RESOLUTION OF THE CABINET OF MINISTERS OF UKRAINE

of January 13, 2016 No. 95

About approval of the modules of assessment of conformity used for development of assessment procedures of compliance, and rules of use of modules of assessment of conformity

List of amending documents

According to article 14 of the Law of Ukraine "About technical regulations and assessment of conformity" the Cabinet of Ministers of Ukraine decides:

1. Approve enclosed:

the modules of assessment of conformity used for development of assessment procedures of compliance;

rules of use of modules of assessment of conformity.

1-1. Operation of this resolution does not extend to use of modules of assessment of conformity in the field of rail transport.

2. Recognize invalid resolutions of the Cabinet of Ministers of Ukraine according to the list which is attached.

3. This resolution becomes effective in six months from the date of its publication.

Approved by the Resolution of the Cabinet of Ministers of Ukraine of January 13, 2016 No. 95

The modules of assessment of conformity used for development of assessment procedures of compliance

Module A (internal control of production)

1. Internal control of production is assessment procedure of compliance by means of which the producer carries out the obligations established in Items 2 - 5 of these modules, both guarantees and declares under the sole responsibility that the corresponding products conform to the requirements of the technical regulation applied to it.

Technical documentation

2. The producer develops technical documentation which shall give the chance to estimate products compliance to relevant requirements and to include the description of carrying out and results of the proper analysis and risk assessment (risks). In technical documentation applicable requirements and questions of designing, production and functioning of products connected with evaluating compliance shall be specified. Technical documentation shall contain in appropriate cases at least the following elements:

general description of products;

outline sketch, production drawings and schemes of components, assembly nodes, chains, etc.;

descriptions and the explanations necessary for understanding of the specified drawings and schemes and functioning of products;

the list of the national standards and/or other corresponding technical specifications applied fully or partially, compliance to which provides products compliance presumption to essential requirements and in case the specified standards were not applied, - descriptions of the decisions made for the purpose of ensuring compliance to essential requirements of the technical regulation. In case of partial application of national standards, compliance to which provides products compliance presumption to essential requirements, in technical documentation their parts which were applied are specified;

results of the executed project calculations, the conducted researches and so forth;

test reports.

Production

3. The producer takes all measures necessary in order that production process and its monitoring provided compliance to the made products of the technical documentation determined in Item 2 of these modules and to the requirements of the technical regulation applied to such products.

Marking of compliance and declaration of conformity

4. The producer puts is determined in the technical regulation of marking of compliance on each separate product conforming to applicable requirements of such technical regulation.

5. The producer constitutes the written declaration of conformity of model of products and stores it together with technical documentation for representation on requests of bodies of the state market supervision within ten years after introduction into circulation of the last sample of such model. In the declaration of conformity information which allows to identify products for which it is constituted is specified.

The copy of the declaration of conformity moves to relevant organs of the state market supervision on their requests.

Authorized representative

6. The obligations of the producer specified in items 4 and 5 of these modules from his name and under its responsibility can be executed by his authorized representative on condition of determination of such obligations in the order.

The A1 module (internal control of production with carrying out testing of products under observation)

7. Internal control of production with carrying out testing of products under observation is assessment procedure of compliance by means of which the producer carries out the obligations established in Items 8-12 of these modules both guarantees and declares under the sole responsibility that the corresponding products conform to requirements of the technical regulation, applied to it.

Technical documentation

8. The producer develops technical documentation which shall give the chance to estimate products compliance to relevant requirements and to include the description of carrying out and results of the proper analysis and risk assessment (risks). In technical documentation shall be specified requirements and questions of designing, production and functioning of products connected with evaluating compliance are applicable. Technical documentation shall contain in appropriate cases at least the following elements:

general description of products;

outline sketch, production drawings and schemes of components, assembly nodes, chains, etc.;

descriptions and the explanations necessary for understanding of the specified drawings and schemes and functioning of products;

the list of the national standards and/or other corresponding technical specifications applied fully or partially, compliance to which provides products compliance presumption to essential requirements and in case the specified standards were not applied, - descriptions of the decisions made for the purpose of ensuring compliance to essential requirements of the technical regulation. In case of partial application of national standards, compliance to which provides products compliance presumption to essential requirements, in technical documentation their parts which were applied shall be specified;

results of the executed project calculations, the conducted researches and so forth;

test reports.

Production

9. The producer takes all measures necessary in order that production process and its monitoring provided compliance to the made products of the technical documentation determined in Item 8 of these modules and to the requirements of the technical regulation applied to such products.

Checks of products

10. For the purpose of check of compliance of products to relevant requirements of the technical regulation the producer or person acting from his name for each made product carries out one or several testing in one or several specific aspects of such product. At the choice of the producer the specified testing are carried out it by accredited internal conformity assessment body or under responsibility of the appointed conformity assessment body (further - the appointed body) elected by producer.

If testing are carried out by authorized body, the producer under responsibility of such body applies in production process its identification number on products.

Marking of compliance and declaration of conformity

11. The producer applies the marking of compliance determined in the technical regulation on each separate product conforming to applicable requirements of such technical regulation.

12. The producer constitutes the written declaration of conformity of model of products and stores it together with technical documentation for representation on requests of bodies of the state market supervision within ten years after introduction into circulation of the last sample of such model. In the declaration of conformity information which allows to identify products for which it is constituted is specified.

The copy of the declaration of conformity moves to relevant organs of the state market supervision on their requests.

Authorized representative

13. The obligations of the producer specified in Items 11 and 12 of these modules from his name and under its responsibility can be executed by his authorized representative on condition of determination of such obligations in the order.

The A2 module (internal control of production with conducting checks of products under observation through certain intervals of time)

14. Internal control of production with conducting checks of products under observation through certain intervals of time is assessment procedure of compliance by means of which the producer carries out the obligations established in Items 15 - 19 of these modules, both guarantees and declares under the sole responsibility that the corresponding products conform to the requirements of the technical regulation applied to it.

Technical documentation

15. The producer develops technical documentation which shall give the chance to estimate products compliance to relevant requirements and to include the description of carrying out and results of the proper analysis and risk assessment (risks). In technical documentation applicable requirements and questions of designing, production and functioning of products connected with evaluating compliance shall be specified. Technical documentation shall contain in appropriate cases at least the following elements:

general description of products;

outline sketch, production drawings and schemes of components, assembly nodes, chains, etc.;

descriptions and the explanations necessary for understanding of the specified drawings and schemes and functioning of products;

the list of the national standards and/or other corresponding technical specifications applied fully or partially, compliance to which provides products compliance presumption to essential requirements and in case the specified standards were not applied, - descriptions of the decisions made for the purpose of ensuring compliance to essential requirements of the technical regulation. In case of partial application of national standards, compliance to which provides products compliance presumption to essential requirements, in technical documentation their parts which were applied shall be specified; results of the executed project calculations, the conducted researches and so forth;

test reports.

Production

16. The producer takes all measures necessary in order that production process and its monitoring provided compliance to the made products of the technical documentation determined in Item 15 of these modules and to the requirements of the technical regulation applied to such products.

Checks of products

17. At the choice of the producer its accredited internal conformity assessment body or the appointed body chosen as it carries out or charges conducting checks of products through the certain intervals of time determined by the relevant accredited internal conformity assessment body or the appointed body for the purpose of quality check of internal checks of products taking into account, in particular, technological complexity of products and production volume. For the purpose of check of compliance of products to relevant requirements of the technical regulation the adequate selection of finished goods which is selected by accredited internal conformity assessment body of the producer or the appointed body on site before introduction of products in turnover is researched and is subject to carrying out proper testing which are determined in the conforming parts of national standards and/or technical specifications, compliance to which provides products compliance presumption to essential requirements, or equivalent testing.

The procedure of statistical acceptance review of product quality which needs to be applied is intended for determination of whether the production process of the specified products in acceptable limits for the purpose of ensuring compliance of products is performed.

If testing are carried out by authorized body, the producer under responsibility of such body applies in production process its identification number on products.

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