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From 01.01.2013 becomes a mandatory technical regulations of Ukraine "Pressure Equipment", which applies to equipment under pressure more than 0.5 bar.

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Technical Regulation and Certification in Ukraine
Certification in Ukraine – Ukrainian State Certification System UkrSEPRO
Certification is a procedure by means of which a recognized body gives a written guaranty in accordance with established procedure that products (quality management system, service) satisfies the established by legislation requirements.
There is a State Certification System in Ukraine – the UkrSEPRO System. Both – obligatory and voluntary – certifications are carried out within this System. The State Committee of Ukraine on questions of technical regulation and consumer policy which is considered to be the National Body on Certification (the former name – the State Standard of Ukraine).
http://www.dssu.gov.ua - is a web-site of the State Committee of Ukraine on questions of technical regulation and consumer policy.

Attention: in accordance with the Decree of the President of Ukraine the State Committee of Ukraine on questions of technical regulation and consumer policy is being reformed nowadays. The certification system stays unaltered.

 

1. Obligatory Certification
The products parameters conformity to requirements of normative documents stated by Ukrainian legislative acts and/or normative documents requirements indicated in the “List of Products Liable to Obligatory Certification in Ukraine” is determined while obligatory certification carrying out. As a rule, those are safety requirements. At that sanitary-epidemiological certificate (“hygienic certificate”) of the Ministry of Health of Ukraine and expert certificate used for receiving of license for products use (application) in Ukraine from the State Department on Supervision of Labor Protection have to be received for many products types.

In the UkrSEPRO System certificates and their copies are given on headed note-papers that have holograms and other protection rates. Certificates for products not included into the “List of Production liable to obligatory certification in Ukraine” are also given on these headed note-papers.

 

2. List of Production Liable to Obligatory Certification in Ukraine
There is an official “List of Products Liable to Obligatory Certification in Ukraine” used to determine products liable to obligatory certification in Ukraine in the UkrSEPRO System. The List is approved by the Order of State Department on Consumer Standards of Ukraine of 04.05.2005 N 466/10746. Names for products sections are given on the page LIST - UA-3 in Russian and English.
The complete perelik 2005 “List of Products Liable to Obligatory Certification in Ukraine” in Ukrainian is given on the web-site http://www.dssu.gov.ua. The CUSTOMS CODE and the list of normative documents that have to be confirmed under certification are given in the mentioned above List. Indicated List can be used by a foreign Applicant as a reference to determine whether its production belongs to the List according to the CUSTOMS CODE. When crossing the Ukrainian border it is necessary to have the certificate of conformity given in the UkrSEPRO System for the products included into the List. It is forbidden to cross the border without certificate of conformity. Customs ordering of products is given in UA-4.
3. Certification Bodies
In Ukraine a legal entity as the third (independent) party (manufacturer and consumer-free) can be recognized as certification body in accordance with established procedure. At that only accredited (assigned, authorized) in the UkrSEPRO System bodies on products certification and/or management quality system certification can be considered as a certification body in Ukraine. Bodies are authorized to carry out works on certification of products in accordance with their fixed sphere of accreditation.

Nowadays the Ukrainian system of certification is under the process of changing. It is connected with creation and start of work of the National Agency on Accreditation of Ukraine (NAAU), and also with the fact that the State Department on Consumer Standards of Ukraine introduced procedures for assignment and authorization of certification bodies (CB) for carrying out of works in the UkrSEPRO System. Therefore it is difficult to determine the number of CB working in the UkrSEPRO System. Approximately, there are around 200 CB in Ukraine. Incomplete information about CB is given on NAAU web-site (http://www.naau.org.ua) where you can find references for 60 bodies on conformity and also on the web-site of the State Department on Consumer Standards of Ukraine (http://www.dssu.gov.ua). On the last one there are references for 118 bodies without their list. It is possible to find certification body worked in the UkrSEPRO System for certification of almost any products. However it is sometimes difficult to realize on practice partially because of lack information for extensive use.

 

4. The UkrSEPRO System Standards
Works on the products and quality management system certification in the Ukrainian State Certification System UkrSEPRO are carried out in accordance with requirements of the UkrSEPRO System standards series. The list of main standards is given in UA-5
Products Certification Procedure in the UkrSEPRO System
In accordance with the approved model (scheme) the products certification procedure envisages:
6. Submission and Consideration of Application for Products Certification
To start certification procedure in Ukraine, the manufacturer or authorized body (any institution of the CERT-CENTER group can be one of it) submits an application for products certification into the Certification Body (CB).
Each CB has its own application form. But in general the application content is standardized and corresponds to the one given in UA-1.   In case you decide to avail yourself of our offer, you will have to hand in an Application RUА-1 for products certification, draw up a Letter of Attorney (a Letter of Attorney is sent after receiving an Application, however the example of it is given here RUА-2) and sign a contract with our agency in Europe or Ukraine.
The documents set for products and, if necessary, for quality management system is submitted together with the Application into the CB. Each CB determines the List of documents attached to the Application taking into account peculiarities of certified products. It should be noticed that in general the List is approximately complied with that one accepted in accordance with the European directives requirements. The approximate list (content) of submitted documents is given in UA-2. If you decide to carry out certification procedure through the CERT-CENTRE group, then we will send you the specified list appropriate to your products, selected certification model, and in accordance with the certain CB requirements.
The CB considers and analyses the submitted application and documentation. If necessary they apply for supplementary data. After that the CB makes a decision on the application (in accordance with the UkrSEPRO rules in not more than a month) and indicates the certification model (scheme) which is, as a rule, reconciled with the Applicant.
Let’s consider the certification models applied in the UkrSEPRO System.
7. Products Certification Models (schemes) in the UkrSEPRO System

There can be determined certification of the products lot (or a single product), and certification of batch production in the UkrSEPRO System.

When certification of a lot of products (or a single product) brought on the territory of Ukraine according to the concrete invoice, the certificate is given for the certain products indicated in the invoice. In this case the lot dimensions are indicated as well as factory numbers of certified products, invoices numbers, CUSTOMS CODE, names and addresses of the Applicant and the products manufacturer if those are available. The certificate period of validity is made up, as a rule, 6 months; maximum is up to a year.
In the UkrSEPRO System UA-6 it is possible to use different certification models (schemes) for certification of batch production.
The period of validity for the batch production certificate depends on the selected model (scheme):

Model (scheme) for certification of batch production
Period of validity for the certificate of conformity
Products certification according to the scheme with analysis of documentation submitted by an Applicant (without production area inspection
up to 1 year
Products certification according to the scheme with production area inspection
up to two years
Products certification according to the scheme with attestation of manufacture of products
up to three years
Products certification according to the scheme with certification (assessment) production quality management system
up to five years

Let’s consider products certification models (schemes or variants) for batch production applied in the UkrSEPRO System in more detail.

 

Products certification model (scheme) without production area inspection. Certificate of conformity is issued for one year term.
When batch production certification in the UkrSEPRO System it is possible to apply the scheme (model) so called “with analysis of documentation – without production area inspection”. However, the use of this model is limited nowadays. This scheme is applicable only once in respect of one individual applicant. Control when certificates registration in the Register of the UkrSEPRO System, when certification of every product according to this scheme, has been envisaged. The scheme “with analysis of documentation” is designed for production certification when launching it out on manufacture, or when studying and developing a market in Ukraine. The production area inspection (production area visit by the CB commission) is not carried out. At that an additional amount of technical documentation set is submitted to the CB.
If this scheme is used the term of product certificate is up to one year. It is issued on the basis of positive outcomes of analysis of documentation submitted by an Applicant and positive outcomes of certification tests of specimen sampled in Ukraine in the storehouse of the manufacturer’s official representative or at the manufacturer's factory.

The further technical supervision within the period of conformity certificate's effect includes periodic control tests of specimen sampled at manufacturers' or suppliers' in the order, terms and amounts approved by the CB in the technical supervision program. If this model is applied, the production control is not carried out. However we remind that this model is applicable only once.

 

Certification model (scheme) of batch production with production area inspection by the CB Commission

Under batch production certification the procedure is carried out with manufacture area inspection by the CB commission. The commission carries out inspection or attestation of the production, or certification (assessment) of the production quality management system.

Production certification model (scheme) with production area inspection. Certificate of conformity is issued for up to two years term.

Purpose: to define the compliance of factual state of manufacturing with document requirements, to confirm that factory capacities allow manufacturing of products in accordance with current normative documents in Ukraine.
Production area is inspected in accordance with the procedure approved in the Public Standard DSTU 3957-2000.
Inspection outcomes are documented in the form of an inspection act. Inspection of production area provides for quantitative stability rating of production and procedure of technical supervision of manufacture of certified products. Before production area inspection the manufacturer submits to the CB a Questionnaire “Preliminary inspection (review) of manufacturing of certification requested products”. This Questionnaire is prepared additionally to the general list of documents submitted to the CB.

 

Production area inspection procedure.

During production area inspection the expertise of normative, technical and processing documentation is carried out. The following has been performed: familiarization with structural scheme of the factory; scrutiny of compliance of product parameters and characteristics stipulated by technical documentation with requirements of effective in Ukraine normative documents; assessment of sufficiency of control operations and tests; assessment of system of input control; scrutiny of availability and efficiency of the system of metrological support.

As a rule, during the production area inspection the CB commission carrying out sampling and samples identification for certification testing. The CB determines the amount of samples and sampling procedure. In case of large dimension samples tests can be carried out at the manufacturer’s laboratory by personnel from testing laboratory accredited in Ukraine in accordance with established procedure.
Under positive outcomes of production area inspection the experts draw an act. The act along with positive reports of certification tests serves the basis for issuance of certificate up to two-year term.

The further technical supervision within the period of conformity certificate's effect includes production inspection and control tests of specimen sampled at manufacturers' or suppliers' in the order, terms and amounts approved by the CB in the technical supervision program.

Production certification model (scheme) with attestation of manufacture of certified products. Certificate of conformity is issued for up to three years term.

Purpose of the production attestation: assessment of the manufacturer's technical capacities to ensure stable output of the products with parameters in line with requirements of normative documents.
Production attestation is carried out by the CB in accordance with the procedure of such works stipulated in the Public Standard DSTU 3414-96.
Attestation outcomes are documented in the form of manufacture certificate given to the Applicant. Production attestation provides for a quantitative assessment of stability of product parameters. It also stipulates the order of technical supervision of manufacture of certified product, and attestation of available technology.
As a rule, during the production area inspection the CB commission carries out sampling and samples identification for certification testing. The CB determines the amount of samples and sampling procedure. In case of large dimension samples tests can be carried out at the manufacturer’s laboratory by personnel from testing laboratory accredited in Ukraine in accordance with established procedure.
Under positive outcomes of manufacture attestation the Applicant is issued a manufacture certificate. The certificate along with positive reports of certification tests serves the basis for issuance of product certificate up to three-year term.
The further technical supervision within the period of conformity certificate's effect includes production inspection and control tests of specimen sampled at manufacturers' or suppliers' in the order, terms and amounts approved by the CB in the technical supervision program.
Production attestation in the UkrSEPRO System for foreign manufacturers is not recommended and rarely carried out. In case if the quality management system (ISO 9001) is introduced at the factory, then it is much simpler to carry out certification in the UkrSEPRO System according to the scheme with certification of quality management system. This model is described below.

 

Production certification model (scheme) with certification (assessment) of production quality management system. Certificate of conformity is issued for up to five years term.

Purpose of certification (assessment) of quality management system: to conform that the quality system meets the Public Standard of Ukraine ISO 9001 (ISO 9001-2000) requirements and to ensure that the manufactured products are in line with normative documents; and all technical, administrative and human factors affecting quality are under control; non bona fide products are timely detected, and the factory takes continuous measures to prevent manufacture of such products. It is necessary to make sure that the factory takes actions on satisfaction of Applicants’ requirements, development and improvements.

Certification (assessment) of quality management systems is carried out by bodies accredited in the UkrSEPRO System authorizing Quality Management System Certification Body (QMSCB) to perform such works. The Public Standard DSTU 3419-96 stipulates the procedure of such works.

8. Procedure of Certification (Assessment) of Quality Management Systems
The Applicant submits an application for products certification into QMSCB according to the scheme with certification (assessment) of production quality management system (or two applications – for products and the system), and necessary documentation for production quality management system. The documentation is complied with item 8 of the List UA-2, which is approved by QMSCB on the basis of the Public Standard DSTU 3419-96. The factory-Applicant fills up questionnaireQMSCB., prepares all the necessary reference data form and submits them into
The QMSCB considers the application and submitted by the applying manufacturer documentation including questionnaire and reference data for preliminary assessment of quality management system and manufacture state.
The certification (assessment) of quality management system process is complied with established order and includes such stages:
As a rule, during the production area inspection the CB commission carries out sampling and samples identification for certification testing. The CB determines the amount of samples and sampling procedure. In case of large dimension samples tests can be carried out at the manufacturer’s laboratory by personnel from test laboratory accredited in Ukraine in accordance with established procedure.
Under positive outcomes of quality management system certification the report and certificate for quality management system are drawn. After positive reports of certification tests these documents serve the basis for issuance of product certificate up to five-year term.

The further technical supervision within the period of effect for production and quality management system includes inspection of quality management system and control tests of specimen according to program approved by the QMSCB. Samples for tests are collected at manufacturers' or suppliers' in the order, terms and amounts approved by the CB in the technical supervision program.

9. Certification Tests
In all the cases certifications testsof products samplesarecarried out by test laboratoriesaccredited in Ukraine in accordance with established procedure.
The CB collects product samples for testing, obtains, and specifies the package of technical documentation. The CB determines the number of test samples and sampling rules.
Sampling is carried out in front of the Applicant representative and registered officially by the act of sampling. The act of samples identification proved the samples conformity to products applied for certification is also drawn up. The delivery of selected samples into the test laboratory and back is carried out by the Applicant at its own expense. In case if products are of large dimension, or not transportable, or require mounting on-site, or require unique test equipment, etc. then certification tests can be carried out on manufacturer site using its test equipment and measurement instrumentation. Tests have to be conducted by specialists from accredited in Ukraine test laboratory.

Should the outcome is positive the test report are given to the CB whereas the copies are given to the Applicant. Should the outcome is negative even for a single factor the certification tests are terminated; both the CB and the Applicant are informed of the negative outcome. The CB annuls the application for certification. Repeated tests can be held only when the Applicant files a new application and presents persuasive evidences of undertaking of corrective measures to eliminate causes, which resulted in non-compliance.

10. Technical Supervision over Manufacture of Certified Products
(Main Requirements)

The Applicant is given the certificate of conformity when batch production certification for the period of validity in accordance with the selected certification scheme. The CB and the Applicant sign the licensing agreement for the right of the certificates use. Then the CB carries out technical supervision over manufacture of certified products.
Technical supervision over the certified products manufacture is carried out on terms determined by the CB while working on certification procedure. These terms are specified in the technical supervision program. As a rule, technical supervision is carried out once a year. Scheduling variances from these terms are possible upwards and downwards bias.
The following has been inspected while technical supervision over manufacture of certified products:

Usually routine tests of certified products are held during technical supervision if it is stipulated by the program. The outcomes of the last technical supervision may be taken into account when a new conformity certificate for a new period is issued.

11. Mutual Recognition of Certification Results

Ukraine has completed bilateral intergovernmental Agreements on mutual recognition of certification results. These Agreements are completed with those former USSR countries where Ukraine has common (harmonized) normative base. Those are: Russian Federation, Belarus, Uzbekistan, Armenia, Kirghizia, Georgia, Azerbaijan, Kazakhstan, Turkmenistan, Moldova, Tadjikistan. It has to be noticed that recognition of certificates of conformity issued by mentioned countries is carried out only for products manufactured in this country. I.e. the UkrSEPRO System does not stipulate the possibility of recognition for certificates issued, for example, in Russia for products manufactured, for example, in Europe.

12. Voluntary Products Certification
In the process of voluntary certification carried out in the UkrSEPRO System it has to be determined the conformity of the products parameters to normative documents requirements that indicated by the Applicant. As a rule, those are safety requirements given in normative documents in force in Ukraine. In all other respects procedures of voluntary certification correspond to procedures of obligatory certification in the UkrSEPRO System.
It has to be noticed here that before autumn 2004 there were more than 60 bodies on voluntary certification in Ukraine. Those bodies were not accredited. They were registered in the State Standard System of Ukraine, worked out of the UkerSEPRO System, and issued certificates of conformity on their own headed note-papers. The State Department on Consumer Standards of Ukraine annulled their registration in autumn, 2004.
Works on voluntary certification for products not included into the “Lists of Products Liable to Obligatory Certification in Ukraine” can be carried out by bodies accredited, assigned and authorized by the State Department on Consumer Standards of Ukraine according to rules and procedures of the UkrSEPRO System described above.
It has to be mentioned that works on voluntary certification significantly raise competitive capacity of certified products; allow manufacturer to participate in tender contests more efficiently, to penetrate into the Ukrainian market more actively.

 

 

The Licensing System in Ukraine
Licenses for Products Use (Application) in Ukraine from
the State Department on Supervision of Labor Protection
(New name: The State Department of Industrial safety,
Labor Protection and Mining Supervision)
When crossing the Ukrainian border it is necessary to have the certificate of conformity given in the UkrSEPRO System for products included into the “List of Products Liable to Obligatory Certification in Ukraine”.
It is necessary to have license for products use (application) for products that are within the jurisdiction of the State Department on Supervision of Labor Protection of Ukraine when putting them into operation. In accordance with article 21 of Labor Protection Law of Ukraine, the Procedure for licenses issue by the State Department on Supervision of Labor Protection and its territorial bodies was approved by the Decree of the Cabinet of Ministers of Ukraine of 15 October 2003 N 1631.
In accordance with this Procedure the following terms are being used:
Expertise meansactivity of expert bodies on assessment of expertise object conformity to requirements of laws and other normative-legal acts on labor protection and industrial safety.
Opinion/decision of a commission of experts – it is a document, which is composed by expert body after expertise results and contains the information about conformity (inconformity) of expertise object to requirements of laws and other normative-legal acts on labor protection and industrial safety.
Decision of a commission of experts is officially registered by an expert body according to form stipulated by the State Department on Supervision of Labor Protection of Ukraine.
The indicated Procedure determines the procedure for issue and annulment of Licenses for equipment exploitation from the State Department on Supervision of Labor Protection and its territorial bodies. At that the license for equipment of foreign manufacture is given by the State Department on Supervision of Labor Protection; for equipment of Ukrainian manufacture – by its territorial bodies.
This Procedure also determines the list UA-9 of products, objects, machines, mechanisms, equipment of enhanced risk, that have to get License for exploitation in Ukraine.
Issue and annulment of Licenses is carried out on the basis of decision of a commission of experts.
For the purpose of license receiving, the entity of economical activity or its authorized entity submits the Application for issue of license for exploitation UA-10 to the State Department on Supervision of Labor Protection in accordance with a set from.
Decision of a commission of experts about conformity of the object to requirements of laws and other normative-legal acts on labor protection and industrial safety and about potentiality of the entity of economical activity to provide legislation requirements compliance during its exploitation is attached to the Application for exploitation (taking into account certification results in the UkrSEPRO System). Exploitation documentation (copies of instructions on mounting and exploitation, passports, etc.) is also attached in Ukrainian, or, as exclusion, in Russian (in case if product is manufactured abroad).
There is a network of expert bodies received License for expert works in the structure of the State Department on Supervision of Labor Protection of Ukraine. There are around 30 expert centers in Ukraine. Around 6-8 of them are also accredited in the UkrSEPRO System as Certification Bodies. They are authorized to carry out technical expertise and products certification in accordance with their sphere of accreditation.
License for object exploitation is issued by the State Department on Supervision of Labor Protection of Ukraine initially for a three-year term. Under absence of reclamations the second license for object exploitation is issued for a five-year term.
The web-site of the State Department on Supervision of Labor Protection of Ukraine is http://www.dnop.kiev.ua/.
Attention: In accordance with the Decree of the President of Ukraineof 20.04.2005 N 681/2005 the State Department on Supervision of Labor Protection (SDSLP) was liquidated with its function and commitments transferred to the Ministry of emergencies and affairs of population protection from the consequences of Chernobyl catastrophe of Ukraine (Ministry of Emergencies).
In the system of Ministry of Emergencies, pursuant to the order of a Cabinet of ministers of Ukraine from 15.07.05 № 590, is organized The State Department of Industrial safety, Labor Protection and Mining Supervision with functions previously carried out by the SDSLP
The system for issue of licenses for products use (application) stays unaltered.
Sanitary-and-Epidemiologic Certificate of the Ministry of Health (MH)

(“hygienic certificate”)

In accordance with a decision of sanitary-and-epidemiological expertise of 27.12.2004 № 05.03.02-03/52400 there was accepted the List of objects for external economic activity complied with CUSTOMS CODE, and also objects subjected to the state sanitary-and-epidemiological expertise on the stage of their legal registration in Ukraine (medical equipment, articles of medical application, pesticides, agrochemicals, etc.). Products indicated in this List can be imported and used in Ukraine without sanitary-and-epidemiological expertise. The List is given in UA-11.
The products not included into the List have to be subjected to sanitary-and-epidemiological expertise. These products have to get a decision of sanitary-and-epidemiological expertise of MH. The decision is made on the basis of control concerning products samples conformity to requirements of sanitary regulations and norms. The control is carried out at authorized enterprises of the MH (territorial sanitary-and-epidemiological services) and drawn up in the form of protocols. To carry out control it is necessary to submit technical documentation referring to sanitary-and-epidemiological products factors in Ukrainian/Russian (paint’s peculiarities, factors of noise, vibration, illumination; parameters of water and other factors after their contact with products, etc.)
In case of sanitary-and-epidemiologic expertise for products of foreign manufacture, the Applicant or authorized entity submits the Application of fixed form UA-12 into the MH. The decision on authorized subdivision of the MH (territorial sanitary-and-epidemiologic service) in charge of the expertise is made up by the chief public sanitary inspector or his/her representative.
The further current sanitary-and-epidemiologic supervision for objects managing on the territory of Ukraine is carried out in accordance with effective sanitary regulations and norms.
In addition to the List of objects for external economic activity without sanitary-and-epidemiologic expertise the products indicated in UA-13can be imported into Ukraine.

 

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