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Certification of products and quality management systems Responsible for technical attestation, products and quality management system certification is Certification and attestation division on hazardous products and quality management systems Division manager – Vladimir Vladimirovich Papazov 1. General provisions of UkrSEPRO certification system Certification is a procedure wherewith a body recognized (authorized) in accordance with established procedure gives a written guaranty that products, quality management systems, occupational health and safety management systems, environmental management systems, personnel meet the requirements of Ukrainian effective normative documents. In Ukraine exists the State system of products certification named the UkrSEPRO System. The present system includes both legally regulated and not-regulated areas of certifications. Activities within UkrSEPRO System are organized by the State Department on Consumer Standards of Ukraine which is the National Certification Body (previously called Gosstandard of Ukraine). Internet-site of the State Department on Consumer Standards of Ukraine: http://www.dssu.gov.ua. 2. Legally regulated certification in Ukraine. UkrSEPRO Standards In process of legally regulated (obligatory) certification is defined whether product parameters are conform with requirements of normative documents appointed in Ukrainian legislative and/or with requirements of normative documents indicated in the "List of products liable to obligatory certification". Generally these are the safety requirements. At that for many products types a Sanitary-and-Epidemiologic Certificate of the MH and an expert’s opinion are required; on its basis the Gospromgornadzor issues a License for Products Use within Ukraine. We can offer our Customers an integrated solution to whole problems complex connecting with technical regulation. We can certify your products jointly with manufacture’s quality management system for the term up to 5 years; perform technical attestation (for obtaining the permit for products use within Ukraine); organize the works for obtaining a sanitary-and-epidemiologic certificate on products we have certified. Certificates and its copies are issued in UkrSEPRO System on official blanks provided with a hologram and other protection means. Certificates of products which are not included to the List of products liable to obligatory certification within Ukraine can be also issued on those blanks. Products and quality management systems certifications are carried out in the Ukrainian State Certification System in compliance with requirements of series of UkrSEPRO Standards. 3. List of products liable to obligatory certification within Products liable to legally regulated certification within Ukraine (in the UkrSEPRO System) are included into the official "List of products liable to obligatory certification within Ukraine" approved by Gospromgornadzor at 01.02.2005 by Order #28 and registered in the Ministry of Justice of Ukraine at 04.05.2005 under #466/10746. The complete List of products liable to obligatory certification within Ukraine you can find on http://www.dssu.gov.ua (chapters of the List in Russian can see HERE). In the complete List of products are given the customs codes and normative documents which must be confirmed by the certification. Foreign applicants could use it as a manual to define per customs code whether their products are included into the List. The products included into the List must be accompanied when crossing Ukrainian boundary with a conformity certificate issued in UkrSEPRO System. Without the conformity certificate the import of the products in Ukraine is not allowed. 4. Order of products certification in the UkrSEPRO Certification Certification procedure according to the accepted model (scheme) provides in generally:
The order for products certification with applying of the different certification models (schemes) we present you in the visual schematic form (rus, eng). 5. Submission and examination of the Application for products certification For starting certification works in Ukraine a manufacturer or his attorney empowered to submit a certification application on behalf of the manufacturer on the ground of signed Letter of attorney (rus, eng) files a certification application to the CB. The Application should be filed in the appropriate Application Form (ukr, rus, eng). We ask you earnestly to classify your products on categories, to indicate the models if any, and to give the customs codes. Is the list of products applied for certification is wide, so give it, please, as an Annex to the Application (a model annex form - ukr, rus, eng). The Certification Application is accompanied with products documentation and, if required, with quality management system documents. The List of documents to be attached to the Application (ukr, rus, eng) is specified with respect to the particular features of certified products. This list is compiled for all types of works under technical regulation: products certification taking into account all the certification schemes (models), quality management systems certification, technical attestation for obtaining license for products use, sanitary-end-epidemiologic certificate of MH. The document under this list should be prepared in full volume, if you want us to accomplish the complete works complex connected with technical regulation on industrial products. But for performance of certain kinds of works the complete set of documents is not required. On receipt of an Application for concrete products we can send you a documents list concreted in respect to the applied products and the chosen certification scheme. CB "PROMBEZPEKA" examines the filed Application and attached documents. Additional documents may be requested if needed. After that the CB makes a decision regarding the Application (under the UkrSEPRO rules the decision shall be made within a month) with indication of the certification model (scheme) which is usually agreed with the Applicant. 6. Models (schemes) of products certification in UkrSEPRO System The products certification in UkrSEPRO System is divided into certification of a single product or a batch and certification of serial production. Under certification of a single product or a batch coming in Ukraine on a concrete invoice a certificate is issued on the concrete applied products indicated in the invoice. In that case batch size, serial number of certificated products (if any present), invoice number, customs code, Applicant’s and manufacturer’s names and addresses shall be stipulated on the certificate. Validity period of the certificate is, as a rule, 6 months, maximum – up to 1 year. Under the certification of serial production different certification models (schemes) (rus, eng) may be used. Depending on chosen certification model (scheme) the term of the serial production certificate can be:
Here is given the schematic representation of the different models used by products certification. Here the products certification models are represented in form of the table described in DSTU 3413. Under certification of a single product or a batch the certificate is issued for concrete declared products. The certificate shall therefore stipulate the serial numbers of certified equipment. Under certification of serial production a CB "PROMBEZPEKA" visits the production area in question (inspection or production attestation, or certification (assessment) of manufacture’s quality management system). Certain kinds of products may however employ a certification model with analysis of documentation filed by applicant (including the production setup) and without visiting the production area. If that's the case additional documentation shall be provided by applicant profiling the production quality management system (the list is made up for every concrete product individually). All the certification models for serial production are considered on our Site. Certification of serial production without production inspection (based on analysis of documentation filed by applicant) 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 documentation filed by applicant and positive outcomes of certification tests of samples taken at manufacturer’s factory or by supplier. This scheme is applicable only for enterprises (firms) having a certified quality management system (ISO 9001). The enterprises should thereat submit additional quality management system documentation (procedures, instructions on organization of input control of materials, raw materials and components, output control of finished products, as well as protocols of finished products tests), whose volumes and requirements should be in line with effective norms in Ukraine. This certification scheme is applicable only once in respect of one individual applicant. The further technical supervision within the period of conformity certificate's effect includes periodic control tests of samples taken at manufacturers' or suppliers' in the order, terms and amounts stipulated by the technical supervision program (if applicable). This scheme does not apply to short-listed products. For example, the scheme does not cover commercial explosives. Certification of serial production with inspection of manufacturing conditions Inspection 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 requirements of Ukrainian normative documents being in force. Production area is inspected under products certification as per initiative of applicant or Certification Body (CB) decision. The procedure of such works is stipulated in the Public Standard DSTU 3957:2000. Before the manufacturing inspection the Applicant shall file to the CB "PROMBEZPEKA" a completed questionnaire for preliminary inspection (review) of manufacturing of certification requested products (rus, eng) as well as documentation set according to the List. Inspection outcomes are documented in form of an inspection act. Inspection of production area provides for quantitative stability rating of production and defining a procedure for technical supervision over the manufacture of certified products. More detailed… Production area inspection procedure During inspection the experts examine normative, technical and processing documentation providing for:
Under positive outcomes of production area inspection the experts draw an act. The act along with positive protocols of certification tests serves the basis for issuance of certificate up to two-year term. Certification of serial production per attestation of manufacturing Purpose of the production attestation: evaluation 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 products certification body on the initiative of applicant or certification body decision. The procedure of such works is specified in 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 evaluation of stability of product parameters. It also stipulates the order of technical supervision of manufacturing certified products. More detailed… General requirements towards production documentation under attestation:
Under positive outcomes of manufacture attestation the applicant is issued a manufacture certificate. The certificate along with positive protocols of certification tests serves the basis for issuance of product certificate up to three-year term. The attestation of products manufacturing in the UkrSEPRO System, as a rule, is not recommended for foreign manufacturers (firms) and is carried out very seldom. The reason is that for production attestation the enterprise shall have an approved and implemented documentation set for quality assurance. The requirements to documents and instruction content for attestation of technical capacities of an enterprise are specified in DSTU 3414-96. The documentation set shall include an instruction on attestation of technical capacities of an enterprise for each type of product manufacturing. These requirements are complicated enough and differ from the requirement stipulated for quality management systems (ISO 9001), though they are also designated for assurance of products quality. For the foreign manufacturers it’s difficult sometimes to develop such documentation set. And in the case the enterprise has implemented quality management system under ISO 9001 it’s much easier obtain certification in the UkrSEPRO System under the scheme of quality management system certification. This model (scheme) is described below. Certification of serial production per certification (assessment) of production quality management Under positive outcomes of the certification (assessment) of production quality management system along with positive protocols of certification tests serve the basis for issuance of product certificate up to five-year term. Purpose of certification (assessment) of quality management system: to conform that the quality management system meets the requirements of Public Standard of Ukraine DSTU ISO 9001-2001 (ISO 9001 : 2000, IDT), 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, to improve the products quality and satisfaction of customers. Certification (assessment) of quality management system ensures that manufacturer is able to maintain stable products quality in conformity with requirements stipulated in normative documents. Certification (assessment) of quality management systems is carried out by bodies accredited in the UkrSEPRO System authorizing Quality Management System Certification Body (QSCB) to perform such works. The Public Standard DSTU 3419-96 stipulates the procedure of such works. CB "PROMBEZPEKA" is authorized (ÐÂ4) as a Quality Management System Certification Body (QMS CB) in the UkrSEPRO System and carries out certification (assessment) of quality management systems. At the same time the CB "PROMBEZPEKA" is Products Certification Body and thus can accomplish end-to-end certification of products within the scopes (ÐÂ2, ÐÂ3) of its authorization and certification of quality management system of manufacturer of those products. Certification works start upon filing a Certification Application. Under product certification scheme providing for quality management system certification (assessment) the submission of an Application for products certification (ukr, rus, eng) will be enough. Herewith by approbation of the applicant the certification scheme with quality management system assessment is applied. If the only certification of quality management system is intended you should file an Application for quality management system certification (rus, eng, ukr). The documents to be attached to the Application for products certification providing for quality management system certification in general case are given in the list (rus, eng, ukr), that may be concretized corresponding to declared products. Together with application the Applicant should submit a completed questionnaire (rus, eng) with reference data for preliminary assessment of manufacturer’s quality system, inspection and evaluation of production conditions. The applying manufacturer prepares also all the documents due both for products certification and quality management system certification and files to the QMS CB. The certification (assessment) of quality system process includes such stages:
Under positive outcomes of the quality management system certification the applicant is issued a certificate on quality management system. Under the positive outcomes of the quality management system evaluation the applicant is issued an inspection report. A copy of the certificate (report) is transmitted to the products certification body and under positive results of certification tests it serves the basis for issuance of a product certificate for up to five-year period. CB "PROMBEZPEKA" also grants services on building production quality management system. Thereat, the quality management system certification is to be carried out by the other QMS CB. 7. Certification tests Certification tests are carried out under all certification schemes (models). The Product Certification Body (CB) takes samples (probes) and receives technical documentation on sampled products. The content of the documentation set is defined by CB. The CB stipulates also the number of test samples and sampling rules. Certification tests are carried out by a test laboratory (centre) accredited for the test types which are stipulated in the product related normative documents or for testing the product in question. According to the Public Standard DSTU 3411:2004 test laboratories cooperating with the CB on contract basis are reported to the UkrSEPRO Register at authorizing the body for work in the UkrSEPRO System. CB "PROMBEZPEKA" is authorized for a wide scope of activities therefore we cooperate with more than sixty test laboratories. Testing of imported products is conducted by test laboratories accredited in UkrSEPRO System. For testing bulky or not transportable product samples or test products demanding the fitting on the operating site, or if applying of particular test equipment is needed it is admitted to conduct the certification tests on the manufacturing factory’s sites using its test equipment and measuring means which conform to defined requirements. But the tests must be carried out by experts of test laboratory. Should the outcome be positive so the test protocols are given to the CB and the copies to the applicant. Should the outcome be negative as per at least one of factors the certification tests are terminated, both the CB and applicant are advised of the negative outcome and the CB annuls the application. 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. The applicant reserves the ownership of tested samples including samples after destructive test methods. The CB's documents regulate the order of write-off, utilization and return of samples as well as storage of reference specimen. 8. Technical supervision of manufacture of certified products Purpose of technical supervision: to control the off-take of certified products and functioning of certified quality management system during the certification lasts. During the technical supervision the routine tests of certified products are conducted. The frequency, volume and order of check tests, the frequency of evaluation of production conditions, as well as efficiency of quality management system are determined by the CP for each concrete case individually. The routine tests are conducted under a technical supervision program. The program is developed by the CB, approved by the CB head and agreed with the applicant. Then the technical supervision over the off-take of certified product (quality management system) is carried out in the terms determined in the technical supervision program, as a rule – once a year. The outcomes of the last technical supervision (including results of the routine tests) may be taken into consideration when issuing the certificate for a new period. In principle, the procedure of technical supervision as to content of works is similar to the procedures of production inspection or production attestation or examination of production quality management system (depending on the applied product certification scheme). The technical supervision is carried out in the same way but usually with reduced volume and with obligatory routine tests of certified products. 1. Documentation: 9. License agreement on manufacturing certified products License is granted to a manufacturer of batch products to use of conformity certificates registered in the UkrSEPRO Register and to marking the certified products with mark of conformity along the period the certificate and license agreement are in force. In the license agreement (Russ ÐÂ36, Engl. ÐÂ35) a license-holder commits himself to fulfill all the certification requirements and assure the continued conformity of products with the parameters once proven during certification. He also obliges himself to inform the certification body about all changes made in construction of certified product or in manufacturing methods. 10. Products certification in legally not regulated area (facultative certification) During the facultative certification in the UkrSEPRO System the conformity of product parameters with provisions of normative documents indicated by applicant is assessed. Generally, that should be safety requirements specified in the normative documents effective in Ukraine. As for the rest, procedures of facultative and obligatory certifications in the UkrSEPRO System are identical. Thus certification of products which are not included to the "List of products liable to obligatory certification in Ukraine" can be carried out under rules and conditions of the UkrSEPRO System that are described above. It must be said that facultative certification significant raises competitive ability of certified product and let the manufacturer be more successful in tenders and more active advance in the Ukrainian market. 11. Mutual recognition of certification outcomes Ukraine has signed bilateral Intergovernmental Agreements about Mutual Recognition of certification results with countries – the former Soviet republics – which have with Ukraine a common (harmonized) normative basis. These are: Russia, Byelorussia, Uzbekistan, Armenia, Kirghizia, Georgia, Azerbaijan, Kazakhstan, Turkmenistan, Moldova, Tajikistan. We must underscore, that recognition of conformity certificates and test reports issued by these countries is applicable only for products manufactured in these countries. In other words the UkrSEPRO System does not provide for recognition of conformity certificates or test reports issued for example in Russia on goods manufactured, for example, in Europe. It should be noted that conformity certificates may be recognized in common case only for batch of products entering the customs territory of Ukraine; thereat a Certificate of Recognition is drawn. The test reports may be recognized; in that case recognizing available test reports the product conformity certificates may be issued after inspection of manufacturing conditions or certification (assessment) of quality management system respectively for 2- or 5-year without conducting certification tests. In all cases the recognition is possible at coincidence of normative documents. That is to say if in Ukraine the same standards are in force as were applied on certification in manufacturer’s country. The below listed documents must be submitted to the CB "PROMBEZPEKA" for recognition of products certification results:
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