CONFORMITY ASSESSMENT of PRODUCTION And SERVICES
(CERTIFICATION, DECLARING of CONFORMITY).

Conformity assessment of production and services is a component of the mechanism for the estimation of their safety. Unlike other ways of estimation, conformity assessment is obtained before the product or the service appears on the market. It can be carried out both by Manufacturers, (Declaring of conformity), and independent bodies (Certification). Both forms of assessment are obtained in the Russian Federation.

To confirm the conformity of certain production (service) it is necessary to have list of the requirements, established in the normative document, and also to have the opportunity to give the proofs of its safety.

During the process of conformity assessment the person, responsible for the gathering of the proofs, is the manufacturer (executor), if necessary it can use for this purpose the third party (for example, a certification agency for systems of quality or a test laboratory). If the documentary certificate on conformity is issued by the third party, it is its task to gather the proofs. The basic distinctions of two forms of assessment are in tab. 1.

Table 1

In the Russian Federation compulsion of obtaining the conformity assessment of production is established by legislation acts. Historically the first form of conformity assessment applied in Russia became certification.

CERTIFICATION.
The beginning of practical activities on mandatory certification was the Federal law of the Russian Federation from 07.02.1992 ¹ 2300 "About protection of the rights of consumers ".

In conditions of market economy, reduction of the degree of the state control and supervision, Certification has become an effective way of protection of consumers from dangerous products and services. Legal bases of certification of production, services and other objects, as well as the rights, the duties and the responsibility of participants of certification were established by the Federal law " About the certification of production and services " in 1993.
According to the Russian legislation, it is impossible to sell the majority of goods to the consumers without the document confirming their conformity to safety requirements. Thus, obtaining the certification for some kinds of goods is an obligatory condition of their access on the market. Therefore the knowledge of basics of the Russian Certification mechanisms is necessary for a successful business of manufacturers and suppliers of production.

The basic questions of manufacturers which are to be solved (when exporting to Russia):
- whether the manufacturing products (or products delivered by a distributing company) are a subject to mandatory certification of conformity (obligatory certification);
- which obligatory requirements the production must comply with;
- what certificating bodies can obtain an estimation and issue the certificate of conformity;
- what are the rules and procedures of affirmation of conformity;
- is there a necessity of having documents of the Russian federal executive authorities (Rospotrebnadzor, Roszdravnadzor, Rosstroy, Rostehnadzor, Rossvyaznadzor etc.) which control and supervise this types of production, for the conformity assessment;
- what are the rights and duties of the manufacturer (supplier) of certificated production.

Conformity to safety requirements should be necessarily confirmed in the cases, stipulated by legislative documents of the Russian Federation. The majority of them provide obligatory certification of objects on which their action extends.
The opportunity of use of the second form of confirmation (declaration) of conformity by the manufacturer (supplier) is stipulated only by two laws: the Federal law from February, 02 2000 ¹29 "About quality and safety of foodstuff" (amendment: December 30, 2001; January 10, 2003; June, 30 2003; August 22, 2004; May 09. 2005; December 31, 2005; March 31, 2006) and the Federal law " About protection of the rights of consumers ".

For definition and restriction of list of objects subject to mandatory conformity confirmation (or, within the limits of corresponding laws, the objects for mandatory certification) exist sub-law acts of the Government of the Russian Federation and also legislative acts of federal executive authorities - lists and nomenclatures. The order of their composition, the affirmation and coming into force is in most cases established legislatively.
The Lists currently in force were approved by the Governmental resolution of the Russian Federation from July 08 1997, 1013 (in edition: the Governmental Resolution of the Russian Federation from April 29, 2002, 287 and Governmental Resolution of the Russian Federation from February 10, 2004, 72).
Governmental Resolution of the Russian Federation-287 from April 29, 04 2002 pdf
Governmental Resolution of the Russian Federation-72 from February 10, 2004 pdf

On the basis of these lists, for their concrete definition Rostekhregulirovanie of Russia (the Federal agency on technical regulation and metrology of the Russian Federation) - earlier Gosstandart of Russia) has created "the Nomenclature of production and services (works) concerning which acts of the Russian Federation stipulate their obligatory certification " (further the Nomenclature) and approved it by the Governmental resoluton. (the Decision of Gosstandart of the Russian Federation from July 30, 2002 64, with amendments on June 05, 2003 and on May 25, 2006).

Resolution of Gosstandart of Russia from July 30, 2002, ¹64 pdf

The nomenclature includes the following information: the name of production; its code in the All-Russian qualifier of production ÎÊ 005-93; requirements confirmed during mandatory certification; the normative document (state standard, SanPiN, etc.) which contains confirmed requirements.
The nomenclature can be used as the working tool for the manufacturer and the supplier not only to decide, whether the mandatory certification is necessary for their goods, but also it is useful to find out with what concrete safety requirements this production must correspond.
On the basis of current Nomenclature Rostekhregulirovanie of Russia together with Federal customs service of Russia has generated and has approved the List of the goods for which acknowledgement of obtaining the obligatory certification is required at release on customs territory of the Russian Federation, directed by the Letter of FTS RF, dated January 12, 2005, 01-06/107 in customs bodies.

Letter of FTS RF, dated January 12, 2005, 01-06/107 pdf

The List contains: the name of the goods; a code of the goods according to the Commodity nomenclature of foreign trade activities (TN VED) of Russia (come into force on January 01, 2007 according to the governmental resolution of the Russian Federation, November 28, 2006, 718).
Governmental resolution of the Russian Federation, November 28, 2006, 718 pdf

The Nomenclature of products and services, which are (according to the legislative acts of the Russian Federation) subjects to mandatory certification is used for finding out, if mandatory certification is needed, when the goods, manufactured in Russia, are concerned.
In the case of goods, imported in Russia and which have the TNVED code, 1. the List of goods which need the confirmation of obtaining the obligatory conformity assessment and 2. the Nomenclature of products and services, which are (according to the legislative acts of the Russian Federation) subjects to mandatory certification are used to make decision, concerning the mandatory certification
To find out, whether obtaining of Declaration of conformity is obligatory, the Nomenclature of goods, whose conformity can be conformed by the declaration of conformity, is used.
The goods, whose conformity can be affirmed by the Declaration of conformity, are excluded from the List of goods, for which acknowledgement of obtaining the obligatory certification is required at release on customs territory of the Russian Federation.
For the goods, exported in Russia "The order of import on territory of the Russian Federation of the goods which are subjects to obligatory certification" was worked out and came into force as the resolution of the State Customs Committee of the Russian Federation ¹ 217 on May 23, 1994.
The resolution of the State Customs Committee of the Russian Federation (GTK RF) ¹ 217, May 23, 1994 pdf

According to The order of import on territory of the Russian Federation of the goods which are subjects to obligatory certification and the List of goods, for which acknowledgement of obtaining the obligatory certification is required at release on customs territory of the Russian Federation, - the following production can be let out on the territory of the Russian Federation without the obtained certificates of conformity:
1. The goods, which have been already used;
2. Production imported as spare parts for earlier imported on customs territory of the Russian Federation of certificated finished goods, under condition of representation of the copies of certificates of conformity on earlier imported above-stated goods and the confirmation that the given spare parts are used at manufacturing of the finished goods and are pointed out in the technical documentation of the product, and also there must be the obligations about use of spare parts only for a complete set of the specified finished goods or for their maintenance service and repair;
3. The goods, imported in Russia as the samples for testing with the purpose of obtaining the certification;
4. Production imported by physical persons and has been not intended for industrial or other commercial activity (except for the cases of import over the established cost and quantitative quotas);
5. Production intended for official using of representations of the foreign states and the international intergovernmental organizations, and also for their personnel.

Under the decision of customs bodies of the Russian Federation, the goods imported in individual quantities and intended for consumption exclusively by the importing persons, can be allowed on the state territory without the certificate of conformity.
The obligatory requirements, which provide safety of production for the consumer, and which are confirmed by obtaining the mandatory certification, can be contained in normative documents of the corresponding status, as a rule, this status is described in the legislative the act.
Under the Federal law "About protection of the rights of consumers" such normative documents are: Laws; Standards (documents, approved in the order established by the law).

For example, normative documents, accepted in the order established by the legislation, are sanitary rules and norms which are composed and affirmed be the department of Rospotrebnadzor of the Ministry of Health and Social Development of the Russian Federation. They contain the information about the minimal admissible values of various toxic substances (these figures are the result of a hygienic estimation and forecasting).
The right of sanitary-and-hygienic normalization is given to this department by the Federal law (March 30, 1999) ¹52 "About sanitary-and-epidemiologic well-being of the population" (with amendments on December 30, 2001; January 10, 2003; June 30, 2003; August 22, 2004; May 09, 2005, December 31, 2005)
FL-52, March 30, 1999. pdf

Standards for mandatory certification:
- International Standards (GOST);
- State Standards of the Russian Federation (GOST R);
- Some republic standards of the RSFSR, which are still valid.

Production which is a subject to obligatory certification, can be issued not only under the state standard; much more often the other documents are used for manufacturing: technical specifications (TU), standards of firms or enterprises, technological regalements, etc. Nevertheless, safety requirements established in the Russian Federation (which can be contained in the state standards, SanPiNs, SniP, etc.) are obligatory.
To define, what safety requirements the manufacturing or distributing goods must meet with (and also, in what documents are these requirements named), it is necessary to use corresponding columns of the Nomenclature of production and services (works) subject to mandatory certification (according to the Russian legislation).
In the Russian Federation certification process is obtained in systems of certification. The system of certification is a set of participants of the certification, operating by rules established in this system. There are two systems of certification:
- obligatory;
- voluntary.
The Systems of Certification are to comply with the following requirements:
1. To have the area of the distribution defined in its documents by the objects of certification and used for affirmation of conformity by certain normative documents.
2. To have organizational structure and rules of cooperation between the participants of certification process; to have uniform rules and procedures of certification assessment; to have the certificate (or certificates) of conformity and a mark (marks) of conformity, which has differences from other systems of certification; to have the register of the certificated objects and participants of system
Considering, that mandatory certification is necessary for exporters to get into the Russian market, it is worth being described in details.
Now there are 18 systems of obligatory certification in the Russian Federation, main ones are listed below.
The goods and services that you can find in Russia are certified according to the System of Certification GOST R, which was created by the Gosstandart of Russia for obtaining mandatory certification, described in legislative acts like The Federal Law "About the protection of rights of consumers", Federal Law (July 07, 1999). ¹181 "About the basics of labour safety in the Russian Federation " (in edition: Federal laws of May 20,.2002 ¹53; January 10, 2003 ¹15 and May 09, 2005 ¹45), the Federal law of the Russian Federation (22.06.1998) ¹86 "About veterinary science", the Federal law (13.12.1996) ¹150 "About weapons", etc.
FL-181 (17.07.1999) pdf

FL-86 (22.06.1998) pdf

The Gost R system of certification has its own certificates if conformity and marks of conformity.

According to GOST R system, the following goods are subjects to mandatory certification:
- The goods for personal (household) needs of citizens;
- an industrial-and-technological production;
- goods for building.

Normative base of mandatory certification of products and services (works) in System of certification of GOST-R is compounded of the state standards, sanitary rules and norms, building norms and rules.

Main principles of activity of System of certification of GOST Ð:
- openness (GOST-R system of certification is opened for participation in it of other federal executive authorities, and other organizations which admit and follow its rules);
- unity of rules and procedures (domestic and imported production in GOST-R will be certificated by uniform rules);

Rules of activity in System of GOST Ð are described in "Regulations of the System of certification GOST R" (in edition: Decisions of Gosstandart of the Russian Federation 17.03.1998 ¹11 and 22.04.2002 ¹30)
Regulations of the System of certification of GOST-Ð pdf
The high level of objectivity and reliability of results of GOST R certification is reached first of all by accreditation of participants of the system (bodies of certification and test laboratories).
The basic criteria and rules of accreditation are harmonized with the international requirements and are formulated in the General rules of carrying out of accreditation in the Russian Federation (this document is registered in the Ministry of Justice of the Russian Federation on February 07, 2000 ¹2094)

General rules of carrying out of accreditation in the Russian Federation pdf

Main principles of accreditation certification agencies and test laboratories: the equal approach to the foreign and national organizations; the admission to accreditation of any legal persons; the process of accreditation, as a rule, is obtained by the state bodies either the authorized or noncommercial organizations; the results of accreditation are published.
Certification of production in the Russian Federation is carried out by certification bodies (certification agencies). To obtain the mandatory certification, the manufacturer (seller) has the right to turn to any certification body, accredited for the certification of concrete production. The information about existing certification bodies can be found on the official site of the Federal agency on technical regulation and metrology (Rostekhregulirovanie) of Russia - www.gost.ru

Algorithm of work of certification agency GOST R
(during the process of certification)
1. To consider the application with the complete set of the documents, presented by the applicant, and to make the decision, concerning this application (not later than 15 days from the moment of receiving the documents);
2. To make selection, identification of product samples, to send the samples for tests to the testing laboratory;
3. To make an estimation of the manufacture (if it is stipulated by the applicant and coordinated with the certification body by the chosen scheme of certification);
4. To analyze the received results and to make a decision upon issuing (or refusal in issuing) of the certificate of conformity;
5. If it is stipulated by the scheme of certification, to carry out the inspection control (of certificated production); and thus to coordinate correcting actions with the holder of the certificate, if necessary;
6. To give the information about the results of certification in Rostekhregulirovanie of the Russian Federation.

Rules and procedures of certification are in the all-Russian rules of certification, documents of the GOST R system of certification and the rules of certification of homogeneous production, which were made according to them. The order of obtaining the mandatory certificates for the products in the Russian Federation is described in the resolution "About the Order of carrying out of certification of production in the Russian Federation" (in edition: Resolutions of Gosstandart of the Russian Federation ¹ 15, July 25, 1996; ¹60 July 11, 2002)

Order of carrying out of certification of production in the Russian Federation pdf

These documents give the precise information about the sequence of work of the participants of certification process, the scheme of certification and the recommendations on their application. The applicant makes an application under the set form in the accredited certification body, which area of accreditation includes production specified in the application, and chooses the scheme of certification.
The scheme of certification is a set of actions, which results are considered as a proof of conformity of production (services, works) to the actual requirements and regulations. The maximal operating set of schemes of certification for production is named in the Amendment 1 to the Order of carrying out of certification of production in the Russian Federation (Table 2).

Table 2
The content of the certification schemes

Comment:
1. The Testing of the Type - the testing of one ore several samples, which are the most typical examples of the manufacturing products.
2. The inspection control, which is mentioned in the table is carried out after the certificate of conformity is issued.
3. In the scheme 5 and 6 Necessity and quantity of tests during the inspection control, as well as the place of sampling are defined by a certification body, basing on the results of the inspection control over system of quality (manufacture).
Schemes 1-6, 9a, 10,10a, are applied to certification of serially manufacturing out production;
Schemes 7,9 are used for certification of a consignment of production;
Scheme 8 - for certification of each product.
Schemes of certification for the concrete production which are chosen by the applicant, are specified in rules and orders of certification of homogeneous production.

For obtaining mandatory certificates of conformity for many kinds of products it is necessary to have the documents of the federal organizations of the executive authorities, such as:

Sanitary-and-Epidemiologic Conclusion of the department or the centers of Rospotrebnadzor of the Ministry of Health and Social Development of the Russian Federation (The Hygienic Certificate)

Registration Certificate (Roszdravnadzor) of the Ministry of Health and Social Development:
a) medical equipment
b) products of medical purpose
c) medicines and pharmaceutical substances
d) new technologies

Certificate of (Rospotrebnadzor) the Ministry of Health and Social Development

Sanction of Rostechnadzor (Technic Control) of the Russian Federation

Pattern Approval Certificate For Measuring Instruments of Rostekhregulirovanie of the Russian Federation

Certificate of Rossvyaznadzor the Ministry of Communications of the Russian Federation (the Certificate of the Communication Facility)

Explosion Safety Certificate

Veterinary Certificate of Rosselhoznadzor of the RF

EMERCOM Certificate of Fire Safety

CERTIFICATE of GOSSTROY (State Construction) of the Russian Federation, and so on

The list of necessary documents is in the rules and orders of the obtaining of certification of homogeneous production. The certification body informs the applicant, what the documents are necessary for certification of production applied by it.
As a rule, the certification body considers the application and makes a decision upon issuing (or refusal in issuing) of the certificate within 3-7 days. In case of the positive decision the certification body starts the process due to the chosen scheme of certification: selects samples of production, sends them to the accredited test laboratory, etc.
If the certification body disagrees with the scheme offered by the applicant, it is obliged to prove the impossibility of obtaining certificates under this scheme.
If the certification process is finished with positive result, the applicant (the manufacturer, the supplier) receives the certificate of conformity, which gives the right to mark production with the mark of conformity.
If it is stipulated by the scheme of certification, the certification agency carries out the inspection control over production (certificated).
In case of negative results of certification the applicant is refused in issuing the certificate of conformity. In this case the products, which have not obtained certificates, cannot be distributed in the Russian market.

Manufacturers (distributors), who take part in the process of mandatory certification of their production, or obtaining the declaration of conformity, are obliged to:

- send the application for carrying out of certification, represent the production (according to rules of system), the normative, technical and other documentation necessary for carrying out of certification;
- accept the declaration of conformity on the basis of the documents confirming the conformity of production to established requirements and register it in certification agency;
- provide conformity of sold production (rendered service) to requirements of normative documents (on the basis of conformity to these documents the production was certified, or confirmed by the declaration on conformity);
- mark certificated production and production which conformity is confirmed by the declaration, registered due to the certain order, with the mark of conformity in the way, established by the rules of system of certification;
- specify in the accompanying engineering specifications the data about the certificate or the declaration of conformity and normative documents to which the production must correspond with, and provide the consumer (the buyer, the customer) with this information;
- apply the certificate, the declaration on conformity and mark of conformity, in accordance with legislative acts of the Russian Federation and rules of system;
- provide unobstructed fulfillment of the duties of the staff of certification bodies and the officials who carry out the control over certificated production (service, work) and production which conformity is confirmed by the declaration of conformity;
- suspend or fully stop selling production (rendering a service) subject to obligatory certification 1. if it does not meet the requirements of normative documents, it is to conform with, according to the certificate of conformity or the declaration of conformity, 2. after validity of the certificate or the declaration on conformity, or working life of production, term of its service is over, 3. and also in case of a suspension or a cancelling of action of the certificate by the decision of certification body;
- inform in three-day term the certification body, which has registered the certificate about the cancellation of the declaration of conformity, if federal executive authorities reveal a discrepancy of production to the established requirements; inform certification agency about the changes made in the engineering specifications and in technological process of manufacture of certificated production if these changes influence the characteristics checked at certification process.

DECLARATION Of CONFORMITY
The declaration on conformity is accepted by the manufacturer (supplier) only concerning the production, included in the corresponding List approved by the Government of the Russian Federation (the List of production which conformity can be confirmed by the declaration of conformity (in edition: The governmental orders of the Russian Federation ¹ 403, 24.05.2000, ¹287, 29.04.2002, ¹302, 08.05.2002, ¹72 10.02.2004)

List of production which conformity can be confirmed by the declaration of conformity pdf

on the basis of both own proofs of conformity and the proofs received with participation of the third party (test reports of the accredited test laboratories, certificates of system of quality, etc.).
The declaration of conformity has validity, considerable to the certificate of conformity.
The declaration on conformity is registered in a certification agency; term of its action is established by the declaring company (manufacturer, distributor, etc).
The legal person registered in the Russian Federation has the right to make the declaration of conformity.
The order of making and registration of the declaration on conformity is approved by the Government of the Russian Federation.
According to the current legislation, the order of payment of works in system of mandatory certification is established by federal executive authorities which are charged with organization and carrying out of mandatory certification of production as agreed with the Ministry of Finance of the Russian Federation.

The basic costs of the applicant connected with work on mandatory certification, consist of the following basic elements:
- payment for works of certification agency;
- payment for tests; payment (if necessary) for estimations of system of quality;
- estimations of manufacture, the analysis of manufacture;
- payment for the inspection control.
The amount of payments for the works connected eith the process of obtaining the mandatory certificates and declarations of conformity is defined on the basis of calculations and depends on the chosen scheme of certification, complexity of production and the applied test method.