State system for ensuring the uniformity of measurements assessment of the state of measurements in testing, measuring laboratories and laboratories for production and analytical control. Assessment of the state of measurements in test and measurement laboratories

27.12.2020

Service Description

The basis for assessing the state of measurements is the application of the organization, which includes the laboratory, submitted to the Krasnoyarsk CSM with the list of objects and indicators controlled in them attached to it. Application form for assessing the state of measurements in the laboratory.

Assessment of the state of measurements is carried out on a contractual basis. Contract for the assessment of the state of measurements in the laboratory.

To assess the state of measurements, the laboratory prepares the following materials:

1. Documents that ensure the functioning of the quality management system in the laboratory.

2. Passport of metrological support of the laboratory (Forms 1-11) in the form of completed forms:

Information data about the laboratory (form 1);
RD for objects, measurement procedures and test methods used in the laboratory (SI) (form 2);
List of measuring instruments used (form 3);
List of test equipment used (form 4);
Information about auxiliary equipment (form 5);
List of standard samples used (form 6);
Status of measurement techniques (methods) (form 7);
Composition and qualifications of personnel (form 8);
Information on the equipment of the laboratory with chemical reagents (form 9);
List of regulatory documentation required for the functioning of the laboratory (form 10);
Condition of the main laboratory premises (Form 11).

Work on assessing the state of measurements in the laboratory is carried out in three stages:

1. Metrological examination of the submitted documents and information about the activities of the laboratory;
2. Inspection of the laboratory at the place of activity (field examination);
3. Registration of the results of the work (Act for assessing the state of measurements in the laboratory, Conclusion confirming the availability of conditions in the laboratory for performing measurements in the declared field of activity).

When examining the laboratory at the place of its activity, the commission checks:

Availability:

Regulations on the laboratory, defining its functions, rights, duties, responsibilities, interaction with other departments of the organization and other organizations;
Quality manual or a document that performs its function and regulates the quality management system for the work performed by the laboratory in the declared field of activity;
updated and registered in the laboratory of the ND fund necessary for the functioning of the laboratory, including a guide for the selection and storage of samples for testing (measurements) of samples, regulating the procedures for obtaining representative samples and the invariance of their composition and properties (for laboratories whose scope of activity includes sampling samples);
plans (schedules) for canceling or revising documents for measurement procedures (methods) that do not meet the requirements of GOST R 8.563-2009, and certification of measurement procedures (if necessary) or assessment of their suitability;
duly approved job descriptions;
requirements for the qualification of personnel and the procedure for their admission to perform measurements in the declared area;
necessary, provided for in the RD SI, including standard samples of all categories, providing measurements and quality control (accuracy) of measurements;
testing and auxiliary equipment, reagents and materials of the required quality;
laboratory premises with the requirements established for them to ensure safe working conditions and environmental safety.

When fixing in the certificate the availability of conditions for performing measurements in the field of activity assigned to the laboratory, FBU "Krasnoyarsk CSM" draws up a Conclusion on the assessment of the state of measurements in the laboratory.

GOST R 8.563-2009

NATIONAL STANDARD OF THE RUSSIAN FEDERATION

State system ensuring the uniformity of measurements

METHODS (METHODS) OF MEASUREMENTS

State system for ensuring the uniformity of measurements. Procedures of measurements

Introduction date 2010-04-15

Foreword

1 DEVELOPED by the Federal State Unitary Enterprise "All-Russian Research Institute of Metrological Service" (FGUP "VNIIMS")

2 INTRODUCED by the Department of Metrology of the Federal Agency for Technical Regulation and Metrology

3 APPROVED AND PUT INTO EFFECT by Order of the Federal Agency for Technical Regulation and Metrology dated December 15, 2009 N 1253-st

4 INSTEAD OF GOST R 8.563-96

5 REVISION. February 2019

The rules for the application of this standard are set out in Article 26 of the Federal Law of June 29, 2015 N 162-FZ "On standardization in the Russian Federation" . Information about changes to this standard is published in the annual (as of January 1 of the current year) information index "National Standards", and the official text of changes and amendments - in the monthly information index "National Standards". In case of revision (replacement) or cancellation of this standard, a corresponding notice will be published in the next issue of the monthly information index "National Standards". Relevant information, notification and texts are also placed in information system general use - on the official website of the Federal Agency for Technical Regulation and Metrology on the Internet (www.gost.ru)

Introduction

Requirements for methods (methods) of measurements in Russian Federation established by Article 5 of the Federal Law of June 26, 2008 N 102-FZ "On Ensuring the Uniformity of Measurements" (hereinafter referred to as the Federal Law "On Ensuring the Uniformity of Measurements"), in accordance with which the measurement techniques (methods) used in the field of state regulation ensuring the uniformity of measurements.

The scope of state regulation of ensuring the uniformity of measurements in accordance with the provisions of Parts 3 and 4 of Article 1 of the Federal Law "On Ensuring the Uniformity of Measurements" extends to measurements for which mandatory requirements are established, and measurements provided for by the legislation of the Russian Federation on technical regulation.

Lists of measurements with mandatory requirements established for them are formed in accordance with Part 2 of Article 27 of the Federal Law "On Ensuring the Uniformity of Measurements".

This standard has been developed in order to provide recommendations on the implementation of the requirements for measurement procedures (methods) established by Article 5 of the Federal Law "On Ensuring the Uniformity of Measurements".

1 area of use

This standard applies to measurement procedures and methods (hereinafter referred to as measurement procedures), including methods of quantitative chemical analysis(hereinafter referred to as MKHA), and establishes general provisions and requirements related to the development, certification, standardization, application of measurement procedures and their metrological supervision.

This standard does not apply to measurement procedures designed to perform direct measurements, i.e. methods, in accordance with which the desired value of the quantity is obtained directly from the measuring instrument. Such measurement techniques are included in the operational documentation for measuring instruments. Confirmation of the compliance of these methods with the mandatory metrological requirements is carried out in the process of approving the data types of measuring instruments.

2 Normative references

This standard uses normative references to the following standards:

GOST 1.5-2001 Interstate standardization system. Interstate standards, rules and recommendations for interstate standardization. General requirements to the construction, presentation, design, content and designation

GOST 10160 Precision soft magnetic alloys. Specifications

GOST R ISO 5725-1 Accuracy (correctness and precision) of measurement methods and results. Part 1. Basic provisions and definitions

GOST R ISO 5725-2 Accuracy (correctness and precision) of measurement methods and results. Part 2: Basic method for determining the repeatability and reproducibility of a standard measurement method

GOST R ISO 5725-3 Accuracy (correctness and precision) of measurement methods and results. Part 3. Intermediate precision values of the standard measurement method

GOST R ISO 5725-4 Accuracy (correctness and precision) of measurement methods and results. Part 4: Basic methods for determining the validity of a standard measurement method

GOST R ISO 5725-5 Accuracy (correctness and precision) of measurement methods and results. Part 5 Alternative Methods determining the precision of a standard measurement method

GOST R ISO 5725-6 Accuracy (correctness and precision) of measurement methods and results. Part 6. Using precision values in practice

GOST R ISO 9000 Quality management systems. Fundamentals and vocabulary

Note - When using this standard, it is advisable to check the validity of reference standards in the public information system - on the official website of the Federal Agency for Technical Regulation and Metrology on the Internet or according to the annual information index "National Standards", which was published as of January 1 of the current year, and on issues of the monthly information index "National Standards" for the current year. If an undated referenced reference standard has been replaced, it is recommended that the current version of that standard be used, taking into account any changes made to that version. If a dated referenced reference standard has been replaced, it is recommended that the current version of that standard be used, taking into account any changes made to that version. If the reference standard to which the dated reference is given is replaced, then it is recommended to use the version of this standard with the year of approval (acceptance) indicated above. If, after the approval of this standard, a change is made to the referenced standard to which a dated reference is given, affecting the provision to which the reference is given, then this provision is recommended to be applied without regard to this change. If the reference standard is canceled without replacement, then the provision in which the reference to it is given is recommended to be applied in the part that does not affect this reference.

3 Terms and definitions

This standard uses the terms according to GOST R ISO 9000 , GOST R ISO 5725-1 , , , *, *, as well as the following terms with the corresponding definitions:
________________
* Pos. - see section Bibliography, here and further in the text. - Database manufacturer's note.

3.2 certification of measurement methods: Research and confirmation of compliance of measurement procedures with established metrological requirements for measurements.

3.3 metrological examination of measurement methods: Analysis and evaluation of the choice of methods and measuring instruments, operations and rules for conducting measurements, as well as processing their results in order to establish the compliance of the measurement technique with the metrological requirements imposed on it.

3.4 measurement accuracy indicator: An established characteristic of the accuracy of any measurement result obtained in compliance with the requirements and rules of this measurement procedure.

Note - As an indicator of the accuracy of the measurement technique, the characteristics of the measurement error in accordance with , the measurement uncertainty indicators in accordance with and , the accuracy indicators in accordance with GOST R ISO 5725-1 can be used.

3.5 arbitration measurement technique: A measurement technique used in the event of disagreements regarding the measurement results obtained using several certified measurement methods of the same quantity under the same conditions, established by the competent federal executive body or by agreement of the parties concerned.

4 General provisions

4.1 Measurement procedures are developed and applied in order to ensure that measurements are performed with the required accuracy.

4.2 Measurement procedures, depending on the complexity and scope, set out:

- in a separate document (normative legal document, document in the field of standardization, instructions, etc.);

- in a section or part of a document (section of a document in the field of standardization, specifications, design or technological document, etc.).

4.3 Documents intended for use in the field of state regulation of ensuring the uniformity of measurements and containing measurement methods (standards, specifications, design, technological documents etc.), should include information on the certification of measurement procedures, as well as information on their availability in the Federal Information Fund for Ensuring the Uniformity of Measurements.

Methods included in draft normative legal acts and documents in the field of standardization are subject to mandatory metrological examination, which is carried out by state scientific metrological institutes.

4.4 Attestation of measurement methods used outside the scope of state regulation of ensuring the uniformity of measurements can be carried out on a voluntary basis in accordance with this standard.

5 Development of measurement procedures

5.1 The development of measurement methods is carried out on the basis of the initial data that can be given in the terms of reference, specifications and other documents.

5.1.1 Source data includes the following:

- scope (object of measurements, including the name of products and controlled parameters, as well as the scope of use - for one enterprise, for a network of laboratories, etc.);

- if the measurement procedure can be used to assess compliance with the requirements established by the technical regulation, then the document for the measurement procedure indicates the name of the technical regulation, the number of the paragraph establishing the requirements (if necessary, the name of the national standard or set of rules), and also indicate whether a document that sets out the measurement methodology, in the list of national standards containing the rules and methods of research (tests) and measurements [or in the composition of the rules and methods of research (tests) and measurements], including the sampling rules necessary for application and execution technical regulations and implementation of conformity assessment;

- name of the measured quantity in units of quantities approved for use in the Russian Federation;

- requirements for the conditions for performing measurements;

- characteristics of the measurement object, if they can affect the accuracy of measurements (output resistance, stiffness at the point of contact with the sensor, sample composition, etc.);

- if necessary, other requirements for the measurement procedure.

5.1.2 Requirements for measurement accuracy are given by specifying accuracy indicators and reference to documents in which these values are established.

When describing the requirements for the expression of the error and uncertainty of measurements made using the theory of scales, the provisions of the recommendations are used, taking into account the characteristics of specific measurement scales.

5.1.3 Measurement methods should provide the required accuracy of the assessment of indicators subject to tolerance control, taking into account the tolerances for these indicators established in standardization documents or other regulatory documents, as well as the acceptable characteristics of the control reliability and the nature of the distribution of controlled indicators.

5.1.4 Measurement conditions are set in the form of nominal values with tolerances and (or) boundaries of the ranges of possible values of the influencing quantities. If necessary, indicate the limiting rates of change or other characteristics of the influencing quantities, as well as restrictions on the duration of measurements, the number of parallel determinations, etc. data.

5.1.5 If measurements are supposed to be performed using measuring systems for which the measuring instruments included in the measuring channels are spatially distant from each other, then the measurement conditions are indicated for the locations of all measuring instruments included in the measuring system.

If software is used as part of the measurement methodology, which can affect the accuracy of measurement results, they are guided by the provisions of the recommendations , , .

5.2 The development of measurement procedures typically includes the following:

- formulation of the measurement task and description of the measured value; preliminary selection of possible methods for solving the measurement problem;

- choice of method and measuring instruments (including standard samples), auxiliary devices, materials and reagents;

- establishing the sequence and content of operations in the preparation and performance of measurements, including requirements for ensuring labor safety and environmental safety and requirements for the qualifications of operators;

- organizing and conducting theoretical and experimental studies to assess the accuracy of the developed measurement technique; experimental testing of measurement techniques; analysis of compliance of accuracy indicators with the initial requirements;

- processing of intermediate measurement results and calculation of the final results obtained using this measurement technique;

- development of procedures and establishment of standards for monitoring the accuracy of the obtained measurement results;

- development of a draft document for the measurement technique;

- certification of measurement techniques;

- approval and registration of the document for the measurement technique, execution of the attestation certificate;

- transfer of information about certified measurement procedures to the Federal Information Fund for Ensuring the Uniformity of Measurements.

5.2.1 Methods and measuring instruments are selected in accordance with the documents related to the choice of methods and measuring instruments of this type, and in the absence of such documents - in accordance with general recommendations.

If the measurement technique is intended for use in the field of state regulation of ensuring the uniformity of measurements, then measuring instruments, standard samples, test equipment must be metrologically provided in the measurement system of the Russian Federation.

Requirements for measurement accuracy are established taking into account all components of the error (methodological, instrumental, introduced by the operator, arising during sampling and sample preparation). Typical components of the measurement error are given in Appendix A. Methods for estimating the characteristics of the measurement error for the MKCA are given in the recommendations.

If the obtained value of the measurement error is outside the specified limits, then the measurement error can be reduced in accordance with the recommendations.

Indicators of measurement accuracy should correspond to the initial data for the development of measurement methods. When evaluating the characteristics of the error, one should be guided by the recommendations,,, uncertainties - recommendations and guidelines, assigned characteristics for measuring the composition and properties of substances and materials - GOST R ISO 5725-1 - GOST R ISO 5725-6.

Planning experiments to evaluate the characteristics of the error of methods for measuring the composition and properties of substances and materials and the choice of methods for experimental evaluation of these characteristics is carried out in accordance with GOST R ISO 5725-1 - GOST R ISO 5725-6, uncertainties - in accordance with the manual.

5.2.2 The document regulating the measurement procedure indicates:

- name of the measurement technique;

- purpose of the measurement technique;

- application area;

- conditions for performing measurements;

- method (methods) of measurements;

- allowable and (or) attributed measurement uncertainty or error rate and (or) attributed measurement error characteristics;

- used measuring instruments, standard samples, their metrological characteristics and information about the approval of their types.

In the case of using certified mixtures according to the recommendations, the document for the measurement procedure should contain the methods for their preparation, requirements for auxiliary devices, materials and reagents (given them specifications and designation of documents in accordance with which they are issued);

- operations in preparation for measurements, including sampling;

- operations during measurements;

- operations for processing measurement results;

- requirements for registration of measurement results;

- procedures and periodicity for monitoring the accuracy of the obtained measurement results;

- requirements for ensuring the safety of work performed;

- requirements for ensuring environmental safety;

- other requirements and operations (if necessary).

Notes

1 In the documents for measurement procedures, which provide for the use of specific copies of measuring instruments and other technical means, additionally indicate the factory (inventory, etc.) numbers of copies of measuring instruments and other technical means.

2 In a document on measurement procedures, references may be given to officially published documents containing requirements or information necessary for the implementation of the procedure.

6 Qualification of measurement procedures

6.1 Measurement methods used in the field of state regulation of ensuring the uniformity of measurements and regulated in accordance with 5.2.2 are subject to mandatory certification.

6.2 Criteria for certification of measurement procedures:

- completeness of the statement of requirements and operations in the document for measurement procedures;

- availability and validity of accuracy indicators;

- compliance with the requirements of regulatory legal documents in the field of ensuring the uniformity of measurements.

6.3 Certification of measurement methods used in the field of state regulation of ensuring the uniformity of measurements is carried out by legal entities and individual entrepreneurs accredited in accordance with the established procedure in the field of ensuring the uniformity of measurements, including state scientific metrological institutes and state regional centers of metrology.

The certification of measurement procedures includes the metrological examination of a set of documents in accordance with 6.5 using the recommendations , , as well as theoretical and experimental studies confirming the compliance of the certified measurement procedure with the requirements of regulatory legal documents in the field of ensuring the uniformity of measurements.

6.4 When certifying measurement procedures, a study and confirmation of compliance is carried out:

- measurement techniques - their intended purpose, i.e. compliance of the proposed methodology with the properties of the measurement object and the nature of the measured values;

- conditions for performing measurements - requirements for the use of this measurement technique;

- indicators of accuracy of measurement results and methods for ensuring the reliability of measurements - established metrological requirements;

- used as part of the measurement methodology of measuring instruments, standard samples - the conditions for ensuring the traceability of measurement results to state primary standards of units of quantities, and in the absence of appropriate state primary standards of units of quantities - to national standards of units of quantities of foreign states;

- records of measurement results - requirements for units of quantities approved for use in the Russian Federation;

- forms of presentation of measurement results - metrological requirements.

6.5 The following documents are submitted for certification of measurement procedures:

- initial data for the development of measurement techniques;

- draft document regulating the measurement procedure;

- the program and results of evaluation of the accuracy indicators of the methodology, including materials of theoretical and experimental studies of the measurement methodology.

6.6 With positive certification results:

- draw up a conclusion on the compliance of the measurement technique with the established metrological requirements with the application of the results of theoretical and experimental studies;

- draw up a certificate of attestation;

- approve the document regulating the measurement procedure.

In case of negative results, the certifying organization draws up a conclusion on the non-compliance of the measurement methodology with the requirements terms of reference for the development of this measurement technique or regulatory legal documents in the field of ensuring the uniformity of measurements.

6.7 The certificate of attestation of the measurement procedure is signed by the head of the legal entity or individual entrepreneur who has certified the measurement procedure and certifies with a seal indicating the date. The attestation certificate is subject to registration legal entity or individual entrepreneur who issued it.

The certificate of attestation of the technique (method) of measurements must contain the following information:

- name and address of the legal entity or individual entrepreneur that certified the measurement technique;

- name of the document: "Certificate of attestation of the technique (method) of measurements";

- registration number of the certificate, consisting of the serial number of the certified measurement technique, the number of the accreditation certificate of a legal entity or individual entrepreneur and the year of approval;

- the name and purpose of the measurement procedure, including an indication of the measured quantity, and, if necessary, the name of the measurement object and its additional parameters, as well as the measurement method being implemented;

- name and address of the developer of the measurement procedure;

- designation and name of the document containing the measurement procedure, the year of its approval and the number of pages;

- designation and name of the regulatory legal document, for compliance with the requirements of which the measurement technique is certified (if there is an appropriate regulatory legal document);

- an indication of the method for confirming the compliance of the measurement technique with the established requirements (theoretical or experimental studies);

- the conclusion that as a result of certification of the measurement procedure, it was established that the measurement procedure meets the requirements for it.

The certificate may be accompanied by a measurement uncertainty budget or a structure for the formation of the total measurement error with an assessment of the contribution of each of the error components.

6.8 The document regulating the measurement technique is approved, after its certification, by the technical manager of the developer organization, the date of approval is affixed, the signature of the manager is certified with a seal. The date of registration is entered into the measurement procedure in accordance with 6.7 and the number of the attestation certificate. Document pages must be identified. After approval, a duplicate of the document is sent to the certifying organization. Changes to measurement procedures should be drawn up in accordance with the requirements of this standard for the development and certification of measurement procedures.

Measurement procedures are recorded in single register measurement techniques. Information about the certified measurement methods shall be submitted by the developer to the Federal Information Fund for Ensuring the Uniformity of Measurements.

6.9 Changes may be made to the measurement procedure. Changes are made by the developer. The measurement procedures with the changes made to them are submitted for certification carried out in accordance with this standard.

7 Standardization of measurement procedures

7.1 National standards and other documents in the field of standardization, including the rules and methods of research (testing) and measurements, as well as the rules for sampling samples for the application of technical regulations, should contain only certified measurement methods in accordance with the procedure for developing a list of national standards.

7.2 The development of standards that set out measurement methods is carried out in accordance with GOST 1.5 and the requirements of sections 5 and 6 of this standard.

Note - In the field of application of standards for control methods (tests, definitions, measurements, analysis), one should indicate the technical regulations, rules and methods of research (tests) and measurements, as well as the rules for sampling samples for the application of technical regulations, a standard or other regulatory document, which establishes the requirements for indicators controlled by a standardized measurement technique, and the measurement ranges of controlled indicators (measured characteristics) corresponding to these requirements.

7.3 The standard for control methods (tests, determinations, measurements, analysis) of the same indicator may provide for two or more alternative measurement methods, and one of them must be determined by the developer of the standard as arbitration (see 7.9.4 GOST 1.5). In this case, in order to confirm the possibility of using several alternative measurement methods to determine this indicator, procedures for evaluating and comparing the accuracy indicators of these measurement methods should be performed during the development of the standard. For them, the norms of permissible shifts (systematic deviations) of the measurement results of the controlled indicator, obtained using each of the alternative measurement methods, from the results of measurements of the same indicator using the arbitration method, should be established.

7.4 Measurement reproducibility indicators are established in standards based on the results of interlaboratory experiments conducted in accordance with GOST R ISO 5725-2, GOST R ISO 5725-3, GOST R ISO 5725-5 and GOST R ISO 5725-6.

7.5 The explanatory note to the set of documents submitted for the approval of the standard, which regulates the measurement procedures, should contain conclusions based on the results of the studies carried out during the certification of the measurement procedure, which allow assessing the compliance of the measurement procedure with the established metrological requirements.

8 Procedure for applying measurement procedures

8.1 Certified measurement procedures are implemented in strict accordance with the document in which they are set out, including control of measurement accuracy.

8.2 In the field of state regulation of ensuring the uniformity of measurements, only certified measurement methods are used.

8.3 Prior to the introduction into practice of the certified measurement technique in each laboratory in which this technique is supposed to be used, its feasibility is confirmed in the conditions of this laboratory with the established accuracy indicators.

8.4 Laboratories using certified measurement procedures are obliged to carry out constant quality control of measurements in accordance with the procedures set forth in the documents for this measurement procedure.

8.5 In the event of disputable situations in the presence of two or more certified methods for measuring the same quantity in the same conditions:

- for measurement methods regulated by officially published documents, an arbitration method must be defined. This measurement technique must be established by the federal executive body, which determines, within its competence, measurements related to the sphere of state regulation of ensuring the uniformity of measurements, and establishes mandatory metrological requirements for them, including requirements for measurement accuracy indicators;

- for methods not regulated by officially published documents, the arbitration method of measurements is determined by the agreement of interested legal entities.

8.6 Claims of users to the certified measurement methods that have arisen in the process of their application should be sent to the developers of the methods with the necessary justifications.

9 Metrological supervision of certified measurement methods

9.1 State metrological supervision is carried out over the availability and observance of certified measurement methods used in the field of state regulation of ensuring the uniformity of measurements.

Certificates of attestation of measurement procedures, which do not contain information according to 6.7, must be recognized by the supervisory authorities as invalid.

9.2 Metrological services of legal entities and individual entrepreneurs carry out metrological supervision over the availability and compliance with certified measurement methods used in the implementation of their activities. Recommendations can be used in the implementation of metrological supervision.

9.3 When exercising state metrological supervision or metrological supervision carried out by the metrological services of legal entities or individual entrepreneurs, check:

- availability of a list of all measurement methods used by a legal entity or an individual entrepreneur in the implementation of their activities, including standardized ones, with the allocation of measurement methods used in the field of state regulation of ensuring the uniformity of measurements;

- availability of documents regulating measurement methods, with attestation certificates (in accordance with the list);

- availability of information on the transfer of information about certified measurement procedures to the Federal Information Fund for Ensuring the Uniformity of Measurements;

- compliance of the measuring instruments and other technical means used, measurement conditions, procedure for preparing and performing measurements, processing and processing the measurement results - specified in the document regulating the measurement procedure;

- compliance with the requirements for the procedure for monitoring the accuracy of measurement results according to the measurement procedure;

- compliance of the qualifications of operators performing measurements with the requirements established in the document for the measurement procedure;

- compliance with the requirements for ensuring labor safety and environmental safety, regulated by the measurement methodology.

Annex A (informative). Typical measurement error components

Annex A
(reference)

A.1 Methodological components of measurement error

A.1.1 Inadequacy of the controlled object of the model, the parameters of which are taken as measured values.

A.1.2 Deviations from the accepted values of the arguments of the function that links the measured value with the value at the "input" of the measuring instrument (primary measuring transducer).

A.1.3 Deviations from the accepted values of the difference between the values of the measured quantity at the input of the measuring instrument and at the sampling point.

A.1.4 Error due to quantization effects.

A.1.5 The difference between the calculation algorithm and the function that strictly links the results of observations with the measured value.

A.1.6 Errors arising during sampling and sample preparation.

A.1.7 Errors caused by the interfering influence of sample factors (interfering sample components, fineness, porosity, etc.).

A.2 Instrumental components of measurement error

A.2.1 Basic errors and additional static errors of measuring instruments caused by slowly changing external influencing quantities.

A.2.2 Errors caused by the limited resolution of measuring instruments.

A.2.3 Dynamic errors of measuring instruments (errors caused by the inertial properties of measuring instruments).

A.2.4 Errors caused by the interaction of the measuring instrument with the object of measurement.

A.2.5 Errors in the transmission of measurement information.

A.3 Errors introduced by the operator (subjective errors)

A.3.1 Errors in reading the values of the measured quantity from scales and diagrams.

A.3.2 Errors in processing diagrams without the use of technical means (when averaging, summing measured values, etc.).

A.3.3 Errors caused by the operator's influence on the object and measuring instruments (distortions in the temperature field, mechanical effects, etc.).

Appendix B (recommended). Construction and presentation of documents on measurement techniques

B.1 The name of the document for measurement procedures must comply with the requirements national system standardization. It is allowed to reflect in the name the specifics of measurements of the quantity. For example: "State system for ensuring the uniformity of measurements. The mass of goods transported across railway. Methods of measurements by heavy platform scales".

With a large number of measured quantities, their generalized name is used, for example: "Parameters of the electromagnetic field in the aperture of highly directional antennas."

B.2 The measurement procedure document should include an introductory part and the following sections:

- requirements for measurement accuracy indicators;

- requirements for measuring instruments, auxiliary devices, materials, reagents;

- method (methods) of measurements;

- safety and security requirements environment;

- qualification requirements for operators;

- requirements for measurement conditions;

- preparation for measurements, including sampling requirements;

- the procedure for performing measurements;

- processing of measurement results;

- registration of measurement results;

- control of measurement results accuracy.

It is allowed to exclude or combine the specified sections or change their names, as well as introduce additional sections, taking into account the specifics of measurements.

B.3 The introductory part establishes the purpose and scope of the document on the measurement procedure.

B.3.1 The introductory part is set out as follows: "This document (indicate the type of document being developed) establishes the measurement methodology (indicate the name of the measured quantity, if necessary, its specifics and the specifics of measurements)". The following are the measurement ranges and the area of application of the measurement technique.

B.3.2 If the measurement procedure can be used to assess compliance with the requirements established by the technical regulation, then the name of the technical regulation, the number of the paragraph establishing the requirements (if necessary, the name of the standard or set of rules), and also indicate whether it is included in the list of national standards containing the rules and methods of research (testing) and measurements, including the rules for sampling, necessary for the application and execution of technical regulations and conformity assessment.

B.3.3 When referring to specific products in the introductory part, indicate the designation of a regulatory document that applies to these products, for example: "This document (indicate a specific type of document for a measurement procedure) establishes measurement procedures for determining the characteristics of soft magnetic alloys according to GOST 10160 at any point of the hysteresis loop. Among the characteristics of magnetic -soft alloys include:

- coercive force by induction;

- squareness coefficient of the hysteresis loop;

- coercive force by magnetization;

- temperature coefficients of the above characteristics".

B.4 Section "Requirements for measurement accuracy indicators" contains numerical values of measurement accuracy indicators and a link to the document in which they are given.

B.4.1 The first paragraph of the section of requirements for accuracy indicators is stated in the wording: "The permissible expanded measurement uncertainty by this technique is 10 μg / m (with a coverage factor of 2)" or "The limits of the permissible relative measurement error by this technique are ± 1.5% (provide a link to the normative document). When specifying the assigned measurement uncertainty, the word "tolerable" is excluded.

When specifying the attributed characteristics of the measurement error, instead of "Limits of permissible error ..." they state "Limits of error ...", instead of "The error of measurements must comply with the requirements specified in ..." they state "The error of measurements corresponds to the characteristics given in ... ".

If a significant random component of the measurement error is assumed, then instead of "limits" indicate "boundaries", which are accompanied by a probability value (for example, 0.95).

Indicators of correctness and precision of measurements are expressed according to GOST R ISO 5725-1 - GOST R ISO 5725-5. The measurement reproducibility indicator is accompanied by information about the interlaboratory experiment, on the basis of which the indicator value was established.

B.4.2 Requirements for measurement accuracy of the same quantity may be different for different measurement ranges, different products, different measurement conditions. In this case, as well as for several measured quantities, the requirements for measurement accuracy indicators are given in the form of tables, graphs or equations.

B.5 Section "Requirements for measuring instruments, auxiliary devices, materials, reagents" contains a list of all measuring instruments, auxiliary devices, materials, reagents used in measurements. The section provides the metrological characteristics of measuring instruments and reference materials, technical characteristics of auxiliary devices and quality characteristics materials and reagents with the designation of the documents in accordance with which they are produced (for measurement procedures in the field of state regulation of ensuring the uniformity of measurements, the types of measuring instruments and reference materials are indicated).

Metrological, technical and other characteristics for large volume may be given in the application.

B.5.1 The annex may contain drawings, specifications and descriptions of measuring instruments and auxiliary devices of one-time production.

B.5.2 The first paragraph of the section is stated as follows: "When performing measurements, the following measuring instruments, auxiliary devices, materials and reagents are used: ..." or "When performing measurements, the measuring instruments, auxiliary devices, materials and reagents listed in Table B are used .one".

Table B.1


Serial number and name of measuring instruments, auxiliary devices, materials and reagents	Designation and name of documents in accordance with which measuring instruments, auxiliary devices, materials and reagents are produced	Metrological, technical specifications or drawing reference. Requirements for the quality of reagents

In the section it is allowed to indicate the possibility of using other measuring instruments, auxiliary devices, materials and reagents with similar or better metrological and technical characteristics.

B.6 Section "Method (methods) of measurements" contains a description of methods for comparing the measured physical quantity with its unit in accordance with the principle underlying the method.

If several methods are used for measurements of one quantity or the document establishes methods for measuring two or more quantities, then a description of each method is given in a separate subsection.

B.6.1 The first paragraph of the section (subsection) is stated as follows: "Measurements (give the name of the measured quantity) are performed by the method (give a description of the method)".

B.7 The section "Requirements for safety, environmental protection" contains requirements, the fulfillment of which ensures labor safety, compliance with industrial hygiene standards and environmental protection when performing measurements.

B.7.1 If available normative documents, regulating the requirements of safety, industrial sanitation and environmental protection, in the section provide a link to these documents.

B.7.2 The first paragraph of the section is stated as follows: "When performing measurements (give the name of the measured value), the following requirements are observed: (list the requirements for safety, industrial sanitation, environmental protection)".

B.8 Section "Requirements for the qualification of operators" contains information about the level of qualification (profession, education, practical experience, etc.) of persons allowed to perform measurements. This section is included in the document on the measurement procedure when using complex non-automated measurement methods and procedures for processing their results.

B.8.1 The first paragraph of the section is stated as follows: "Persons are allowed to perform measurements and (or) process their results (provide information about the level of qualification)".

B.9 Section "Requirements for measurement conditions" contains a list of influencing quantities, their nominal values and (or) limits of the ranges of possible values, as well as other characteristics of influencing quantities, requirements for the measurement object. Among the influencing quantities are the parameters of the media (samples), the voltage and frequency of the supply current, the internal impedances of the measurement objects, and other characteristics.

It is allowed to give lists of influencing quantities in the form of a table.

B.9.1 The first paragraph of the section is stated as follows: "When performing measurements, the following conditions are observed: ..." or "When performing measurements, the conditions given in Table B.2 are observed."

Table B.2

B.10 Section "Preparing for measurements" contains a description preparatory work, which are carried out before performing direct measurements. These works include the preliminary determination of the values of the influencing quantities, the assembly of circuits (for this, diagrams are given in the section or appendix), the preparation and verification of the operating modes of measuring instruments and other technical means (zero setting, exposure in the on state, testing, etc.) , sample preparation for measurements.

B.10.1 If the establishment of a calibration characteristic is provided for when performing a quantitative chemical analysis, then the section provides methods for its establishment and control, as well as the procedure for manufacturing and using samples for calibration.

B.10.2 If the order of preparatory work is established in the documents for measuring instruments and other technical means, then the section provides links to these documents.

B.10.3 The first paragraph of the section is stated as follows: "In preparation for the measurement, the following work is carried out: (a list and description of the preparatory work are given)".

B.11 The section "Procedure for performing measurements" contains a list, scope, sequence of operations, frequency and number of measurements, description of operations, acceptance criteria for the results of intermediate measurements, requirements for the presentation of intermediate and final results (number of significant digits, etc.).

For MKCA, the section also provides requirements for the mass and number of sample portions, and, if necessary, instructions on conducting a "control (blank) experiment" and a description of operations to eliminate the influence of interfering sample components.

B.11.1 If the procedure for performing operations is established in the documents for the measuring instruments and other technical means used, then the section provides links to these documents.

B.11.2 If several methods are used to measure one quantity or the document establishes a method for measuring two or more quantities, then the description of each operation is given in a separate subsection.

B.11.3 In the section (subsection) there is a requirement for mandatory registration of the results of intermediate measurements and values of influencing quantities. If necessary, indicate the forms of registration of intermediate measurement results and values of influencing quantities.

B.11.4 The first paragraph of the section is stated as follows: "When performing measurements (give the name of the measured quantity), perform the following operations: (give descriptions of operations)".

B.12 Section "Processing measurement results" contains a description of the methods of processing and obtaining measurement results. If the methods for processing measurement results are established in other documents, the section provides links to these documents.

B.12.1 In the section, if necessary, indicate the data required to obtain measurement results (constants, tables, graphs, equations, etc.). With a large amount of data, they are given in the application.

B.12.2 The section provides a requirement for mandatory registration of processing the results of intermediate measurements, indicating, if necessary, the form of such registration (in in electronic format or on paper).

B.12.3 The first paragraph of the section is stated as follows: "Processing of the measurement results is performed by the method (describe the method)".

B.13 Section "Formation of measurement results" contains requirements for the form of presentation of measurement results. This section may provide guidance on how to round measurement results. The forms of presentation of measurement results in the document for the measurement procedure must correspond to the forms of presentation of measurement results given in the attestation certificate.

B.14 The section "Monitoring the accuracy of measurement results" contains instructions on the controlled parameters, means, procedures, control standards, as well as instructions (recommendations) on the frequency of control. Individual procedures, such as sample preparation for accuracy control, may be described in an annex to the measurement procedure document.

Bibliography


		State system for ensuring the uniformity of measurements. Measurement results and measurement error characteristics. Presentation forms. Methods of use in testing product samples and monitoring their parameters
		State system for ensuring the uniformity of measurements. Application of the "Guide to the Expression of Uncertainty in Measurement"
EURACHIM/SITAC Manual "Quantifying Uncertainty in Analytical Measurements" (2nd ed., 2000) - In trans. from English. - St. Petersburg: VNIIM im. D.I. Mendeleev, 2002
		State system for ensuring the uniformity of measurements. Measurement scales. Terms and Definitions
		State system for ensuring the uniformity of measurements. Certification of algorithms and programs for data processing during measurements. Key points
State system for ensuring the uniformity of measurements. Standard methodology for certification software measuring instruments and the procedure for its implementation
		State system for ensuring the uniformity of measurements. The choice of methods and means of measurement in the development of methods for performing measurements. General provisions
		State system for ensuring the uniformity of measurements. Indicators of accuracy, correctness, precision of methods of quantitative chemical analysis. Assessment Methods
		State system for ensuring the uniformity of measurements. Ensuring the efficiency of measurements in process control. Estimation of measurement error with limited initial information
Guidance document	State system for ensuring the uniformity of measurements. Blends certified. General development requirements
		State system for ensuring the uniformity of measurements. Methods of quantitative chemical analysis. Content and procedure for metrological examination
		State system for ensuring the uniformity of measurements. Ensuring the efficiency of measurements in process control. Metrological examination of technical documentation
			State system for ensuring the uniformity of measurements. Metrological supervision carried out by metrological services of legal entities


UDC 389.14:006.354

Keywords: technique (method) of measurements, technique of quantitative chemical analysis, certification, metrological examination

Electronic text of the document
prepared by Kodeks JSC and verified against:
official publication
Moscow: Standartinform, 2019

The goals and principles of standardization in the Russian Federation are established by the Federal Law of December 27, 2002 N 184-FZ "On Technical Regulation", and the rules for the application of national standards of the Russian Federation - GOST R 1.0-2004 "Standardization in the Russian Federation. Basic provisions"

1 DEVELOPED by the Federal State Unitary Enterprise "All-Russian Research Institute of Metrological Service" (FGUP "VNIIMS")

Information about changes to this standard is published in the annually published information index "National Standards", and the text of changes and amendments - in the monthly published information indexes "National Standards". In case of revision (replacement) or cancellation of this standard, a corresponding notice will be published in the monthly published information index "National Standards". Relevant information, notification and texts are also posted in the public information system - on the official website of the Federal Agency for Technical Regulation and Metrology on the Internet

Requirements for measurement techniques (methods) in the Russian Federation are established by Article 5 federal law dated June 26, 2008 N 102-FZ "On Ensuring the Uniformity of Measurements" (hereinafter referred to as the Federal Law "On Ensuring the Uniformity of Measurements"), according to which measurement techniques (methods) used in the field of state regulation of ensuring the uniformity of measurements are subject to certification.

The scope of state regulation of ensuring the uniformity of measurements in accordance with the provisions of Parts 3 and 4 of Article 1 of the Federal Law "On Ensuring the Uniformity of Measurements" extends to measurements for which mandatory requirements are established, and measurements provided for by the legislation of the Russian Federation on technical regulation.

Lists of measurements with mandatory requirements established for them are formed in accordance with Part 2 of Article 27 of the Federal Law "On Ensuring the Uniformity of Measurements".

This standard has been developed in order to provide recommendations on the implementation of the requirements for measurement procedures (methods) established by Article 5 of the Federal Law "On Ensuring the Uniformity of Measurements".

This standard does not apply to measurement procedures designed to perform direct measurements, i.e. methods, in accordance with which the desired value of the quantity is obtained directly from the measuring instrument. Such measurement techniques are included in the operational documentation for measuring instruments. Confirmation of the compliance of these methods with the mandatory metrological requirements is carried out in the process of approving the data types of measuring instruments.

GOST R ISO 5725-2-2002 Accuracy (correctness and precision) of measurement methods and results. Part 2: Basic method for determining the repeatability and reproducibility of a standard measurement method

GOST R ISO 5725-3-2002 Accuracy (correctness and precision) of measurement methods and results. Part 3. Intermediate precision values of the standard measurement method

GOST R ISO 5725-4-2002 Accuracy (correctness and precision) of measurement methods and results. Part 4: Basic methods for determining the validity of a standard measurement method

GOST R ISO 5725-5-2002 Accuracy (correctness and precision) of measurement methods and results. Part 5: Alternative methods for determining the precision of a standard measurement method

GOST R ISO 5725-6-2002 Accuracy (correctness and precision) of measurement methods and results. Part 6. Using precision values in practice

GOST 1.5-2001 Interstate standardization system. Interstate standards, rules and recommendations for interstate standardization. General requirements for construction, presentation, design, content and designation

Note - When using this standard, it is advisable to check the validity of reference standards in the public information system - on the official website of the Federal Agency for Technical Regulation and Metrology on the Internet or according to the annually published information index "National Standards", which was published as of January 1 of the current year , and according to the corresponding monthly published information signs published in the current year. If the reference standard is replaced (modified), then when using this standard, you should be guided by the replacing (modified) standard. If the referenced standard is canceled without replacement, the provision in which the reference to it is given applies to the extent that this reference is not affected.

This standard uses the terms according to GOST R ISO 9000, GOST R ISO 5725-1, , , , , as well as the following terms with the corresponding definitions:

3.2 qualification of measurement procedures: Examination and confirmation of compliance of measurement procedures with established metrological requirements for measurements.

3.3 metrological examination of measurement procedures: Analysis and evaluation of the choice of methods and measuring instruments, operations and rules for conducting measurements, as well as processing their results in order to establish the compliance of the measurement procedure with the metrological requirements imposed on it.

3.4 indicator of measurement accuracy: An established characteristic of the accuracy of any measurement result obtained in compliance with the requirements and rules of this measurement procedure.

- in the column "main technical characteristics (measurement range, error, characteristics that may affect the test results)" the information given in the technical passport or operation manual is indicated. If the test equipment is intended for control tests and the value of the controlled characteristic is not subject to evaluation, this is reflected in the "note" column.

Form 5. Information about auxiliary equipment.

— name, type (model), manufacturer;

- appointment;

— carrying out Maintenance(when installed in ED).

- note.

it new form, introduced in MI 2427-2016, and filling it out may cause certain problems. Therefore, here are some recommendations:

- the name of the auxiliary equipment should also be indicated in accordance with the technical documentation accompanying it;

- the purpose of auxiliary equipment is indicated in accordance with those functions, the implementation of which requires its use in the conditions of the measurement or test procedure used;

— auxiliary equipment, like any equipment, requires periodic maintenance. The procedure for the development and approval of documents containing instructions on the timing and content of such maintenance work, provided for by the operational documentation, should be contained in the Quality Manual. Records of its implementation are usually contained in forms or other documents for accounting for auxiliary equipment. It is these records that serve as the basis for filling out the corresponding column of Form 5.

Often, laboratories are limited to entering Form 5 only electrical equipment. The absence of the necessary material and technical support corresponding to the chosen methodology (method) of measurements is the basis for the decision on the absence of conditions for measurements. Therefore, it is recommended to enter in the form all the equipment necessary for the implementation of the methodology (method) of measurements or tests: equipment, inventory, etc.

There are situations when the technical documentation for the equipment (measuring instruments, test or auxiliary equipment) is lost. In this case, it is extremely necessary to restore it, since it contains basic information about the equipment, without which full-fledged operation is impossible (name, technical characteristics, safety requirements, operating rules, maintenance regulations, etc.). This is possible by issuing duplicates and copies of documents that can be requested from the manufacturer.

Form 6. List of reference materials used.

This form must contain the following information:

— developer (manufacturer) of a standard sample;

- purpose (graduation, accuracy control, etc.);

— metrological characteristics:

. name and certified value;

. certified value error;

. additional information;

— ND on the order and conditions of use;

— date of issue of a copy of the reference material;

— the expiration date of a copy of the standard sample;

- note.

This form is not new and, as a rule, no questions arise when filling it out. However, it is worth pointing out that in the absence of standard samples, it is desirable to indicate in the first line of the form: “not applicable”. The same can be done, with the validity of such a provision, with forms 3, 4 and 5.

Form 7. State of measurement techniques (methods).

This form must contain the following information: