all regulated measuring instruments of the lot shall be considered approved, except for those regulated measuring instruments from the sample that have been found not to satisfy the tests. The approved 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 instrument or have it affixed under its responsibility. The manufacturer shall keep the certificates of conformity at the disposal of the market surveillance authorities for 10 years after the instrument has been placed on the market. (5) If a lot is rejected, the approved body shall take appropriate measures to prevent the placing on the market of that lot. In the event of frequent rejection of lots the approved body may suspend the statistical verification and take appropriate measures. (6) (6) The manufacturer shall affix the UK marking and the M marking set out in these Regulations, and, under the responsibility of the approved body referred to in paragraph 3, the latter's identification number to each individual instrument that is in conformity with the approved type described in the type examination certificate and satisfies the applicable requirements of these Regulations. (6) The manufacturer shall draw up a written declaration of conformity for each instrument model and keep it at the disposal of the market surveillance authorities for 10 years after the instrument has been placed on the market. The declaration of conformity shall identify the instrument model for which it has been drawn up. A copy of the declaration of conformity shall be made available to the market surveillance authorities upon request. A copy of the declaration of conformity shall be supplied with each regulated measuring instrument that is placed on the market. However, this requirement may be interpreted as applying to a batch or consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user. If the approved body referred to in paragraph 3 agrees and under its responsibility, the manufacturer may also affix the approved body's identification number to the regulated measuring instruments. (7) If the approved body agrees and under its responsibility, the manufacturer may affix the approved body's identification number to the regulated measuring instruments during the manufacturing process. (8) 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 paragraphs 2 and 5.1. (1) Conformity based on product verification is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 2, 3, 6.1 and 7 and ensures and declares on his sole responsibility that the regulated measuring instruments concerned which have been subject to the provisions of paragraph 4, are in conformity with the requirements of these Regulations that apply to them. (2) The manufacturer shall establish the technical documentation set out in regulations 44 and 45. The documentation shall make it possible to assess the instrument'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 instrument. The manufacturer shall keep the technical documentation at the disposal of the market surveillance authorities for 10 years after the instrument has been placed on the market. (3) The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured regulated measuring instruments with the applicable requirements of these Regulations. (4) An approved body chosen by the manufacturer shall carry out the appropriate examinations and tests, or have them carried out, to verify the conformity of the regulated measuring instruments with the applicable requirements of these Regulations. The examinations and tests to verify the conformity with the requirements shall be carried out, at the choice of the manufacturer, either by examination and testing of every instrument as specified in paragraph 5, or by examination and testing of the regulated measuring instruments on a statistical basis as specified in paragraph 6. (5) (5) All regulated measuring instruments shall be individually examined and appropriate tests, set out in the relevant designated standards and/or normative documents, and/or equivalent tests set out in other relevant technical specifications, shall be carried out to verify their conformity with the requirements that apply to them. In the absence of such a designated standard, or normative document, the approved body concerned shall decide on the appropriate tests to be carried out. (5) The approved 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 instrument or have it affixed under its responsibility. The manufacturer shall keep the certificates of conformity at the disposal of the market surveillance authorities for 10 years after the instrument has been placed on the market. (6) (6) The manufacturer shall take all measures necessary so that the manufacturing process ensures the homogeneity of each lot produced, and shall present his regulated measuring instruments for verification in the form of homogeneous lots. (6) A random sample shall be taken from each lot according to the requirements of paragraph 6.4. (6) All regulated measuring instruments in the sample shall be individually examined and appropriate tests set out in the relevant designated standards and/or normative documents, and/or equivalent tests set out in other relevant technical specifications, shall be carried out in order to verify their conformity with the applicable requirements of these Regulations and to determine whether the lot is accepted or rejected. In the absence of such designated standard, or normative document, the approved body concerned shall decide on the appropriate tests to be carried out. (6) The statistical procedure shall meet the following requirements: The statistical control will be based on attributes. The sampling system shall ensure: (a) a level of quality corresponding to a probability of acceptance of 95 %, with a non-conformity of less than 1 %; (b) a limit quality corresponding to a probability of acceptance of 5 %, with a non-conformity of less than 7 %. (6) If a lot is accepted, all regulated measuring instruments of the lot shall be considered approved, except for those regulated measuring instruments from the sample that have been found not to satisfy the tests. The approved 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 instrument or have it affixed under its responsibility. The manufacturer shall keep the certificates of conformity at the disposal of the market surveillance authorities for 10 years after the instrument has been placed on the market. If a lot is rejected, the approved body shall take appropriate measures to prevent that lot from being placed on the market. In the event of frequent rejection of lots the approved body may suspend the statistical verification and take appropriate measures. (7) (7) The manufacturer shall affix the UK marking and the M marking set out in these Regulations, and under the responsibility of the approved body referred to in paragraph 4, the latter's identification number to each individual regulated measuring instrument that satisfies the applicable requirements of these Regulations. (7) The manufacturer shall draw up a written declaration of conformity for each instrument model and keep it at the disposal of the market surveillance authorities for 10 years after the instrument has been placed on the market. The declaration of conformity shall identify the instrument model for which it has been drawn up. A copy of the declaration of conformity shall be made available to the market surveillance authorities upon request. A copy of the declaration of conformity shall be supplied with each regulated measuring instrument that is placed on the market. However, this requirement may be interpreted as applying to a batch or consignment rather than individual regulated measuring instruments in those cases where a large number of instruments is delivered to a single user. If the approved body referred to in paragraph 5 agrees and under its responsibility, the manufacturer may also affix the approved body's identification number to the regulated measuring instruments. (8) If the approved body agrees and under its responsibility, the manufacturer may affix the approved body's identification number to the regulated measuring instruments during the manufacturing process. (9) Authorised representative The manufacturer's obligations may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. An authorised representative may not fulfil the manufacturer's obligations set out in the first paragraph of paragraph 2, paragraph 3 and paragraph 6.1. (1) Conformity based on unit verification is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 2, 3 and 5 and ensures and declares on his sole responsibility that the instrument concerned, which has been subject to the provisions of paragraph 4, is in conformity with the requirements of these Regulations that apply to it. (2) The manufacturer shall establish the technical documentation and make it available to the approved body referred to in paragraph 4. The documentation shall make it possible to assess the instrument'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 instrument. The manufacturer shall keep the technical documentation at the disposal of the market surveillance authorities for 10 years after the instrument has been placed on the market. (3) The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured instrument with the applicable requirements of these Regulations. (4) An approved body chosen by the manufacturer shall carry out the appropriate examinations and tests set out in the relevant designated standards, and/or normative documents, or equivalent tests set out in other relevant technical specifications, to verify the conformity of the instrument with the applicable requirements of these Regulations, or have them carried out. In the absence of such a designated standard, or normative document, the approved body concerned shall decide on the appropriate tests to be carried out. The approved body shall issue a certificate of conformity in respect of the examinations and tests carried out and affix its identification number to the approved instrument, or have it affixed under its responsibility. The manufacturer shall keep the certificates of conformity at the disposal of the market surveillance authorities for 10 years after the instrument has been placed on the market. (5) (5) The manufacturer shall affix the UK marking and the M marking set out in these Regulations and, under the responsibility of the approved body referred to in paragraph 4, the latter's identification number to each instrument that satisfies the applicable requirements of these Regulations. (5) The manufacturer shall draw up a written declaration of conformity and keep it at the disposal of the market surveillance authorities for 10 years after the instrument has been placed on the market. The declaration of conformity shall identify the instrument for which it has been drawn up. A copy of the declaration of conformity shall be made available to the market surveillance authorities upon request. A copy of the declaration of conformity shall be supplied with the regulated measuring instrument. (6) The manufacturer's obligations set out in paragraphs 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. (1) Conformity based on full quality assurance is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 2 and 5, and ensures and declares on his sole responsibility that the regulated measuring instruments concerned satisfy the requirements of these Regulations that apply to them. (2) The manufacturer shall operate an approved quality system for design, manufacture and final product inspection and testing of the regulated measuring instruments concerned as specified in paragraph 3, and shall be subject to surveillance as specified in paragraph 4. (3) (3) The manufacturer shall lodge an application for assessment of his quality system with the approved body of his choice, for the regulated measuring instruments concerned. The application shall include: (a) the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well, (b) the technical documentation for one model of each category of regulated measuring instruments intended to be manufactured. The documentation shall make it possible to assess the instrument'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 instrument, (c) the documentation concerning the quality system, and (d) a written declaration that the same application has not been lodged with any other approved body. (3) The quality system shall ensure compliance of the regulated measuring instruments with the requirements of these Regulations that apply to them. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records. It shall, in particular, contain an adequate description of: (a) the quality objectives and the organisational structure, responsibilities and powers of the management with regard to design and product quality; (b) the technical design specifications, including standards, that will be applied and, where the relevant designated standards, and/or normative documents will not be applied in full, the means that will be used to ensure that the essential requirements of these Regulations that apply to the regulated measuring instruments will be met applying other relevant technical specifications; (c) the design control and design verification techniques, processes and systematic actions that will be used when designing the regulated measuring instruments pertaining to the instrument category covered; (d) the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used; (e) the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out; (f) the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned; (g) the means of monitoring the achievement of the required design and product quality and the effective operation of the quality system. (3) The approved body shall assess the quality system to determine whether it satisfies the requirements referred to in paragraph 3.2. It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant designated standard. In addition to experience in quality management systems, the auditing team shall have at least one member experienced as an assessor in the relevant instrument field and instrument technology concerned, and knowledge of the applicable requirements of these Regulations. The audit shall include an assessment visit to the manufacturer's premises. The auditing team shall review the technical documentation referred to in paragraph 3.1(b) to verify the manufacturer's ability to identify the applicable requirements of these Regulations and to carry out the necessary examinations with a view to ensuring compliance of the instrument with those requirements. The manufacturer or his authorised representative shall be notified of the decision. The notification shall contain the conclusions of the audit and the reasoned assessment decision. (3) The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient. (3) The manufacturer shall keep the approved body that has approved the quality system informed of any intended change to the quality system. The approved body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in paragraph 3.2 or whether a re-assessment is necessary. It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision. (4) (4) The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system. (4) The manufacturer shall, for assessment purposes, allow the approved body access to the design, manufacture, inspection, testing and storage sites, and shall provide it with all necessary information, in particular: (a) the quality system documentation; (b) the quality records as provided for by the design part of the quality system, such as results of analyses, calculations, tests.; (c) 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. (4) The approved body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report. (4) In addition, the approved body may pay unexpected visits to the manufacturer. During such visits the approved body may, if necessary, carry out instrument tests, or have them carried out, in order to check the proper functioning of the quality system. It shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report. (5) (5) The manufacturer shall affix the UK marking, the M marking set out in these Regulations and, under the responsibility of the approved body referred to in paragraph 3.1, the latter's identification number to each individual instrument that satisfies the applicable requirements of these Regulations. (5) The manufacturer shall draw up a written declaration of conformity for each instrument model and keep it at the disposal of the market surveillance authorities for 10 years after the instrument has been placed on the market. The declaration of conformity shall identify the instrument model for which it has been drawn up. A copy of the declaration of conformity shall be made available to the market surveillance authorities upon request. A copy of the declaration of conformity shall be supplied with each regulated measuring instrument that is placed on the market. However, this requirement may be interpreted as applying to a batch or consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user. (6) The manufacturer shall, for a period ending 10 years after the instrument has been placed on the market, keep at the disposal of the market surveillance authorities: (a) the technical documentation referred to in paragraph 3.1, (b) the documentation concerning the quality system referred to in paragraph 3.1, (c) the information relating to the change referred to in paragraph 3.5, as approved; (d) the decisions and reports of the approved body referred to in paragraphs 3.5, 4.3 and 4.4. (7) Each approved body shall inform the Secretary of State of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to the Secretary of State the list of quality system approvals refused, suspended or otherwise restricted. (8) The manufacturer's obligations set out in paragraphs 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. (1) Conformity based on full quality assurance plus design examination is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 2 and 6, and ensures and declares on his sole responsibility that the regulated measuring instruments concerned satisfy the requirements of these Regulations that apply to them. (2) The manufacturer shall operate an approved quality system for design, manufacture and final product inspection and testing of the regulated measuring instruments concerned as specified in paragraph 3, and shall be subject to surveillance as specified in paragraph 5. The adequacy of the technical design of the regulated measuring instruments shall have been examined in accordance with paragraph 4. (3) (3) The manufacturer shall lodge an application for assessment of the quality system with the approved body of his choice for the regulated measuring instruments concerned. The application shall include: (a) the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well; (b) all relevant information for the instrument category envisaged; (c) the documentation concerning the quality system; (d) a written declaration that the same application has not been lodged with any other approved body. (3) The quality system shall ensure compliance of the regulated measuring instruments with the requirements of these Regulations that apply to them. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records. It shall, in particular, contain an adequate description of: (a) the quality objectives and the organisational structure, responsibilities and powers of the management with regard to design and product quality; (b) the technical design specifications, including standards, that will be applied and, where the relevant designated standards and/or normative documents will not be applied in full, the means that will be used to ensure that the essential requirements of these Regulations that apply to the regulated measuring instruments will be met, applying other relevant technical specifications; (c) the design control and design verification techniques, processes and systematic actions that will be used when designing the regulated measuring instruments pertaining to the instrument category covered; (d) the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used; (e) the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out; (f) the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned; (g) the means of monitoring the achievement of the required design and product quality and the effective operation of the quality system. (3) The approved body shall assess the quality system to determine whether it satisfies the requirements referred to in paragraph 3.2. It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant designated standard. In addition to experience in quality management systems, the auditing team shall have at least one member experienced as an assessor in the relevant instrument field and instrument technology concerned, and knowledge of the applicable requirements of these Regulations. 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. (3) The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient. (3) The manufacturer shall keep the approved body that has approved the quality system informed of any intended change to the quality system. The approved body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in paragraph 3.2 or whether a re-assessment is necessary. It shall notify the manufacturer or his authorised representative of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision. (3) Each approved body shall inform the Secretary of State of quality system approvals issued or withdrawn, and shall periodically or upon request, make available to the Secretary of State the list of quality system approvals refused, suspended or otherwise restricted. (4) (4) The manufacturer shall lodge an application for examination of the design with the approved body referred to in paragraph 3.1. (4) The application shall make it possible to understand the design, manufacture and operation of the instrument, and to assess the conformity with the requirements of these Regulations that apply to it. It shall include: (a) the name and address of the manufacturer; (b) a written declaration that the same application has not been lodged with any other approved body; (c) the technical documentation. The documentation shall make it possible to assess the instrument's conformity with the relevant requirements, and shall include an adequate analysis and assessment of the risk(s). It shall, as far as relevant for such assessment, cover the design and operation of the instrument; (d) 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 designated standards and/or normative documents have not been applied in full, and shall include, where necessary, the results of tests carried out in accordance with other relevant technical specifications, by the appropriate laboratory of the manufacturer, or by another testing laboratory on his behalf and under his responsibility. (4) The approved body shall examine the application, and where the design meets the requirements of these Regulations that apply to the instrument it shall issue a design examination certificate to the manufacturer. That certificate shall give the name and address of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity and the data necessary for identification of the approved design. That certificate may have one or more annexes attached. That certificate and its annexes shall contain all relevant information to allow the conformity of manufactured regulated measuring instruments with the examined design to be evaluated and to allow for in-service control. It shall allow the evaluation of conformity of the manufactured instruments with the examined design regarding the reproducibility of their metrological performances, when they are properly adjusted using appropriate means, including: (a) the metrological characteristics of the design of the instrument; (b) measures required for ensuring the integrity of the instruments (sealing, identification of software, etc.); (c) information on other elements necessary for the identification of the instrument and to check its visual external conformity to the design; (d) if appropriate, any specific information necessary to verify the characteristics of manufactured instruments; (e) in the case of a sub-assembly, all necessary information to ensure the compatibility with other sub-assemblies or regulated measuring instruments. The approved body shall establish an evaluation report in this regard and keep it at the disposal of the Secretary of State. Without prejudice to paragraph 9 of Schedule 5, the approved body shall release the content of this report, in full or in part, only with the agreement of the manufacturer. The certificate shall have a validity of 10 years from the date of its issue, and may be renewed for subsequent periods of 10 years each. Where the design does not satisfy the applicable requirements of these Regulations, the approved body shall refuse to issue a design examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal. (4) The approved body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved design may no longer comply with the applicable requirements of these Regulations, and shall determine whether such changes require further investigation. If so, the approved body shall inform the manufacturer accordingly. The manufacturer shall keep the approved body that has issued the design examination certificate informed of any modification to the approved design that may affect the conformity with the essential requirements of these Regulations or the conditions for validity of the certificate. Such modifications shall require additional approval – from the approved body that issued the design examination certificate – in the form of an addition to the original design examination certificate. (4) Each approved body shall inform the Secretary of State of the design examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to the Secretary of State the list of certificates and/or any additions thereto refused, suspended or otherwise restricted. The other approved bodies and the Secretary of State may, on request, obtain a copy of the design examination certificates and/or additions thereto. On request, the Secretary of State may obtain a copy of the technical documentation and of the results of the examinations carried out by the approved body. The approved body shall keep a copy of the design examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer until the expiry of the validity of the certificate. (4) The manufacturer shall keep a copy of the design examination certificate, its annexes and additions with the technical documentation at the disposal of the market surveillance authorities for 10 years after the instrument has been placed on the market. (5) (5) The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system. (5) The manufacturer shall, for assessment purposes, allow the approved body access to the design, manufacture, inspection, testing and storage sites, and shall provide it with all necessary information, in particular: (a) the quality system documentation; (b) the quality records as provided for by the design part of the quality system, such as results of analyses, calculations, tests, etc.; (c) the quality records as provided for by the manufacturing part of the quality system, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc. (5) The approved body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report. (5) In addition, the approved body may pay unexpected visits to the manufacturer. During such visits the approved body may, if necessary, carry out instrument tests, or have them carried out, in order to check the proper functioning of the quality system. It shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report. (6) (6) The manufacturer shall affix the UK marking and the M marking set out in these Regulations, and, under the responsibility of the approved body referred to in paragraph 3.1, the latter's identification number to each individual instrument that satisfies the applicable requirements of these Regulations. (6) The manufacturer shall draw up a written declaration of conformity for each instrument model and keep it at the disposal of the market surveillance authorities for 10 years after the instrument has been placed on the market. The declaration of conformity shall identify the instrument model for which it has been drawn up and shall mention the number of the design examination certificate. A copy of the declaration of conformity shall be made available to the market surveillance authorities upon request. A copy of the declaration of conformity shall be supplied with each regulated measuring instrument that is placed on the market. However, this requirement may be interpreted as applying to a batch or consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user. (7) The manufacturer shall, for a period ending 10 years after the instrument has been placed on the market, keep at the disposal of the market surveillance authorities: (a) the documentation concerning the quality system referred to in paragraph 3.1, (b) the information relating to the change referred to in paragraph 3.5, as approved; (c) the decisions and reports of the approved body referred to in paragraphs 3.5, 5.3 and 5.4. (8) The manufacturer's authorised representative may lodge the application referred to in paragraphs 4.1 and 4.2 and fulfil the obligations set out in paragraphs 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. SCHEDULE 1C The relevant requirements of Schedule 1A, the specific requirements of this Schedule and the conformity assessment procedures listed in this Schedule, apply to water meters intended for the measurement of volumes of clean, cold or heated water in residential, commercial and light industrial use. DEFINITIONS