Art. 5

Art. 6 Satisfaction with essential requirements

Art. 7 Technical standards and normative documents

Art. 8 Maximum tolerable errors and reference conditions

Art. Traceability

Art. 10 Information on the measuring instrument

Art. 11 Conformity Assessment Procedures

Art. 12 ¹ Conformity Assessment Bodies

Art. 13 Declaration of Conformity

Art. 14 Technical documentation

Art. 15 ¹ Compliance Marks

Art. 16 Approval of measuring instruments

Art. 17 Initial Verification

Art. 18 Approval and Verification Marks

Art. 19

A measuring instrument shall ensure a high level of metrological protection so that any party concerned can have confidence in the outcome of the measurement. Its design and manufacture must be of high quality with respect to metrological technology and the safety of measurement data.

The solutions adopted according to the requirements must take into account the intended use of the instrument of measurement and any foreseeable abuse.

Mesurande

A particular size that is subject to measurement.

Grandeur d ' Influence

The size of influence is a size that is not the measurement but which has an effect on the result of the measurement.

Nominal Operating Conditions

Values for the measurement and influence quantities that constitute the normal operating conditions of a measuring instrument.

Disturbance

A weight of influence whose value is within the limits specified in the applicable requirement, but outside the assigned nominal operating conditions that are specified for the measuring instrument. A magnitude of influence is a disturbance if, for this magnitude of influence, the nominal operating conditions are not specified.

Critical Variation Value

The value from which the variation of the measurement result is considered undesirable.

Materialized measure

A measuring instrument that is intended to reproduce or provide permanently, during its use, one or more known values of a given quantity.

Direct selling

Commercial transaction in which:

-

The result of the measurement is the basis for the price to be paid;

-

At least one of the parties to the metering transaction is a consumer or another party that requires a similar level of protection, and

-

All parties to the transaction accept the result of the measurement at the time and place considered.

Climate Environments

Conditions under which measuring instruments can be used. A range of temperature limits has been defined so that climate differences between different states can be taken into account.

Services d ' Public utility

Companies providing electricity, gas, remote or water heating are considered to be utilities.

1.1

In nominal operating conditions and in the absence of disturbance, the measurement error shall not exceed the value of the maximum permissible error (TRM) defined in the ordinances on specific measuring instruments.

Unless otherwise specified in the orders on specific measuring instruments, the EMT shall be expressed as a bilateral value of the deviation from the true measurement value.

1.2

For a measuring instrument operating under the nominal operating conditions and in the presence of a disturbance, the performance requirement must be that defined in the ordinances on the specific measuring instruments.

Where the measuring instrument is intended for use in a fixed continuous continuous electromagnetic field, the permissible performance during the radiated electromagnetic field test, amplitude modulated, shall be within the limits of the EMT.

1.3

The manufacturer shall specify the climatic, mechanical and electromagnetic environments in which the measuring instrument is intended to be used, the power supply and the other influence sizes liable to affect them Accuracy, taking into account the requirements set out in the ordinances on specific measuring instruments.

1.3.1

Climate Environments

The manufacturer shall specify the maximum and minimum temperatures chosen from the values shown in Table 1, unless otherwise provided for in the Ordinances on specific measuring instruments, and indicate whether the measuring instrument is designed For moisture with or without condensation and the place intended for the measuring instrument, i.e. open or closed.

Table 1

Temperature Limits

1.3.2

A. The mechanical environments are distributed between the M1 to M3 classes defined below.

M1

This class applies to measuring instruments used in places exposed to vibrations and small shocks, for example for measuring instruments fixed on light bearing structures subjected to vibration and shock Negligible due to local percussions or works, to doors that clap, etc.

MM2

This class applies to measuring instruments used in places exposed to a non-negligible or high level of vibration and shock, for example those transmitted by machinery and vehicles in the vicinity or on the side of machines Heavy, conveyor belts, etc.

M3

This class applies to measuring instruments used in places where the level of vibration and shock is high to very high, for example for measuring instruments mounted directly on machines, conveyor belts, etc.

B.

In connection with mechanical environments, the following influence sizes must be taken into account:

-

Vibrations;

-

Mechanical shock.

1.3.3

A. Electromagnetic environments are distributed between the E1, E2 and E3 classes as defined below, except as otherwise provided by ordinances on specific measuring instruments.

E1

This class applies to measuring instruments used in places where electromagnetic disturbances are consistent with those found in residential and commercial buildings and in light industry.

E2

This class applies to measuring instruments used in places where electromagnetic disturbances correspond to those that can be found in other industrial buildings.

E3

This class applies to measuring instruments powered by the battery of a vehicle. These measuring instruments shall comply with the requirements of Class E2 and the following additional requirements:

-

A decrease in the supply voltage caused by the initiation of the internal combustion engine starter circuits;

-

A transient loss of load that occurs when an unloaded battery is disconnected while the engine is running.

B.

In connection with electromagnetic environments, the following influence sizes must be taken into account:

-

Power cuts;

-

Brief voltage drops;

-

Voltage transient on power lines and/or signal lines;

-

Electrostatic discharge;

-

Radiated electromagnetic fields at radio frequencies;

-

Electromagnetic fields at radio frequencies that induce disturbances on the power lines and/or signal lines;

-

Shock waves on power lines and/or signal lines.

1.3.4

Other influence sizes to be taken into account where appropriate are:

-

Voltage variations;

-

Variations in frequency area;

-

Industrial frequency magnetic fields;

-

Any other size that may have a significant influence on the accuracy of the measuring instrument.

1.4

When carrying out the tests provided for in this order, the following requirements shall apply:

1.4.1

Basic Requirements for Error Determination

The essential requirements specified in the c. 1.1. And 1.2. Shall be verified for each relevant quantity of influence. Except as otherwise provided in the corresponding order on specific measuring instruments, these essential requirements shall apply when each size of influence is applied and its effect evaluated separately, all other sizes Of influence being maintained relatively constant at their reference value.

The metrological test shall be carried out during or after the application of the influence quantity, depending on the situation which corresponds to the normal state of operation of the measuring instrument when this magnitude of influence is likely to occur Present.

1.4.2

Ambient Humidity

-

Depending on the climatic environment in which the measuring instrument is intended to be used, the test can be carried out under moist heat under established regime (without condensation) or under cyclic wet heat (with condensation).

-

The cyclic wet heat test is appropriate in the event of significant condensation or when vapour penetration is accelerated by the effect of respiration. In the case of moisture without condensation, it is possible to opt for the wet heat test under established regime.

In case of application of the same measurand in different places and by different users, all other conditions being identical, the results of successive measurements must be very close to each other. The difference between the measurement results must be small compared to the EMT.

In the case of application of the same measurand under identical measuring conditions, the results of successive measurements shall be very close to each other. The difference between the measurement results must be small compared to the EMT.

The measuring instrument must be sufficiently sensitive and present a sufficiently low mobility threshold for the intended measurement.

The measuring instrument shall be designed to maintain adequate constancy of its metrological characteristics during a period evaluated by the manufacturer when, in the environmental conditions to which it is intended, it is correctly Installed, maintained and used in accordance with the manufacturer's instructions.

The measuring instrument must be designed in such a way that it best reduces the effect of a defect which would lead to an incorrect measurement result, unless the presence of such a defect is obvious.

7.1

The instrument of measurement shall not have any characteristics which may facilitate fraudulent use; the possibilities of unintentional misuse must be kept to a minimum.

7.2

The measuring instrument shall be suitable for the use for which it is intended, taking into account the practical operating conditions and shall not impose undue requirements on the user to obtain a correct measurement result.

7.3

Errors in an instrument of measurement for utility services to flows or currents outside the controlled range shall not be unduly biased.

7.4

When a measuring instrument is designed for the measurement of measurement values that are constant over time, the measuring instrument must either be insensitive to small fluctuations in the value of the measurand, or react appropriately.

7.5

The measuring instrument shall be robust, and the materials with which it is constructed shall be suitable for the intended conditions of use.

7.6

The measuring instrument shall be designed in such a way as to enable the monitoring of the measuring functions after the measuring instrument has been placed on the market and put into service. If necessary, special equipment or software for this control shall be integrated into the measuring instrument. The test procedure shall be described in the User Manual.

Where an instrument of measurement has an associated software which has other functions than that of measurement, the software which is essential for the metrological characteristics must be identifiable and cannot be influenced in an unacceptable manner by the Associated software.

8.1

The metrological characteristics of the measuring instrument shall not be unduly influenced by the connection to another device, by any characteristic of the connected device or by a remote device Communicates with the measuring instrument.

8.2

A material component which is essential for metrological characteristics must be designed in such a way that it can be rendered inviolable. The planned security arrangements must make any intervention clear.

8.3

The software that is essential for metrological characteristics must be identified as such and made inviolable.

The identification of the software must be easily delivered by the measuring instrument.

Evidence of intervention must be available for a reasonable period of time.

8.4

Measurement data, the software that is essential for metrological characteristics and parameters stored or transmitted and important from the metrological point of view must be sufficiently protected against accidental alteration or Intentional.

8.5

In the case of measuring instruments used by public utilities, the display of the total quantity delivered or the displays used to calculate the total delivered quantity, to which reference is made in whole or in part to establish The payment must not be allowed to be reset to zero in use.

9.1

The instrument of measurement shall bear the following entries:

-

The brand or name of the manufacturer;

-

Information about its accuracy;

And, if applicable:

-

Information on the conditions of use;

-

Measuring capacity;

-

The measurement range;

-

Identification marking;

-

The type examination certificate number or the design review certificate;

-

Information indicating whether the additional devices delivering metrological results comply with the provisions of this Ordinance relating to legal metrological control following their placing on the market.

9.2

Where the measuring instrument has too small dimensions or is too sensitive to contain the required information, the packaging, if any, and the documentation to accompany the measuring instrument in accordance with the Must be marked appropriately.

9.3

The instrument of measurement must be accompanied by information on its operation, unless the simplicity of the measuring instrument makes this information unnecessary. The information shall be readily understandable and include, where appropriate:

-

Nominal operating conditions;

-

Mechanical and electromagnetic environment classes;

-

The maximum and minimum temperatures, indications of whether or not condensation is possible, indications of whether it is an open or closed place;

-

Instructions for installation, maintenance, repairs, and qualifying adjustments;

-

Instructions for proper use and specific terms and conditions of use;

-

Compatibility conditions with interfaces, subsets, or measuring instruments.

9.4

In the case of groups of identical measuring instruments used in the same place or measurement instruments used for utility services, individual user manuals are not necessarily required.

9.5

Except as otherwise provided by ordinances on specific measuring instruments, the level of indication of a measured value shall be in form 1 ' 10 ^N , 2 ' 10 ^N Or 5 ' 10 ^N , where n is an integer or zero. The unit of measurement or its symbol must be indicated near the numerical value.

9.6

A materialized measure must bear a nominal value or a scale with a unit of measurement.

9.7

The units of measure used and their symbols shall comply with the provisions of the Ordinance of 23 November 1994 on units ² .

9.8

All marks and inscriptions required by any requirement must be clear, indelible, unambiguous and non-transferable.

10.1

The result must be indicated by display or as a printed copy.

10.2

The indication of any result must be clear and unambiguous; it must be accompanied by the marks and inscriptions necessary to inform the user of the meaning of the result. Under normal conditions of use, the specified result must be easily legible. Additional indications are permitted provided that they do not cause confusion with the metrologically controlled indications.

10.3

In the case of printed results, the printed copy must be easily legible and ineffable.

10.4

A measurement instrument for direct sale must be designed in such a way that, when installed as intended, it indicates the result of the measurement to the two parts of the transaction. Where this is of decisive importance in the context of direct sales, any ticket supplied to the consumer by means of an accessory device which does not satisfy the requirements of this order must bear the restrictive indications Appropriate.

10.5

Whether or not it is possible to remotely read a measuring instrument intended for measurement in the field of utility services, it must in any event be equipped with a controlled display system which is metrologically accessible to the public. Consumer without tools. The results of this display are used as the basis for determining the price to be paid.

10.6

The Federal Department of Justice and Police may provide for exceptions to the installation of a display system according to c. 10.5 when:

A.

The function of the display is ensured in another way, in particular where the measurement results are accessible in a manner equivalent to the consumers; and that

B.

There is no objection in international law.

11.1

A measuring instrument other than a measuring instrument used in the framework of utility services shall record by a sustainable means the result of the measurement and the information to identify a given commercial transaction:

-

When measurement is non-repeatable, and

-

Where the measuring instrument is normally intended for use in the absence of one of the parties to the transaction.

11.2

In addition, lasting proof of the measurement result and the information identifying the transaction must be available upon request at the time the measurement ends.

The measuring instrument shall be designed in such a way that it permits an easy assessment of its conformity with the requirements of this order.

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¹ Update as per c. I of the O of August 26, 2015, in force since 1 ^Er Oct. 2015 ( RO 2015 3083 ).
² RS 941.202

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State 1 ^Er January 2016

1

The declaration of conformity on the basis of an internal control of manufacture is the conformity assessment procedure by which the manufacturer fulfils the obligations laid down in this module, but also ensures and declares that the The measuring instruments concerned satisfy the essential requirements laid down in this order.

2

The manufacturer shall establish the technical documentation described in c. II. The documentation shall permit the assessment of the conformity of the measuring instrument with the corresponding requirements laid down in this order. It shall cover, to the extent necessary for this evaluation, the design, manufacture and operation of the measuring instrument.

3

The manufacturer shall keep this documentation available to the competent authorities for a period of ten years from the time of manufacture of the last measuring instrument.

4

The manufacturer shall take all measures necessary to ensure the conformity of the measuring instruments manufactured with the corresponding requirements laid down in this order.

5

The manufacturer shall affix the mark of conformity and the additional metrological marking on each measuring instrument which meets the corresponding requirements laid down in this order.

6

A declaration of conformity shall be drawn up for each model of measuring instrument and shall be made available to the competent authorities for a period of ten years from the manufacture of the last measuring instrument. It identifies the model of the measurement instrument for which it is based.

A copy of the declaration accompanies each measuring instrument placed on the market. However, this requirement can be interpreted as applying to a set or batch rather than to individual measuring instruments when many measuring instruments are delivered to a single user.

7

The manufacturer's obligations under c. 3 and 6 may be completed, on its behalf and under its responsibility, by its representative established in Switzerland.

Where the manufacturer is not established in Switzerland and has no agent in Switzerland, the obligations referred to in c. 3 and 6 is the responsibility of the importer or any other person placing the measuring instrument on the Swiss market.

1

The declaration of conformity on the basis of an internal control of the manufacture and testing of the product by a conformity assessment body is the conformity assessment procedure by which the manufacturer fulfils the obligations As defined in this module, but also ensures and declares that the measuring instruments concerned satisfy the essential requirements laid down in this order.

2

The manufacturer shall establish the technical documentation described in c. II. The documentation shall permit the assessment of the conformity of the measuring instrument with the corresponding requirements laid down in this order. It shall cover, to the extent necessary for this evaluation, the design, manufacture and operation of the measuring instrument.

3

The manufacturer shall keep this documentation available to the competent authorities for a period of ten years from the time of manufacture of the last measuring instrument.

4

The manufacturer shall take all measures necessary to ensure the conformity of the measuring instruments manufactured with the corresponding requirements laid down in this order.

5

A conformity assessment body chosen by the manufacturer shall carry out or have carried out checks on the product at appropriate intervals, in order to verify the quality of the internal controls of the product, taking into account, in particular, the Technological complexity of measuring instruments and production volume. An appropriate sample of finished products, collected by the conformity assessment body prior to placing on the market, shall be examined and the appropriate tests described by the relevant document (s) referred to in s. 7, or equivalent tests, shall be carried out to verify the conformity of the measuring instruments with the corresponding requirements laid down in this order. In the absence of a relevant document, the conformity assessment body shall decide on appropriate tests to be carried out.

If a specified number of measurement instruments in the sample do not conform to an acceptable level of quality, the conformity assessment body shall take the appropriate measures.

6

The manufacturer shall affix the mark of conformity, the additional metrological marking and, under the responsibility of the conformity assessment body referred to in the c. 5, the identification number of the latter on each measuring instrument that meets the corresponding requirements set out in this order.

7

A declaration of conformity shall be drawn up for each model of measuring instrument and shall be made available to the competent authorities for a period of ten years from the manufacture of the last measuring instrument. It identifies the model of the measurement instrument for which it is based.

A copy of the declaration accompanies each measuring instrument placed on the market. However, this requirement can be interpreted as applying to a set or batch rather than to individual measuring instruments when many measuring instruments are delivered to a single user.

8

The manufacturer's obligations under c. 3 and 7 may be fulfilled, on its behalf and under its responsibility, by its representative established in Switzerland.

Where the manufacturer is not established in Switzerland and has no agent in Switzerland, the obligations referred to in c. 3 and 7 is the responsibility of the importer or any other person placing the measuring instrument on the Swiss market.

1

The type examination is the part of the conformity assessment procedure by which a conformity assessment body reviews the technical design of a measuring instrument, but also ensures and declares that the technical design Meets the essential requirements set out in this order which are applicable to the instrument of measurement concerned.

2

The type test can be performed using one of the following methods. The conformity assessment body shall decide on the appropriate method and samples required:

A.

Examination of a sample, representative of the manufacturing concerned, of the complete measuring instrument;

B.

Examination of samples, representative of the manufacture concerned, of one or more critical parts of the measuring instrument, supplemented by an assessment of the adequacy of the technical design of the other parts of the measuring instrument by A review of the technical documentation and additional evidence referred to in c. 3;

C.

Assessment of the adequacy of the technical design of the measuring instrument through a review of the technical documentation and additional evidence referred to in c. 3, without examination of a sample.

3

The application for a type examination must be submitted by the manufacturer to a conformity assessment body of its choice.

The application must include:

-

The name and address of the manufacturer, but also the name and address of the representative if he or she submits the application;

-

A written statement that the same application was not submitted to another conformity assessment body;

-

The technical documentation described in c. II. The documentation shall permit the assessment of the conformity of the measuring instrument with the corresponding requirements laid down in this order. It shall cover, to the extent necessary for this evaluation, the design, manufacture and operation of the measuring instrument;

-

Samples, representative of the manufacture concerned, required by the conformity assessment body;

-

Additional evidence to assess the adequacy of the technical design of the parts of the measuring instrument for which a sample is not required. This additional evidence must contain a reference to all relevant documents that have been applied, in particular where the relevant documents referred to in s. 7 have not been fully applied, and include, where applicable, the results of tests carried out by the appropriate manufacturer's laboratory or by another test laboratory on its behalf and under its responsibility.

4

The conformity assessment body shall perform the following tasks:

In relation to samples:

4.1

The conformity assessment body shall review the technical documentation, verify that the samples have been manufactured in accordance with the technical documentation and identify the elements which have been designed in accordance with the applicable provisions of the documents Relevant to s. 7 as well as the elements whose design does not rely on the provisions of the said documents;

4.2

Conducting or conducting the appropriate tests and tests to ensure that, in the event that the manufacturer chooses to apply the solutions identified in the relevant documents referred to in s. 7, these have been correctly applied;

4.3

Conducting or conducting the appropriate tests and tests to ensure that, in the event that the manufacturer chooses not to apply the solutions identified in the relevant documents referred to in s. 7, the solutions that it has adopted meet the essential requirements set out in this order;

4.4

It agrees with the applicant where the examinations and tests will be carried out.

In relation to other parts of the ' Measuring instrument:

4.5

The conformity assessment body shall examine the technical documentation and additional evidence to assess the adequacy of the technical design of the other parts of the measuring instrument.

In relation to the manufacturing process:

4.6

The conformity assessment body shall examine the technical documentation to determine whether the manufacturer has the appropriate means to ensure regular manufacture.

5.1

The conformity assessment body shall draw up an evaluation report listing the activities carried out in accordance with the c. 4 and their results. Without prejudice to Annex 3, c. 8, it must disclose the contents of this report in whole or in part only with the consent of the manufacturer.

5.2

Where the technical design satisfies the requirements set out in this order which are applicable to the measuring instrument, the conformity assessment orga-nisme shall issue to the applicant a certificate of exa-men of type. The certificate shall contain the name and address of the manufacturer and, where appropriate, his authorised representative, the conclusions of the examination, the possible conditions of the validity of the certificate and the data necessary for the identification of the device Measurement. One or more schedules can be attached to the certificate.

The certificate and its annexes must contain all relevant information for conformity assessment and in-service control. In order to allow conformity assessment of measuring instruments manufactured with the type examined in respect of the reproducibility of their metrological performance when properly adjusted using the appropriate means, they Must include:

-

Metrological characteristics of the type of measurement instrument;

-

Measures to ensure the integrity of the measuring instrument (sealing, identification of software, etc.);

-

Information concerning other elements necessary for the identification of the measuring instrument and verification of its external visual conformity with the type;

-

Where appropriate, all the specific information necessary to verify the characteristics of the measuring instruments manufactured;

-

In the case of a subset, all the information necessary to ensure compatibility with other sub-assemblies or measuring instruments.

The certificate shall be valid for ten years from the date of its grant and may be renewed for new periods of ten years.

5.3

The conformity assessment body shall draw up an evaluation report in that regard and shall keep it available to the Contracting State which appointed it.

6

The manufacturer shall inform the conformity assessment body which holds the technical documentation of the type examination certificate of all modifications to the measuring instrument which may call into question the conformity of the instrument Measure with the essential requirements or the conditions of validity of the certificate. These amendments require further approval in the form of an addendum to the original type examination certificate.

7

Each conformity assessment body shall immediately inform the Contracting State which has appointed it on the following:

-

Certificates of examination of type issued and their annexes;

-

Additives and amendments relating to certificates already issued.

Each conformity assessment body shall immediately inform the Contracting State which designated it in the event of revocation of a type examination certificate.

The conformity assessment body shall keep the technical documentation, including the documentation provided by the manufacturer, for a period of up to the end of the validity of the certificate.

8

The manufacturer shall maintain with the technical documentation a copy of the type examination certificate, its annexes, additives and modifications for a period of ten years from the manufacture of the last measuring instrument.

9

The manufacturer's agent may file the application referred to in c. 3 and meet the obligations set out in c. 6 and 8.

Where the manufacturer is not established in Switzerland and has no agent in Switzerland, the obligation to provide the technical documentation upon request shall be the responsibility of the person designated by the manufacturer.

1

The declaration of conformity to the type on the basis of an internal control of manufacture is the part of the conformity assessment procedure by which the manufacturer fulfils the obligations laid down in this module, but also ensures and Declares that the measuring instruments concerned conform to the type described in the type examination certificate and meet the corresponding requirements set out in this order.

2

The manufacturer shall take all measures necessary to ensure the conformity of measuring instruments manufactured with the type described in the type examination certificate and with the corresponding requirements laid down in this order.

3

The manufacturer shall affix the mark of conformity and the additional metrological marking on each measuring instrument which complies with the type described in the type examination certificate and satisfies the corresponding requirements defined in the This order.

4

A declaration of conformity shall be drawn up for each model of measuring instrument and shall be made available to the competent authorities for a period of ten years from the manufacture of the last measuring instrument. It identifies the model of the measurement instrument for which it is based.

A copy of the return must be provided with each measuring instrument placed on the market. However, this requirement can be interpreted as applying to a set or batch rather than to individual measuring instruments when many measuring instruments are delivered to a single user.

5

The manufacturer's obligations under c. 4 may be fulfilled, in its name and under its responsibility, by its representative established Switzerland.

Where the manufacturer is not established in Switzerland and has no representative in Switzerland, the obligation referred to in c. 4 is the responsibility of the importer or any other person placing the measuring instrument on the Swiss market.

1

The declaration of conformity to the type on the basis of a control of the manufacture and testing of the product by a conformity assessment body shall be the part of the conformity assessment procedure by which the manufacturer completes the Obligations set out in this module, but also assures and declares that the measuring instruments concerned conform to the type described in the type examination certificate and meet the corresponding requirements defined in the present Order.

2

The manufacturer shall take all measures necessary to ensure the conformity of measuring instruments manufactured with the type described in the type examination certificate and with the corresponding requirements laid down in this order.

3

A conformity assessment body, chosen by the manufacturer, shall carry out or have carried out checks on the product at appropriate intervals, which it shall determine, in order to verify the quality of the internal controls of the product, taking account in particular of The technological complexity of measuring instruments and the volume of production. An appropriate sample of the finished products, taken by the conformity assessment body prior to placing on the market, shall be examined and appropriate tests described by the relevant document (s) referred to in Art. 7, or equivalent tests, shall be performed to verify the conformity of the product with the type described in the type examination certificate and with the corresponding requirements set out in this order. In the absence of a relevant document, the conformity assessment body shall decide on appropriate tests to be carried out.

If a specified number of measurement instruments in the sample do not conform to an acceptable level of quality, the conformity assessment body shall take the appropriate measures.

4

The manufacturer shall affix the mark of conformity, the additional metrological marking and, under the responsibility of the conformity assessment body referred to in the c. 3, the identification number of the latter on each measuring instrument that conforms to the type described in the type examination certificate and meets the corresponding requirements set out in this order.

5

A declaration of conformity shall be drawn up for each model of measuring instrument and shall be made available to the competent authorities for a period of ten years from the manufacture of the last measuring instrument. It identifies the model of the measurement instrument for which it is based.

A copy of the return must be provided with each measuring instrument placed on the market. However, this requirement can be interpreted as applying to a set or batch rather than to individual measuring instruments when many measuring instruments are delivered to a single user.

6

The manufacturer's obligations under c. 5 may be completed, on its behalf and under its responsibility, by its representative established in Switzerland.

Where the manufacturer is not established in Switzerland and has no representative in Switzerland, the obligation referred to in c. 5 is the responsibility of the importer or any other person placing the measuring instrument on the Swiss market.

1

The declaration of conformity to the type on the basis of quality assurance of the manufacturing process is the part of the conformity assessment procedure by which the manufacturer fulfils the obligations defined in this module, but Shall also ensure and declare that the measuring instruments concerned conform to the type described in the type examination certificate and meet the corresponding requirements laid down in this order.

2

The manufacturer shall implement, for the manufacture, the final inspection of the product and the tests of the instrument of measurement concerned, a recognised quality management system, as specified in the c. 3, and is subject to the supervision referred to in c. 4.

3.1

The manufacturer shall submit to the conformity assessment body its choice of a request for the evaluation of its quality management system.

The application must include:

-

All relevant information on the category of measurement instruments considered;

-

Documentation of the quality management system;

-

The technical documentation for the approved type and a copy of the examination certificate of this type.

3.2

The quality management system shall ensure the conformity of the measuring instruments with the type described in the examination certificate of this type and with the corresponding requirements laid down in this order.

All elements, requirements and provisions adopted by the manufacturer shall be the subject of systematic and regulatory documentation in the form of written principles, procedures and instructions. This quality management system documentation should allow for a consistent interpretation of quality programs, plans, manuals and reports.

This documentation shall include, in particular, an adequate description:

-

Quality objectives as well as the organization, responsibilities and authority of the management in terms of product quality;

-

Manufacturing techniques and processes, quality control and assurance, and other systematic measures to be used;

-

Tests and tests to be carried out before, during and after manufacture, and their frequency;

-

Quality reports such as inspection reports, test and calibration data and reports on the qualification of the personnel involved;

-

Means to monitor the achievement of the quality required for the product and the proper functioning of the quality management system.

3.3

The conformity assessment body shall assess the quality management system to determine whether it meets the requirements set out in c. 3.2. It shall presume compliance with these requirements where a quality management system complies with the corresponding specifications of the Swiss standard which transposes the relevant harmonised standard, from the date on which its references have Published.

In addition to experience in quality management systems, the audit team must have sufficient experience in the relevant field of metrology and instrumental technology as well as a knowledge of the applicable requirements Defined in this order. The evaluation procedure shall include an inspection visit to the manufacturer's premises.

The decision on the evaluation of the quality management system shall be notified to the manufacturer. The notification shall include the conclusions of the examination and the reasoned assessment decision.

3.4

The manufacturer is committed to fulfilling the obligations of the quality management system as it is recognized and to ensuring that it remains adequate and effective.

3.5

The manufacturer shall inform the conformity assessment body which has recognised the quality management system of any draft amendments to it.

The conformity assessment body shall evaluate the proposed amendments and decide whether the modified quality management system will still satisfy the requirements referred to in the c. 3.2 or if re-evaluation is required.

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

4.1

The purpose of monitoring is to ensure that the manufacturer properly meets the obligations arising from the recognized quality management system.

4.2

The manufacturer shall authorize the conformity assessment body to access, for inspection purposes, the premises of manufacture, inspection, testing and storage and shall provide it with all necessary information, in particular:

-

Documentation of the quality management system;

-

Quality records such as inspection reports, test and calibration data and reports on the qualification of the personnel involved.

4.3

The conformity assessment body shall conduct periodic audits to ensure that the manufacturer maintains and applies the quality management system and provides an audit report to the manufacturer.

4.4

In addition, the conformity assessment body may make impromptu visits to the manufacturer. On the occasion of such visits, it may, if necessary, carry out or have carried out product tests intended to verify the proper functioning of the quality management system. It shall provide the manufacturer with a report on the visit and, if a trial is carried out, a test report.

5

The manufacturer shall affix the mark of conformity, the additional metrological marking and, under the responsibility of the conformity assessment body referred to in the c. 3.1, the identification number of the latter on each measuring instrument conforming to the type described in the type examination certificate and meeting the corresponding requirements set out in this order.

6

A declaration of conformity shall be drawn up for each model of measuring instrument and shall be made available to the competent authorities for a period of ten years from the manufacture of the last measuring instrument. It identifies the model of the measurement instrument for which it is based.

A copy of the return must be provided with each measuring instrument placed on the market. However, this requirement can be interpreted as applying to a set or batch rather than to individual measuring instruments when many measuring instruments are delivered to a single user.

7

The manufacturer shall make available to the competent authorities for a period of ten years from the manufacture of the last measuring instrument:

-

The documentation referred to in c. 3.1, second indent;

-

The amendments referred to in c. 3.5;

-

The decisions and reports of the conformity assessment body referred to in c. 3.5, 4.3 and 4.4.

8

Each conformity assessment body shall periodically make available to the Contracting State which has designated it the list of recognition of quality management systems issued or refused and shall immediately inform the State which has it Designated in case of revocation of recognition of a quality management system.

9

The manufacturer's obligations under c. 3.1, 3.5, 6 and 7 may be completed, on its behalf and under its responsibility, by its representative established in Switzerland.

1

The declaration of conformity on the basis of quality assurance of the manufacturing process is the part of the conformity assessment procedure by which the manufacturer fulfils the obligations defined in this module, but also Ensures and declares that the measuring instruments concerned satisfy the corresponding requirements laid down in this order.

2

The manufacturer shall establish the technical documentation described in c. II. The documentation shall permit the assessment of the conformity of the measuring instrument with the corresponding requirements laid down in this order. It shall cover, to the extent necessary for this evaluation, the design and operation of the measuring instrument.

3

The manufacturer shall keep this documentation available to the competent authorities for a period of ten years from the time of manufacture of the last measuring instrument.

4

The manufacturer shall implement, for the manufacture, the final inspection of the product and the tests of the instrument of measurement concerned, a recognised quality management system, as specified in the c. 5, and is subject to the supervision referred to in c. 6.

5.1

The manufacturer shall submit to the conformity assessment body its choice of a request for the evaluation of its quality management system.

The application must include:

-

All relevant information on the category of measurement instruments considered;

-

Documentation of the quality management system;

-

The technical documentation referred to in c. 2.

5.2

The quality management system shall ensure the conformity of the measuring instruments with the corresponding requirements laid down in this order.

All elements, requirements and provisions adopted by the manufacturer shall be the subject of systematic and regulatory documentation in the form of written principles, procedures and instructions. This quality management system documentation should allow for a consistent interpretation of quality programs, plans, manuals and reports.

This documentation shall include, in particular, an adequate description:

-

Quality objectives as well as the organization, responsibilities and authority of the management in terms of product quality;

-

Manufacturing techniques and processes, quality control and assurance, and other systematic measures to be used;

-

Tests and tests to be carried out before, during and after manufacture, and their frequency;

-

Quality reports such as inspection reports, test and calibration data and reports on the qualification of the personnel involved;

-

Means to monitor the achievement of the quality required for the product and the proper functioning of the quality management system.

5.3

The conformity assessment body shall assess the quality management system to determine whether it meets the requirements set out in c. 5.2. It shall presume compliance with these requirements where a quality management system complies with the corresponding specifications of the Swiss standard which transposes the relevant harmonised standard, from the date on which its references have Published.

In addition to experience in quality management systems, the audit team must have sufficient experience in the relevant field of metrology and instrumental technology as well as a knowledge of the applicable requirements Defined in this order. The evaluation procedure shall include an inspection visit to the manufacturer's premises.

The decision on the evaluation of the quality management system shall be notified to the manufacturer. The notification shall include the conclusions of the examination and the reasoned assessment decision.

5.4

The manufacturer is committed to fulfilling the obligations of the quality management system as it is recognized and to ensuring that it remains adequate and effective.

5.5

The manufacturer shall periodically inform the conformity assessment body which has recognised the quality management system of any draft amendments to it.

The conformity assessment body shall evaluate the proposed amendments and decide whether the modified quality management system will still satisfy the requirements referred to in the c. 5.2 or if re-evaluation is required.

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

6.1

The purpose of monitoring is to ensure that the manufacturer properly meets the obligations arising from the recognized quality management system.

6.2

The manufacturer shall authorize the conformity assessment body to access, for inspection purposes, the premises of manufacture, inspection, testing and storage and shall provide it with all necessary information, in particular:

-

Documentation of the quality management system;

-

The technical documentation referred to in c. 2;

-

Quality records such as inspection reports, test and calibration data and reports on the qualification of the personnel involved.

6.3

The conformity assessment body shall conduct periodic audits to ensure that the manufacturer maintains and applies the quality management system and provides an audit report to the manufacturer.

6.4

In addition, the conformity assessment body may make impromptu visits to the manufacturer. On the occasion of such visits, it may, if necessary, carry out or have carried out product tests intended to verify the proper functioning of the quality management system. It shall provide the manufacturer with a report on the visit and, if a trial is carried out, a test report.

7

The manufacturer shall affix the mark of conformity, the additional metrological marking and, under the responsibility of the conformity assessment body referred to in the c. 5.1, the identification number of the latter on each measuring instrument that meets the corresponding requirements set out in this order.

8

A declaration of conformity shall be drawn up for each model of measuring instrument and shall be made available to the competent authorities for a period of ten years from the manufacture of the last measuring instrument. It identifies the model of the measurement instrument for which it is based.

A copy of the return must be provided with each measuring instrument placed on the market. However, this requirement can be interpreted as applying to a set or batch rather than to individual measuring instruments when many measuring instruments are delivered to a single user.

9

The manufacturer shall make available to the competent authorities for a period of ten years from the manufacture of the last measuring instrument:

-

The documentation referred to in c. 5.1, second indent;

-

The amendments referred to in c. 5.5;

-

The decisions and reports of the conformity assessment body referred to in c. 5.5, 6.3 and 6.4.

10

Each conformity assessment body shall periodically make available to the Contracting State which has designated it the list of recognition of quality management systems issued or refused and shall immediately inform the State which has it Designated in case of revocation of recognition of a quality management system.

11

The manufacturer's obligations under c. 3, 5.1, 5.5, 8 and 9 may be completed, on its behalf and under its responsibility, by its representative established in Switzerland.

1

The declaration of conformity to the type on the basis of quality assurance of the inspection and testing of the finished product is the part of the conformity assessment procedure by which the manufacturer fulfils the obligations defined in the Module, but also assures and declares that the measuring instruments concerned conform to the type described in the type examination certificate and meet the corresponding requirements set out in this order.

2

The manufacturer shall implement, for the final inspection of the product and the tests of the instrument of measurement concerned, a recognised quality management system, as specified in the c. 3, and is subject to the supervision referred to in c. 4.

3.1

The manufacturer shall submit a request for the assessment of its quality management system to a conformity assessment body of its choice.

The application must include:

-

All relevant information on the category of measurement instruments considered;

-

Documentation of the quality management system;

-

The technical documentation for the approved type and a copy of the type examination certificate.

3.2

The quality management system shall ensure the conformity of the measuring instruments with the type described in the type examination certificate and with the corresponding requirements set out in this order.

All elements, requirements and provisions adopted by the manufacturer shall be the subject of systematic and regulatory documentation in the form of written principles, procedures and instructions. This quality management system documentation should allow for a consistent interpretation of quality programs, plans, manuals and reports.

This documentation shall include, in particular, an adequate description:

-

Quality objectives as well as the organization, responsibilities and authority of the management in terms of product quality;

-

Tests and tests to be carried out after manufacture;

-

Quality reports such as inspection reports, test and calibration data and reports on the qualification of the personnel involved;

-

Ways to monitor the proper functioning of the quality management system.

3.3

The conformity assessment body shall assess the quality management system to determine whether it meets the requirements set out in c. 3.2. It shall presume compliance with these requirements where a quality management system complies with the corresponding specifications of the Swiss standard which transposes the relevant harmonised standard, from the date on which its references have Published.

In addition to experience in quality management systems, the audit team must have sufficient experience in the relevant field of metrology and instrumental technology as well as a knowledge of the applicable requirements Defined in this order. The evaluation procedure shall include an inspection visit to the manufacturer's premises.

The decision on the evaluation of the quality management system shall be notified to the manufacturer. The notification shall include the conclusions of the examination and the reasoned assessment decision.

3.4

The manufacturer is committed to fulfilling the obligations of the quality management system as it is recognized and to ensuring that it remains adequate and effective.

3.5

The manufacturer shall inform the conformity assessment body which has recognised the quality management system of any draft amendments to it.

The conformity assessment body shall evaluate the proposed amendments and decide whether the modified quality management system will still satisfy the requirements referred to in the c. 3.2 or if re-evaluation is required.

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

4.1

The purpose of monitoring is to ensure that the manufacturer properly meets the obligations arising from the recognized quality management system.

4.2

The manufacturer shall authorize the conformity assessment body to access, for inspection purposes, the premises of manufacture, inspection, testing and storage and shall provide it with all necessary information, in particular:

-

Documentation of the quality management system;

-

Quality records such as inspection reports, test and calibration data and reports on the qualification of the personnel involved.

4.3

The conformity assessment body shall conduct periodic audits to ensure that the manufacturer maintains and applies the quality management system and provides an audit report to the manufacturer.

4.4

In addition, the conformity assessment body may make impromptu visits to the manufacturer. On the occasion of such visits, it may, if necessary, carry out or have carried out product tests intended to verify the proper functioning of the quality management system. It shall provide the manufacturer with a report on the visit and, if a trial is carried out, a test report.

5

The manufacturer shall affix the mark of conformity, the additional metrological marking and, under the responsibility of the conformity assessment body referred to in the c. 3.1, the identification number of the latter on each measuring instrument conforming to the type described in the type examination certificate and meeting the corresponding requirements set out in this order.

6

A declaration of conformity shall be drawn up for each model of measuring instrument and shall be made available to the competent authorities for a period of ten years from the manufacture of the last measuring instrument. It identifies the measuring instrument model for which it is based.

A copy of the return must be provided with each measuring instrument placed on the market. However, this requirement can be interpreted as applying to a set or batch rather than to individual measuring instruments when many instruments are delivered to a single user.

7

The manufacturer shall make available to the competent authorities for a period of ten years from the manufacture of the last measuring instrument:

-

The documentation referred to in c. 3.1, second indent;

-

The amendments referred to in c. 3.5, para. 2;

-

The decisions and reports of the conformity assessment body referred to in c. 3.5, last paragraph, and c. 4.3 and 4.4.

8

Each conformity assessment body shall periodically make available to the Contracting State which has designated it the list of recognition of quality management systems issued or refused and shall immediately inform the State which has it Designated in case of revocation of recognition of a quality management system.

9

The manufacturer's obligations under c. 3.1, 3.5, 6 and 7 may be completed, on its behalf and under its responsibility, by its representative established in Switzerland.

1

The declaration of conformity on the basis of quality assurance of the inspection and testing of the finished product is the conformity assessment procedure by which the manufacturer fulfils the obligations defined in this module, but Shall also ensure and declare that the measuring instruments concerned satisfy the corresponding requirements laid down in this order.

2

The manufacturer shall establish the technical documentation described in c. II. The documentation shall permit the assessment of the conformity of the measuring instrument with the corresponding requirements laid down in this order. It shall cover, to the extent necessary for this evaluation, the design, manufacture and operation of the measuring instrument.

3

The manufacturer shall keep this documentation available to the competent authorities for a period of ten years from the time of manufacture of the last measuring instrument.

4

The manufacturer shall implement, for the final inspection of the product and the tests of the instrument of measurement concerned, a recognised quality management system, as specified in the c. 5, and is subject to the supervision referred to in c. 6.

5.1

The manufacturer shall submit a request for the assessment of its quality management system to a conformity assessment body of its choice.

The application must include:

-

All relevant information on the category of measurement instruments considered;

-

Documentation of the quality management system;

-

The technical documentation referred to in c. 2.

5.2

The quality management system shall ensure the conformity of the measuring instruments with the corresponding requirements laid down in this order.

All elements, requirements and provisions adopted by the manufacturer shall be the subject of systematic and regulatory documentation in the form of written principles, procedures and instructions. This quality management system documentation should allow for a consistent interpretation of quality programs, plans, manuals and reports.

This documentation shall include, in particular, an adequate description:

-

Quality objectives as well as the organization, responsibilities and authority of the management in terms of product quality;

-

Tests and tests to be carried out after manufacture;

-

Quality reports such as inspection reports, test and calibration data and reports on the qualification of the personnel involved;

-

Ways to monitor the proper functioning of the quality management system.

5.3

The conformity assessment body shall assess the quality management system to determine whether it meets the requirements set out in c. 5.2. It shall presume compliance with these requirements where a quality management system complies with the corresponding specifications of the Swiss standard which transposes the relevant harmonised standard, from the date on which its references have Published.

In addition to experience in quality management systems, the audit team must have sufficient experience in the relevant field of metrology and instrumental technology as well as a knowledge of the applicable requirements Defined in this order. The evaluation procedure shall include an inspection visit to the manufacturer's premises.

The decision on the evaluation of the quality management system shall be notified to the manufacturer. The notification shall include the conclusions of the examination and the reasoned assessment decision.

5.4

The manufacturer is committed to fulfilling the obligations of the quality management system as it is recognized and to ensuring that it remains adequate and effective.

5.5

The manufacturer shall inform the conformity assessment body which has recognised the quality management system of any draft amendments to it.

The conformity assessment body shall evaluate the proposed amendments and decide whether the modified quality management system will still satisfy the requirements referred to in the c. 5.2 or if re-evaluation is required.

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

6.1

The purpose of monitoring is to ensure that the manufacturer properly meets the obligations arising from the recognized quality management system.

6.2

The manufacturer shall authorise the conformity assessment body to access, for inspection purposes, the inspection, testing and storage facilities; it shall provide it with all necessary information, in particular:

-

Documentation of the quality management system;

-

The technical documentation referred to in c. 2;

-

Quality records such as inspection reports, test and calibration data and reports on the qualification of the personnel involved.

6.3

The conformity assessment body shall conduct periodic audits to ensure that the manufacturer maintains and applies the quality management system and provides an audit report to the manufacturer.

6.4

In addition, the conformity assessment body may make impromptu visits to the manufacturer. On the occasion of such visits, it may, if necessary, carry out or have carried out product tests intended to verify the proper functioning of the quality management system. It shall provide the manufacturer with a report on the visit and, if a trial is carried out, a test report.

7

The manufacturer shall affix the mark of conformity, the additional metrological marking and, under the responsibility of the conformity assessment body referred to in the c. 5.1, the identification number of the latter on each measuring instrument that meets the corresponding requirements set out in this order.

8

A declaration of conformity shall be drawn up for each model of measuring instrument and shall be made available to the competent authorities for a period of ten years from the manufacture of the last measuring instrument. It identifies the model of the measurement instrument for which it is based.

A copy of the return must be provided with each measuring instrument placed on the market. However, this requirement can be interpreted as applying to a set or batch rather than to individual measuring instruments when many measuring instruments are delivered to a single user.

9

The manufacturer shall make available to the competent authorities for a period of ten years from the manufacture of the last measuring instrument:

-

The documentation referred to in c. 5.1, second indent;

-

The amendments referred to in c. 5.5;

-

The decisions and reports of the conformity assessment body referred to in c. 5.5, 6.3 and 6.4.

10

Each conformity assessment body shall periodically make available to the Contracting State which has designated it the list of recognition of quality management systems issued or refused and shall immediately inform the State which has it Designated in case of revocation of recognition of a quality management system.

11

The manufacturer's obligations under c. 3, 5.1, 5.5, 8 and 9 may be completed, on its behalf and under its responsibility, by its representative established in Switzerland.

1

The declaration of conformity to the type on the basis of a verification of the product is the part of the conformity assessment procedure by which the manufacturer fulfils the obligations laid down in this module, but also assures and declares that The instruments of measurement which have been submitted to the procedure referred to in c. 3 conform to the type described in the type examination certificate and meet the corresponding requirements set out in this order.

2

The manufacturer shall take all necessary measures to ensure that the measuring instruments manufactured comply with the approved type described in the type examination certificate and the corresponding requirements set out in this order.

3

A conformity assessment body chosen by the manufacturer shall carry out or have carried out the appropriate tests and tests to verify the conformity of the measuring instruments with the type described in the type examination certificate and with the Corresponding requirements as set out in this order.

Tests and tests intended to verify compliance with metrological requirements shall be carried out, at the choice of the manufacturer, either by examination and testing of each measuring instrument as described in c. 4, by examination and testing of measuring instruments on a statistical basis as described in c. 5.

4

Verification of compliance with metrological requirements by examination and testing of each measuring instrument

4.1

All instruments must be examined individually and subjected to appropriate tests as defined in the relevant documents referred to in s. 7, or equivalent tests, to verify compliance with the corresponding requirements set out in this order. In the absence of a relevant document, the conformity assessment body shall decide on appropriate tests to be carried out.

4.2

The conformity assessment body shall issue a certificate of conformity with regard to the examinations and tests carried out and affix, or cause to be affixed to it, its identification number on each approved instrument of measurement.

The manufacturer shall keep the certificates of conformity available to the competent authorities for inspection for a period of ten years from the date of the certification of the measuring instrument.

5

Statistical audit of compliance with metrological requirements

5.1

The manufacturer shall take all necessary measures to ensure that the manufacturing process ensures the homogeneity of each batch produced and presents its measuring instruments to be verified in the form of homogeneous lots.

5.2

A sample shall be drawn at random from each lot according to the c. 5.3. All instruments of the sample shall be examined individually, and appropriate tests, as defined in the relevant documents referred to in s. 7, or equivalent tests, to determine their compliance with the metrological requirements, shall be performed to determine the acceptance or rejection of the lot. In the absence of a relevant document, the conformity assessment body shall decide on appropriate tests to be carried out.

5.3

The statistical procedure must meet the following requirements:

Statistical control is performed by attributes. The sampling system shall ensure:

-

A normal quality level corresponding to a 95 % probability of acceptance, with a non-compliance of less than 1 %;

-

A quality level corresponding to a 5 % probability of acceptance, with a non-compliance of more than 7 %.

5.4

When a lot is accepted, all measuring instruments in that lot are accepted, with the exception of the sample measuring instruments that have been found to be non-compliant.

The conformity assessment body shall issue a certificate of conformity on the basis of examinations and tests carried out and shall affix, or cause to be affixed to it, its identification number on each approved instrument of measurement.

The manufacturer shall keep the certificates of conformity available to the competent authorities for inspection for a period of ten years from the date of the certification of the measuring instrument.

5.5

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

6

The manufacturer shall affix the mark of conformity and the additional metrological marking on each measuring instrument which complies with the approved type and meets the corresponding requirements laid down in this order.

7

A declaration of conformity shall be drawn up for each model of measuring instrument and shall be made available to the competent authorities for a period of ten years from the manufacture of the last measuring instrument. It identifies the model of the measurement instrument for which it is based.

A copy of the return must be provided with each measuring instrument placed on the market. However, this requirement can be interpreted as applying to a set or batch rather than to individual measuring instruments when many measuring instruments are delivered to a single user.

If the conformity assessment body referred to in c. 3 gives its agreement, the manufacturer also affix, under the responsibility of that body, the identification number of the latter on the measuring instruments.

8

If the conformity assessment body agrees, the manufacturer may, under the responsibility of the conformity assessment body, affix the manufacturer's identification number to the measuring instruments during the manufacturing process.

9

The obligations of the manufacturer may be fulfilled, in his name and under his responsibility, by his authorised representative in Switzerland, with the exception of the obligations referred to in c. 2 and 5.1.

1

The declaration of conformity on the basis of a verification of the product is the conformity assessment procedure by which the manufacturer fulfils the obligations laid down in this module, but also ensures and declares that the instruments of Measure which have been submitted to the procedure referred to in c. 5 are in accordance with the corresponding requirements set out in this order.

2

The manufacturer shall establish the technical documentation described in c. II. The documentation shall permit the assessment of the conformity of the measuring instrument with the corresponding requirements laid down in this order. It shall cover, to the extent necessary for this evaluation, the design, manufacture and operation of the measuring instrument.

3

The manufacturer shall keep this documentation available to the competent authorities for a period of ten years from the time of manufacture of the last measuring instrument.

4

The manufacturer shall take all necessary measures to ensure that the manufactured instruments comply with the corresponding requirements laid down in this order.

5

A conformity assessment body chosen by the manufacturer shall carry out or have carried out the appropriate tests and tests to verify the conformity of the measuring instruments with the corresponding requirements laid down in this order.

Tests and tests intended to verify compliance with metrological requirements shall be carried out, at the choice of the manufacturer, either by examination and testing of each measuring instrument as described in c. 6, by means of control and testing of measuring instruments on a statistical basis as described in c. 7.

6

Verification of compliance with metrological requirements by checking and testing of each measuring instrument

6.1

All instruments must be examined individually and subjected to appropriate tests as defined in the relevant documents referred to in s. 7, or equivalent tests, to verify compliance with the corresponding requirements set out in this order. In the absence of a relevant document, the conformity assessment body shall decide on appropriate tests to be carried out.

6.2

The conformity assessment body shall issue a certificate of conformity on the basis of examinations and tests carried out and affix, or cause to be affixed to it, its identification number on each approved instrument of measurement.

The manufacturer shall keep the certificates of conformity available to the competent authorities for inspection for a period of ten years from the date of the certification of the measuring instrument.

7

Statistical audit of compliance with metrological requirements

7.1

The manufacturer shall take all necessary measures to ensure that the manufacturing process ensures the homogeneity of each batch produced and presents its measuring instruments to be verified in the form of homogeneous lots.

7.2

A sample shall be drawn at random from each lot according to the c. 7.3. All instruments of the sample shall be examined individually, and the appropriate tests, as defined in the relevant documents referred to in s. 7, or equivalent tests, to determine their compliance with the metrological requirements, shall be performed to determine the acceptance or rejection of the lot. In the absence of a relevant document, the conformity assessment body shall decide on appropriate tests to be carried out.

7.3

The statistical procedure must meet the following requirements:

Statistical control is performed by attributes. The sampling system shall ensure:

-

A normal quality level corresponding to a 95 % probability of acceptance, with a non-compliance of less than 1 %;

-

A quality level corresponding to a 5 % probability of acceptance, with a non-compliance of more than 7 %.

7.4

When a lot is accepted, all measuring instruments in that lot are accepted, with the exception of the sample measuring instruments that have been found to be non-compliant.

The conformity assessment body shall issue a certificate of conformity on the basis of examinations and tests carried out and affix, or cause to be affixed to it, its identification number on each approved instrument of measurement.

The manufacturer shall keep the certificates of conformity available to the competent authorities for inspection for a period of ten years from the date of the certification of the measuring instrument.

7.5

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

8

The manufacturer shall affix the mark of conformity and the additional metrological marking on each measuring instrument which meets the corresponding requirements laid down in this order.

9

A declaration of conformity shall be drawn up for each model of measuring instrument and shall be made available to the competent authorities for a period of ten years from the manufacture of the last measuring instrument. It identifies the model of the measurement instrument for which it is based.

A copy of the return must be provided with each measuring instrument placed on the market. However, this requirement can be interpreted as applying to a set or batch rather than to individual measuring instruments when many measuring instruments are delivered to a single user.

If the conformity assessment body referred to in c. 5 gives its agreement, the manufacturer also affix, under the responsibility of that body, the identification number of the latter on the measuring instruments.

10

If the conformity assessment body agrees, the manufacturer may, under the responsibility of the conformity assessment body, affix the manufacturer's identification number to the measuring instruments during the manufacturing process.

11

The obligations of the manufacturer may be fulfilled, in his name and under his responsibility, by his authorised representative in Switzerland, with the exception of the obligations referred to in c. 4 and 7.1.

1

The declaration of conformity on the basis of verification to the unit is the conformity assessment procedure by which the manufacturer fulfils the obligations defined in this module, but also assures and declares that a measuring instrument Which has been submitted to the procedure referred to in c. 4 is consistent with the corresponding requirements set out in this order.

2

The manufacturer shall establish the technical documentation described in c. II and shall make it available to the conformity assessment body referred to in the c. 4. The technical documentation shall permit the assessment of the conformity of the measuring instrument with the corresponding requirements laid down in this order and shall cover, to the extent necessary for this evaluation, the design, the Manufacturing and operation of the measuring instrument.

The manufacturer shall keep this documentation available to the competent authorities for a period of ten years.

3

The manufacturer shall take all necessary measures to ensure that the measuring instrument manufactured complies with the corresponding requirements laid down in this order.

4

A conformity assessment body chosen by the manufacturer shall carry out or have carried out the appropriate examinations and tests described in the relevant documents referred to in Art. 7, or equivalent tests, to verify the conformity of the measuring instruments with the corresponding requirements laid down in this order. In the absence of a relevant document, the conformity assessment body shall decide on appropriate tests to be carried out.

The conformity assessment body shall issue a certificate of conformity on the basis of examinations and tests carried out and affix, or cause to be affixed to it, its identification number on the approved measuring instrument.

The manufacturer shall keep the certificates of conformity available to the competent authorities for inspection for a period of ten years from the date of the certification of the measuring instrument.

5

The manufacturer shall affix the mark of conformity, the additional metrological marking and, under the responsibility of the conformity assessment body referred to in the c. 4, the identification number of the latter on each measuring instrument that meets the corresponding requirements set out in this order.

6

A declaration of conformity shall be made and shall be made available to the competent authorities for a period of ten years from the manufacture of the last measuring instrument. It identifies the instrument of measurement for which it is established.

A copy of the return must be provided with each measuring instrument placed on the market.

7

The manufacturer's obligations under c. 2 and 4 may be fulfilled, in its name and under its responsibility, by its representative established in Switzerland.

1

The declaration of conformity on the basis of comprehensive quality assurance is the conformity assessment procedure by which the manufacturer fulfils the obligations laid down in this module, but also assures and declares that the Instruments of measurement concerned satisfy the corresponding requirements laid down in this order.

2

The manufacturer shall implement, for the design, manufacture, final inspection and testing of the instrument of measurement concerned, a recognized quality management system, as specified in c. 3, and is subject to the supervision referred to in c. 4.

3.1

The manufacturer shall submit to the conformity assessment body its choice of a request for the evaluation of its quality management system.

The application must include:

-

All relevant information on the category of measurement instruments considered;

-

Documentation of the quality management system.

3.2

The quality management system shall ensure the conformity of the measuring instruments with the corresponding requirements laid down in this order.

All elements, requirements and provisions adopted by the manufacturer shall be the subject of systematic and regulatory documentation in the form of written principles, procedures and instructions. This quality management system documentation should allow for a consistent interpretation of quality programs, plans, manuals and reports. This documentation shall include, in particular, an adequate description:

-

Quality objectives as well as the organization, responsibilities and authority of the management in terms of product quality;

-

Technical design specifications, including standards, that will be applied and, where relevant documents referred to in s. 7 will not be fully implemented, means which will be used to ensure that the applicable essential requirements set out in this order are met;

-

Systematic techniques, procedures and actions for the control and verification of the design that will be used during the design of the measuring instruments of the category in question;

-

Manufacturing, quality control and assurance techniques and procedures and other systematic measures to be used;

-

Tests and tests to be carried out before, during and after manufacture, and their frequency;

-

Quality reports such as inspection reports, test and calibration data and reports on the qualification of the personnel involved;

-

Means to monitor the achievement of the quality required for the design and the product and the proper functioning of the quality management system.

3.3

The conformity assessment body shall assess the quality management system to determine whether it meets the requirements set out in c. 3.2. It assumes compliance with these requirements where the quality management system complies with the corresponding specifications of the Swiss standard, which transposes the relevant harmonised standard, from the date on which its references Have been published.

In addition to experience in quality management systems, the audit team must have sufficient experience in the relevant field of metrology and instrumental technology as well as a knowledge of the applicable requirements Defined in this order. The evaluation procedure shall include an inspection visit to the manufacturer's premises.

The decision on the evaluation of the quality management system shall be notified to the manufacturer. The notification shall include the conclusions of the examination and the reasoned assessment decision.

3.4

The manufacturer is committed to fulfilling the obligations of the quality management system as it is recognized and to ensuring that it remains adequate and effective.

3.5

The manufacturer shall inform the conformity assessment body which has recognised the quality management system of any draft amendments to it.

The conformity assessment body shall evaluate the proposed amendments and decide whether the modified quality management system will still satisfy the requirements referred to in the c. 3.2 or if re-evaluation is required.

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

4.1

The purpose of monitoring is to ensure that the manufacturer properly meets the obligations arising from the recognized quality management system.

4.2

The manufacturer shall authorize the conformity assessment body to access, for inspection purposes, the premises of manufacture, inspection, testing and storage and shall provide it with all necessary information, in particular:

-

Documentation of the quality management system;

-

Minutes of quality, as provided for in the "design" part of the quality management system, such as the results of analyses, calculations and testing;

-

The quality records, as provided for in the manufacturing part of the quality management system, such as inspection reports, test and calibration data, and reports on the qualification of the personnel involved.

4.3

The conformity assessment body shall conduct periodic audits to ensure that the manufacturer maintains and applies the quality management system and provides an audit report to the manufacturer.

4.4

In addition, the conformity assessment body may make impromptu visits to the manufacturer. On the occasion of such visits, it may, if necessary, carry out or cause to be carried out, under its responsibility, product tests intended to verify the proper functioning of the quality management system. It shall provide the manufacturer with a report on the visit and, if a trial is carried out, a test report.

5

The manufacturer shall affix the mark of conformity, the additional metrological marking and, under the responsibility of the conformity assessment body referred to in the c. 3.1, the identification number of the latter on each measuring instrument that meets the corresponding requirements set out in this order.

6

A declaration of conformity shall be drawn up for each model of a measuring instrument and shall be made available to the competent authorities for a period of ten years from the manufacture of the last measuring instrument. It identifies the model of the measurement instrument for which it is based.

A copy of the return must be provided with each measuring instrument placed on the market. However, this requirement can be interpreted as applying to a set or batch rather than to individual measuring instruments when many measuring instruments are delivered to a single user.

7

The manufacturer shall make available to the competent authorities for a period of ten years from the manufacture of the last measuring instrument:

-

Documentation concerning the quality management system referred to in the c. 3.1, second indent;

-

The amendments referred to in c. 3.5;

-

The decisions and reports of the conformity assessment body referred to in c. 3.5, 4.3 and 4.4.

8

Each conformity assessment body shall periodically make available to the Contracting State which has designated it the list of recognition of quality management systems issued or refused and shall immediately inform the State which has it Designated in case of revocation of recognition of a quality management system.

9

The manufacturer's obligations under c. 3.1, 3.5, 6 and 7 may be completed, on its behalf and under its responsibility, by its representative established in Switzerland.

1

The declaration of conformity on the basis of comprehensive quality assurance and design control is the conformity assessment procedure by which the manufacturer fulfils the obligations defined in this module, but also Ensures and declares that the measuring instruments concerned satisfy the corresponding requirements laid down in this order.

2

The manufacturer shall implement, for the design, manufacture, final inspection and testing of the instrument of measurement concerned, a recognized quality management system, as specified in c. 3, and is subject to the supervision referred to in c. 5. The adequacy of the design of the measuring instrument must have been controlled in accordance with the provisions of the ch. 4.

3.1

The manufacturer shall submit a request for the assessment of its quality management system to a conformity assessment body of its choice.

The application must include:

-

All relevant information on the category of measurement instruments considered;

-

Documentation of the quality management system.

3.2

The quality management system shall ensure the conformity of the measuring instruments with the corresponding requirements laid down in this order.

All elements, requirements and provisions adopted by the manufacturer shall be the subject of systematic and regulatory documentation in the form of written principles, procedures and instructions. This quality management system documentation should allow for a consistent interpretation of quality programs, plans, manuals and reports. This documentation shall include, in particular, an adequate description:

-

Quality objectives as well as the organization, responsibilities and authority of the management in terms of product quality;

-

Technical design specifications, including standards, that will be applied and, where relevant documents referred to in s. 7 will not be fully implemented, means which will be used to ensure that the applicable essential requirements set out in this order are met;

-

Systematic techniques, procedures and actions for the control and verification of the design that will be used during the design of the measuring instruments of the category in question;

-

Manufacturing, quality control and assurance techniques and procedures and other systematic measures to be used;

-

Tests and tests to be carried out before, during and after manufacture, and their frequency;

-

Quality reports such as inspection reports, test and calibration data and reports on the qualification of the personnel involved;

-

Means to monitor the achievement of the quality required for the design and the product and the proper functioning of the quality management system.

3.3

The conformity assessment body shall assess the quality management system to determine whether it meets the requirements set out in c. 3.2. It shall presume compliance with these requirements where a quality management system complies with the corresponding specifications of the Swiss standard which transposes the relevant harmonised standard, from the date on which its references have Published.

In addition to experience in quality management systems, the audit team must have sufficient experience in the relevant field of metrology and instrumental technology as well as a knowledge of the applicable requirements Defined in this order. The evaluation procedure shall include an inspection visit to the manufacturer's premises.

The decision on the evaluation of the quality management system shall be notified to the manufacturer. The notification shall include the conclusions of the examination and the reasoned assessment decision.

3.4

The manufacturer is committed to fulfilling the obligations of the quality management system as it is recognized and to ensuring that it remains adequate and effective.

3.5

The manufacturer shall inform the conformity assessment body which has recognised the quality management system of any draft amendments to it.

The conformity assessment body shall evaluate the proposed amendments and decide whether the modified quality management system will still satisfy the requirements referred to in the c. 3.2 or if re-evaluation is required.

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

3.6

Each conformity assessment body shall periodically make available to the Contracting State which has designated it the list of recognition of quality management systems issued or refused and shall immediately inform the State which has it Designated in case of revocation of recognition of a quality management system.

4.1

The manufacturer shall submit to the conformity assessment body referred to in the c. 3.1 a request for design review.

4.2

The application shall provide an understanding of the design, manufacture and operation of the device and permit an assessment of its compliance with the corresponding requirements set out in this order. It should include:

-

The name and address of the manufacturer

-

A written statement that the same application was not submitted to another conformity assessment body;

-

The technical documentation described in c. II. The documentation shall permit the assessment of the conformity of the measuring instrument with the corresponding requirements laid down in this order. It must cover, to the extent necessary for this evaluation, the design and operation of the measuring instrument;

-

Additional evidence to support the adequacy of the technical design. This evidence shall refer to all documents that have been applied, in particular where the relevant documents referred to in s. 7 have not been fully applied, and shall include, if necessary, the results of tests carried out by the appropriate laboratory of the manufacturer or by another test laboratory in its name and under its responsibility.

4.3

The conformity assessment body shall review the application and, where the design complies with the provisions of this order which apply to the measuring instrument, shall issue to the manufacturer a certificate of examination of the design. The certificate shall contain the name and address of the manufacturer, the conclusions of the examination, the possible conditions of its validity and the data necessary for the identification of the approved measuring instrument.

4.3.1

All relevant parts of the technical documentation are attached to the certificate.

4.3.2

The certificate or its annexes must contain all relevant information concerning conformity assessment and in-service control. In particular, to enable the conformity assessment of measuring instruments manufactured with the examined design in relation to the reproducibility of their metrological performance when properly adjusted by means of means Such information shall include, in particular:

-

The metrological characteristics of the design of the measuring instrument;

-

Measures to ensure the integrity of the measuring instrument (sealing, software identification, etc.);

-

Information concerning other elements necessary for the identification of the measuring instrument and the verification of its external visual conformity with the design;

-

Where appropriate, all the specific information necessary to verify the characteristics of the measuring instruments manufactured;

-

In the case of subsets, all the information necessary to ensure compatibility with other sub-assemblies or measuring instruments.

4.3.3

The conformity assessment body shall draw up an evaluation report in that regard and shall keep it available to the Contracting State which appointed it. Without prejudice to Annex 3, c. 8, the conformity assessment body shall disclose the contents of this report in whole or in part only with the consent of the manufacturer.

The certificate shall be valid for ten years from the date of its grant and may be renewed for new periods of ten years.

If a design review certificate is denied to the manufacturer, the conformity assessment body provides the detailed reasons for the refusal.

4.4

The manufacturer shall inform the conformity assessment body which has issued the certificate of examination of the design of all the fundamental modifications of the approved design. These amendments shall be subject to further approval by the conformity assessment body which has issued the design examination certificate where such modifications may call into question the conformity of the The instrument of measurement with the essential requirements defined in this order, the conditions of validity of the certificate or the conditions prescribed for the use of the instrument of measurement. The supplementary approval shall be issued in the form of an addendum to the original design examination certificate.

4.5

Each conformity assessment body shall periodically make available to the Contracting State which designated it:

-

Design review certificates issued and their annexes;

-

Additives and amendments relating to certificates issued.

Each conformity assessment body shall immediately inform the Contracting State which has designated it of the revocation of a design examination certificate.

4.6

The manufacturer, or his authorised representative established in Switzerland, shall keep with the technical documentation a copy of the design examination certificate, its annexes and its additives for a period of ten years from the manufacture of the last instrument Measurement.

Where neither the manufacturer nor his authorised representative is established in Switzerland, the obligation to communicate the technical documentation on request shall be the responsibility of the person designated by the manufacturer.

5.1

The purpose of monitoring is to ensure that the manufacturer properly meets the obligations arising from the recognized quality management system.

5.2

The manufacturer shall authorize the conformity assessment body to access, for inspection purposes, the premises of design, manufacture, inspection, testing and storage and shall provide it with all necessary information, in particular:

-

Documentation of the quality management system;

-

Minutes of quality, as provided for in the "design" part of the quality management system, such as the results of analyses, calculations and testing;

-

The quality records, as provided for in the manufacturing part of the quality management system, such as inspection reports, test and calibration data, and reports on the qualification of the personnel involved.

5.3

The conformity assessment body shall conduct periodic audits to ensure that the manufacturer maintains and applies the quality management system and provides an audit report to the manufacturer.

5.4

In addition, the conformity assessment body may make impromptu visits to the manufacturer. On the occasion of such visits, the conformity assessment body may, if necessary, carry out or cause to be carried out, under its responsibility, product tests intended to verify the proper functioning of the quality management system. It shall provide the manufacturer with a report on the visit and, if a trial is carried out, a test report.

6

The manufacturer shall affix the mark of conformity, the additional metrological marking and, under the responsibility of the conformity assessment body referred to in the c. 3.1, the identification number of the latter on each measuring instrument that meets the corresponding requirements set out in this order.

7

A declaration of conformity shall be drawn up for each model of measuring instrument and shall be made available to the competent authorities for a period of ten years from the manufacture of the last measuring instrument. It identifies the model of the measurement instrument for which it is based and the design examination certificate number.

A copy of the return must be provided with each measuring instrument placed on the market. However, this requirement can be interpreted as applying to a set or batch rather than to individual measuring instruments when many measuring instruments are delivered to a single user.

8

The manufacturer shall make available to the competent authorities for a period of ten years from the manufacture of the last measuring instrument:

-

The documentation referred to in c. 3.1, second indent;

-

The amendments referred to in c. 3.5;

-

The decisions and reports of the conformity assessment body referred to in c. 3.5, 5.3 and 5.4.

9

The manufacturer's obligations under c. 3.1, 3.5, 7 and 8 may be completed, on its behalf and under its responsibility, by its representative established in Switzerland.

1

The technical documentation shall describe in an intelligible way the design, manufacture and operation of the measuring instrument and permit the assessment of the conformity of the measuring instrument with the corresponding requirements defined in the present Order.

2

The technical documentation must be sufficiently detailed to ensure:

-

Description of metrological characteristics;

-

The reproducibility of the metrological performance of the measuring instruments manufactured when they are properly adjusted using the appropriate means, and

-

The integrity of the measuring instrument.

3

For the purposes of the assessment and identification of the type and/or instrument of measurement, the technical documentation shall include:

3.1

A general description of the measuring instrument;

3.2

Design and manufacturing plans and schematics of components, subassemblies, circuits, etc.;

3.3

Manufacturing processes that ensure the homogeneity of production;

3.4

Where applicable, a description of the electrical devices incorporating drawings, diagrams, flow diagrams of the logical elements and general information on the characteristics and operation of the software components;

3.5

The descriptions and explanations necessary for the understanding of the c. 3.2, 3.3 and 3.4, including the operation of the measuring instrument;

3.6

A list of standards and normative documents referred to in s. 7, applied in whole or in part;

3.7

A description of the solutions adopted to meet the essential requirements set out in this order when the standards and normative documents referred to in s. 7 have not been applied;

3.8

Results of design calculations, tests performed, etc.;

3.9

If necessary, the results of the appropriate tests demonstrating that the type and/or instrument of measurement satisfies:

A.

The requirements set out in this order under the assigned nominal operating conditions and in the event of exposure to the specified environment disturbance;

B.

The durability criteria applicable to water, gas and heat meters and to the measuring sets of liquids other than water.

3.10

Type examination certificates or design examination certificates for measuring instruments that are composed of elements identical to those used in the new instrument of measurement.

4

The manufacturer specifies the seals and markings it has operated.

5

The manufacturer indicates, where applicable, the compatibility conditions for the interfaces and subsets.

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State 1 ^Er January 2016

1

The conformity assessment body, its director and staff responsible for conformity assessment work may not be the designer, the manufacturer, the supplier, the installer or the user of the instruments Assess, or the agent of any of them. In addition, they cannot intervene directly in the design, manufacture, marketing or maintenance of measuring instruments, nor can they represent the parties involved in these activities. The above criteria, however, in no way preclude the possibility of exchanging technical information for conformity assessment purposes between the manufacturer and the body.

2

The conformity assessment body, its director and its staff responsible for conformity assessment work shall be protected from any bottom-up, in particular financial, which may influence their judgment or the results of the conformity assessment. Their conformity assessment work, in particular on the part of persons or groups of persons interested in these results.

3

The tasks of conformity assessment must be carried out with the highest professional integrity and competence required in the field of metrology.

If the conformity assessment body contracts out specific tasks, it must first ensure that the subcontractor complies with the provisions of this order and in particular of this Annex. It shall make available to the designating authority the relevant documents relating to the qualifications of the subcontractor and to the work carried out by the subcontractor under this order.

4

The conformity assessment body must be able to perform all the conformity assessment tasks for which it has been designated, whether these tasks are carried out by the body itself or under its responsibility. It must have the necessary staff and access to the facilities required for the proper implementation of the technical and administrative tasks involved in the conformity assessment.

5

The staff of the conformity assessment body shall have:

-

Good technical and professional training covering all the conformity assessment tasks for which the organisation has been designated;

-

Satisfactory knowledge of the rules applicable to the tasks carried out and sufficient experience of these tasks;

-

The ability to write the certificates, minutes and reports that represent the materialization of the tasks performed.

6

The impartiality of the conformity assessment body, its director and its staff must be guaranteed. The remuneration of the organization may not depend on the results of the work performed. The remuneration of the Director and staff of the organization shall not depend on the number or results of the tasks performed.

7

The conformity assessment body shall take out civil liability insurance if its liability is not borne by the State in accordance with national law.

8

The Director and the staff of the conformity assessment body shall be bound by professional secrecy for any information obtained in the performance of their tasks under this Ordinance, except with regard to the authority of the State Contractor who has appointed the organization.

1.1

The graphic representation of the compliance mark is as follows:

The mark has a size of at least 5 mm. In the event of a reduction or expansion of the conformity mark, the proportion of the conformity mark must be respected.

1.2

The additional metrological marking shall consist of the letter "M" and the last two digits of the year of its apposition, surrounded by a rectangle. The rectangle height is equal to the size of the compliance mark. The additional metrological marking shall immediately follow the conformity mark.

1.3

If the conformity assessment procedure prescribes it, the identification number of the conformity assessment body concerned shall be affixed immediately after the mark of conformity and the additional metrological marking.

1.4

Where a measuring instrument consists of several devices which work together but which are not subsets, the marks shall be affixed to the main device. When the measuring instrument is too small or too sensitive to carry the marks described in the c. 1.1 and 1.2, the marks shall be affixed to the packaging, if any, and on the documentation which shall accompany the measuring instrument in accordance with this order.

1.5

The mark of conformity and the additional metrological marking shall be affixed by or under the responsibility of the manufacturer.

2.1

The mark of conformity and the additional metrological marking shall be indelible. The identification number of the conformity assessment body concerned must be indelible or self-destrucble when removed. All trademarks must be clearly visible and easily accessible.

2.2

The affixing of marks which may be confused with the marks of conformity prescribed by reason of their meaning or form or which may restrict the visibility or legibility of such marks shall be prohibited. Therefore misleading.

1.1.1

The application for approval must be filed with METAS. Approval of a measuring instrument shall normally be preceded by a type examination in accordance with Annex 2, Module B. The type examination shall be carried out in one of the METAS laboratories for the category of measurement instruments or in A testing laboratory mandated by METAS.

1.1.2

For the examination, the applicant shall provide free documentation and samples of the type in accordance with Annex 2, Module B, c. 3, and, upon request, the means necessary for testing and qualified personnel.

1.1.3

The technical documentation remains in METAS. The latter may require a sample of the type or part thereof.

1.1.4

The testing laboratory shall prepare a report on the tests carried out and their evaluation. METAS decides on the approval on the basis of the test report.

1.1.5

To control the proper operation, METAS may make the approval of experiments dependent on normal use, and issue a limited validity approval.

1.1.5.1

Limited validity approval is issued for a limited number of measuring instruments and, as a general rule, for a limited period of experimentation.

1.1.5.2

The applicant shall communicate to METAS and the competent cantonal authority the location of the instruments for the benefit of limited validity approval. METAS may order additional examinations at the expense of the applicant.

1.1.5.3

A limited validity approval does not qualify for regular approval. If the latter is refused, the measuring instruments are withdrawn from trade. The applicant has an obligation to inform the users of this restriction.

1.1.6

If the technical project complies with the legal provisions applicable to the category of measuring instruments, METAS shall issue a certificate of approval to the applicant. It shall include any conditions or restrictions on validity and, if necessary, the requirements relating to the use of the measuring instrument. All important elements of the technical documentation are attached to the certificate of approval, and METAS retains a copy.

1.1.7

The certificate shall include the approval mark described in Annex 6, the serial number, the name and address of the manufacturer and the data necessary for the identification of the measuring instrument.

1.1.8

The certificate of approval shall be valid for ten years from the date of its grant and may be extended each time ten years.

1.1.9

For certain types of measuring instruments, METAS may depend on the approval of the maintenance and, where appropriate, the repair of the measuring instrument within a reasonable time.

1.1.10

The applicant shall inform of all modifications made to the measuring instrument which may influence its conformity with the essential requirements or the conditions of validity of the certificate. METAS decides whether a change involves further examination. It shall issue a new approval in the form of a supplement to the original approval certificate.

1.1.11

The approval is withdrawn if the holder fails to comply with the requirements and guidelines despite a written warning from METAS or if the holder is placing non-compliant or metrologically unsatisfactory measuring instruments on the market. As a general rule, the withdrawal of approval has no effect on the measuring instruments placed on the market before the withdrawal.

1.1.12

METAS publishes the indications relating to the granting, withdrawal and expiry of approvals.

1.2.1

Isolated measuring instruments manufactured in series and particularly unalterable benefit from general approval, that is, without a type examination.

1.2.2

The measuring instruments for the benefit of general approval must bear a mark.

1.2.3

This mark must be approved by METAS, which determines, in particular, whether it is not likely to be confused with previously approved marks.

1.2.4

The request must include:

A.

The name and seat of the applicant and, where applicable, those of the importer;

B.

A description of the measuring instrument;

C.

Intended use;

D.

Metrological characteristics;

E.

The mark affixed to the measuring instrument.

1.2.5

METAS decides that a measuring instrument of a particular type does not benefit from or more than general approval if the conditions of approach are no longer met.

1.2.6

General approval has unlimited validity.

1.2.7

METAS publishes a register of approved marks.

1.2.8

The provisions of the c. 1.1.2 to 1.1.4 and 1.1.9 to 1.1.11 apply by analogy.

1.3.1

If specific operating conditions at the point of use require a different regulation of the requirements, the user, the installer or, where appropriate, the manufacturer must request individual approval from METAS.

1.3.2

Where necessary, an additional examination shall be carried out at the expense of the applicant.

1.3.3

The provisions of the c. 1.1.1 to 1.1.11 shall apply mutatis mutandis.

2.1

In the initial verification of a measuring instrument, one controls in particular:

A.

The construction and metrological characteristics of the measuring instrument correspond to the approved type or requirements;

B.

If the designations, markings and punching or sealing locations prescribed are on the measuring instrument.

2.2

If a measuring instrument meets the requirements, the verification shall be attested by the identification of the verification mark or mark, by the identification of the competent body in accordance with Annex 6 and by the expiry date (month, year) of The validity of the audit. If necessary, access to metrologically determined parts of the measuring instrument is protected by sealing seals.

2.3

If necessary, a verification certificate shall be issued. The agreement between the certificate and the instrument of measurement examined must be ensured.

2.4

METAS may recognize foreign initial verifications if they meet Swiss requirements.

2.1

Federal Office of Metrology

-

METAS or

-

MET

2.2

Cantonal Audit Offices

-

Canton Sigle and Order Number

-

Principality of Liechtenstein: abbreviation FL and order number

2.3

Audit Laboratories

-

One or two digit number

-

Combination of two alphanumeric signs with the exception of those listed under c. 2.1 and 2.2

2.4

Private Marks

The mark used to identify individuals by an order number may be combined with the private sealing mark. Identification marks should be chosen so as to exclude any likelihood of confusion. METAS maintains a registry.

Control if the construction, condition and metrological characteristics of an individual measuring instrument always correspond to the requirements; in particular, control whether the maximum permissible errors applicable to the verification are Respected. If this is the case, the measuring instrument may continue to be used.

1.1

The subsequent verification shall be carried out by the competent body at the location of the measuring instrument or in a testing laboratory.

1.2

If the measuring instrument meets the requirements, the verification shall be attested by the identification of the verification mark or mark, by the identification of the competent body in accordance with Annex 6 and by the expiry date (month, year) of The validity of the audit. If necessary, access to metrologically determined parts of the measuring instrument is protected by sealing seals.

1.3

If necessary, an audit certificate or a certificate of compliance is issued. The agreement between the certificate and the instrument of measurement must be ensured.

The competent body shall check by sampling whether the metrological condition and characteristics of a sufficiently large batch of measuring instruments of the same type correspond to the requirements. In particular, it controls whether the individual measuring instruments in the sample comply with the maximum tolerated errors. If this is the case, all measuring instruments belonging to the controlled lot can continue to be used.

2.1

The procedure during the tests, the size of the lot and the samples, the decision criteria and the measures envisaged are laid down in the Ordinance on the specific measuring instruments.

2.2

If the result of the sampling inspection does not meet all the prescribed criteria, the competent body shall take the measures provided for in the Ordinance on the specific measuring instruments.

Periodic seizure of operating data at regular intervals according to a plan fixed by the operator and approved by the competent body, and comparison of the measured values with comparable values noted in the past.

3.1

The application of defined examination criteria allows for the detection of measurement instruments which probably no longer meet the legal requirements; these measuring instruments must be submitted individually to one of the procedures defined in the Annex.

3.2

Regular monitoring is the responsibility of the user. It gives the competent body a right of scrutiny over supervisory activities. In particular, the user is required to submit to the competent body the full results of its periodic monitoring activities with a view to the possible adaptation of the time limits for monitoring the stability of measurement.

Control whether the metrological condition and characteristics of an individual measuring instrument and its use correspond to the requirements by performing on specimens or on materialized measures of intercomparisons with a Reference laboratory designated by the competent body.

4.1

If the result of this control shows that the measuring instrument does not comply with the maximum permissible errors, the instrument of measurement shall apply the procedure for maintaining the stability of measurement provided for in the Ordinance on Measuring Instruments Specific.

4.2

This procedure requires measurements at the location of the measuring instrument and in a reference laboratory.

The user regularly monitors the proper functioning and the stability of measurement of a measuring instrument through specified procedures and establishes a record of the results, in particular for the competent body to proceed with the Monitoring that is incumbent upon it.

5.1

The detailed procedure shall be laid down in the Ordinance on specific instruments of measurement or, in particular cases, by the competent body.

5.2

If the control shows that the measuring instrument does not comply with the maximum tolerated errors, the instrument of measurement must be restored if necessary and undergo the procedure for maintaining the stability of measurement laid down in the Ordinance on Specific measuring instruments.

The user himself or the body authorised by the competent supervisory authority shall periodically calibrate the measuring instrument and monitor compliance with the maximum tolerated errors.

6.1

The detailed procedure shall be laid down in the order on specific instruments of measurement or, in particular cases, by the competent body, taking into account the specific characteristics and the intended use of the measuring instrument.

6.2

The calibrations carried out must be recorded in the Minutes. The calibration certificate and certificates shall be made available to the competent body.

6.3

If the results of a calibration indicate that the requirements set out in the Ordinance on specific measuring instruments are no longer complied with, the user is required to have the measuring instrument reviewed and the procedures initiated Prescribed for the maintenance of measurement stability.

Periodic maintenance work specified to ensure that the measuring instrument remains in good working order. The maintenance work is carried out by a person who has the required professional competence and is registered and confirmed by it in the document of maintenance of the instrument of measurement.

7.1

Maintenance shall be performed in accordance with the specifications and instructions of the manufacturer of the measuring instrument. Normally, the maintenance shall be followed by a fitting in accordance with the c. 8.

7.2

The Ordinance on specific measuring instruments sets out the minimum requirements for the scope and frequency of maintenance work and sets out the details. The procedure may also include obligations to advertise.

Removal of unacceptable measurement deviations from the measurement in relation to an adequate and traceable reference to allow the measuring instrument to re-comply with the prescribed maximum tolerated errors.

8.1

The fitting shall be in accordance with the manufacturer of the instrument of measurement. The order on specific measuring instruments or the manufacturer shall fix the time limits for implementation.

8.2

The adjustment can be made by the user himself or by a person with the required professional competence. In certain circumstances, it can also be triggered and carried out automatically by the measuring instrument.

Repair of an instrument of measurement which presents a malfunction or whose metrological characteristics no longer meet the requirements of this order, followed by sealing of all the metrologically decisive parts The instrument of measurement by the person responsible for the repair.

9.1

Individuals authorized by the cantonal audit offices can seal a measuring instrument by means of private seals to allow its use after repair or restoration until the next periodic check of stability A measure set out in s. 24, para. 1.

9.2

Individuals must prove their ability. In addition, each individual must follow an instruction on the sealing of measurement instruments with a cantonal audit office.

9.3

The person responsible for the rehabilitation or fitting of a measuring instrument, where appropriate the user, announces the instrument of measurement to the competent body for the procedure for maintaining the stability of measurement.