One of the statutory activities of the centers of standardization and metrology is assessing the state of measurements in testing laboratories. The work was carried out on the basis of MI 2427-97 “GSI. Assessment of the state of measurements in test and measurement laboratories" FSUE "VNIIMS" together with FSUE "UNIIM" in 2016 developed recommendations MI 2427-2016 "GSI. Assessment of the state of measurements in testing, measuring laboratories and laboratories of production and analytical control”, canceling the effect of previous MI 2427-97. Clause 1.2 of MI 2427-2016 provides for the Performers of these works (including CSM) accreditation in the field of ensuring the uniformity of measurements to carry out metrological examination work.

Please clarify:

The competence of FSUE "VNIIMS" to develop and approve MI 2427-2016, intended for use by state regional centers of standardization, metrology and testing, without the approval of Rosstandart.

The legality of introducing requirements for accreditation of Performers of work to assess the state of measurements in testing laboratories, while in the accreditation criteria approved by the Order of the Ministry of Economic Development Russian Federation No. 326 dated May 30, 2014, there are no requirements for legal entities providing services in the field of assessing the state of measurements in testing laboratories.

The question came from the standardization department of the Federal Budgetary Institution "Khakassian Center for Medical Sciences" on e-mail November 25, 2016 at 09:36.

Alexey Vladimirovich Abramov: MI 2427-2016, like other methods of the institute, is a methodological recommendation document aimed at improving the quality of metrological work. The methodology was developed jointly by two state scientific metrology institutes - FSUE "VNIIMS" and FSUE "UNIIM", agreed with Rosstandart and recommended for use in subordinate organizations.

Since work on assessing the state of measurements is not mandatory and is not subject to accreditation, accordingly, they are not subject to the accreditation criteria established by Order of the Ministry of Economic Development of Russia dated May 30, 2014 No. 326.

This technique is recommended for use in organizations subordinate to Rosstandart to improve the quality of work on assessing the state of measurements. Accordingly, it contains recommendations on the involvement of organizations accredited for metrological examination for this type of work.

The answer is awesome!!! and so it is clear that it is voluntary. and all its points accordingly! but when work on the “Assessment...” begins, they are carried out in accordance with what??? Naturally MI 2427-2016!!! And then what? said? who is doing? how does? Here is the paradox! Create your MI as Old Call HER ( Rating CONDITION MEASUREMENT in laboratories) and work on it! Her status will be the SAME as MI 2427-2016!

And the most important thing!!

"Since work on assessing the state of measurements is not mandatory and is not subject to accreditation, accordingly, they are not subject to the accreditation criteria established by Order of the Ministry of Economic Development of Russia dated May 30, 2014 No. 326." ...AND MI 2427-2016's REQUIREMENT for accreditation is generally ILLEGAL!............ Well, let's write there that you must first pull out the chief metrologist's hair and break his arm, and then you can work! current, this is also ILLEGAL and draws on the Article of the Criminal Code of the Russian Federation... and they answer us, well, it’s voluntary... if you want to comply, then BREAK IT!

FEDERAL AGENCY
ON TECHNICAL REGULATION AND METROLOGY
(ROSSTANDART)

(FSUE "UNIIM")

FEDERAL STATE UNITARY ENTERPRISE
ALL-RUSSIAN RESEARCH INSTITUTE
METROLOGICAL SERVICE
(VNIIMS)

STATE UNITY SYSTEM
MEASUREMENTS

ASSESSMENT OF MEASUREMENT STATUS
IN TESTING, MEASURING LABORATORIES AND LABORATORIES
PRODUCTION AND ANALYTICAL CONTROL

MI 2427-2016

Moscow
2016

INFORMATION DATA

DEVELOPED

"URAL RESEARCH INSTITUTE OF METROLOGY"
(FSUE "UNIIM")

Performers: Bessonov Yu.S., Medvedevskikh M.Yu., Ponomareva O.B.

FEDERAL STATE UNITARY ENTERPRISE
"ALL-RUSSIAN RESEARCH INSTITUTE
METROLOGICAL SERVICE"
(FSUE "VNIIMS")

Performers: Pashaev B.M., Lukashov Yu.E., Rozumenko S.B.

APPROVED

Providing guarantees of control over the stability of production technological processes(certification, declaration);

Production control, including industrial environmental monitoring at the enterprise and internal control quality of products and raw materials;

Presentation of the results of monitoring environmental indicators (in particular, analysis of wastewater and industrial emissions in the Centers for Laboratory Analysis and Technical Measurements (for sanitary and industrial laboratories);

Entry of a legal entity or its laboratory into self-regulatory organizations (for construction and soil laboratories).

5. ORGANIZATION OF WORK TO ASSESS THE STATE OF MEASUREMENTS

5.1. The assessment of the state of measurements is carried out on the basis of an application from an organization that includes a laboratory with an attached list of objects and indicators controlled in them.

5.2. To assess the state of measurements, the head of an organization subordinate to Rosstandart, who has received the corresponding application, appoints persons responsible for carrying out this work, who form the composition of the commission,, if necessary, coordinate it with the applicant and draw up a draft contract for the work.

Personal composition commission depends on the specifics, volume and complexity of the work.

5.3. To assess the state of measurements, the laboratory prepares materials in the form of completed forms (Metrological Support Certificate) in accordance with this recommendation.

The prepared materials should reflect the following information:

List of documents on standardization and other normative documents (ND) regulating the requirements for:

Types of work performed in the laboratory;

Tested (analyzed) objects;

The measured (controlled) parameters of these objects;

Data on the standards used in the laboratory, measuring instruments (MI) and their metrological confirmation (verification, calibration);

Data on the testing equipment (TE) used and its certification;

Data on the auxiliary equipment used;

Equipping the laboratory with the required standard samples;

List of RD for measurement techniques (methods) and test methods (including national and interstate standards), data on the applied measurement techniques (methods) and test methods;

Data on the composition and qualifications of personnel, including current documents on advanced training;

Information about the availability and condition of laboratory premises;

List of chemical reagents (if available), indicating the date of their manufacture, expiration date and qualifications;

A list of updated and taken into account regulatory documentation necessary for the functioning of the laboratory in the declared field of activity, including documents regulating the procedures for the collection and storage of samples (test samples).

Information about laboratory premises may be accompanied by certificates, conclusions on the compliance of the premises with safety requirements (fire, biological, electromagnetic, radiation), labor protection, etc., which can be drawn up in any form or be conclusions of competent authorities, as well as protocols measurements of physical and chemical factors of the production environment.

5.4. To carry out work to assess the state of measurements, a program for assessing the state of measurements can be developed. An example of a typical program for assessing the state of measurements in a laboratory is given in the Appendix.

5.5. The commission conducts an inspection of the laboratory to verify the actual state of measurements, including the conditions for their implementation and confirmation of the information stated in the documents, directly at the place where the laboratory operates.

5.6. The management of the laboratory (enterprise) provides the conditions necessary for the work of the commission, including allocating premises for work, representing Required documents and materials, provides duplication services, and also allocates an official with the right to sign documents.

6. CONTENT OF WORK TO ASSESS THE STATE OF MEASUREMENTS

6.1. Work to assess the state of measurements is carried out in 3 stages:

The first stage is studying the documents;

The second stage is an inspection of the laboratory at the place of activity;

The third stage is the presentation of the results of the work.

6.2. Work at stage 1 includes conducting a metrological examination of documents and information about the activities of the laboratory, submitted by the applicant, in terms of compliance with the requirements of the legislation of the Russian Federation on ensuring the uniformity of measurements and in the field of technical regulation, regulatory legal acts and standardization documents related to the performance of the functions assigned to the laboratory .

6.3. Work at stage 2 includes checking the compliance of the information presented in forms 1 - 11 of the Passport with the actual state of affairs in the local laboratory production activities taking into account the requirements imposed by the legislation of the Russian Federation.

6.4. Stage 3 work includes:

Drawing up a Report based on the results of assessing the state of measurements in the laboratory, containing a conclusion about the compliance or non-compliance of the conditions for performing measurements in the declared field of activity with the metrological requirements for measurements;

Drawing up a Conclusion confirming the availability in the laboratory of conditions for performing measurements in the declared field of activity in relation to specific measurement objects, taking into account the metrological requirements imposed by the legislation of the Russian Federation on ensuring the uniformity of measurements (if the conclusions of the Act are positive based on the results of assessing the state of measurements in the laboratory).

6.5. The examination of the information submitted by the applicant in forms 1 - 11 involves their analysis and assessment, including from the point of view of the sufficiency of the information provided in terms of:

Availability in the laboratory of the necessary documents establishing the requirements for the declared measurement objects, the indicators (parameters) measured in them and the measurement (testing) techniques (methods), taking into account the possible belonging of the objects to the scope of technical regulations, and the measurements and measured indicators to the scope government regulation ensuring uniformity of measurements;

Availability of the necessary nomenclature of measuring instruments and measurement methods, taking into account the scope of their application and metrological confirmation;

Equipping the laboratory with the necessary testing equipment;

Nomenclatures of reference materials various types, used for calibration and control of the accuracy of measurement results, taking into account:

Referring measurements to the scope of state regulation to ensure the uniformity of measurements;

Correspondence of the metrological characteristics of the reference material to the measurement range of the applied measurement techniques;

Shelf life of RMs and their use in accordance with established requirements;

Application of measurement (testing) techniques (methods) in terms of the presence of metrological characteristics in them, corresponding to GOST R ISO 5725-1 and RMG 61-2010 and procedures for monitoring the accuracy of measurement results in accordance with GOST R ISO 5725-6 and RMG 76-2014, allowing to ensure reliability of measurement results;

Methodology (methods) of measurements (tests) used in the control of declared objects and indicators for which certification or suitability assessment (validation) is required in accordance with R 50.2.090;

The personnel performing the measurements in relation to their competence (if this is provided for by the established requirements for the measurements performed);

Laboratory premises necessary for carrying out measurements (tests) that have documentary evidence of compliance with their safety requirements, including safe conditions labor in the declared field of activity;

A fund of regulatory and technical documents necessary for the implementation of laboratory activities in the declared area of ​​measurements.

6.6. When examining a laboratory at its place of activity, the following is carried out:

Checking the following documents:

▪ Regulations on the laboratory, defining its functions, rights, duties, responsibilities, interaction with other divisions of the organization (if it is not legal entity) and other organizations;

▪ Quality manual or document performing its function and regulating the quality management system of work performed by the laboratory in the declared field of activity;

▪ updated and registered in the laboratory fund of RD necessary for the functioning of the laboratory, including guidelines for the selection and storage of samples for testing (measurement) samples, regulating the procedures for obtaining representative samples and the invariability of their composition and properties (for laboratories whose area of ​​activity includes Sample selection);

▪ plans (schedules) for cancellation or revision of documents for measurement techniques (methods) that do not meet the requirements of GOST R 8.563-2009, and certification of measurement techniques (if necessary) or assessment of their suitability;

▪ approved in accordance with the established procedure job descriptions;

▪ requirements for the qualifications of personnel and the procedure for their admission to performing measurements in the declared area.

▪ - analysis and assessment of the compliance of the laboratory’s activities according to the submitted documents in terms of:

▪ compliance of the used measuring instruments, standard samples and testing equipment with the requirements provided for in the RD for measurement and testing techniques (methods), taking into account whether the measurements performed are within the scope of state regulation of ensuring the uniformity of measurements or outside it;

▪ compliance of the used measuring instruments and reference materials with their purpose and conditions of use provided for in the technical and (or) operational documentation for measuring instruments and normative documents for RMs;

▪ compliance of the applied normative documents for measurement techniques (methods) and test methods nomenclature and range of indicators provided for by regulatory legal acts and regulatory documents establishing requirements for the parameters of controlled objects, as well as compliance of documents regulating measurement techniques (methods) with the requirements of Order of the Ministry of Industry and Trade of December 15, 2015 No., GOST R 8.563-2009 or GOST 8.010 -2013 (for techniques intended for use in the CIS);

▪ the presence and functioning of procedures to ensure the quality of measurements performed by the laboratory, including:

◦ availability and compliance with schedules for metrological confirmation of used measuring instruments and measuring instruments, as well as Maintenance auxiliary equipment;

◦ availability and application of certified and (or) validated measurement techniques (methods) in the practice of analytical control;

◦ availability and application of procedures for quality control of measurement results (operational, statistical control of accuracy, control of the stability of the calibration characteristic, assessment of the acceptability of measurement results);

◦ implementation of procedures for assessing the suitability of chemical reagents (if used);

◦ compliance with schedules for advanced training and certification of personnel (if any);

◦ participation in laboratory qualification testing through interlaboratory comparative tests;

◦ systems for monitoring and recording the measurement conditions provided for in the measurement procedures and in the operational documentation for measuring instruments;

▪ compliance of methods for preparing certified mixtures (AC) with the requirements of RMG 60-2003 (if the laboratory has independently developed methods for preparing AC);

▪ compliance of laboratory premises with the requirements established for them to ensure safe working conditions and environmental safety;

▪ compliance of the laboratory with other requirements (for example, ensuring safety from radiation; electrical, fire, explosion safety, etc.) established in regulatory legal acts Federal executive authorities, standardization documents or in the applicant’s ND (if any).

7. PRESENTATION OF RESULTS

7.1. An act based on the results of assessing the state of measurements in the laboratory is drawn up in the form of an appendix, which is signed by the members of the commission and brought to the attention of the head of the laboratory and a representative of the applicant’s administration.

7.1.1. Depending on the results of the metrological examination, the report makes a conclusion about the presence (absence) of conditions for performing measurements in the area of ​​activity assigned to the laboratory in accordance with the metrological requirements.

PASSPORT
metrological support

_______________________________________________

laboratory name

Form 1

INFORMATION ABOUT THE LABORATORY

1. Name of the laboratory:

2. Laboratory address:

3. Phone __________________ fax _______________ e-mail ___________________

4. Full name of the head of the laboratory:

5. Organization, the structure of which includes the laboratory (if it is not a legal entity), legal and actual address

6. Full name of the head of the organization:

7. Telephone

8. Registration number of the certificate of assessment of the state of measurements, validity period of the certificate (if any)

Form 2

ND on objects, measurement techniques and test methods used
in the laboratory as of “__” ___________ 20__

Head of Laboratory ________________________________________________ Full name

_______________________________________________________________________

date of testing in the laboratory "__" ________________ 20__

Appendix B
(required)

Appendix D
(required)

Application form
Conclusion on the state of measurements in the laboratory

STATE SYSTEM FOR ENSURING THE UNIFORMITY OF MEASUREMENTS

ASSESSMENT OF MEASUREMENT STATUS
IN TESTING, MEASURING LABORATORIES
AND LABORATORIES PRODUCTION AND
ANALYTICAL CONTROL

MI 2427-2016

(with changes No. 1)

MOSCOW
2017

INFORMATION DATA

DEVELOPED

"URAL RESEARCH INSTITUTE OF METROLOGY"
(FSUE "UNIIM")

Performers: Bessonov Yu.S., Medvedevskikh M.Yu., Ponomareva O.B.

FEDERAL STATE UNITARY ENTERPRISE
"ALL-RUSSIAN RESEARCH INSTITUTE
METROLOGICAL SERVICE"
(FSUE "VNIIMS")

Performers: Pashaev B.M., Lukashov Yu.E.

APPROVED

1 AREA OF USE

1.1. This recommendation establishes the goals, objectives, procedure for organizing and assessing the state of measurements in testing, measuring laboratories (centers), laboratories carrying out production, analytical control, research and other tests and measurements (hereinafter referred to as laboratories).

Analytical control can be part of other types of control (environmental, sanitary, technological control; internal quality control of products and raw materials, etc.).

Providing guarantees of control over the stability of production processes (certification, declaration);

Production control, including industrial environmental monitoring at the enterprise and internal quality control of products and raw materials;

Presentation of the results of monitoring environmental indicators (in particular, analysis of wastewater and industrial emissions in the Centers for Laboratory Analysis and Technical Measurements (for sanitary and industrial laboratories);

Entry of a legal entity or its laboratory into self-regulatory organizations (for construction, soil laboratories, etc.).

5. ORGANIZATION OF WORK TO ASSESS THE STATE OF MEASUREMENTS

5.1. The assessment of the state of measurements is carried out on the basis of an application from an organization that includes a laboratory with an attached list of objects and indicators controlled in them.

5.2. To assess the state of measurements, the head of an organization subordinate to Gosstandart, who has received the corresponding application, appoints persons responsible for carrying out this work, who form the composition of the commission,, if necessary, coordinate it with the applicant and draw up a draft contract for the work.

The composition of the commission depends on the specifics, volume and complexity of the work.

5.3. To assess the state of measurements, the laboratory prepares materials in the form of completed forms (Metrological Support Certificate) in accordance with this recommendation.

The prepared materials should reflect the following information:

List of documents on standardization and other normative documents (ND) regulating the requirements for:

Types of work performed in the laboratory;

Tested (analyzed) objects;

The measured (controlled) parameters of these objects;

Data on the standards used in the laboratory, measuring instruments (MI) and their metrological confirmation (verification, calibration);

Data on the testing equipment (TE) used and its certification;

Data on the auxiliary equipment used;

Equipping the laboratory with the required standard samples;

List of RD for measurement techniques (methods) and test methods (including national and interstate standards), data on the applied measurement techniques (methods) and test methods:

Data on the composition and qualifications of personnel, including current documents on advanced training;

Information about the availability and condition of laboratory premises;

List of chemical reagents (if available), indicating the date of their manufacture, expiration date and qualifications;

A list of updated and taken into account regulatory documentation necessary for the functioning of the laboratory in the declared field of activity, including documents regulating the procedures for the collection and storage of samples (test samples).

Information about laboratory premises may be accompanied by certificates, conclusions on the compliance of the premises with safety requirements (fire, biological, electromagnetic, radiation), labor protection, etc., which can be drawn up in any form or be conclusions of competent authorities, as well as protocols measurements of physical and chemical factors of the production environment.

5.4. To carry out work to assess the state of measurements, a program for assessing the state of measurements can be developed. Example standard program An assessment of the state of measurements in the laboratory is given in the Appendix.

A specific Measurement Status Assessment Program can be developed taking into account the requirements of the applicant and the specifics of the measurements performed in the laboratory, and previously sent to the applicant.

5.5. The commission conducts an inspection of the laboratory to verify the actual state of measurements, including the conditions for their implementation and confirmation of the information stated in the documents, directly at the place where the laboratory operates.

5.6. The management of the laboratory (enterprise) provides the conditions necessary for the work of the commission, including allocating premises for work, presenting the necessary documents and materials, providing copying services, and also assigning an official with the right to sign documents.

6. CONTENT OF WORK TO ASSESS THE STATE OF MEASUREMENTS

6.1. Work to assess the state of measurements is carried out in 3 stages:

The first stage is studying documents;

The second stage is an inspection of the laboratory at the place of activity;

The third stage is the presentation of the results of the work.

6.2. Work at stage 1 includes an examination of the documents and information submitted by the applicant about the activities of the laboratory in terms of compliance with the requirements of the legislation of the Russian Federation on ensuring the uniformity of measurements and in the field of technical regulation, regulatory legal acts and standardization documents related to the performance of the functions assigned to the laboratory.

6.3. Work at stage 2 includes checking the compliance of the information presented in the forms - the Passport with the actual state of affairs in the laboratory at the place of production activity, taking into account the requirements imposed by the legislation of the Russian Federation.

6.4. Stage 3 work includes:

Drawing up a Certificate of Assessment of the State of Measurements in the Laboratory, containing a conclusion on the compliance or non-compliance of the conditions for performing measurements in the declared field of activity with the metrological requirements for measurements;

Drawing up a Conclusion confirming the availability in the laboratory of conditions for performing measurements in the declared field of activity in relation to specific measurement objects, taking into account the metrological requirements imposed by the legislation of the Russian Federation on ensuring the uniformity of measurements (if the conclusions of the Certificate of Assessment of the State of Measurements in the Laboratory are positive).

6.5. The examination of the information submitted by the applicant in the forms involves their analysis and assessment, including from the point of view of the sufficiency of the information provided in terms of:

Availability in the laboratory of the necessary documents establishing the requirements for the declared measurement objects, the indicators (parameters) measured in them and the measurement (testing) techniques (methods), taking into account the possible belonging of the objects to the scope of technical regulations, and the measurements and measured indicators to the scope of state regulation ensuring uniformity of measurements;

Availability of the necessary nomenclature of measuring instruments and measurement methods, taking into account the scope of their application and metrological confirmation;

Equipping the laboratory with the necessary testing and auxiliary equipment;

Nomenclatures of standard samples of various types used for calibration and control of the accuracy of measurement results, taking into account:

Referring measurements to the scope of state regulation to ensure the uniformity of measurements;

Correspondence of the metrological characteristics of the reference material to the measurement range of the applied measurement techniques;

Shelf life of RMs and their use in accordance with established requirements;

Application of measurement (testing) techniques (methods) in terms of the presence in them of metrological characteristics corresponding to GOST R ISO 5725-1 and RMG 61 and procedures for monitoring the accuracy of measurement results in accordance with GOST R ISO 5725-6 and RMG 76, allowing to ensure the reliability of measurement results;

Methodology (methods) of measurements (tests) used in the control of declared objects and indicators for which certification or suitability assessment (validation) is required in accordance with R 50.2.090;

The personnel performing the measurements in relation to their competence (if this is provided for by the established requirements for the measurements performed);

Laboratory premises necessary for carrying out measurements (tests) that have documentary evidence of compliance with their safety requirements, including safe working conditions in the declared field of activity;

A fund of regulatory and technical documents necessary for the implementation of laboratory activities in the declared area of ​​measurements.

6.6. When examining a laboratory at its place of activity, the following is carried out:

Checking the following documents:

■ Regulations on the laboratory, defining its functions, rights, duties, responsibilities, interaction with other divisions of the organization (if it is not a legal entity) and other organizations;

■ Quality manual or document performing its function and regulating the quality management system of work performed by the laboratory in the declared field of activity;

■ an updated and registered fund of RD necessary for the functioning of the laboratory, including guidelines for the selection and storage of samples for testing (measurement) samples, regulating the procedures for obtaining representative samples and the invariability of their composition and properties (for laboratories whose area of ​​activity includes Sample selection);

■ plans (schedules) for canceling or revising documents on measurement techniques (methods) that do not meet the requirements of GOST R 8.563, and conducting certification of measurement techniques (if necessary) or assessing their suitability:

■ job descriptions approved in accordance with the established procedure;

■ requirements for the qualifications of personnel and the procedure for their admission to performing measurements in the declared area;

Analysis and assessment of the compliance of the laboratory’s activities according to the submitted documents in terms of:

■ compliance of the measuring instruments used, standard samples and testing equipment with the requirements stipulated in the RD for measurement and testing techniques (methods), taking into account whether the measurements performed are within the scope of state regulation of ensuring the uniformity of measurements or outside it;

■ compliance of the measuring instruments and reference materials used with their purpose and conditions of use provided for in the technical and (or) operational documentation for measuring instruments and documents for reference materials;

■ compliance of the applied documents on measurement techniques (methods) and test methods with the nomenclature and range of indicators provided for by regulatory legal acts and regulatory documents establishing requirements for the parameters of controlled objects, as well as compliance of documents regulating measurement techniques (methods) with the requirements of the order of the Ministry of Industry and Trade dated December 15 2015 No., GOST R 8.563 or GOST 8.010 (for methods intended for use in the CIS);

■ the presence and functioning of procedures to ensure the quality of measurements performed by the laboratory, including:

○ availability and compliance with schedules for metrological confirmation of used measuring instruments and measuring instruments, as well as maintenance of auxiliary equipment;

○ availability and application of certified and (or) validated measurement techniques (methods) in the practice of analytical control;

○ availability and application of procedures for quality control of measurement results (operational, statistical control of accuracy, control of the stability of the calibration characteristic, assessment of the acceptability of measurement results);

○ implementation of procedures for assessing the suitability of chemical reagents (if used);

○ compliance with schedules for advanced training and certification of personnel (if any);

○ participation in testing the qualifications of the laboratory through interlaboratory comparison tests (ICT);

○ systems for monitoring and recording the measurement conditions provided for in the measurement procedures and in the operational documentation for measuring instruments;

■ compliance of methods for preparing certified mixtures (AC) with the requirements of RMG 60 (if the laboratory has independently developed methods for preparing AC);

■ compliance of laboratory premises with the requirements established for them to ensure safe working conditions and environmental safety;

■ compliance of the laboratory with other requirements (for example, ensuring safety from radiation; electrical, fire, explosion safety, etc.) established in the regulatory legal acts of the Federal executive authorities, standardization documents or in the applicant’s RD (if any).

7. PRESENTATION OF RESULTS

7.1. An act based on the results of assessing the state of measurements in the laboratory is drawn up in the form of an appendix, which is signed by the members of the commission and brought to the attention of the head of the laboratory and a representative of the applicant’s administration.

7.1.1. Depending on the results of the work carried out by the commission to assess the state of measurements, the act makes a conclusion about the presence (absence) of conditions for performing measurements in the area of ​​activity assigned to the laboratory in accordance with the metrological requirements.

INFORMATION ABOUT THE LABORATORY

1. Name of the laboratory:

2. Laboratory address:

3. Phone _____________ fax _____________ e-mail _____________

4. Full name of the head of the laboratory:

5. Organization, the structure of which includes the laboratory

(if it is not a legal entity), legal and actual address

6. Full name of the head of the organization:

7. Telephone

8. Registration number of the certificate (conclusion) on the assessment of the state of measurements, its validity period (if any)

Recommendation MI-2427-2016
"STATE SYSTEM FOR ENSURING THE UNIFORMITY OF MEASUREMENTS.
ASSESSMENT OF THE STATE OF MEASUREMENTS IN TESTING, MEASURING LABORATORIES AND PRODUCTION AND ANALYTICAL CONTROL LABORATORIES"

Information data

Developed

Federal State Unitary Enterprise "Ural Research Institute of Metrology" (FSUE "UNIIM")

Performers: Bessonov Yu.S., Medvedevskikh M.Yu., Ponomareva O.B.

Federal State Unitary Enterprise "All-Russian Research Institute of Metrological Service" (FSUE "VNIIMS")

Performers: Pashaev B.M., Lukashov Yu.E., Rozumenko S.B.

Approved

Introduced to replace MI 2427-97

Date of introduction 2016

Instead of MI 2427-1997

1 area of ​​use

1.1. This recommendation establishes the goals, objectives, procedure for organizing and assessing the state of measurements in testing, measuring laboratories (centers), laboratories carrying out production, analytical control, research and other tests and measurements (hereinafter referred to as laboratories).

Analytical control can be part of other types of control (environmental, sanitary, technological control; internal quality control of products and raw materials, etc.)

1.2. The recommendation is intended for use by organizations under the jurisdiction Federal agency for technical regulation and metrology (Rosstandart) - state scientific metrological institutes and state regional centers of standardization, metrology and testing, accredited in the field of ensuring the uniformity of measurements to carry out metrological examination work. These organizations are authorized performers of work to assess the state of measurements in laboratories in order to confirm compliance of the measurement conditions with metrological requirements.

1.3. This recommendation does not apply to activities to assess the compliance of laboratories with the competency requirements of Federal law RF dated December 28, 2013 N 412-FZ "On accreditation in the national accreditation system."

2. Normative references

Federal Law of the Russian Federation of June 26, 2008 N 102-FZ "On ensuring the uniformity of measurements"

Federal Law of the Russian Federation of December 28, 2013 N 412-FZ "On accreditation in the national accreditation system"

Order of the Ministry of Industry and Trade of the Russian Federation dated December 15, 2015 N 4091 "On approval of the Procedure for certification of primary reference measurement techniques (methods), reference measurement techniques (methods) and measurement techniques (methods) and their application"

GOST R 8.820-2013 State system ensuring uniformity of measurements. Metrological support. Basic provisions

GOST R 52361-2005 Analytical control of an object. Terms and Definitions

GOST R ISO 10012-2008 Organizational management. Measurement management systems. Requirements for measurement processes and measuring equipment

GOST R ISO 5725-1-2002. Accuracy (correctness and precision) of measurement methods and results. Part 1. Basic provisions and definitions

GOST R ISO 5725-6-2002 Accuracy (correctness and precision) of measurement methods and results. Part 6: Using Accuracy Values ​​in Practice

GOST R 8.563-2009 State system for ensuring the uniformity of measurements. Measurement techniques (methods)

GOST 8.010-2013 Interstate standard. Measurement techniques

RMG 29-2013 State system for ensuring the uniformity of measurements. Metrology. Basic terms and definitions

RMG 76-2014 State system for ensuring the uniformity of measurements. Internal quality control of quantitative chemical analysis results

RMG 60-2003 State system for ensuring the uniformity of measurements. Certified mixtures. General requirements to development

R 50.2.090-2013 State system for ensuring the uniformity of measurements. Methods of quantitative chemical analysis. General requirements for development, certification and use

3. Terms and definitions

These recommendations use the terms “metrological requirements”, “metrological examination” in accordance with Federal Law N 102-FZ, “standard”, “measuring instrument”, “metrological traceability” according to RMG 29-2013, “metrological support of the object”, “ metrological support of measurements" according to GOST R 8.820-2013, "analytical control" according to GOST R 52361-2005, as well as the following terms with corresponding definitions:

3.1. production control - control carried out at the production stage.

3.2. assessment of the state of measurements - confirmation of the compliance of the laboratory’s capabilities to perform measurements in the declared (assigned) field of activity.

3.3. metrological confirmation is a set of operations carried out to ensure compliance of an object with metrological requirements.

4. General provisions

4.1. Assessment of the state of measurements is one of the forms of independent confirmation of the laboratory’s compliance with the requirements of the legislation of the Russian Federation in the field of ensuring the uniformity of measurements and technical regulation in relation to specific assigned objects and measured indicators.

4.2. An assessment of the state of measurements is carried out in order to establish and confirm the compliance of the conditions for performing measurements in the laboratory in accordance with the direction of its activities, taking into account the current regulatory legal acts and standardization documents that impose requirements for the measurements performed in the field of activity of a particular laboratory.

4.3. The main tasks of assessing the state of measurements in the laboratory include:

Identification of metrological requirements imposed by current regulatory legal acts, standardization documents and technical documents for measurement objects, as well as for measuring instruments and methods used in the laboratory when carrying out measurements in accordance with the tasks assigned to the laboratory and assigned measurement objects;

Metrological examination of declared objects, including assessment of compliance in the laboratory with metrological requirements for measurements in the declared field of activity;

Establishing the presence in the laboratory of all conditions that ensure the performance of measurements in accordance with the metrological requirements for measurements, including the availability of appropriate infrastructure, personnel and the technical ability to carry out measurements in the declared field of activity.

4.4. The decision to carry out work to assess the state of measurements is made by the head of a legal entity (association of legal entities) or an individual entrepreneur whose structure includes the laboratory.

4.5. Assessment of the state of measurements is carried out by State Scientific Metrological Institutes and State Regional Centers for Standardization, Metrology and Testing, accredited in the field of ensuring the uniformity of measurements to carry out metrological examination work, based on the received application.

4.6. The contractor may create a commission to carry out the work.

If necessary, the commission may include specialists in the relevant types of measurements or measurement objects. It is allowed to include specialists from third-party organizations in the commission, as well as representatives of the Federal executive body or its structural unit performing the functions of the metrological service, or the metrological service of the applicant (legal entity, associations of legal entities, individual entrepreneur).

When carrying out work of particular complexity or specificity, of large volume, it is recommended to assess the state of measurements with the participation of metrology experts in the field of types of measurements related to the activities of the laboratory being inspected.

If the amount of work is small, it is permissible to assign these functions to a separate specialist performer.

4.7. To assess the state of measurements, the contractor issues an order (instruction), which establishes the purpose, order of organization, content (if necessary), and deadlines for completing work for a specific laboratory (group of laboratories). It is allowed to provide a link to a regulatory legal act (standardization document), taking into account the requirements of which the work will be carried out.

4.8. Assessment of the state of measurements is carried out on a contractual basis.

4.9. Upon completion of the work, the commission draws up an act that reflects the results of the metrological examination, including the results of the examination of the metrological support of the declared objects and the results of the survey at the applicant’s place of business, taking into account the assessment of the compliance of the existing infrastructure of the facility and personnel. The report must contain unambiguous conclusions about the presence (absence) of all necessary conditions for carrying out measurements in accordance with the metrological requirements. If the results of the examination are positive, the contractor draws up a Conclusion on assessing the state of measurements in the laboratory, confirming the presence of the necessary conditions for performing measurements and their compliance with the requirements in the declared field of activity of the laboratory. An Appendix containing . The conclusion and each sheet of the Appendix are signed by the head of the contractor, which are registered in the prescribed manner.

If the results of the metrological examination are negative, the applicant is sent a Report, which reflects the identified significant inconsistencies with the conclusion that there are no conditions in the laboratory for performing measurements in the declared field of activity.

If it is possible to promptly eliminate identified inconsistencies, the applicant may be given a specific deadline for their elimination, after which the applicant must present results indicating that the identified inconsistencies have been eliminated. If an on-site assessment is required after corrective action has been taken, it will be carried out on a contractual basis.

4.10. A conclusion about the state of measurements can be presented and taken into account when:

Conducting state metrological supervision;

Conducting metrological supervision carried out in accordance with MI 2304 by metrological services federal bodies executive power, legal entities or their associations;

Formation of competitive documentation for participation in tenders and competitions for the conclusion of contracts, as an element of competitiveness and ensuring consumer confidence;

Declaration of conformity of products based on own evidence;

Production certification or management system certification;

To demonstrate the presence and effectiveness of the measurement process control system (taking into account the requirements of GOST R ISO 10012-2008) with:

Providing guarantees of control over the stability of production processes (certification, declaration);

Production control, including industrial environmental monitoring at the enterprise and internal quality control of products and raw materials;

Presentation of the results of monitoring environmental indicators (in particular, analysis of wastewater and industrial emissions in the Centers for Laboratory Analysis and Technical Measurements (for sanitary and industrial laboratories);

Entry of a legal entity or its laboratory into self-regulatory organizations (for construction and soil laboratories).

5. Organization of work to assess the state of measurements

5.1. The assessment of the state of measurements is carried out on the basis of an application from an organization that includes a laboratory with an attached list of objects and indicators controlled in them.

5.2. To assess the state of measurements, the head of an organization subordinate to Rosstandart, who has received the corresponding application, appoints persons responsible for carrying out this work, who form the composition of the commission,, if necessary, coordinate it with the applicant and draw up a draft contract for the work.

The composition of the commission depends on the specifics, volume and complexity of the work.

5.3. To assess the state of measurements, the laboratory prepares materials in the form of completed forms (Metrological Support Certificate) in accordance with this recommendation.

The prepared materials should reflect the following information:

List of documents on standardization and other normative documents (ND) regulating the requirements for:

Types of work performed in the laboratory;

Tested (analyzed) objects;

The measured (controlled) parameters of these objects;

Data on the standards used in the laboratory, measuring instruments (MI) and their metrological confirmation (verification, calibration);

Data on the testing equipment (TE) used and its certification;

Data on the auxiliary equipment used;

Equipping the laboratory with the required standard samples;

List of RD for measurement techniques (methods) and test methods (including national and interstate standards), data on the applied measurement techniques (methods) and test methods;

Data on the composition and qualifications of personnel, including current documents on advanced training;

Information about the availability and condition of laboratory premises;

List of chemical reagents (if available), indicating the date of their manufacture, expiration date and qualifications;

A list of updated and taken into account regulatory documentation necessary for the functioning of the laboratory in the declared field of activity, including documents regulating the procedures for the collection and storage of samples (test samples).

Information about laboratory premises may be accompanied by certificates, conclusions on the compliance of the premises with safety requirements (fire, biological, electromagnetic, radiation), labor protection, etc., which can be drawn up in any form or be conclusions of competent authorities, as well as protocols measurements of physical and chemical factors of the production environment.

5.4. To carry out work to assess the state of measurements, a program for assessing the state of measurements can be developed. An example of a typical program for assessing the state of measurements in a laboratory is given in Appendix B.

5.5. The commission conducts an inspection of the laboratory to verify the actual state of measurements, including the conditions for their implementation and confirmation of the information stated in the documents, directly at the place where the laboratory operates.

5.6. The management of the laboratory (enterprise) provides the conditions necessary for the work of the commission, including allocating premises for work, presenting the necessary documents and materials, providing copying services, and also assigning an official with the right to sign documents.

6. Contents of work on assessing the state of measurements

6.1. Work to assess the state of measurements is carried out in 3 stages:

The first stage is studying the documents;

The second stage is an inspection of the laboratory at the place of activity;

The third stage is the presentation of the results of the work.

6.2. Work at stage 1 includes conducting a metrological examination of documents and information about the activities of the laboratory, submitted by the applicant, in terms of compliance with the requirements of the legislation of the Russian Federation on ensuring the uniformity of measurements and in the field of technical regulation, regulatory legal acts and standardization documents related to the performance of the functions assigned to the laboratory .

6.3. Work at stage 2 includes checking the compliance of the information presented in Forms 1-11 of the Passport with the actual state of affairs in the laboratory at the place of production activity, taking into account the requirements imposed by the legislation of the Russian Federation.

6.4. Stage 3 work includes:

Drawing up a Report based on the results of assessing the state of measurements in the laboratory, containing a conclusion about the compliance or non-compliance of the conditions for performing measurements in the declared field of activity with the metrological requirements for measurements;

Drawing up a Conclusion confirming the availability in the laboratory of conditions for performing measurements in the declared field of activity in relation to specific measurement objects, taking into account the metrological requirements imposed by the legislation of the Russian Federation on ensuring the uniformity of measurements (if the conclusions of the Act are positive based on the results of assessing the state of measurements in the laboratory).

6.5. The examination of the information submitted by the applicant in forms 1-11 involves their analysis and assessment, including from the point of view of the sufficiency of the information provided in terms of:

Availability in the laboratory of the necessary documents establishing the requirements for the declared measurement objects, the indicators (parameters) measured in them and the measurement (testing) techniques (methods), taking into account the possible belonging of the objects to the scope of technical regulations, and the measurements and measured indicators to the scope of state regulation ensuring uniformity of measurements;

Availability of the necessary nomenclature of measuring instruments and measurement methods, taking into account the scope of their application and metrological confirmation;

Equipping the laboratory with the necessary testing equipment;

Nomenclatures of standard samples of various types used for calibration and control of the accuracy of measurement results, taking into account:

Referring measurements to the scope of state regulation to ensure the uniformity of measurements;

Correspondence of the metrological characteristics of the reference material to the measurement range of the applied measurement techniques;

Shelf life of RMs and their use in accordance with established requirements;

Application of measurement (testing) techniques (methods) in terms of the presence of metrological characteristics in them, corresponding to GOST R ISO 5725-1 and RMG 61.2010 and procedures for monitoring the accuracy of measurement results in accordance with GOST R ISO 5725-6 and RMG 76-2014, allowing to ensure the reliability of the results measurements;

Methodology (methods) of measurements (tests) used in the control of declared objects and indicators for which certification or suitability assessment (validation) is required in accordance with R 50.2.090;

The personnel performing the measurements in relation to their competence (if this is provided for by the established requirements for the measurements performed);

Laboratory premises necessary for carrying out measurements (tests) that have documentary evidence of compliance with their safety requirements, including safe working conditions in the declared field of activity;

A fund of regulatory and technical documents necessary for the implementation of laboratory activities in the declared area of ​​measurements.

6.6. When examining a laboratory at its place of activity, the following is carried out:

Checking the following documents:

Regulations on the laboratory, defining its functions, rights, duties, responsibilities, interaction with other divisions of the organization (if it is not a legal entity) and other organizations;

Quality manual or document that performs its function and regulates the quality management system of work performed by the laboratory in the declared field of activity;

An updated and registered in the laboratory fund of RD necessary for the functioning of the laboratory, including guidelines for the selection and storage of samples for testing (measurement) samples, regulating the procedures for obtaining representative samples and the invariance of their composition and properties (for laboratories whose scope of activities includes sampling samples);

Plans (schedules) for the cancellation or revision of documents for measurement techniques (methods) that do not meet the requirements of GOST R 8.563-2009, and certification of measurement techniques (if necessary) or assessment of their suitability;

Duly approved job descriptions;

Requirements for the qualifications of personnel and the procedure for their admission to perform measurements in the declared area.

Analysis and assessment of the compliance of the laboratory’s activities according to the submitted documents in terms of:

Compliance of the used measuring instruments, standard samples and testing equipment with the requirements provided for in the RD for measurement and testing techniques (methods), taking into account whether the measurements performed are within the scope of state regulation of ensuring the uniformity of measurements or outside it;

Compliance of the used measuring instruments and reference materials with their purpose and conditions of use provided for in the technical and (or) operational documentation for measuring instruments and normative documents for the reference materials;

Compliance of the applied RD for measurement techniques (methods) and test methods with the nomenclature and range of indicators provided for by regulatory legal acts and regulatory documents establishing requirements for the parameters of controlled objects, as well as compliance of documents regulating measurement techniques (methods) with the requirements of the order of the Ministry of Industry and Trade dated December 15, 2015 N 4091, GOST R 8.563-2009 or GOST 8.010-2013 (for methods intended for use in the CIS);

The existence and operation of procedures to ensure the quality of measurements performed by the laboratory, including:

Availability and compliance with schedules for metrological confirmation of used measuring instruments and measuring instruments, as well as maintenance of auxiliary equipment;

Availability and application of certified and (or) validated measurement techniques (methods) in the practice of analytical control;

Availability and application of procedures for quality control of measurement results (operational, statistical control of accuracy, control of the stability of the calibration characteristic, assessment of the acceptability of measurement results);

Implementation of procedures for assessing the suitability of chemical reagents (if used);

Compliance with schedules for advanced training and certification of personnel (if any);

Participation in laboratory qualification testing through interlaboratory comparative tests;

Systems for monitoring and recording the measurement conditions provided for in the measurement procedures and in the operational documentation for measuring instruments;

Compliance of methods for preparing certified mixtures (AC) with the requirements of RMG 60-2003 (if the laboratory has independently developed methods for preparing AC);

Compliance of laboratory premises with the requirements established for them to ensure safe working conditions and environmental safety;

Compliance of the laboratory with other requirements (for example, ensuring safety from radiation; electrical, fire, explosion safety, etc.) established in the regulatory legal acts of the Federal executive authorities, standardization documents or in the applicant’s RD (if any).

7. Presentation of results

7.1. An act based on the results of assessing the state of measurements in the laboratory is drawn up in the form of Appendix B, which is signed by the members of the commission and brought to the attention of the head of the laboratory and a representative of the applicant’s administration.

7.1.1. Depending on the results of the metrological examination, the report makes a conclusion about the presence (absence) of conditions for performing measurements in the area of ​​activity assigned to the laboratory in accordance with the metrological requirements.

7.1.2. A decision on the absence of conditions for performing measurements is made if one of the violations is detected:

Inconsistency of the measurement technique (method) used with the controlled object;

Application of a certified measurement technique (method) outside the scope of its application;

The use of measuring instruments or standard samples that have not undergone the type approval procedure in the field of state regulation of ensuring the uniformity of measurements or their use contrary to the purpose established in the operational documentation, without carrying out procedures for assessing their suitability for a new application;

Failure to apply procedures for monitoring the accuracy of measurement results provided for in documents regulating measurement (test) techniques (methods);

Lack of corrective measures when receiving unsatisfactory results of accuracy control or participation in interlaboratory comparison tests (ICT);

Systematic acquisition results of tests and measurements in violation of the requirements of measurement methods;

Absence necessary funds measurements, testing and auxiliary equipment, reference materials, reagents and materials or their non-compliance established requirements;

Insufficient staffing with appropriate qualifications;

Non-compliance of laboratory premises with established requirements.

7.2. If the results of the metrological examination are positive, the performing organization draws up a Conclusion on assessing the state of measurements in the laboratory in the form of Appendix D and an appendix indicating the controlled objects and indicators in the form of Appendix D, which are signed by the head of the performing organization and sends them to the applicant.

If the shortcomings specified in clause 7.1.2 relate only to part of the declared objects, an appendix to the conclusion is drawn up only for those objects and indicators for which the conditions for performing measurements are provided.

A conclusion on the state of measurements in the laboratory is issued with a validity period of three years.

Laboratory metrological support certificate

NAME OF COMPANY

I approve

Head of the enterprise

(Head of structural

divisions)

metrological support

_______________________________________

laboratory name

INFORMATION ABOUT THE LABORATORY

1. Name of the laboratory:

2. Laboratory address:

3. Phone____________ fax___________ e-mail ________________

4. Full name laboratory head:

5.Organization, which includes the laboratory

(if it is not a legal entity), legal and actual

6. Full name head of the organization:

7. Telephone

8. Registration number of the certificate of assessment of the state of measurements,

validity period of the certificate (if available)

ND on objects, measurement techniques and test methods used

in the laboratory as of "__"__________ 20__

List of measuring instruments used

Note: If the organization is accredited for the right to verify this type

SI, in column 10 indicate the number, date and validity period of the certificate

accreditation

Head of Laboratory _________________________________ Full name

List of test equipment used,

as of "___"___________ 20__

Head of Laboratory _________________________________ Full name

Accessories Information

Head of Laboratory _________________________________ Full name

List of used reference materials

as of "___"___________ 20__

Head of Laboratory _________________________________ Full name

State of measurement techniques (methods)

as of "___"___________ 20__

Head of Laboratory _________________________________ Full name

Composition and qualifications of personnel

Head of Laboratory _________________________________ Full name

Information about the laboratory’s equipment with chemical reagents

as of "___"___________ 20__

Head of Laboratory _________________________________ Full name

List of regulatory documentation required for operation

laboratories

as of "___"___________ 20__

______________________________

* Information about changes to documentation includes the date of introduction

changes, the basis for making changes and the person who made the changes

Head of Laboratory _________________________________ Full name

CONDITION OF MAIN LABORATORY FACILITIES

as of "___"___________

Head of Laboratory _________________________________ Full name

Program for assessing the state of measurements in

________________________________________________

date of testing in the laboratory "___"____________ 20__

Appendix B
(required)

assessment of the state of measurements in the laboratory

_________________________________________________________________________

Issued "__"________ 20

Valid until "__"________ 20

In the period from ____ to ____ 20__ on the basis of agreement N____ dated ____ 2013.

and order (name of the executing organization) N___ dated _______ 20__.

Commission consisting of:

Chairman of the commission: ____________________ (N expert certificate)

Members of the commission - experts: ____________________ (N expert certificate)

____________________ (N expert certificate)

carried out a metrological examination of the state of measurement of indicators

(composition, properties, consumption, volume................) of declared objects

(list objects) performed in ___________________________________

________________________________________________________________________

name of the laboratory and name of the legal entity

During the examination it was established:

Conclusion:

The laboratory meets the necessary conditions for performing measurements in the declared field of activity of the laboratory.

The Commission considers it possible to approve the Appendix to the Expert Opinion in the form of a List of objects assigned to (name of the laboratory, name of a legal entity or individual entrepreneur) on ___ sheets, confirming compliance with the conditions necessary to perform measurements in the area of ​​activity of the laboratory given in the Appendix.

Chairman of the commission:

Members of the commission:

Appendix D
(required)

Form of Conclusion on assessment of the state of measurements in the laboratory

┌──────────────────────────────────────────────────────────────────────────┐

│ Name of the legal entity that assessed the state of measurements │

│(number of the accreditation certificate in the field of ensuring the uniformity of measurements according to │

│ metrological examination) │

│ CONCLUSION │

│ N............. │

│ ABOUT THE STATE OF MEASUREMENTS IN THE LABORATORY │

│ Issued "__"________ 20│

│ Valid until "__"________ 20│

│ This conclusion certifies that ___________________________________│

│ name of the laboratory │

│ _________________________________________________________________________│

│ location of the laboratory │

│ _________________________________________________________________________│

│ name of the legal entity │

│ _________________________________________________________________________│

│ legal address of a legal entity │

│ has the necessary conditions to perform measurements in the area │

│ activities according to the application. │

│ The conclusion was drawn up based on the results of the │

│ metrological examination. │

│ Appendix: list of objects and indicators controlled in them │

│ on...... sheets │

│ Manager ______________________ (signature transcript) │

│ signature │

│ Address of the legal entity that assessed the measurement status │

└──────────────────────────────────────────────────────────────────────────┘

Application form

Conclusion on the state of measurements in the laboratory

FEDERAL AGENCY

ON TECHNICAL REGULATION AND METROLOGY

Name of the performing organization

Appendix to the conclusion

on assessing the state of measurements

N______ from _____________

valid until _____________

On ___ sheets, sheet ____.

Laboratory name

Name of the applicant organization

(option 1)

LIST OF OBJECTS AND INDICATORS CONTROLLED THEREIN

(option 2)

LIST OF OBJECTS AND INDICATORS CONTROLLED THEREIN

Head of the implementing organization Full name

STATE COMMITTEE OF THE RUSSIAN FEDERATION
ON STANDARDIZATION AND METROLOGY

Ural Research Institute of Metrology
(UNIIM)

All-Russian Research Institute
metrological service
(VNIIMS)

STATE UNITY SYSTEM
MEASUREMENTS

Measurement Status Assessment
in testing and measurement laboratories

MI 2427-97

(with change no. 1)

Moscow
2002

INFORMATION DATA

DEVELOPED

URAL RESEARCH INSTITUTE OF METROLOGY (UNIIM)

Performers: Paneva V.I., Zakharova T.M., Ponomareva O.B.

ALL-RUSSIAN RESEARCH INSTITUTE OF METROLOGICAL SERVICE (VNIIMS)

Performers: Zaets E. A., Ivanova T. A., Yazhborovskaya Yu. I.

APPROVED scientific and technical commission on metrology and measuring technology of the State Standard of Russia (protocol dated December 23, 1997 No. 18)

INTRODUCED first

Change No. 1 was registered in October 2002.

Date of introduction: 07/01/1998

1 AREA OF USE

1.1 This recommendation establishes the goals, objectives, procedure for organizing and assessing the state of measurements in testing and measuring (including analytical) laboratories (hereinafter referred to as laboratories) and is intended for use by metrological services of federal executive authorities, associations of legal entities and legal entities , as well as bodies of the State Metrological Service and state scientific metrological centers.

1.2 Based on this recommendation, federal executive authorities and associations of legal entities may develop regulations(hereinafter - ND), developing and specifying the procedure for organizing and assessing the state of measurements in laboratories.

Note. In laboratories previously certified in accordance with RD 50-194-80, the decision to assess the state of measurements is made upon expiration of the certification certificate.

Law of the Russian Federation “On ensuring the uniformity of measurements”,

GOST R 8.563-96 “State system for ensuring the uniformity of measurements. Methods of performing measurements" (as amended No. 1 and No. 2, 2001, 2002),

GOST 8.315-97 “State system for ensuring the uniformity of measurements. Standard samples of the composition and properties of substances and materials. Basic provisions",

GOST R 8.568-97 “State system for ensuring the uniformity of measurements. Certification of testing equipment. Basic provisions" (as amended No. 1 2002),

GOST R ISO/IEC 17025-2000 “General requirements for the competence of testing and calibration laboratories”,

GOST R ISO 5725-1-2002 - GOST R ISO 5725-6-2002“Accuracy (correctness and precision) of measurement methods and results”,

PR 50.2.002-94 “State system for ensuring the uniformity of measurements. The procedure for implementing state metrological supervision over the production, condition and use of measuring instruments, measurement methods, standards and compliance with metrological rules and norms,”

MI 2304-94 “State system for ensuring the uniformity of measurements. Metrological control and supervision carried out by metrological services of legal entities",

MI 2240-98 “State system for ensuring the uniformity of measurements. Analysis of the state of measurements, control and testing at an enterprise, organization, association,”

MI 2334-2002 “State system for ensuring the uniformity of measurements. Certified mixtures. General provisions. Procedure for development and certification."

3. GENERAL PROVISIONS

3.1 An assessment of the state of measurements is carried out in order to establish compliance of the conditions for performing measurements with the requirements of Russian legislation in the field of ensuring the uniformity of measurements.

3.2 Assessment of the measurement state is carried out for:

3.2.1 establishing compliance of the achieved level of metrological support for measurements with modern requirements;

3.2.2 official certification of the presence in the laboratory of the conditions necessary to perform measurements (for example, to obtain a license for the type of activity, etc.).

3.3 The decision to carry out work to assess the state of measurements is made by the head of the metrological service of the federal executive body, an association of legal entities, or the head of the enterprise (organization) whose structure includes the laboratory.

3.4 To organize work to assess the state of measurements, an order (instruction) can be issued, which establishes the purpose, order of organization, content (if necessary) and timing of work for a specific laboratory (groups of laboratories).

3.5 A commission may be created to carry out the work.

If the volume is small, it is permissible to delegate this work to a separate specialist.

3.6 Assessment of the state of measurements to establish compliance of the achieved level of metrological support for measurements with modern requirements is carried out in accordance with MI 2240.

3.6.1 The work is carried out under the guidance of the metrological service of the federal executive body, legal entities (their associations) with the participation of specialists from the technical services of the enterprise (organization) within which the laboratory operates, if necessary, with the involvement of representatives of the State Metrological Service.

The implementation of work to assess the state of measurements can be entrusted on a contractual basis to state scientific metrological centers or bodies of the State Metrological Service.

3.6.2 The results of work to assess the state of measurements are documented in an act, and on their basis a plan of organizational and technical measures can be developed to improve the state of metrological support for measurements in the laboratory. The plan of organizational and technical measures and measures for its implementation are approved by the head of the organization, by whose decision the measurement status was assessed.

3.7 Assessment of the state of measurements to officially certify the presence in the laboratory of the conditions necessary to perform measurements is carried out on a contractual basis.

3.7.1 Assessment of the state of measurements can be carried out:

Metrological service of federal executive authorities (service of the chief metrologist, head organization of the metrological service, base organization metrological service) or associations of legal entities;

State scientific metrological center or body of the State metrological service.

Note. In laboratories carrying out industrial environmental control, assessment of the state of measurements is carried out by the above-listed bodies together with the metrological services of territorial bodies for environmental protection.

3.7.2 Based on the results of the work, a report is drawn up and a certificate is issued on the state of measurements in the laboratory with a list of objects and indicators controlled in them.

The certificate and each sheet of the application is signed by the head of the organization that carried out the work and issued the certificate, and is registered in accordance with the procedure in force in this organization.

3.7.3 The certificate may be presented to obtain a license to carry out the types of activities assigned to the legal entity.

3.7.4 Materials for assessing the state of measurements can also be taken into account when carrying out:

State metrological supervision (in accordance with PR 50.2.002);

Metrological supervision carried out by metrological services of legal entities (in accordance with MI 2304);

Assessing the competence of laboratories for the purpose of their accreditation in accordance with the requirements GOST R ISO/IEC 17025;

Production certification or Quality System certification.

3.7.5 At the initiative of the laboratory, the organization assessing the state of measurements can provide methodological assistance to the laboratory in its preparation for performing these works.

4. ORGANIZATION OF WORK TO ASSESS THE STATE OF MEASUREMENTS

4.1 To organize work to assess the state of measurements in the laboratory, carried out by decision of federal executive authorities or legal entities (their associations), a schedule for carrying out these works can be drawn up, approved by the head of the federal executive authority or association of legal entities.

An assessment of the state of measurements can also be carried out on the basis of an application from an organization with an attached list of objects and indicators controlled in them, sent to the authorities (organizations) according to paragraphs. 3.6.1 and 3.7.1.

4.2 To assess the state of measurements by the commission, the head of the organization responsible for carrying out this work establishes the composition of the commission.

The composition of the commission depends on the specifics, volume and complexity of the work.

4.3 To assess the state of measurements, the laboratory prepares materials in accordance with this recommendation or ND of federal executive authorities (associations of legal entities (if any)).

The prepared materials should reflect the following information:

List of normative documents establishing requirements for the types of work performed in the laboratory, the objects being tested and the measured (controlled) parameters of these objects;

List of RD for measurement techniques (hereinafter referred to as MVI) and test methods (including state and industry standards); data on the state of the MVI;

Data on measuring instruments (MI) used in the laboratory:

Data on test equipment (ET);

Laboratory equipment with standard samples of all categories;

Data on the composition and qualifications of personnel, including current forms of advanced training;

Statement certificate production premises.

Recommended forms for submitting materials are given in Appendix A (forms 1 - 6). A certificate of the condition of production premises is drawn up in any form, with the attachment, if necessary, of an inspection report (protocol) conducted by the competent authority.

4.5 The commission carries out work directly in the laboratory.

4.6 The management of the laboratory (enterprise) provides the conditions necessary for the work of the commission, including allocating premises for work, presenting the necessary documents and materials, providing copying services, and also assigning an official with the right to sign documents.

When assessing the state of measurements in the laboratory, the following is checked:

5.1 Availability:

Regulations on the laboratory, defining its functions, rights, duties, responsibilities, interaction with other divisions of the organization (if it is not a legal entity) and other organizations;

An updated and registered in the laboratory fund of RD necessary for the functioning of the laboratory, including guidelines for the selection and storage of samples for testing (measurement) samples, regulating the procedures for obtaining representative samples and the invariance of their composition and properties (for laboratories whose scope of activities includes sampling samples);

Plans (schedules) for canceling or revising documents for MVI that do not meet the requirements of GOST R 8.563 with amendment No. 2, 2002, and conducting certification (if necessary);

Necessary measuring instruments provided for in the RD, including standard samples of all categories, ensuring measurements and quality control (accuracy) of the measurements performed;

Testing and auxiliary equipment, reagents and materials required quality:

Duly approved job descriptions.

5.2 Compliance of the actual state of affairs in the laboratory with the presented materials, including:

Compliance of the applied RD on MVI and test methods with the nomenclature and range of indicators according to ND, establishing requirements for the parameters of controlled objects, as well as compliance of ND on MVI with the requirements of GOST R 8.563 as amended No. 2, 2002;

Compliance of the measurement procedure with the requirements of the RD for MVI and test methods;

Compliance of procedures for monitoring the accuracy of measurement results with the requirements of the ND for MVI and other documents regulating control of the stability of measurement results in the laboratory;

Compliance of measuring instruments and testing equipment with the requirements of the RD for MVI and test methods and the requirements for their metrological support, including the provision of measuring instruments with verification (calibration) and IO certification;

Compliance of the applied standard samples with the requirements of GOST 8.315 and ND on MVI and test methods;

Compliance of methods for preparing certified mixtures (AC) with the requirements of MI 2334 (if the laboratory has independently developed methods for preparing AC);

Availability of a documented procedure for checking the suitability of reagents released without indication warranty period storage or after its completion, to perform measurements with a given accuracy, etc.;

Compliance of laboratory premises with the requirements established for them, including labor protection requirements;

Compliance of the laboratory with other requirements established in the ND of federal executive authorities and ND of enterprises (if any).

6. PRESENTATION OF RESULTS

6.1 Based on the results of assessing the state of measurements, a report is drawn up in the form of Appendix B, which is brought to the attention of the head of the laboratory and submitted to the organization responsible for assessing the state of measurements.

6.1.1 Depending on the goals of the work and the identified state of measurements in the laboratory, the report makes a conclusion about the compliance of the achieved level of metrological support for measurements with modern requirements or the presence (absence) of conditions for performing measurements in the field of activity assigned to the laboratory.

6.1.2 A decision on the absence of conditions for performing measurements is made if one of gross violations:

Inconsistency of the used methodology with the controlled object;

Violation of the MVI certification rules established by GOST R 8.563 with amendment No. 2, 2002;

Illegality of using measuring instruments, MVIs and test methods or reference materials;

Systematic obtaining of test and measurement results in violation of the requirements of the methods;

Lack of necessary measuring instruments, testing and auxiliary equipment, standard samples, reagents and materials or their non-compliance with established requirements;

Insufficient staffing with appropriate qualifications;

Non-compliance of laboratory premises with established requirements.

6.2 When recording in the act the existence of conditions for performing measurements in the area of ​​activity assigned to the laboratory according to clause 3.7, the organization responsible for conducting the assessment issues a certificate in the form of Appendix B and sends it to the laboratory within a month.

If the shortcomings specified in clause 6.1.2 relate only to part of the declared objects, an annex to the certificate is drawn up only for those objects and indicators for which the conditions for performing measurements are provided.

The certificate is issued with a validity period of up to 5 years.

Appendix A

FORMS
REPRESENTATIONS OF SOURCE MATERIALS ABOUT THE STATE OF MEASUREMENTS IN THE LABORATORY

Note.

*) If the organization is accredited for the right to verify (calibrate) this type of measuring instrument, column 5 indicates the number, date and validity period of the accreditation certificate.

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